Chemomab Therapeutics Ltd (CMMB) 2023 Q1 法說會逐字稿

Greetings, and welcome to Chemomab Therapeutics first-quarter 2023 earnings call and corporate update. (Operators Instructions) As a reminder, this conference is being recorded.

您好，歡迎參加 Chemomab Therapeutics 2023 年第一季度財報電話會議和公司最新動態。 （操作員說明）謹此提醒，本次會議正在錄製中。

It is now my pleasure to introduce your host, Barbara Lindheim, Consulting Vice President of Strategic Communications. Thank you. You may begin.

現在我很高興向您介紹主持人，戰略傳播諮詢副總裁芭芭拉·林德海姆 (Barbara Lindheim)。謝謝。你可以開始了。

Welcome to the Chemomab Therapeutics 2023 first-quarter conference call. Thank you for attending. I am Barbara Lindheim, Consulting Vice President of Strategic Communications at Chemomab. With me today are Dale Pfost, our Chairman and CEO; Don Marvin, CFO, Chief Operating Officer, and Executive Vice President; Dr. Adi Mor, our Co-Founder and Chief Scientific Officer; and Dr. Matt Frankel, our Chief Medical Officer.

歡迎參加 Chemomab Therapeutics 2023 年第一季度電話會議。感謝您的出席。我是 Barbara Lindheim，Chemomab 戰略傳播諮詢副總裁。今天與我在一起的有我們的董事長兼首席執行官戴爾·普福斯特 (Dale Pfost)； Don Marvin，首席財務官、首席運營官兼執行副總裁；我們的聯合創始人兼首席科學官 Adi Mor 博士；以及我們的首席醫療官馬特·弗蘭克爾 (Matt Frankel) 博士。

Before turning the call over to Dale, please take note of our forward-looking statements. Today's call may contain forward-looking statements, which may be identified by words such as may, could, will, expect, intend, plan, and other similar words and expressions. All forward-looking statements made today are based on management's current expectations, assumptions, and beliefs about our business and the environment in which we operate. These statements are subject to risks and uncertainties that could cause our actual results to materially differ from those expressed or implied on today's call. Listeners should not place undue reliance on forward-looking statements and are encouraged to review our earnings press release that we issued this morning, together with our SEC filings for a more complete discussion of factors that could cause our actual results to differ materially from those expressed or implied in forward-looking statements.

在將電話轉給戴爾之前，請注意我們的前瞻性聲明。今天的電話會議可能包含前瞻性陳述，這些陳述可以通過“可能”、“能夠”、“將”、“期望”、“打算”、“計劃”等詞語以及其他類似的詞語和表達來識別。今天做出的所有前瞻性陳述均基於管理層當前對我們的業務和運營環境的預期、假設和信念。這些陳述存在風險和不確定性，可能導致我們的實際結果與今天電話會議中明示或暗示的結果存在重大差異。聽眾不應過分依賴前瞻性陳述，並鼓勵聽眾查看我們今天早上發布的收益新聞稿以及我們向 SEC 提交的文件，以更全面地討論可能導致我們的實際結果與所表達的結果存在重大差異的因素或在前瞻性陳述中暗示。

You can read a copy [which have] a list of those factors under the heading Risk Factors contained in our annual report on Form 10 K together with factors under similar headings in the other reports and materials we filed with the SEC. Except as required by federal security laws, Chemomab does not undertake to publicly update or revise any forward-looking statements subsequent to the date made as a result of new information, future events, changing circumstances or for any other reason. Let me now turn the call over to Dale.

您可以閱讀一份副本，其中列出了我們 10 K 表格年度報告中包含的風險因素標題下的這些因素，以及我們向 SEC 提交的其他報告和材料中類似標題下的因素。除聯邦安全法要求外，Chemomab 不承諾在發布日期之後因新信息、未來事件、情況變化或任何其他原因而公開更新或修改任何前瞻性聲明。現在讓我把電話轉給戴爾。

Welcome to the Chemomab conference call covering updates through the first quarter of 2023. I am pleased to report that we have continued to make good progress on multiple fronts since our last investor call. Today, we will review financial results for the first quarter. Please see the press release we issued this morning for details. We will also discuss advances we achieved during the first quarter and note several significant developments that occurred late last year.

歡迎參加 Chemomab 電話會議，其中涵蓋了 2023 年第一季度的最新情況。我很高興地報告，自上次投資者電話會議以來，我們在多個方面繼續取得了良好進展。今天，我們將回顧第一季度的財務業績。詳情請參閱我們今天上午發布的新聞稿。我們還將討論我們在第一季度取得的進展，並指出去年年底發生的幾項重大進展。

In January, we reported encouraging top line results from our CM-101 Phase 2 liver fibrosis trial in patients with NASH. In this study, CM-101 appeared safe and demonstrated improvements across multiple disease-related fibrotic and inflammatory biomarkers. We believe that the data have been well received by opinion leaders working in NASH and other fibrotic diseases as well as by pharma firms with whom we are in ongoing dialogue. Adi will discuss the liver fibrosis NASH trial results shortly.

