Cyclacel Pharmaceuticals Inc (CYCC) 2024 Q2 法說會逐字稿

Good afternoon, everyone.

大家下午好。

And thank you for joining today's conference call to discuss Cyclacel's financial results and business highlights for the second quarter ended June 30, 2024.

感謝您參加今天的電話會議，討論 Cyclacel 截至 2024 年 6 月 30 日的第二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》和《1995 年私人證券訴訟改革法》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 表格等和10-K。

All of our projections and other forward-looking statements represent our judgment as of today, and Cyclacel does not take any responsibility to update such information.

我們所有的預測和其他前瞻性陳述均代表我們截至目前為止的判斷，Cyclacel 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, Brian will provide details on Cyclacel's clinical programs, and then Paul will provide financial highlights for the second quarter of 2024, which will be followed by a Q&A session.

Spiro 將首先概述我們的業務戰略和進展，Brian 將提供 Cyclacel 臨床項目的詳細信息，然後 Paul 將提供 2024 年第二季度的財務要點，隨後將進行問答環節。

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

這時，我想把電話轉給 Spiro。

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

謝謝大家，也謝謝大家今天加入我們的 2024 年第二季業務更新。

We are pleased to report on our progress with the precision medicine strategy for fadraciclib or Fadra, oral CDK29 inhibitor which was highlighted at the ASCO Annual Meeting in June.

我們很高興地報告我們在 fadraciclib 或 Fadra（口服 CDK29 抑制劑）的精準醫療策略方面取得的進展，該策略在 6 月的 ASCO 年會上得到了強調。

Recruitment in the enriched cohort of our 065-101 phase 2 proof-of-concept study is going well.

我們的 065-101 第二階段概念驗證研究豐富隊列的招募進展順利。

In this cohort, we're evaluating Fadra as a monotherapy in patients with CDKN2A and/or CDKN2B chromosomal abnormalities, including deep deletions or loss of function.

在這個隊列中，我們正在評估 Fadra 作為 CDKN2A 和/或 CDKN2B 染色體異常（包括深度缺失或功能喪失）患者的單一療法。

There are processes we are testing prospectively built on preclinical evidence and the phase 1 clinical data presented at ASCO, which evaluated Fadra's monotherapy from an unselected population.

我們正在前瞻性地測試一些基於臨床前證據和 ASCO 提交的 1 期臨床數據的流程，該數據評估了來自未經選擇的人群的 Fadra 單一療法。

Clinical benefit was observed in heavily pre-treated patients with several tumor types including endometrial, lung, ovarian, pancreatic cancer, and T-cell lymphoma

在接受過大量預先治療的多種腫瘤類型（包括子宮內膜癌、肺癌、卵巢癌、胰腺癌和 T 細胞淋巴瘤）患者中觀察到臨床獲益

Retrospective analysis suggests that this activity may be associated in part with alterations in certain tumor suppressor veins specifically to CDKN2A and CDKN2B.

回顧性分析表明，這種活性可能部分與特定於 CDKN2A 和 CDKN2B 的腫瘤抑制靜脈的改變有關。

We believe that there is great unmet medical need and industry interest in the patient population identified by CDKN2A of the abnormalities, which are closely located from chromosome nine and are often co-deleted.

我們相信，透過 CDKN2A 發現的異常患者群體存在巨大的未滿足的醫療需求和行業興趣，這些異常與 9 號染色體緊密相連，並且經常被共同刪除。

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，包括膀胱癌、乳癌、子宮內膜癌、食道癌、神經膠質瘤、頭頸癌、肝膽癌、肺癌（包括鱗狀細胞瘤、黑色素瘤、卵巢癌、胰臟癌）以及某些T 細胞淋巴瘤。

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

CDKN2B 缺失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、頭頸癌、肝膽癌、肺癌，包括鱗狀細胞瘤和間皮瘤、黑色素瘤、胰臟癌等。

Based on the currently available data, we believe that Fadra has a strong competitive profile in its therapeutic class.

根據目前可用的數據，我們相信 Fadra 在其治療類別中具有強大的競爭優勢。

We expect to report on initial clinical activity from the phase 2 proof-of-concept part of the study starting at the fourth quarter of this year.

我們預計從今年第四季開始報告該研究第二階段概念驗證部分的初步臨床活動。

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

我現在將把電話轉給 Brian，回顧我們的進展並討論我們在 Fadra 計畫中的一些臨床結果。

Brian?

布萊恩？

Thank you, Spiro.

