Cyclacel Pharmaceuticals Inc (CYCC) 2024 Q1 法說會逐字稿

Good afternoon and welcome to the Cyclacel Pharmaceuticals first quarter 2024 results conference call and Webcast.

下午好，歡迎來到 Cyclacel Pharmaceuticals 2024 年第一季業績電話會議和網路廣播。

(Operator Instructions) Please note today's call is being recorded.

（操作員說明）請注意今天的通話正在錄音。

I would now like to turn the conference call over to the company.

我現在想把電話會議轉給公司。

Please go ahead.

請繼續。

Good afternoon, everyone, and thank you for joining today's conference call to discuss Cyclacel's financial results and business highlights for the first quarter ending March 31, 2024.

大家下午好，感謝您參加今天的電話會議，討論 Cyclacel 截至 2024 年 3 月 31 日的第一季度的財務業績和業務亮點。

Before turning the call over to management, I would like to remind everyone that during this conference call, forward-looking statements made by management are intended to fall within the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995 and Section 21E of the Securities Exchange Act of 1934 as amended.

在將電話轉交給管理階層之前，我想提醒大家，在本次電話會議中，管理階層所做的前瞻性陳述旨在符合1995 年《私人證券訴訟改革法案》和《1995 年私人證券訴訟改革法案》第21E 條的安全港條款的範圍內。

As set forth in our press release, forward-looking statements involve risks and uncertainties that may affect the company's business and prospects, including those discussed in our filings with the Securities and Exchange Commission, which include, among other things, our forms 10-Q and 10-K.

正如我們的新聞稿中所述，前瞻性陳述涉及可能影響公司業務和前景的風險和不確定性，包括我們向美國證券交易委員會提交的文件中討論的風險和不確定性，其中包括我們的10 -Q 表格和10-K。

Although projections and other forward-looking statements represent our judgment as of today and cycle itself does not take any responsibility to update such information.

儘管預測和其他前瞻性陳述代表了我們截至今天的判斷，但 Cycle 本身不承擔更新此類資訊的任何責任。

With us today are Spiro Rombotis, President, and Chief Executive Officer; Paul McBarron, Executive Vice President, Finance and Chief Operating Officer; and Dr. Brian Schwartz, Chief Medical Officer.

今天與我們在一起的有總裁兼執行長 Spiro Rombotis； Paul McBarron，財務執行副總裁兼營運長；和首席醫療官 Brian Schwartz 博士。

Spiro will begin with an overview of our business strategy and progress.

Spiro 將首先概述我們的業務策略和進展。

Brian will provide details on cyclicals clinical programs, and then Paul will provide financial highlights for the first quarter of 2024, which will be followed by a Q&A session.

Brian 將提供有關週期性臨床計劃的詳細信息，然後 Paul 將提供 2024 年第一季度的財務要點，隨後將進行問答環節。

At this time, I would like to turn the call over to Spiro

這時候我想把電話轉給Spiro

Thank you, Grace, and thank you, everyone, for joining us today for our first quarter 2024 business update.

謝謝 Grace，也謝謝大家今天加入我們的 2024 年第一季業務更新。

As previously reported, we have closed the financing for $8 million in gross proceeds in a private placement priced at the market per NASDAQ rules.

如同先前所報道的，我們已經完成了私募融資，總收益為 800 萬美元，按照納斯達克規則的市場定價。

With additional resources in place, we have begun dosing patients in the Phase 2 proof of concept part of our 065-101 study evaluating fadraciclib or fadra for short in patients with one or more chromosomal abnormalities, including CDKN2A and or CDKN2B deep deletions or loss of function.

有了額外的資源，我們已經開始在065-101 研究的第2 期概念驗證部分給患者用藥，該研究評估了fadraciclib 或簡稱fadra 對患有一種或多種染色體異常（包括CDKN2A 和/或CDKN2B 深度缺失或缺失）的患者的影響。

You will recall that we are pursuing a potential precision medicine approach or fadra for oral CDK2/9 inhibitor following findings in our clinical and preclinical data would suggest the hypothesis that patients with one or more of these chromosomal abnormalities may be sensitive to fadra.

您可能還記得，我們​​正在尋求一種潛在的精準醫學方法或fadra 口服CDK2/9 抑制劑，根據我們的臨床和臨床前數據的發現，我們假設患有一種或多種染色體異常的患者可能對fadra敏感。

In the Phase 2 part, we are evaluating patients selected for their mutational profile and or Phase 1 activity in various solid tumors and lymphoma.

