美國
證券交易委員會
華盛頓特區20549
表格
(標記一)
根據1934年證券交易法第13或15(d)條,本季度報告 |
截至季度結束日期的財務報告
或者
根據1934年證券交易法第13或15(d)條的轉型報告 | ||
對於 __________________ 到 __________________ 的轉型期 | ||
佣金文件號
(根據其章程規定的註冊人準確名稱)
| ||
(註冊地或其他司法管轄區) | (IRS僱主 | |
,(主要行政辦公地址) | (郵政編碼) |
公司電話,包括區號:(
根據證券法第12(b)條註冊的證券:
每一類的名稱 |
| 交易標誌 |
| 在其上註冊的交易所的名稱 |
請在以下方框內打勾:(1) 在過去的12個月內(或者在註冊公司需要提交此類報告的較短時期內),公司已經提交了根據證券交易法1934年第13或15(d)條規定需要提交的所有報告;以及 (2) 在過去的90天內,公司一直受到了此類報告提交的要求。
請在以下勾選方框表示註冊人是否已在Regulation S-T Rule 405規定的前12個月(或在註冊人需要提交此類文件的較短期間內)提交了每個互動數據文件。
大型加速歸檔人☐ |
| 加速報告人☐ |
( | ||
| 新興成長公司 |
如果申請人是新興成長公司,請用複選標記表示申請人是否選擇不使用根據交易所法案第13(a)條提供的遵守任何新的或修訂的財務會計準則的擴展過渡期。◻
股票,每股面值0.0001美元
截至2024年11月11日
2
第一部分 財務信息
項目1:基本報表
賽泰克製藥公司
基本報表
Fair Value of Financial Instruments
(未經審計)
| 九月30日, | 12月31日, | ||||
| 2024 |
| 2023 | |||
資產 | ||||||
流動資產: |
|
|
|
| ||
現金及現金等價物 | $ | | $ | | ||
預付費用和其他流動資產 |
| |
| | ||
總流動資產 |
| |
| | ||
資產和設備,淨值 |
| |
| | ||
使用權租賃資產 | | | ||||
非流動存款 | | | ||||
總資產 | $ | | $ | | ||
負債和股東權益(赤字) |
|
|
|
| ||
流動負債: |
|
|
|
| ||
應付賬款 | $ | | $ | | ||
應計及其他流動負債 |
| |
| | ||
流動負債合計 |
| |
| | ||
租賃負債 | | | ||||
總負債 |
| |
| | ||
股東權益(赤字): | ||||||
優先股,$0.0001 |
| |||||
| |
| | |||
65 |
| |
| | ||
|
| |
| | ||
普通股,每股面值爲 $0.0001; |
| |
| | ||
額外實收資本 |
| |
| | ||
累計其他綜合損失 |
| ( |
| ( | ||
累積赤字 |
| ( |
| ( | ||
股東權益(赤字) |
| ( |
| | ||
負債和股東權益(赤字)總額 | $ | | $ | |
附註是這些合併財務報表的一部分。
3
璨克醋酸西素製藥股份有限公司。
綜合營運狀況表
(以千美元為單位,除股份和每股金額外)
(未經審核)
| 截至三個月的結束 |
| 截至九個月的結束 | |||||||||
September 30, | 九月三十日, | |||||||||||
| 2024 |
| 2023 |
| 2024 |
| 2023 | |||||
營業收入: |
| |||||||||||
臨床試驗供應 | $ | | $ | | | | ||||||
收益 | $ | | $ | | $ | | $ | | ||||
營業費用: |
|
|
|
|
|
|
|
| ||||
研發 |
| |
| |
| |
| | ||||
一般和行政 |
| |
| |
| |
| | ||||
總營業費用 |
| |
| |
| |
| | ||||
營業虧損 |
| ( |
| ( |
| ( |
| ( | ||||
其他(費用)收入: |
|
|
|
|
|
|
|
| ||||
匯率期貨收益(損失) |
| |
| |
| |
| ( | ||||
利息(費用)收入 |
| |
| |
| ( |
| | ||||
其他收入(費用),淨額 |
| — |
| ( |
| |
| | ||||
其他合計(費用)收益,淨額 |
| |
| |
| |
| | ||||
稅前損失 |
| ( |
| ( |
| ( |
| ( | ||||
所得稅利益 |
| |
| |
| |
| | ||||
淨虧損 |
| ( |
| ( |
| ( |
| ( | ||||
可轉換交換優先股股息 |
| — |
| ( |
| — |
| ( | ||||
適用於普通股股東的淨虧損 | $ | ( | $ | ( | $ | ( | $ | ( | ||||
普通和稀釋每股盈利: |
|