謝謝你，斯皮羅。

As Spiro mentioned, we are recruiting well in the Fadra POC study and I'm very encouraged by the enthusiasm of our clinical investigators about enrollment of patients with CDKN2A B cohorts.

正如 Spiro 所提到的，我們在 Fadra POC 研究中招募工作進展順利，我們的臨床研究人員對招募 CDKN2A B 隊列患者的熱情令我深受鼓舞。

Based on the pace of enrollments we anticipate reporting initial results from around a dozen patients by the end of 2024.

根據入組速度，我們預計到 2024 年底將報告約 12 名患者的初步結果。

We have also opened a second cohort which is recruiting patients with T-cell lymphoma.

我們也開設了第二個隊列，正在招募 T 細胞淋巴瘤患者。

This was based on phase 1 single productivity, including partial responses in two out of the three patients with T cell lymphoma.

這是基於第一階段的單一生產力，包括三名 T 細胞淋巴瘤患者中的兩名的部分緩解。

As we progress with the Fadra phase 2 study, let me summarize the data presented at ASCO and the rationale for our clinical strategy.

隨著 Fadra 2 期研究的進展，讓我總結一下 ASCO 上提供的數據以及我們臨床策略的基本原理。

The extra dataset included, 47 patients from the phase 1 dose escalation part of the CYC065-101 study, evaluating different further dosing schedule as monotherapy in unselected population.

額外的數據集包括來自 CYC065-101 研究 1 期劑量遞增部分的 47 名患者，評估了未選定人群中作為單一療法的不同進一步給藥方案。

Patients who are pre-treated having received a median of four prior lines of therapy, Fadra was generally well tolerated with good compliance between dose level one and five.

接受過中位四線治療的預先治療患者，Fadra 通常耐受性良好，在劑量水平 1 和 5 之間具有良好的依從性。

Dose level five or a hundred milligrams, twice-daily, five days a week, four out of four weeks were selected for the phase 2 proof-of-concept part of the study.

劑量等級為五毫克或一百毫克，每天兩次，每週五天，四週中的四週被選用於研究的第二階段概念驗證部分。

There were no drug-related SAEs at this dose level.

在此劑量水平下沒有發生與藥物相關的嚴重不良事件。

The most commonly reported treatment-related adverse events were; nausea, vomiting, diarrhea, fatigue and hyperglycemia.

最常見的治療相關不良事件是：噁心、嘔吐、腹瀉、疲勞和高血糖。

A total of 25 drug-related, SAEs were reported in eight patients.

8 名患者共報告了 25 起與藥物相關的 SAE。

Most common were hyperglycemia in four patients, platelet count decrease in three, and accidental overdose in three,

最常見的是四名患者出現高血糖，三名患者出現血小板數量減少，三名患者出現意外用藥過量。

A total of 34 patients had measurable target lesions at baseline.

共有 34 名患者在基線時有可測量的目標病灶。

Two partial responses were reported in patients with T-cell lymphoma, one of whom had a CDK2N2A loss.

據報道，T 細胞淋巴瘤患者有兩種部分緩解，其中一名患者出現 CDK2N2A 缺失。

A squamous non-small cell lung cancer patient, with CDKN2A and CDKN2B loss achieved a 22% reduction in tumor burden at four weeks.

一名患有 CDKN2A 和 CDKN2B 缺失的鱗狀非小細胞肺癌患者在 4 週內腫瘤負荷減少了 22%。

In addition, clinical benefit was reported in two patients with endometrial cancer, one each with ovarian and pancreatic cancer.

此外，也報告了兩名子宮內膜癌患者的臨床效益，其中一名患者患有卵巢癌和胰腺癌。

A retrospective analysis of previously treated phase 1 patients identified and endometrial cancer patients, who achieved a complete response over three years of treatment in a previous intravenous Fadra monotherapy study and was found to have a CDKN2A CDKN2B and NCAP loss.

對先前接受治療的1 期患者進行回顧性分析，確定了子宮內膜癌患者，這些患者在先前的靜脈Fadra 單藥治療研究中經過三年的治療獲得了完全緩解，並發現CDKN2A、CDKN2B 和NCAP缺失。

Although the phase 1 hypothesis generating data are limited and cannot be generalized, we believe that the data supports evaluating the two patient cohorts with specific cancer types in the phase 2 POC part of the study.

儘管 1 期假設產生的數據有限且不能一概而論，但我們相信這些數據支持在該研究的 2 期 POC 部分中評估具有特定癌症類型的兩個患者群組。

We look forward to reporting initial data in the upcoming months.