在第二階段部分，我們正在評估根據其突變譜和/或各種實體瘤和淋巴瘤的第一階段活性而選擇的患者。

We're initially enrolling two patient cohorts those with CDKN2A and or CDKN2B abnormalities and also T-cell lymphoma based on observation of anticancer activity, including responses in multiple Phase 1 patients.

我們最初根據抗癌活性（包括多個 1 期患者的反應）觀察，招募了兩個患有 CDKN2A 和/或 CDKN2B 異常以及 T 細胞淋巴瘤的患者群組。

We believe that there is great unmet medical need and industry interest in the cancer patient populations identified by these abnormalities which are closely located on chromosome 9 and are often co-deleted.

我們相信，由這些緊密位於 9 號染色體上並且經常被共同刪除的異常所識別的癌症患者群體存在巨大的未滿足的醫療需求和行業興趣。

CKN2A gene deletions occur in several solid tumors, including bladder, breast, endometrial, esophageal, glioma, head, and neck, hepatobiliary, lung, including squamous, melanoma, ovarian, pancreatic, and also in certain T-cell lymphomas.

CKN2A 基因缺失發生在多種實體腫瘤中，包括膀胱腫瘤、乳癌、子宮內膜腫瘤、食道腫瘤、神經膠質瘤、頭頸部腫瘤、肝膽腫瘤、肺腫瘤（包括鱗狀腫瘤、黑色素瘤、卵巢腫瘤、胰臟腫瘤）以及某些T 細胞淋巴瘤。

CDKN2B lesions occur in several solid tumors including bladder, the breast, cholangiocarcinoma, endometrial, esophageal, glioma, head, and neck, hepatobiliary, lung including squamous and mesothelioma, melanoma, pancreatic, and others.

CDKN2B 病灶發生在多種實體腫瘤中，包括膀胱癌、乳癌、膽管癌、子宮內膜癌、食道癌、神經膠質瘤、頭頸部腫瘤、肝膽腫瘤、肺腫瘤（包括鱗狀細胞瘤和間皮瘤）、黑色素瘤、胰臟癌等。

There are no approved drugs to treat patients with CDKN2A or B abnormalities.

目前尚無核准藥物用於治療 CDKN2A 或 B 異常患者。

We expect two key data readouts for fadra this year, final data from the dose escalation part of the 065-101 study to be presented at the ASCO 2024 annual meeting in a few weeks and report on initial clinical activity from the Phase 2 proof of concept part of the study in the second half of this year.

我們預計今年 fadra 的兩個關鍵數據將公佈，065-101 研究劑量遞增部分的最終數據將在幾週後的 ASCO 2024 年會上公佈，並報告第二階段概念驗證的初步臨床活動今年下半年的部分研究。

I will now turn the call over to Brian to review our progress and discuss some of our clinical results in the Fadra study.

我現在會把電話轉給 Brian，回顧我們的進展並討論我們在 Fadra 研究中的一些臨床結果。

Brian

布萊恩

?

？

Thank you, Spiro.

謝謝你，斯皮羅。

In our recently completed 065-101 study, we determined the recommended Phase 2 dose for Fadra As a reminder, this is 100 milligrams BID dosed orally five days per week in a four week cycle.

在我們最近完成的 065-101 研究中，我們確定了 Fadra 的建議 2 期劑量。

No dose-limiting toxicities were observed on this schedule.

在此方案中沒有觀察到劑量限制性毒性。

We have now dosed the first patient in the Phase 2 proof-of-concept part of the study.

我們現在已經在該研究的第二階段概念驗證部分對第一位患者進行了給藥。

With the initial focus of the cohort in patients with CDK2NA or B alterations.

該隊列最初的重點是 CDK2NA 或 B 突變的患者。

In order to speed up enrollment, we have opened additional sites with up to seven participating in the Phase 2 .

為了加快註冊速度，我們開設了更多站點，最多有 7 個站點參與第二階段。

We expect to deliver initial results by the second half of 2024.

我們預計在 2024 年下半年之前交付初步結果。

As we progress through the Phase 2 study.

隨著我們第二階段研究的進展。

And let me summarize the rationale for our clinical strategy.

讓我總結一下我們臨床策略的基本原理。

We have observed CDKN2A or B alterations, including loss of function in multiple pretreated Phase 1 patients with various cancers.