|
|
|
|
|
|
| ||||
基本和稀釋每股淨損 - 普通股股東 | ( | ( | ( | ( | ||||||||
基本和稀釋每股淨損 - 可贖回普通股股東 | — | ( | — | ( |
附注是這些綜合基本報表的重要部分。
4
5
賽泰克製藥公司
股東權益(赤字)合併報表
15,294
(未經審計)
| 累積 | |||||||||||||||||||||
| 附加的 |
| 其他 |
| 總計 | |||||||||||||||||
| 優先股 |
| 普通股 |
| 實收資本 |
| 綜合 |
| 累積 |
| 股東的 | |||||||||||
| 股份 |
| 金額 |
| 股份 |
| 金額 |
| 資本 |
| 虧損 |
| 赤字 |
| 權益(虧損) | |||||||
2022年12月31日的餘額 | | $ | — |
| | $ | | $ | | $ | ( | $ | ( | $ | | |||||||
以股票爲基礎的補償 |
| — |
| — |
| — |
| — |
| |
| — |
| — |
| | ||||||
優先股股利 |
| — |
| — |
| — |
| — |
| ( |
| — |
| — |
| ( | ||||||
|
| — |
| — |
| — |
| — |
| — |
| |
| — |
| | ||||||
翻譯調整 |
| — |
| — |
| — |
| — |
| — |
| ( |
| — |
| ( | ||||||
損失期 |
| — |
| — |
| — |
| — |
| — |
| — |
| ( |
| ( | ||||||
EXHIBIT 31.1 |
| | $ | — |
| | $ | | $ | | $ | ( | $ | ( | $ | | ||||||
根據市場發行協議發行普通股,扣除費用後的淨額 |
| — |
| — |
| |
| — |
| |
| — |
| — |
| | ||||||
基於股票的報酬 |
| — |
| — |
| — |
| — |
| |
| — |
| — |
| | ||||||
優先股送轉 |
| — |
| — |
| — |
| — |
| ( |
| — |
| — |
| ( | ||||||
|
| — |
| — |
| — |
| — |
| — |
| |
| — |
| | ||||||
翻譯調整 |
| — |
| — |
| — |
| — |
| — |
| ( |
| — |
| ( | ||||||
損失期 |
| — |
| — |
| — |
| — |
| — |
| — |
| ( |
| ( | ||||||
2023年6月30日的餘額 |
| | $ | — |
| | $ | | $ | | $ | ( | $ | ( | $ | | ||||||
可贖回普通股重新分類 |
| — |
| — |
| |
| — |
| |
| — |
| — |
| | ||||||
以股票爲基礎的補償 |
| — |
| — |
| |
| — |
| |
| — |
| — |
| | ||||||
優先股股利 | — |
| — |
| — |
| — |
| ( |
| — |
| — |
| ( | |||||||
跨公司貸款的未實現匯率期貨 | — |
| — |
| — |
| — |
| — |
| ( |
| — |
| ( | |||||||
翻譯調整 |
| — |
| — |
| — |
| — |
| — |
| |
| — |
| | ||||||
本期虧損 |
| — |
| — |
| — |
| — |
| — |
| — |
| ( |
| ( | ||||||
2023年9月30日的餘額 |
| | $ | — |
| | $ | | $ | | $ | ( | $ | ( | $ | | ||||||
2023年12月31日的餘額 | | $ | — |
| | $ | | $ | | $ | ( | $ | ( | $ | | |||||||
在承銷發行中轉換預資助權證發行普通股產生的發行費用 | — |
| — |
| |
| — |
| ( |
| — |
| — |
| ( | |||||||
B系列優先股轉換 | ( | — | | — | — |
| — |
| — | — | ||||||||||||
以股票爲基礎的補償 |
| — |
| — |
| — |
| — |
| |
| — |
| — |
| | ||||||
|
| — |
| — |
| — |
| — |
| — |
| ( |
| — |
| ( | ||||||
翻譯調整 |
| — |
| — |
| — |
| — |
| — |
| |
| — |
| | ||||||
損失期 |
| — |
| — |
| — |
| — |
| — |
| — |
| ( |
| ( | ||||||