一月份，我們報告了針對 NASH 患者的 CM-101 2 期肝纖維化試驗的令人鼓舞的頂線結果。在這項研究中，CM-101 看起來很安全，並證明了多種疾病相關纖維化和炎症生物標誌物的改善。我們相信這些數據受到了 NASH 和其他纖維化疾病領域的意見領袖以及我們正在與之對話的製藥公司的好評。阿迪將很快討論肝纖維化 NASH 試驗結果。

Importantly, these results are consistent with the encouraging biomarker changes that we observed in two earlier CM-101 clinical trials. These results from these clinical trials and multiple non-clinical studies showing groups of fibro-inflammatory markers moving in the same right direction, along with physiological measures too increased our optimism about the potential for CM-101 as a treatment for fibro-inflammatory diseases.

重要的是，這些結果與我們在兩項早期 CM-101 臨床試驗中觀察到的令人鼓舞的生物標誌物變化一致。這些臨床試驗和多項非臨床研究的結果顯示，纖維炎症標記物組朝著相同的正確方向移動，再加上生理測量，也增加了我們對 CM-101 作為纖維炎症疾病治療潛力的樂觀態度。

Although we don't have immediate plans to pursue additional studies in NASH, we believe that CM-101 may have therapeutic potential in NASH as a solo therapy or in combination regimen. And we will continue to assess partnership opportunities in NASH and other indications. Additionally, we believe that these results support the therapeutic potential of CM-101 across multiple organs and inflammatory fibrotic diseases and are especially encouraging in support of the prospects for our two main indications of primary sclerosing cholangitis or PSC and systemic sclerosis or SSc, two rare diseases that share some of the same fibro-inflammatory features as NASH.

儘管我們沒有立即計劃對 NASH 進行更多研究，但我們相信 CM-101 作為單獨療法或聯合療法可能具有治療 NASH 的潛力。我們將繼續評估 NASH 和其他適應症的合作機會。此外，我們相信這些結果支持了 CM-101 在多個器官和炎性纖維化疾病中的治療潛力，並且特別令人鼓舞地支持了我們的兩個主要適應症的前景，即原發性硬化性膽管炎或 PSC 和系統性硬化症或 SSc，這兩種罕見的疾病與 NASH 具有一些相同纖維炎症特徵的疾病。

We're making good progress in advancing our CM-101 Phase 2 clinical program in PSC. We are pleased with a good productivity we have achieved by adding clinical sites and enhancing our patient outreach activities in line with our plans to report top line data from this trial in the second half of next year. We are also pleased late last year when the independent drug monitoring committee conducted a review of CM-101 safety data and cleared us to add the planned 20 milligrams per kilogram dose arm to the PSC trial. We are now enrolling patients in this higher dose cohort.

我們在 PSC 中推進 CM-101 2 期臨床項目方面取得了良好進展。我們很高興通過增加臨床地點和加強患者外展活動來實現良好的生產力，這符合我們計劃在明年下半年報告該試驗的主要數據。去年年底，獨立藥物監測委員會對 CM-101 安全數據進行了審查，並批准我們將計劃的每公斤 20 毫克劑量組添加到 PSC 試驗中，我們對此感到非常高興。我們現在正在將患者納入這個更高劑量的隊列。

Turning to SSc. Earlier this year, we reported that our IND for our Phase 2 trial was cleared by the FDA. We've been working diligently to prepare for the start of this trial, which will be conducted at sites in the US, Europe, and Israel. We are on track to open our initial US sites around midyear. We expect to report data from this trial in the latter part of 2024.

轉向 SSc。今年早些時候，我們報告說，我們的 2 期試驗 IND 已獲得 FDA 批准。我們一直在努力準備這次試驗的開始，該試驗將在美國、歐洲和以色列的地點進行。我們有望在年中左右開設最初的美國站點。我們預計將在 2024 年下半年報告該試驗的數據。

We're also supporting our clinical programs with an active schedule of scientific presentations at major medical meetings in the US and Europe. And we anticipate several scientific publications in respected journals in the coming months. These activities aim to build knowledge about and interest in our unique approach to fibro-inflammatory diseases among researchers and opinion leaders.

我們還在美國和歐洲的主要醫學會議上積極安排科學演講，以支持我們的臨床項目。我們預計未來幾個月將在受人尊敬的期刊上發表幾篇科學論文。這些活動旨在提高研究人員和意見領袖對我們治療纖維炎症疾病的獨特方法的了解和興趣。

Finally, since our last investor call, we've added two exceptional senior executives, our Chief Medical Officer, Dr. Matt Frankel; and our Vice President of Corporate Development and Strategy, Dr. Mitch Jones. Matt brings us a wealth of global-pharma and biotech industry experience across all aspects of clinical development and medical affairs, along with his outstanding track record in helping to bring numerous drugs to market in both rare and chronic diseases.