我們觀察到了 CDKN2A 或 B 的改變，包括多個接受過治療的 1 期各種癌症患者的功能喪失。

These included gynecological, hepatobiliary, lung, pancreatic and recently testicular, who benefited from further factor monotherapy.

這些包括婦科、肝膽、肺、胰腺和最近的睪丸，他們從進一步的因子單一療法中受益。

These patient groups are associated with a high unmet need and often have poor clinical outcomes.

這些患者群體的需求未被滿足，臨床結果往往較差。

As an illustration, we were excited to see shrinkage of 22% in the sum of all target lesions of the one cycle of oral Fadra monotherapy in squamous non-small cell lung cancer patient with CDKN2B deletions refractory to standard of care chemo and immunotherapY.

作為一個例子，我們很高興地看到，對於標準護理化療和免疫治療難治的CDKN2B 缺失的鱗狀非小細胞肺癌患者，口服Fadra 單藥治療一個週期後，所有目標病變的總和縮小了22% 。

A recently enrolled patients with advanced testicular cancer patient post-surgery achieved a 12% reduction in the sum of all target lesions in the first cycle and continues on therapy now at cycle three.

最近入組的一名晚期睪丸癌患者術後在第一個週期中所有目標病變的總和減少了 12%，並在第三個週期中繼續治療。

After retrospectively analyzing a subset of previously treated Phase 1 patients, we found a total of eight patients with CDKN2A or 2B alterations, all of whom experienced clinical benefit of the fadra monotherapy.

在回顧性分析了先前接受過 1 期治療的一部分患者後，我們發現總共有 8 名患者存在 CDKN2A 或 2B 改變，他們都經歷了 Fadra 單藥療法的臨床效益。

These included an endometrial cancer patient who achieved a CR and over three years of treatment on the previous IV fadra monotherapy study and was found to have CDKN2A and CDKN2B loss.

其中包括一名子宮內膜癌患者，該患者在先前的 IV fadra 單藥治療研究中獲得 CR 並接受了三年以上的治療，並發現 CDKN2A 和 CDKN2B 缺失。

We are also encouraged by Phase 1 anticancer activity observed in T-cell lymphoma patients, including PRs in two out of three patients treated, one of whom who had loss of CDK into a literature suggests that a large percentage of T-cell lymphoma patients have loss of CDKN2A.

我們也對T 細胞淋巴瘤患者中觀察到的1 期抗癌活性感到鼓舞，包括三分之二接受治療的患者達到PR，其中一名患者CDK 丟失，文獻表明很大一部分T 細胞淋巴瘤患者已出現CDK 缺失。

Although the Phase 1 hypothesis-generating data are limited and cannot be generalized, we believe that the data supports evaluating patients with these cancer types in Phase 2 proof of concept part of the study.

儘管第一階段的假設生成數據有限且不能一概而論，但我們相信這些數據支持在第二階段研究的概念驗證部分中評估患有這些癌症類型的患者。

I will now turn the call over to Paul to review our first quarter results.

我現在將把電話轉給保羅，以審查我們第一季的業績。

Thank you, Brian.

謝謝你，布萊恩。

As of March 31, 2024, pro forma cash and cash equivalents totaled $9.9 million, which includes proceeds from this month's private placement and $0.8 million cash received for the second and final part of the United Kingdom.

截至 2024 年 3 月 31 日，預計現金和現金等價物總計 990 萬美元，其中包括本月私募收益以及為英國第二部分和最後部分收到的 80 萬美元現金。

Research and Development Tax Credit claim for 2023, cash and cash equivalents as of March 31, 2024 totaled $2.8 million compared to $3.4 million as of December 31, 2023.

截至 2024 年 3 月 31 日，2023 年研發稅收抵免申請、現金及現金等價物總額為 280 萬美元，而截至 2023 年 12 月 31 日為 340 萬美元。

Net cash used in operating activities was $0.5 million for the three months ended March 31, 2024, which includes $2.9 million received in March in respect of the first part of the 2023 R & D tax credit claim compared to $6.9 million for the same period of 2023.

截至2024 年3 月31 日的三個月，經營活動使用的淨現金為50 萬美元，其中包括3 月份收到的2023 年研發稅收抵免申請第一部分的290 萬美元，而2024 年同期為690萬美元。

Research and development or R&D expenses were $2.8 million for the three months ended March 31, 2024, as compared to $5.7 million for the same period in 2023.