我們期待在未來幾個月內報告初步數據。

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

我現在將電話轉交給保羅，以審查第二季度的業績。

Thank you, Brian.

謝謝你，布萊恩。

As of June 30, 2024, cash equivalents totaled $6 million, compared to $3.4 million as of December 31, 2023.

截至2024年6月30日，現金等價物總額為600萬美元，而截至2023年12月31日為340萬美元。

Net cash used in operating activities was $3.6 million for the six months ended June 30, 2024, compared to $8.2 million for the same period of 2023.

截至2024年6月30日的六個月，經營活動使用的現金淨額為360萬美元，而2023年同期為820萬美元。

Net cash provided by financing activities was $6.3 million for the six month ended June 30, 2024, as a result of receiving approximately $6.3 million net of expenses from the issue of common stock and warrants under securities purchase agreement.

截至 2024 年 6 月 30 日的六個月，融資活動提供的淨現金為 630 萬美元，扣除根據證券購買協議發行普通股和認股權證的費用後，收到約 630 萬美元的淨現金。

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

該公司估計其目前的現金資源將為 2024 年第四季的計畫項目提供資金。

Research and development or R&D expenses were $2 million for the three months ended June 30, 2024, as compared to $4.7 million for the same period in 2023.

截至 2024 年 6 月 30 日止三個月，研發費用為 200 萬美元，而 2023 年同期為 470 萬美元。

R&D expenses relating to Fadra were $1.5 million for the three months ended June 30, 2024.

截至 2024 年 6 月 30 日止三個月，與 Fadra 相關的研發費用為 150 萬美元。

As compared to $3 million for the same period in 2023 due to the decrease in clinical trial and other non-clinical expenditures.

相較之下，2023 年同期為 300 萬美元，原因是臨床試驗和其他非臨床支出減少。

R&D expenses relative to plogosertib, our PLK1 inhibitor were $0.5 million for the three months ended June 30, 2024 as compared to $1.4 million for the same period in 2023, due to a decrease in manufacturing costs and other non-clinical expenditures.

截至 2024 年 6 月 30 日止三個月，我們的 PLK1 抑制劑 plogosertib 的研發費用為 50 萬美元，而 2023 年同期為 140 萬美元，原因是製造成本和其他非臨床支出減少。

General, and administrative expenses remain flat at approximately $1.6 million for each of the three months ended of June 2024 and 2023.

截至 2024 年 6 月和 2023 年 6 月的三個月，一般和行政費用保持不變，約 160 萬美元。

Total other expenses net were $0.1 million for each of the three months ended June 2024 and 2023.

截至 2024 年 6 月及 2023 年 6 月的三個月，其他費用淨額總額均為 10 萬美元。

The United Kingdom research and development tax credits for the three months ended June 30, 2024, were $0.4 million, compared to $6 million for the same period in the previous year and are directly correlated to qualifying R&D expenditure.

截至 2024 年 6 月 30 日的三個月，英國的研發稅收抵免為 40 萬美元，而去年同期為 600 萬美元，並且與合格的研發支出直接相關。

Net loss for the three months June 30, 2024, was $3.3 million, including stock-based compensation expense of $0.2 million, compared to $5.5 million including stock-based compensation expense of $0.4 million for the same period in 2023.

截至 2024 年 6 月 30 日的三個月淨虧損為 330 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 550 萬美元，包括 40 萬美元的股票補償費用。

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。

Good afternoon.

午安.

Thank you very much for taking my questions.

非常感謝您回答我的問題。

We have couple.

我們有情侶。

First question is, what is the enrollment target for the CDKN2A and 2B program?

第一個問題是，CDKN2A和2B計畫的招生目標是什麼？

And other part of the question is, what would be the - what are the scenarios for this program?

問題的另一部分是，該計劃的場景是什麼？

And what would be the benchmark and success that you would consider based on the data that you plan to disclose in the second half of this year?

根據今年下半年計畫揭露的數據，您認為的基準和成功是什麼？

Ahu, thank you for your question.

阿胡，謝謝你的提問。

I think this is for Brian.

我想這是給布萊恩的。

Turn over to you.

轉給你。

Hi, Ahu.

嗨，阿胡。

So the first question is it's a a two-stage process.

所以第一個問題是這是一個兩個階段的過程。

At stage one, is to look at approximately 12 to 14 patients, where you need to see more than two responses.

第一階段是觀察大約 12 到 14 名患者，您需要看到兩個以上的反應。

And then you would move on to the next phase of the study.

然後你將進入下一階段的研究。

The success for the first part will be at least two research responses in the first 12 to 14 patients.