2024年3月31日的餘額 |
| | $ | — |
| | $ | | $ | | $ | ( | $ | ( | $ | ( | ||||||
在定向增發中,按照證券認購協議發行普通股和預資劵,扣除費用後 | — |
| — |
| |
| |
| |
| — |
| — |
| | |||||||
股票爲基礎的薪酬 |
| — |
| — |
| — |
| — |
| |
| — |
| — |
| | ||||||
母公司貸款的未實現匯率期貨 |
| — |
| — |
| — |
| — |
| — |
| |
| — |
| | ||||||
翻譯調整 |
| — |
| — |
| — |
| — |
| — |
| ( |
| — |
| ( | ||||||
本期虧損 |
| — |
| — |
| — |
| — |
| — |
| — |
| ( |
| ( | ||||||
2024年6月30日的餘額 |
| | $ | — |
| | $ | | $ | | $ | ( | $ | ( | $ | | ||||||
與定向增發中證券購買協議相關的費用 | — |
| — |
| — |
| — |
| ( |
| — |
| — |
| ( | |||||||
行使預先擔保的認股權 |
| — |
| — |
| |
|
| — |
| — |
| — |
| — | |||||||
基於股票的薪酬 | — |
| — |
| — |
| — |
| |
| — |
| — |
| | |||||||
母公司貸款的未實現外匯損益 |
| — |
| — |
| — |
| — |
| — |
| |
| — |
| | ||||||
翻譯調整 |
| — |
| — |
| — |
| — |
| — |
| ( |
| — |
| ( | ||||||
期間虧損 |
| — |
| — |
| — |
| — |
| — |
| — |
| ( |
| ( | ||||||
2024年9月30日的餘額 |
| | $ | — |
| | $ | | $ | | $ | ( | $ | ( | $ | ( |
附註是這些合併財務報表的一部分。
6
賽泰克製藥公司
綜合現金流量表
(以千美元計)
(未經審計)
九個月結束 | ||||||
九月三十日, | ||||||
| 2024 |
| 2023 | |||
經營活動: |
|
| ||||
淨損失 | $ | ( | $ | ( | ||
調整爲淨損失到經營活動現金流量淨使用: |
|
| ||||
折舊 | | | ||||
基於股票的補償 | | | ||||
租賃責任的變化 | ( | ( | ||||
經營性資產和負債變動: | ||||||
預付款項和其他資產 | | | ||||
應付賬款、應計費用和其他流動負債 | ( | | ||||
經營活動使用的淨現金流量 | ( | ( | ||||
投資活動: |
|
| ||||
購買固定資產和設備 | | ( | ||||
用於投資活動的淨現金 | | ( | ||||
籌資活動: |
|
| ||||
發行普通股和預融資認股權證的淨收益 | | | ||||
支付優先股股息 | | ( | ||||
籌資活動的淨現金提供(使用) | | ( | ||||
匯率變動對現金及現金等價物的影響 | | ( | ||||
現金及現金等價物的淨增加(減少) | ( | ( | ||||
現金及現金等價物期初餘額 | | | ||||
現金及現金等價物期末餘額 | $ | | $ | | ||
補充現金流量信息: |
|
| ||||
期間收到的現金: |
|
| ||||
利益 | $ | | $ | | ||
研究和開發稅收抵免 | $ | | $ | | ||
期間支付的現金用於: | ||||||
稅收 | $ | | $ | | ||
非現金融資活動: |
|
| ||||
優先股股利的應計 | $ | | $ | |
附註是這些合併財務報表的一部分。
7
賽泰克製藥公司
未經審計的合併財務報表附註
1. 公司資料
業務性質
Cyclacel製藥公司(「Cyclacel」或「公司」) 是一家臨床階段的生物製藥 公司,專注於開發基於細胞週期、轉錄調控、表觀遺傳學和有絲分裂控制生物學的創新癌症藥物。 Cyclacel是一家在癌症細胞週期生物學領域的先鋒公司,其願景是通過將癌症生物學的見解轉化爲能夠克服支撐位的藥物,從而改善患者的醫療保健,最終提高患者的整體生存率。
截至2024年9月30日,公司迄今爲止的所有努力幾乎全部致力於進行研究和開發、開展臨床試驗、開發和獲取知識產權、籌集資金以及招聘和培訓人員。
2. 重要會計政策摘要
報告範圍