截至 2024 年 3 月 31 日止三個月，研發費用為 280 萬美元，而 2023 年同期為 570 萬美元。

R&D expenses related to fadra were $1.8 million for the three months ended March 31, 2024, as compared to $4.1 million for the same period in 2023.

截至 2024 年 3 月 31 日止三個月，與 fadra 相關的研發費用為 180 萬美元，而 2023 年同期為 410 萬美元。

Due to a decrease in clinical trial and other nonclinical expenditures, R&D expenses related to plogo were $1 million for the three months ended March 31, 2024 as compared to $1.4 million for the same period of 2023 due to a decrease in manufacturing and other nonclinical expenditures.

由於臨床試驗和其他非臨床支出減少，截至2024年3月31日止三個月，與plogo相關的研發費用為100萬美元，而2023年同期由於製造業和其他非臨床支出減少，研發費用為140萬美元。

Expenses related to plogo will be greatly reduced in 2024 as we have paused the 140-101 study while a new salt formulation becomes available.

由於我們暫停了 140-101 研究，同時推出了新的鹽配方，因此與 plogo 相關的費用將在 2024 年大幅減少。

General and administrative expenses remained relatively flat at approximately $1.6 million for each of the three months ended March 31, 2024 and 2023.

截至2024年3月31日及2023年3月31日的三個月，一般及行政費用保持相對穩定，約160萬美元。

Total other expenses net for the three months ended March 31, 2024 were $0.1 million compared to $0.2 million for the same period of the previous year.

截至 2024 年 3 月 31 日的三個月其他費用淨額總額為 10 萬美元，而去年同期為 20 萬美元。

United Kingdom research development tax credits for the three months ended March 31, 2024 were $1.4 million, which includes $0.8 million related to the 2023 claim, which as I mentioned previously, we have now received payment.

截至 2024 年 3 月 31 日的三個月，英國研究開發稅收抵免為 140 萬美元，其中包括與 2023 年索賠相關的 80 萬美元，正如我之前提到的，我們現在已收到付款。

Compared to $1.3 million for the same period of the previous year and are directly correlated to qualifying research and development expenditure.

與去年同期的 130 萬美元相比，與合格的研發支出直接相關。

Net loss for the three months ended March 31, 2024 were $2.9 million, which includes stock-based compensation expense of $0.2 million compared to $5.8 million, including stock-based compensation expense of $0.4 million for the same period in 2023.

截至 2024 年 3 月 31 日的三個月淨虧損為 290 萬美元，其中包括 20 萬美元的股票補償費用，而 2023 年同期的淨虧損為 580 萬美元，其中包括 40 萬美元的股票補償費用。

As we concentrate our resources on recruiting patients in the specific cohorts in the Fadra Phase 2 study, we anticipate that our expenditures in 2024 will continue to decrease.

由於我們將資源集中在 Fadra 第 2 期研究的特定隊列中招募患者，因此我們預計 2024 年的支出將繼續減少。

The company estimates that its current cash resources will fund currently planned programs into the fourth quarter of 2024.

該公司估計，其目前的現金資源將為目前計劃的項目提供資金，直至 2024 年第四季。

Operator, we are now ready to take questions.

接線員，我們現在準備好回答問題。

(Operator Instructions)

（操作員說明）

Ahu Demir, Ladenburg Thalmann

阿胡·德米爾、拉登堡·塔爾曼

Thank you very much for taking my questions.

非常感謝您回答我的問題。

Two from us.

我們兩個。

First one is what are we expecting to see at ASCO from the fadraciclib 101 study?

第一個是我們期望在 ASCO 上從 fadraciclib 101 研究中看到什麼？

Could you provide more color?

可以提供更多顏色嗎？

How many patients are we going to see subset analysis and any additional information would be very helpful.

我們將看到多少患者的子集分析以及任何其他資訊都會非常有幫助。

Thank you for your question.

謝謝你的問題。

Ahi, I will turn it over to Brian to answer the question on the ASCO content.

啊嗨，我將把它交給 Brian 來回答有關 ASCO 內容的問題。

Ahu, we basically plan to present almost the totality of the dose escalation portion of the study.

啊胡，我們基本上計劃展示該研究的劑量遞增部分的幾乎全部內容。

The data [cut] was a couple of weeks ago, but we should have full dataset and around the Phase 1 dose escalation portion, including both the safety and efficacy seen so far.