最後，自上次投資者電話會議以來，我們增加了兩位傑出的高級管理人員，我們的首席醫療官馬特·弗蘭克爾 (Matt Frankel) 博士；以及我們的企業發展和戰略副總裁 Mitch Jones 博士。馬特為我們帶來了臨床開發和醫療事務各個方面的豐富的全球製藥和生物技術行業經驗，以及他在幫助將眾多罕見病和慢性病藥物推向市場方面的傑出記錄。

Mitch, who is an MD, PhD has a rich combination of science and business skills that make him well qualified to lead the corporate development function at Chemomab. His academic background in Medicine and Biomedical Research is complemented by an extensive hands on industry experience as a biotech entrepreneur, strategist, clinical researcher, and deal maker. Matt and Mitch have already proven to be major contributors to Chemomab, and we are delighted to have them on Board.

Mitch 是一名醫學博士、博士，擁有豐富的科學和商業技能，這使他非常有資格領導 Chemomab 的企業發展職能。他在醫學和生物醫學研究方面的學術背景與作為生物技術企業家、戰略家、臨床研究員和交易撮合者的豐富行業實踐經驗相輔相成。 Matt 和 Mitch 已被證明是 Chemomab 的主要貢獻者，我們很高興他們加入。

Let me now turn the call over to Dr. Adi Mor, our co-founder and CSO. Adi?

現在讓我將電話轉給我們的聯合創始人兼首席戰略官 Adi Mor 博士。阿迪？

Thank you, Dale. As Dale noted in January, we reported top-line results from our Phase 2a liver fibrosis trial in NASH patients. This randomized placebo-controlled trial enrolled 23 patients and evaluated eight doses of CM-101 administered subcutaneously at a dose of 5 milligram per kilogram. The primary objective was to assess the safety and tolerability of our subcutaneous formulation.

謝謝你，戴爾。正如 Dale 一月份指出的那樣，我們報告了 NASH 患者 2a 期肝纖維化試驗的主要結果。這項隨機安慰劑對照試驗招募了 23 名患者，並評估了皮下注射 8 劑 CM-101，劑量為每公斤 5 毫克。主要目的是評估我們的皮下製劑的安全性和耐受性。

Secondary objectives included evaluating PK data, liver fibrosis biomarker, physiological markers, and anti-drug antibodies. We believe the results are encouraging. CM-101 appeared safe. Most adverse events were mild with one unrelated serious adverse event.

次要目標包括評估 PK 數據、肝纖維化生物標誌物、生理標誌物和抗藥物抗體。我們相信結果令人鼓舞。 CM-101 看起來很安全。大多數不良事件都是輕微的，只有一種不相關的嚴重不良事件。

We did not see any significant injection site reactions, no evidence of ADA. Overall, we were very pleased to see favorable pharmacokinetic target engagement profiles that are consistent with what we've seen in earlier studies. With multiple administrations, we saw an increase over the time in the level of CM-101 until it reaches a steady state.

我們沒有看到任何明顯的注射部位反應，沒有 ADA 的證據。總的來說，我們非常高興看到有利的藥代動力學靶點參與概況，這與我們在早期研究中看到的一致。通過多次給藥，我們看到 CM-101 的水平隨著時間的推移而增加，直到達到穩定狀態。

We also saw as expected an increase in target engagement in the CM-101 treated group, indicating CM-101's robust and specific engagement with its target and a strong PK target engagement relationship. In this trial, we evaluated the activity of CM-101 by measuring the variety of biomarkers that were known to be relevant to inflammation and fibrosis and are commonly used to assess the stage of liver fibrosis. Using a responder analysis, we demonstrated that higher percentage of patients in the CM-101 treated group showed improvement in the number of important biomarkers, including ELF, ProC-3, ProC-4 and TIMP-1, and this is compared to the placebo group.

我們還看到 CM-101 治療組的目標參與度如預期有所增加，這表明 CM-101 與其目標有強大且特定的參與度，並且具有強大的 PK 目標參與關係。在這項試驗中，我們通過測量已知與炎症和纖維化相關且通常用於評估肝纖維化階段的各種生物標誌物來評估 CM-101 的活性。通過應答者分析，我們證明，與安慰劑組相比，CM-101 治療組中較高比例的患者在重要生物標誌物數量上表現出改善，包括 ELF、ProC-3、ProC-4 和 TIMP-1團體。

In addition, we evaluated the biomarker improvement in patients who were defined as multiple responders that is patients who improved in at least three biomarkers. Importantly, the data showed almost 60% of the CM-101 group responded in at least three biomarkers compared to no patients in the placebo group. These findings further showed the broad effect of CM-101 on multiple biomarkers and suggest that it is inhibiting core pathological processes that lead to fibrosis.