截至2024年9月30日的合併資產負債表、截至2024年和2023年9月30日的三個月及九個月的合併損益表、全面損失表和股東權益(赤字)表,以及截至2024年和2023年9月30日的九個月的合併現金流量表,及所有相關披露均未經過審計。截止2023年12月31日的合併資產負債表源於以2023年12月31日結束的財政年度爲基礎的已審計合併基本報表,納入於2023年3月21日向證券交易委員會(「SEC」)提交的10-k表格的年度報告。合併基本報表是按照美國普遍接受的會計原則(「GAAP」)爲中期基本報表的會計原則的基礎上列示,並符合證券交易委員會(SEC)的規則和規定。因此,它們不包括美國普遍接受的會計原則對於完整的基本報表所要求的所有信息和附註。管理層認爲,所有調整,包括僅爲公允呈現截至2024年9月30日的合併資產負債表所必需的正常經常性調整,及截至2024年9月30日的三個月和九個月的損益、全面損失及股東權益(赤字)的變化、以及截至2024年9月30日的九個月的現金流量,均已完成。截止2024年9月30日的三個月和九個月的中期結果不一定代表截至2024年12月31日或任何其他報告期間應預期的結果。合併基本報表應與截至2023年12月31日的已審計合併基本報表及隨附的附註一同閱讀,該報表已包含在公司於2024年3月21日向證券交易委員會(SEC)提交的10-k年度報告中。
持續經營
根據會計準則分類(ASC)205-40的要求, 財務報表的呈現 - 持續經營,在每個報告期間,管理層需評估是否存在條件或事件,整體考慮會對企業在財務報表發佈之日起一年內持續經營能力產生重大懷疑。該評估最初不考慮在財務報表發佈之日尚未完全實施的管理計劃可能產生的減輕影響。當根據此方法存在重大懷疑時,管理層評估其計劃的減輕效果是否足以緩解對公司持續經營能力的重大懷疑。然而,只有在(1)這些計劃在財務報表發佈之日起一年內可能會被有效實施,並且(2)在實施後,這些計劃可能會減輕引發對實體持續經營能力在本財務報表發佈之日後一年內產生重大懷疑的相關條件或事件的情況下,才會考慮管理計劃的減輕效果。
8
聲明已發佈。在進行分析時,管理層排除了運營計劃的某些不可能的內容。根據ASC 205-40,目前不認爲未來可能通過未來股權或債務發行或簽訂合夥協議獲得潛在資金,因爲截至本合併財務報表發佈之日,這些計劃並不完全在公司的控制範圍內,也尚未獲得董事會的批准。
根據公司目前的運營計劃,預計現金和現金等價物爲美元
2024年8月26日,納斯達克股票市場有限責任公司(「納斯達克」)的上市資格員工(「員工」)確定該公司不遵守納斯達克上市規則5550(b)(1)(「股權規則」),因爲截至2024年6月30日,該公司報告的股東權益低於250萬美元。工作人員的通知進一步指出,除非公司及時要求納斯達克聽證小組(「小組」)舉行聽證會,否則該公司的證券將被除名。截至2024年9月30日,該公司的股東權益赤字約爲美元
所附的合併財務報表是在持續經營的基礎上編制的,其中考慮在正常業務過程中變現資產和清償負債。
最近發佈的會計公告
財務會計準則委員會已經發布了亞利桑那州立大學2023-07年 「分部報告(主題280)」。該標準將要求所有公共實體,包括像公司這樣擁有單一可報告細分市場的公共實體,披露有關首席運營決策者(「CODM」)的頭銜和職位、CodM在評估細分市場績效和決定如何分配資源時使用的細分市場損益衡量標準、解釋Codm如何使用報告的衡量標準來評估細分市場績效、定期提供給的重大細分市場支出 CodM 和區段對賬損益與根據美國公認會計原則編制的最接近的合併總額之比。亞利桑那州立大學2023-07年的修正案對2023年12月15日之後開始的財政年度以及2024年12月15日之後開始的財政年度內的過渡期有效。亞利桑那州立大學2023-07不會改變確定應報告細分市場的方式。但是,該公司目前正在評估亞利桑那州立大學2023-07年對其財務報表列報和披露的影響。
財務會計準則委員會發布了亞利桑那州立大學2023-09年 「所得稅(主題740):所得稅披露的改進」。該標準將要求所有實體在按百分比和絕對美元計算法定所得稅率與有效稅率進行對賬時包括特定的標題。亞利桑那州立大學2023-09年度還將要求各實體披露每個年度報告期內按聯邦(國家)、州和外國分列的已繳所得稅金額(扣除收到的退款),並單獨披露向其繳納的稅款或從其收到的稅款超過規定門檻的個別司法管轄區。亞利桑那州立大學2023-09年的指導方針在2024年12月15日之後開始的年度內生效。該公司預計,亞利桑那州立大學2023-09年不會要求對該信息的列報方式進行重大調整。
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金融工具的公允價值
金融工具包括現金等價物、應付賬款和應計負債。由於帳戶的性質和其短期到期,現金等價物、應付賬款和應計負債的賬面金額大致接近其公允價值。
綜合收益(虧損)
所有綜合收益(損失)的元件,包括淨利潤(損失),均在其確認的期間內報告於基本報表中。綜合收益(損失)被定義爲在一段期間內,由交易和其他事件及非所有者來源的情況導致的股權變化。淨利潤(損失)和其他綜合收益(損失),包括外匯轉換調整,在淨處理任何相關稅務影響後報告,以得出綜合收益(損失)。
外幣和貨幣翻譯