數據[剪切]是幾週前的，但我們應該擁有完整的數據集和第一階段劑量遞增部分的數據，包括迄今為止所看到的安全性和有效性。

There will also be PK and PD included.

還將包括PK和PD。

Thank you, Brian, and nice to chat with you again.

謝謝你，布萊恩，很高興再次與你聊天。

Another question I have is on the proof of concept Phase 2 portion of the same study we are expecting to see data later this year.

我的另一個問題是關於同一研究的概念驗證第二階段部分，我們預計將在今年稍後看到數據。

Curious what is the time line, what are you going to present and currently, how many sites are open and what are your thoughts on the enrollment, how fast that might move forward

好奇時間軸是什麼，您目前要展示什麼，有多少個網站開放，您對註冊有何想法，進展速度有多快

?\

？

Brian

布萊恩

?

？

We've just opened the T-cell lymphoma slightly starting to open slightly different from the Phase 1 solid tumor sites.

我們剛打開了 T 細胞淋巴瘤，開始與第一期實體瘤部位略有不同。

The solid tumor sites, we had already four sites enrolling so it's just opening an additional three in terms of timing.

對於實體瘤站點，我們已經有四個站點正在招募中，因此在時間上只是開放了另外三個站點。

These new to these known mutations are sometimes difficult to determine the frequency, but we quite encouraged at the moment of patients being identified.

這些已知的新突變有時很難確定頻率，但在患者被識別的那一刻我們非常鼓舞。

We anticipate most probably by the end of the year, we've enrolled both cohorts.

我們預計最有可能到今年年底，我們已經招收了這兩個群體。

Thank you.

謝謝。

Let me also add to Brian's color, Ahu that these mutations are readily available as part of standard panels would not need a companion diagnostic to identify the patients or the company is collecting data for future regulatory discussions.

我還要補充一下 Brian 的觀點，Ahu，這些突變很容易作為標準面板的一部分獲得，不需要伴隨診斷來識別患者，或者公司正在為未來的監管討論收集數據。

But the important part of their amply available and there is no approved drug to treat these patients once they're identified with abnormality.

但他們的重要部分是充分可用的，一旦發現這些患者有異常，就沒有批准的藥物可以治療這些患者。

Very helpful.

很有幫助。

Thank you, Spiro.

謝謝你，斯皮羅。

Thanks, Brian.

謝謝，布萊恩。

Thank you, Ahu.

謝謝你，阿胡。

We have no further questions in the queue at this time.

目前我們隊列中沒有其他問題。

I'd now like to turn the call back over to today's speakers for any additional our closing remark.

現在我想將電話轉回給今天的講者，讓他們發表更多的結束語。

Thank you, operator, and thanks to all of you for joining Cyclacel's first quarter 2024 earnings call.

謝謝業者，也謝謝大家參加 Cyclacel 的 2024 年第一季財報電話會議。

Fadraciclib has achieved a key milestone with the first patients dosed in the Phase 2 proof of concept stage with important catalysts anticipated in 2024 and the strong competitive profile in its therapeutic class.

Fadraciclib 已經實現了一個重要的里程碑，第一批患者在第二階段概念驗證階段接受了給藥，預計在 2024 年將出現重要的催化劑，並且在其治療類別中具有強大的競爭優勢。

As a reminder, our upcoming key milestones are report data from the dose escalation stage of the O65-101 study, overall Fadra in patients with advanced solid tumors and lymphoma at the ASCO 2024 Annual meeting.

提醒一下，我們即將到來的關鍵里程碑是 O65-101 研究劑量遞增階段的報告數據，以及 ASCO 2024 年年會上晚期實體瘤和淋巴瘤患者的整體 Fadra。

Report interim data from initial cohorts in Phase 2, open-label proof-of-concept part of O65-101 study with oral Fadraciclib in patients with advanced solid tumors and lymphoma.

報告第 2 期初始隊列的中期數據，這是 O65-101 研究的開放標籤概念驗證部分，口服 Fadraciclib 治療晚期實體瘤和淋巴瘤患者。

We look forward to providing you with further updates and hope to meet some of you at upcoming conferences.

我們期待為您提供進一步的更新，並希望在即將舉行的會議上見到你們中的一些人。

Operator, at this time, you may end the call.

接線員，此時您可以結束通話了。

Thank you sir.

謝謝你，先生。

So this does conclude today's program.

今天的節目到此結束。

Thank you for your participation.

感謝您的參與。

You may disconnect at any time.

您可以隨時斷開連線。