此外，我們還評估了被定義為多重反應者的患者的生物標誌物改善情況，即至少三種生物標誌物有所改善的患者。重要的是，數據顯示，CM-101 組中近 60% 的患者對至少三種生物標誌物有反應，而安慰劑組中則沒有患者。這些發現進一步表明 CM-101 對多種生物標誌物的廣泛影響，並表明它正在抑制導致纖維化的核心病理過程。

In a different set of analysis, we evaluated the association between CCL24 levels at baseline and patient's response to CM-101. We divided the patients into low and high CCL24 categories based on their serum levels at baseline and found the CM-101 treated patients with higher CCL24 levels of baseline showed greater reductions in fibrosis related biomarkers than patients with lower levels. These results provide further evidence of the role of CCL24 in fibrotic liver disease.

在另一組不同的分析中，我們評估了基線 CCL24 水平與患者對 CM-101 的反應之間的關聯。我們根據基線血清水平將患者分為低 CCL24 和高 CCL24 類別，發現接受 CM-101 治療的基線 CCL24 水平較高的患者與水平較低的患者相比，纖維化相關生物標誌物的減少幅度更大。這些結果進一步證明了 CCL24 在纖維化肝病中的作用。

In addition to the biomarker analysis, we used FibroScan assessments at baseline and at week 16. The assessed liver stiffness is the geological measure that is a proxy for liver fibrosis. The data indicates that a much higher percentage of patients in the active arm showed an improvement of at least one grade in their fibrosis score.

除了生物標誌物分析之外，我們還在基線和第 16 週使用 FibroScan 評估。評估的肝臟硬度是代表肝纖維化的地質指標。數據表明，活動組中有更高比例的患者的纖維化評分至少改善了一級。

The combination of improvements across multiple circulating fibrosis related biomarkers and the positive FibroScan results is encouraging and add to the growing evidence that CM-101 may have the potential to be safe and effective treatments for fibro-inflammatory diseases such as NASH and PSC. I will now turn the call over to Dr. Matt Frankel, our Chief Medical Officer.

多種循環纖維化相關生物標誌物的改善和 FibroScan 的陽性結果相結合令人鼓舞，並增加了越來越多的證據表明 CM-101 可能有潛力安全有效地治療 NASH 和 PSC 等纖維炎症性疾病。我現在將把電話轉給我們的首席醫療官馬特·弗蘭克爾博士。

Thank you, Adi. It's useful to view the CM-101 Phase 2 liver fibrosis NASH trial results in the context of data from the three other CM-101 clinical trials that has been reported. The initial Phase 1a safety study, the Phase 1b trial in patients with nonalcoholic fatty liver disease, and the investigator-initiated study in a severe lung injury model in hospitalized COVID-19 patients.

謝謝你，阿迪。在已報告的其他三項 CM-101 臨床試驗的數據背景下查看 CM-101 2 期肝纖維化 NASH 試驗結果很有用。最初的 1a 期安全性研究、針對非酒精性脂肪肝患者的 1b 期試驗以及研究者發起的針對住院 COVID-19 患者的嚴重肺損傷模型的研究。

In summary, based on these four clinical trials of CM-101 completed to date, we see that CM-101 is pretty safe in more than 70 healthy subjects and patients who have received it. It reduced fibrogenesis related biomarkers in patients with fatty liver, liver fibrosis, NASH, and severe lung inflammation. It demonstrated anti-inflammatory effect in NASH and acute lung inflammation. and no antidrug antibodies have been detected. Importantly, we are seeing consistent signals across these studies. The CM-101 may have the potential to positively impact patients with a variety of fibro inflammatory diseases.

總之，根據迄今為止完成的 CM-101 的這四項臨床試驗，我們發現 CM-101 在 70 多名健康受試者和已接受治療的患者中相當安全。它減少了脂肪肝、肝纖維化、NASH 和嚴重肺部炎症患者的纖維發生相關生物標誌物。它在 NASH 和急性肺部炎症中具有抗炎作用。並且沒有檢測到抗藥物抗體。重要的是，我們在這些研究中看到了一致的信號。 CM-101 可能對患有多種纖維炎症性疾病的患者產生積極影響。

Turning now to our Phase 2 PSC trial. As Dale noted, we continue to actively recruit patients across clinical trial sites in the US, Europe, and Israel. Since our last call, we have opened additional trial sites and implemented a protocol amendment, adding a higher dose cohort and an open-label extension. We are pleased at the progress of the PSC trial and remain on track to report top line data from the double-blind portion in the second half of 2024.

現在轉向我們的第二階段 PSC 試驗。正如戴爾指出的那樣，我們繼續在美國、歐洲和以色列的臨床試驗地點積極招募患者。自上次通話以來，我們開設了更多試驗中心並實施了方案修訂，增加了更高劑量的隊列和開放標籤擴展。我們對 PSC 試驗的進展感到高興，並將繼續按計劃在 2024 年下半年報告雙盲部分的頂線數據。

Turning to systemic sclerosis. As we have described previously, SSc is a complex immunological disorder characterized by inflammatory and fibrotic pathophysiology in multiple tissues. Despite approvals of therapies that can slow the progression of the interstitial lung disease in the SSc patients, there remains a clear unmet medical need in this disorder, which affects an estimated 180,000 patients in major markets. It has the highest mortality of all the systemic rheumatic diseases.