以外幣計價的交易在交易日期按當前匯率重新計量爲功能貨幣。任何以外幣計價的貨幣資產和負債隨後按照當前匯率重新計量,收益或損失在基本報表中作爲匯率期貨(損失)收益確認。該會計政策同樣適用於計劃或預期在可預見的未來進行結算的以外幣計價的公司間應付款或應收款。
公司的國際子公司的資產和負債按資產負債表日期的匯率從其功能貨幣轉換爲美元。在該期間內的平均匯率用於轉換基本報表,而歷史匯率用於轉換任何股權交易。由於平均匯率與資產負債表匯率之間的差異以及由於將公司間貸款翻譯成匯率期貨收益或損失而產生的未實現匯率期貨收益或損失,合併時產生的翻譯調整被記錄在其他綜合損失中。
對於計劃或預期在可預見的未來不進行結算且屬於長期投資性質的交易被記錄在其他綜合損失中。
租賃協議
本公司依據ASC 842處理租賃合同。截至2024年9月30日,本公司未結租賃被歸類爲經營租賃。
公司確認一項資產,用於在租賃期內使用基礎租賃資產,並根據公司在租賃下支付租金的義務現值記錄租賃負債。由於公司的租賃未指明隱含利率,公司使用增量借款利率的最佳估計值來折現未來的租金支付。公司根據與租賃期限相同的無風險利率的可觀察信息,調整各類因素,包括假定抵押品的影響、貸款償還的方式(如攤銷與到期償還)以及公司的信用風險,來估算其增量借款利率。
公司評估其租賃協議中包含的承租人控制的選項,以延長或終止租賃。在合理確定公司將行使該選項的情況下,公司將在租賃期內反映行使這些選項的影響。在評估公司是否合理確定將行使選項時,公司考慮諸如:
● | 任何可選擇期間內到期的租金支付; |
● | 未行使(或不行使)選項的處罰; |
● | 市場因素,如類似資產的可用性和這些資產的當前租金率; |
● | 基礎租賃資產的性質及其對公司的運營的重要性;並且 |
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● | 任何相關租賃改良的剩餘有用壽命。 |
經營租賃的租賃費用按直線法分攤到租賃期內。如果有的話,可變租金會在產生支付義務的期間確認。在租賃開始前收到的租賃激勵會記錄爲減少使用權資產。在租賃開始後收到的固定租賃激勵會同時減少租賃負債和使用權資產。
公司已選擇一種會計政策,將租賃和非租賃元素視爲單一租賃元素。
收入確認
當公司與客戶簽訂合同時,公司會使用ASC 606提供的五步模型確認營業收入。 《與客戶的合同收益》 「Topic 606」方式於2018年1月1日起生效,使用修正追溯法採用收入的新準則。2018年1月1日起使用新的收入準則並未改變公司的收入確認,因爲當期沒有收入。(「ASC 606」):
(1) | 確定與客戶的合同; |
(2) | 確定合同中的績效義務; |
(3) | 確定交易價格; |
(4) | 將交易價格分配給合同中的履約義務;並 |
(5) | 在公司滿足履約義務時,或者隨時確認營業收入。 |
交易價格包括固定支付和可變考慮的估計,包括里程碑支付。公司通過估計最可能收到的金額來確定應包括在交易價格中的可變考慮,並應用約束條件將該金額減少到有可能收到的金額。在應用約束條件時,公司考慮以下因素:
● | 是否開發里程碑的達成在很大程度上受到實體無法控制的因素的影響,例如涉及第三方判斷或行動的里程碑,包括監管機構的里程碑; |
● | 里程碑的實現是否不太可能在很長一段時間內得到解決; |
● | 公司能否基於以往經驗合理預測里程碑的達成;並且 |
● | 實現里程碑存在的複雜性和固有不確定性。 |
交易價格根據每項履約義務的相對銷售價格分配。在考慮所有合理可獲得的信息後,包括市場數據和情況,實體特定因素,例如可交付物的成本結構以及內部利潤和定價目標後,銷售價格的最佳估計確定。
分配給每個履約責任的營業收入在公司履行履約責任時或認可。
當公司已滿足履約義務的價值(部分滿足)超過應付給公司的付款時,公司確認合同資產;當無條件考慮金額超過已滿足(或部分滿足)履約義務的價值時,確認遞延營業收入。一旦收款權無條件,該金額將被列示爲應收款。
來自非公司客戶(如慈善基金會或政府機構)的補助收入作爲與相關的研發費用相抵。
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3. Revenue
The Company recognized $
4. Net Loss per Common Share
The Company calculates net loss per common share in accordance with ASC 260 “Earnings Per Share” (“ASC 260”). Basic and diluted net loss per common share was determined by dividing net loss applicable to common stockholders by the weighted average number of shares of common stock outstanding during the period.