第一部分的成功將是在前 12 至 14 名患者中至少有兩項研究反應。

I hope that clarifies and the next phase will be to confirm that dose responses just confirm in the biggest cohorts.

我希望這一點能夠澄清，下一階段將是確認劑量反應只是在最大的隊列中得到證實。

Yeah, that's helpful, Brian.

是的，這很有幫助，布萊恩。

And how many patients are you planning to show data in the second half of this year?

今年下半年您計劃展示多少患者的數據？

And what is the target enrollment for this program?

該計畫的目標招生人數是多少？

Accrual has been good and the patients required have this, that we need have been screened.

應計情況一直很好，所需的患者已經得到了我們需要的篩檢。

So we anticipate that's why we are reasonably confident we will be able to present at least just around a dozen patients worth of response data by the end of the year.

因此，我們預計這就是為什麼我們有理由相信，到今年年底，我們將能夠提供至少約十幾名患者的反應數據。

Just a reminder everyone, we scan here every two months.

只是提醒大家，我們每兩個月掃描一次。

So we are already in August.

所以我們已經是八月了。

This would be two months for the first scan, two months for the second to get the efficacy later on that group.

第一次掃描需要兩個月，第二次掃描需要兩個月才能獲得該組的療效。

If I could ask one more question, Brian, I think I would research that question to you, as well.

如果我能再問一個問題，布萊恩，我想我也會向你研究這個問題。

In terms of the alteration, is there any reason to change the local CDKN2B, 2A and 2B would be more potent form instead of the mutations and other alterations?

就改變而言，是否有任何理由改變局部CDKN2B、2A和2B將是更有效的形式而不是突變和其他改變？

Or it could be any of these and with the data disclosure in the second half would we be able to see what is the status of this different alterations?

或者可能是其中任何一個，隨著下半年的數據揭露，我們是否能夠看到這種不同改變的狀態是什麼？

You bring up a really interesting point in terms of the different either deletions or different mutations that are that are present.

關於存在的不同缺失或不同突變，您提出了一個非常有趣的觀點。

I think from what we've seen so far is WE will be able to get at least a feel from our old treated patients plus the muted which would be way over 20, 25 persons to see is there specific alteration that's mostly into the drugs.

我認為，從我們迄今為止所看到的情況來看，我們至少能夠從我們接受過治療的老患者以及超過20、25 名沉默的患者那裡得到一種感覺，看看是否有主要與藥物有關的具體改變。

So we'll get an idea.

所以我們會有一個想法。

There are numerous different ones and then hopefully from that analysis we will be able to hold it down, even a little bit more.

有很多不同的因素，希望透過分析我們能夠控制住它，甚至更多一點。

Great.

偉大的。

Thank you so much for answering my questions.

非常感謝您回答我的問題。

(Operator Instructions) Ladies and gentlemen, it appears, we have no further questions this afternoon.

（操作員指示）女士們先生們，看來我們今天下午沒有其他問題了。

Mr. Rombotis, I'll turn things back to you sir for any closing comments.

Rombotis 先生，我將把事情轉回給您，先生，請您發表任何結束意見。

And thanks to all of you for joining Cyclacel's second quarter 2024 earnings call.

感謝大家參加 Cyclacel 的 2024 年第二季財報電話會議。

We have achieved key milestones for Fadra with multiple patients dosed in the phase 2 proof-of-concept stage and look forward to important catalysts in 2024.

我們已經實現了 Fadra 的關鍵里程碑，在第二階段概念驗證階段，多名患者接受了給藥，並期待 2024 年出現重要的催化劑。

These include, reporting interim data from initial cohorts in the phase 2 proof-of-concept stage of the 065-11 study with oral Fadra in patients with advanced solid tumors and lymphoma.

其中包括報告 065-11 研究的 2 期概念驗證階段初始隊列的中期數據，該研究使用口服 Fadra 治療晚期實體瘤和淋巴瘤患者。

We look forward to providing you with further updates.

我們期待為您提供進一步的更新。

I hope to meet some of you at upcoming conferences.

我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, Mr. Rombotis.

謝謝您，龍博蒂斯先生。

Again ladies and gentlemen, that will conclude Cyclacel's financial results conference call.

女士們先生們，Cyclacel 的財務業績電話會議到此結束。

Again, thanks so much for joining us everyone.

再次非常感謝大家加入我們。

And we wish you all a great remainder of the day.

我們祝福大家在這一天剩下的時間裡度過愉快的時光。

Goodbye.

再見。