轉向系統性硬化症。正如我們之前所描述的，SSc 是一種複雜的免疫性疾病，其特徵是多個組織中的炎症和纖維化病理生理學。儘管可以減緩 SSc 患者間質性肺疾病進展的療法已獲得批准，但這種疾病的醫療需求仍然明顯未得到滿足，該疾病影響了主要市場中估計 180,000 名患者。它是所有系統性風濕病中死亡率最高的。

We believe that a novel therapeutic that addresses various manifestations of the disease, including the dermatological aspects, would represent a major advance in the treatment of SSc. We're now building upon our strong preclinical data package with this initial trial, but we see to confirm the critical role of CCL24 in this disease and to establish biological and clinical proof of concept of CM-101 in patients with SSc. Notably, this is the first study where we recapture tissue samples, allowing us to see the direct impact of CM-101 on patient's tissue.

我們相信，一種解決該疾病各種表現（包括皮膚病學方面）的新療法將代表 SSc 治療的重大進展。我們現在正在通過這項初步試驗建立強大的臨床前數據包，但我們希望確認 CCL24 在這種疾病中的關鍵作用，並在 SSc 患者中建立 CM-101 概念的生物學和臨床證明。值得注意的是，這是我們重新採集組織樣本的第一項研究，使我們能夠看到 CM-101 對患者組織的直接影響。

The study is designed to generate additional information about disease mechanisms and to enable more informed decisions about future patient stratification strategies as well as to inform the selection of endpoints for registrational studies. This randomized placebo-controlled trial will enroll 45 patients with SSc with 30 patients receiving CM-101 and 15 receiving placebo. We are targeting about half the patients with the diagnosis of limited SSc and half with diffuse SSc.

該研究旨在生成有關疾病機制的更多信息，並就未來患者分層策略做出更明智的決策，並為註冊研究終點的選擇提供信息。這項隨機安慰劑對照試驗將招募 45 名 SSc 患者，其中 30 名患者接受 CM-101，15 名患者接受安慰劑。我們的目標是大約一半診斷為局限性 SSc 的患者和一半診斷為瀰漫性 SSc 的患者。

To be eligible, patients must have clinically active disease, either dermatologic or pulmonary or vascular along with moderate to high serum levels of circulating CCL24. The trial includes a 24-week double-blind period during which active treatment patients will receive 10 milligrams per kilogram of CM-101 every three weeks, followed by a 24-week open-label extension where all patients will receive a 10 mg per kg dose. All patients will undergo a skin biopsy at baseline and again, after the double-blind treatment period, along with multiple clinical assessments of the skin, vasculature, and pulmonary function. The primary outcome measure is safety.

為了符合資格，患者必須患有臨床活動性疾病，無論是皮膚病、肺病還是血管疾病，並且循環 CCL24 血清水平為中等到高。該試驗包括為期 24 週的雙盲期，在此期間，積極治療的患者將每三週接受 10 毫克/公斤的 CM-101，隨後是 24 週的開放標籤延期，其中所有患者將接受 10 毫克/公斤的 CM-101。劑量。所有患者都將在基線時接受皮膚活檢，並在雙盲治療期後再次接受皮膚活檢，並對皮膚、脈管系統和肺功能進行多項臨床評估。主要結果指標是安全性。

Secondary endpoints include multiple serum based biological markers and a variety of exploratory biological and clinical outcomes, including the ACR-CRISS and the revised CRISS. As noted, we expect to open the trial for patient enrollment soon around midyear. We currently anticipate an initial data readout from the trial in the second half of 2024. With that, I will turn the call over to Don Marvin, our Chief Financial Officer, Chief Operating Officer, and Executive Vice President. Don?

次要終點包括多種基於血清的生物標誌物和各種探索性生物學和臨床結果，包括 ACR-CRISS 和修訂版 CRISS。如前所述，我們預計將在年中左右開始接受患者入組試驗。目前，我們預計將於 2024 年下半年公佈試驗的初步數據。之後，我會將電話轉給我們的首席財務官、首席運營官兼執行副總裁 Don Marvin。大學教師？

Thank you, Matt. Good day. As CFO of Chemomab, I am pleased to have this opportunity to communicate directly with our shareholders and other stakeholders. Today, I will review highlights of our first-quarter 2023 financial performance. Please see the press release we issued this morning for more detail.