The following potentially dilutive securities have not been included in the computation of diluted net loss per share for the three months ended September 30, 2024 and 2023, as the result would be anti-dilutive:
| September 30, | September 30, | ||
| 2024 |
| 2023 | |
Stock options |
| |
| |
Restricted Stock Units |
| |
| |
| |
| | |
Series A preferred stock |
| |
| |
Series B preferred stock |
| |
| |
Common stock warrants |
| |
| |
Total shares excluded from calculation |
| |
| |
5. Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consisted of the following (in $000s):
| September 30, | December 31, | ||||
| 2024 |
| 2023 | |||
Research and development tax credit receivable | $ | | $ | | ||
Prepayments and VAT receivable | |
| | |||
Other current assets |
| | | |||
$ | | $ | |
6. Non-Current Assets
As of September 30, 2024, the Company had non-current assets of $
7. Accrued and Other Liabilities
Accrued and other current liabilities consisted of the following (in $000s):
| September 30, | December 31, | ||||
| 2024 |
| 2023 | |||
Accrued research and development | $ | | $ | | ||
Accrued legal and professional fees |
| |
| | ||
Other current liabilities |
| |
| | ||
$ | | $ | |
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8. Leases
The Company currently has an operating lease liability relating to its facilities in Berkeley Heights, New Jersey.
For the nine months ended September 30, 2024 and 2023, the Company recognized operating lease expenses of $
Remaining lease payments for both facilities are as follows (in $000s):
2024 |
| $ | |
2025 | | ||
Thereafter | | ||
Total future minimum lease obligation | $ | | |
Less discount | ( | ||
Total |
| $ | |
9. Stock Based Compensation
ASC 718 requires compensation expense associated with share-based awards to be recognized over the requisite service period which, for the Company, is the period between the grant date and the date the award vests or becomes exercisable. The Company recognizes all share-based awards under the straight-line attribution method, assuming that all granted awards will vest. Forfeitures are recognized in the periods when they occur.