謝謝你，馬特。再會。作為 Chemomab 的首席財務官，我很高興有機會與我們的股東和其他利益相關者直接溝通。今天，我將回顧我們 2023 年第一季度財務業績的亮點。請參閱我們今天早上發布的新聞稿了解更多詳情。

As you know, the market for biotech stocks remains very challenging. I want to note again that while we cannot change the markets, we can ensure that we are not distracted from focusing on what we need to do to build a successful company. And Chemomab, that is to ensure we are pursuing the optimal development path for CM-101, prudently managing our finances, and conserving capital to the extent feasible while advancing our clinical programs in as rigorous a fashion as possible.

如您所知，生物技術股票市場仍然充滿挑戰。我想再次指出，雖然我們無法改變市場，但我們可以確保我們不會分心，專注於建立一家成功的公司所需要做的事情。而Chemomab，那就是確保我們追求CM-101的最佳開發路徑，審慎管理我們的財務，在可行的範圍內節省資金，同時盡可能嚴格地推進我們的臨床項目。

We believe we are doing a good job delivering on these goals. And we will strive to continue to do so going forward. In line with these principles, I am pleased to note that today we are reporting that we have extended our estimated cash runway from the prior date of March 31, 2024, the end of the first quarter until June 30, 2024, the end of the first half of the year.

我們相信我們在實現這些目標方面做得很好。我們將努力繼續這樣做。根據這些原則，我很高興地註意到，今天我們報告稱，我們已將預計現金跑道從前一日期（即第一季度末）2024 年 3 月 31 日延長至 2024 年 6 月 30 日（即第二季度末）。今年上半年。

We have done so through a thorough review of our budgets that has enabled us to trim expenditures while maintaining the resources needed to advance our two clinical programs towards achieving our data milestones targeted for the second half of 2024. We believe we have a number of options for addressing the funding needed to advance our trials through to the readouts projected in the second half of the year. And we will have more to say about these options in the coming months.

我們通過徹底審查預算來做到這一點，這使我們能夠削減支出，同時保留推進我們的兩個臨床項目所需的資源，以實現 2024 年下半年的數據里程碑。我們相信我們有多種選擇解決將我們的試驗推進到今年下半年預計結果所需的資金問題。我們將在未來幾個月內對這些選項進行更多討論。

Let me now share a summary of our financial performance for the first quarter 2023. Cash, cash equivalents, and bank deposits were $32.8 million as of March 31, 2023, compared to approximately $40 million on December 31st, 2022. R&D expenses were $6.9 million for the quarter ended March 31, 2023, compared to $2.7 million for the same quarter in 2022. Research and development expenses increased by approximately $4.1 million or 151% for the three months ended March 31, 2023, as compared to the same period of 2022. The increase was primarily due to increased clinical and preclinical activities.

現在讓我總結一下我們 2023 年第一季度的財務業績。截至 2023 年 3 月 31 日，現金、現金等價物和銀行存款為 3,280 萬美元，而 2022 年 12 月 31 日約為 4,000 萬美元。研發費用為 690 萬美元截至2023年3月31日的季度，相比2022年同期的270萬美元。截至2023年3月31日的三個月，研發費用與2022年同期相比增加約410萬美元，即151% .這一增長主要是由於臨床和臨床前活動的增加。

G&A expenses were $2.2 million for the quarter ended March 31, 2023, compared to $2.6 million for the same quarter in 2022. General administrative expenses decreased by approximately $0.4 million or 16% for the three months ended March 31, 2023, as compared to the same period of 2022. The decrease was primarily due to a decrease in noncash, share-based expenses and a decrease in insurance expenses.

截至 2023 年 3 月 31 日的季度，一般管理費用為 220 萬美元，而 2022 年同期為 260 萬美元。截至 2023 年 3 月 31 日的三個月，一般管理費用較 2023 年 3 月 31 日止三個月減少約 40 萬美元，即 16%。與 2022 年同期相比。減少的主要原因是非現金、股份費用的減少以及保險費用的減少。

Our net loss was $8.8 million or a net loss of approximately $0.04 per basic and diluted ordinary share for the first quarter of 2023 compared to $5.1 million or a net loss of approximately $0.02 per basic and diluted ordinary share for the quarter ended March 31, 2022. The weighted average number of ordinary shares outstanding, basic and diluted were 220,996,240 equal to approximately 11 million ADSs for the quarter ended March 31, 2023. We appreciate your continuing support and invite you to reach out if you would like to communicate with us directly. I will now turn the call back to Dale. Dale?

2023 年第一季度，我們的淨虧損為 880 萬美元，即每股基本和稀釋普通股淨虧損約 0.04 美元，而截至 2022 年 3 月 31 日的季度為 510 萬美元，即每股基本和稀釋普通股淨虧損約 0.02 美元截至 2023 年 3 月 31 日的季度，已發行普通股、基本股和稀釋股的加權平均數為 220,996,240 股，相當於約 1100 萬股美國存託股份。我們感謝您的持續支持，如果您想直接與我們溝通，請聯繫我們。我現在將電話轉回戴爾。戴爾？

I hope we've conveyed some of our enthusiasm about the momentum we are building at Chemomab. Despite the challenges facing our sector, we believe that CM-101 has the potential to make a real difference in deadly diseases with few current treatment options, and we are committed to fully assessing its potential. We intend to stay laser-focused on continuing our advance in the PSC trial and launching our innovative systemic sclerosis trial in the coming weeks.