Stock based compensation has been reported within expense line items on the consolidated statement of operations for the three and nine months ended September 30, 2024 and 2023 as shown in the following table (in $000s):
| Three Months Ended |
| Nine Months Ended |
| |||||||||
| September 30, |
| September 30, |
| |||||||||
| 2024 |
| 2023 |
| 2024 |
| 2023 | ||||||
General and administrative | $ | | $ | | $ | | $ | | |||||
Research and development | | $ | | | | ||||||||
Stock-based compensation costs | $ | | $ | | $ | | $ | |
2018 Plan
In May 2018, the Company’s stockholders approved the 2018 Equity Incentive Plan (the “2018 Plan”), under which Cyclacel may make equity incentive grants to its officers, employees, directors and consultants. The 2018 Plan replaced the 2015 Equity Incentive Plan (the “2015 Plan”).
The 2018 Plan allows for various types of award grants, including stock options and restricted stock units.
On June 21, 2024, the Company’s stockholders approved an additional
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2020 Inducement Equity Incentive Plan
In October 2020, the Inducement Equity Incentive Plan (the “Inducement Plan”), became effective. Under the Inducement Plan, Cyclacel may make equity incentive grants to new senior level Employees (persons to whom the Company may issue securities without stockholder approval). The Inducement Plan allows for the issuance of up to
Option Grants and Exercises
There were
All of the options granted during the nine months ended September 30, 2024 shall vest
The fair value of the stock options granted is calculated using the Black-Scholes option-pricing model as prescribed by ASC 718 using the following assumptions:
Nine months ended | Nine months ended | |||
| September 30, 2024 |
| September 30, 2023 | |
Expected term (years) |
|
| ||
Risk free interest rate |
| |||
Volatility |
| |||
Expected dividend yield over expected term |
| |||
Resulting weighted average grant date fair value |
| $ | $ |
There were
As of September 30, 2024, the total remaining unrecognized compensation cost related to the non-vested awards with service conditions amounted to approximately $
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Outstanding Options
A summary of the share option activity and related information is as follows:
|
|
| Weighted |
| ||||||
|
| Weighted |
| Average |
| |||||
| Number of |
| Average |
| Remaining |
| Aggregate | |||
Options |
| Exercise |
| Contractual | Intrinsic | |||||
Outstanding | Price Per Share |
| Term (Years) | Value ($000) | ||||||
Options outstanding at December 31, 2023 |
| | $ | |
| $ | — | |||
Granted | | $ | |
| — | $ | — | |||
Exercised | — | $ | |
| — | $ | — | |||
Cancelled/forfeited | ( | $ | |
| — | $ | — | |||
Options outstanding at September 30, 2024 |
| | $ | |
| $ | — | |||
Unvested at September 30, 2024 |
| | $ | |
| $ | — | |||
Vested and exercisable at September 30, 2024 |
| | $ | |
| $ | — |
Restricted Stock Units
The Company issued
A total of
Summarized information for restricted stock units as of September 30, 2024 is as follows:
|
| Weighted | ||
|
| Average | ||
Restricted |
| Remaining | ||
Stock Units | Term | |||
Restricted Stock Units outstanding at December 31, 2023 |
| | ||
Granted | | |||
Cancelled/forfeited | ( | |||
Restricted Stock Units outstanding at September 30, 2024 | | |||
Unvested at September 30, 2024 |
| | ||
Vested at September 30, 2024 |
| |
10. Stockholders Equity
April 2024 Securities Purchase Agreement
On April 30, 2024, the Company entered into a securities purchase agreement (the “Purchase Agreement”) with an institutional investor (the “Purchaser”) for the issuance and sale in a private placement (the “Private Placement”) of (i)
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“Series A Warrants”), and (iv) series B warrants to purchase up to
The Common Warrants are exercisable immediately upon issuance at an exercise price of $
In connection with the Private Placement, the Company entered into a registration rights agreement (the “Registration Rights Agreement”), dated as of April 30, 2024, with the Purchaser, pursuant to which the Company agreed to prepare and file a registration statement with the Securities and Exchange Commission (the “SEC”) registering the resale of the securities issued in the Private Placement.