我希望我們已經表達了對 Chemomab 正在建立的勢頭的一些熱情。儘管我們的行業面臨挑戰，但我們相信 CM-101 有潛力對目前治療選擇很少的致命疾病產生真正的影響，並且我們致力於充分評估其潛力。我們打算繼續專注於繼續推進 PSC 試驗，並在未來幾週內啟動我們創新的系統性硬化症試驗。

We also will continue to manage our resources with great prudence, make every expenditure count towards completing our current clinical programs. We appreciate your continued support and invite you to reach out with questions, comments, or suggestions. Operator, we are ready to open the floor to questions.

我們也將繼續謹慎管理我們的資源，讓每一筆支出都用於完成我們當前的臨床項目。我們感謝您持續的支持，並邀請您提出問題、意見或建議。接線員，我們準備好開始提問了。

(Operators Instructions) Kristen Kluska, Cantor Fitzgerald.

（操作員說明）Kristen Kluska、Cantor Fitzgerald。

Hi. Good morning, good afternoon, everybody. Thanks for taking my questions. So given that 2023 is largely an executional year for use as these Phase 2 trials progress. Can you talk about your plans this year to speak at different medical conferences and any new data findings from previous studies that you would look to present?

你好。大家早上好，下午好。感謝您回答我的問題。因此，隨著第二階段試驗的進展，2023 年很大程度上是執行年。您能否談談您今年在不同醫學會議上發表演講的計劃以及您希望展示的之前研究的任何新數據發現？

Hi, Kristen. This is Dale. That's a great question. And we actually have a quite a bit of activity there. Maybe Adi could kick off and then Matt.

嗨，克里斯汀。這是戴爾。這是一個很好的問題。實際上我們在那裡有很多活動。也許阿迪可以首發，然後是馬特。

Yeah, absolutely. Hi, Kristen. So we definitely have a lot of activities over the next couple of months. On that front, we are planning to present both in the EASL Biliary Conference as well as in the EASL larger conference in Wien in June. We will be presenting data that are based on some clinical samples, patient samples, and the preclinical research and present hopefully our NASH study data are still under review for late breaking.

是的，絕對是。嗨，克里斯汀。所以我們在接下來的幾個月里肯定會有很多活動。在這方面，我們計劃在 EASL 膽道會議以及 6 月在維也納舉行的 EASL 大型會議上進行展示。我們將提供基於一些臨床樣本、患者樣本和臨床前研究的數據，並希望我們的 NASH 研究數據仍在審查中，以供後期突破。

And in addition to that, later in the year, we are planning also to submit some exciting new data to the later conferences in the US as well. Inhibition on the systemic sclerosis is strong. So once again, data will be available in the upcoming EULAR conference and hopefully also later in the year in the ACR. Matt, any addition to that?

除此之外，今年晚些時候，我們還計劃向稍後在美國舉行的會議提交一些令人興奮的新數據。對系統性硬化症的抑製作用較強。因此，數據將在即將召開的 EULAR 會議上提供，並有望在今年晚些時候在 ACR 中提供。馬特，還有什麼補充嗎？

No, we are definitely focused on ensuring that we're communicating and providing any updates that we have to ensure that the community is aware of all of our great scientific progress.

不，我們絕對專注於確保我們進行溝通並提供任何更新，以確保社區了解我們所有偉大的科學進步。

Okay, thanks. I appreciate that. And I know you've made it clear that you as a company want to look to move any studies forward in NASH, has given me time and expenses associated with it. But you did mention in your prepared remarks that you've been talking to different partners. So I'm curious if that indication or specifically any other liver fibrotic diseases are being discussed in those conversations? Or is it really just focusing on your two lead asset indications at this stage?

好的謝謝。我很感激。我知道你們已經明確表示，作為一家公司，你們希望推動 NASH 方面的研究，並為我提供了與之相關的時間和費用。但您在準備好的發言中確實提到您一直在與不同的合作夥伴進行交談。所以我很好奇這些對話中是否正在討論該適應症或特別是任何其他肝纖維化疾病？或者現階段它真的只是專注於您的兩個主要資產指標嗎？

We are indeed exploring dialogues with a variety of companies, and those did include NASH. NASH is a fascinating fibro-inflammatory disease. We've received some very encouraging data in NASH. And so it makes sense for key opinion leaders and folks that are in that indication to be interested in our data and our emerging data analysis from our prior trial.

我們確實正在探索與各種公司進行對話，其中確實包括 NASH。 NASH 是一種令人著迷的纖維炎症性疾病。我們收到了一些 NASH 方面非常令人鼓舞的數據。因此，關鍵意見領袖和相關人士對我們的數據和我們之前試驗中的新興數據分析感興趣是有意義的。

So although we don't plan on pursuing trials ourselves, it does seem like a very appropriate indication for CM-101 to be active. And we are laser focused on primary sclerosing cholangitis and systemic sclerosis. It's our to go forward trials. But I think the unique aspect and insight that we have to fibro-inflammatory diseases is now being recognized by a larger group of key opinion leaders and people in this set of diseases.

因此，儘管我們不打算自己進行試驗，但這似乎是 CM-101 活躍的一個非常合適的跡象。我們專注於原發性硬化性膽管炎和系統性硬化症。我們要繼續進行試驗。但我認為，我們對纖維炎症性疾病的獨特方面和見解現在正在被更多的關鍵意見領袖和此類疾病領域的人們所認識。

So although we've considered them individual diseases over history increasingly as additional data coming out from other trials. In fibro-inflammatory spaces, we seen a consistent pattern, and we've a lot of supporting data to support CCL24. It's a very important target in a variety of these diseases. So we're focused and at the same time, we recognize that there's a variety of players out there that are interested in our assets.

因此，儘管我們越來越多地將它們視為歷史上的個別疾病，作為來自其他試驗的附加數據。在纖維炎症空間中，我們看到了一致的模式，並且我們有大量支持數據來支持 CCL24。它是多種此類疾病的非常重要的靶點。因此，我們很專注，同時我們認識到有各種各樣的參與者對我們的資產感興趣。

Great, thanks for taking my questions.

太好了，感謝您回答我的問題。

(Operators Instructions) Jeff Jones, Oppenheimer.

（操作員說明）傑夫·瓊斯，奧本海默。

Good morning, guys or afternoon for our Adi and the team in Israel. Question on the SSc trial. Why did you decide to go with the lower of the two doses you're studying, the 10 mg per kg? And then why enroll both diffuse and limited patients as the question being around the variability in those patients in a relatively small study and so then how you interpret the results? Thanks.

各位早上好，我們的阿迪和以色列團隊下午好。關於 SSc 試驗的問題。您為什麼決定採用您正在研究的兩個劑量中較低的一個，即每公斤 10 毫克？那麼為什麼要招募瀰漫型和有限型患者，因為問題是在一項相對較小的研究中圍繞這些患者的變異性，那麼您如何解釋結果呢？謝謝。

Matt?

馬特？

Yeah. So let me touch the first, which is why the 10 mg per kg. And the reason there is that when we worked with the FDA, we really felt that that's an opportunity to see the tissue effect, and that's a viable way forward to do that demonstration in the Phase 2a program. If we were going to do multiple doses, there was a thought process that it would be a much broader study and much larger study and a much larger with a number of blinded. So we felt that that population with 45 would really give us the indication that we really had tissue engagement as appropriate.

是的。那麼讓我先談談第一個，這就是為什麼每公斤10毫克。原因是，當我們與 FDA 合作時，我們確實覺得這是一個觀察組織效應的機會，並且這是在 2a 階段項目中進行演示的可行方法。如果我們要進行多次劑量，我們有一個思考過程，這將是一項更廣泛的研究，更大的研究，並且是一個更大的、有許多盲法的研究。因此，我們認為 45 歲的人群確實向我們表明，我們確實進行了適當的組織參與。

The number two question was as far as, why include both limited and diffused? And that comes down to a number of factors. Number one is that the patient populations really do differ. You see the progression of the diseases very dramatically. So we felt that it was very important. Both patient populations suffered dramatically from the disease. And it's an opportunity to explore the impact of CM-101 in both patient populations.

第二個問題是，為什麼要同時包括有限的和分散的？這取決於很多因素。第一是患者群體確實存在差異。你會看到疾病的進展非常顯著。所以我們覺得這非常重要。兩種患者群體都遭受了這種疾病的嚴重痛苦。這是一個探索 CM-101 對這兩個患者群體影響的機會。

The second is a practical, if you will. There are a number of molecules that are just pursuing the diffused. And we feel it's an opportunity to ensure that we have the opportunity to expand that and focus on those patients who were being neglected as well.

如果你願意的話，第二個是實用的。有許多分子只是追求擴散。我們認為這是一個機會，可以確保我們有機會擴大這一範圍並關注那些被忽視的患者。

Great. Thanks, guys.

偉大的。多謝你們。

Thank you.

謝謝。

We have reached the end of our question-and-answer session. And I would now like to turn the call back over to Dale for closing comments.

我們的問答環節已經結束。現在我想將電話轉回戴爾以徵求結束意見。

Well, thank you for your questions and continued support. We believe we have made great progress towards demonstrating CM-101 in our clinical programs. And we look forward to giving you additional updates later in the year. Thank you.

好的，感謝您的提問和持續的支持。我們相信，我們在臨床項目中展示 CM-101 方面已經取得了巨大進展。我們期待在今年晚些時候為您提供更多更新。謝謝。

This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.

今天的會議到此結束。此時您可以斷開線路。感謝您的參與。