The Private Placement closed on May 2, 2024. The gross proceeds to the Company from the Private Placement were approximately $
H.C. Wainwright & Co., LLC (“Wainwright”) acted as the Company’s exclusive placement agent in connection with the Private Placement, pursuant to that certain engagement letter, dated as of April 29, 2024, between the Company and Wainwright (as amended, the “Engagement Letter”). Pursuant to the Engagement Letter, the Company paid Wainwright (i) a cash fee equal to
In connection with this transaction, the Company was required to compensate Roth Capital Partners, LLC, pursuant to a tail provision contained in an engagement letter entered into on March 14, 2024, in an amount equal to
Each of the instruments issued in the Private Placement have been classified and recorded as part of shareholders’ equity (deficit). The amounts allocated to each issued security were based on their relative fair values, resulting in initial carrying values of the respective instruments as follows:
Allocated Amount | |
Common shares | $ |
Prefunded warrants | |
Common warrants | |
Net proceeds | $ |
The aggregate fair value of the Placement Agent Warrants was $
In determining the fair values of the Pre-Funded Warrants, Common Warrants, and Placement Agent Warrants, the Company used a Black-Scholes Option Pricing model with the following assumptions:
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Pre-Funded Warrants | Common Warrants | Placement Agent Warrants | |
Expected volatility | |||
Contractual term | - | ||
Risk-free interest rate | |||
Expected dividend yield |
The fair value of the common shares was determined using the closing price of the Company’s common stock as of May 2, 2024, which is the date that the Private Placement closed.
December 2023 Registered Direct Offering Securities Purchase Agreement
On December 21, 2023, the Company entered into a securities purchase agreement (the “Securities Purchase Agreement”) with certain institutional investors (“Purchasers”). Pursuant to the Securities Purchase Agreement, the Company agreed to sell in a registered direct offering (“Registered Direct Offering”)
Pursuant to the Securities Purchase Agreement, in a concurrent private placement (together with the Registered Direct Offering, the “Offerings”), the Company also agreed to issue to the Purchasers unregistered warrants (“Common Warrants”) to purchase up to
On December 21, 2023, in a separate concurrent insider private placement (the “Insider Private Placement”), the Company also entered into a Securities Purchase Agreement with certain of its executive officers (the “Insider Securities Purchase Agreement”) pursuant to which the Company agreed to sell in a private placement (i)
Ladenburg Thalmann & Co. Inc. (the “Placement Agent”) acted as the exclusive placement agent for the Offerings, pursuant to a placement agency agreement (the “Placement Agency Agreement”), dated December 21, 2023, by and between the Company and the Placement Agent.
Pursuant to the Placement Agency Agreement, the Company paid the Placement Agent a cash placement fee equal to
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equal to
Each of the instruments issued in the Offerings and the Insider Private Placement have been classified and recorded as part of shareholders’ equity (deficit). The amounts allocated to each issued security were based on their relative fair values, resulting in initial carrying values of the respective instruments as follows:
The aggregate fair value of the Placement Agent Warrants was $
In determining the fair values of the Pre-Funded Warrants, Regular Warrants, and Placement Agent Warrants, the Company used a Black-Scholes Option Pricing model with the following assumptions:
The fair value of the common shares was determined using the closing price of the Company’s common stock as of December 26, 2023, which is the date that the Offerings and the Insider Private Placement closed.
August 2021 Controlled Equity Offering Sales Agreement
On August 12, 2021, the Company entered into a Controlled Equity Offering Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co. ("Cantor"), pursuant to which the Company could issue and sell, from time to time, shares of its common stock having an aggregate offering price of up to $
On August 12, 2022, the Company became aware that the shelf registration statement on Form S-3 (file number 333-231923) (the “Registration Statement”) associated with this Sales Agreement had expired on June 21, 2022. Prior to becoming aware of the expiration, the Company sold an aggregate of
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rescission rights for these shares have lapsed and the shares were reclassified back to permanent equity. There have been no claims or demands to exercise such rights.
On August 15, 2022, due to expiry of the Registration Statement, the Sales Agreement was mutually terminated. A total of
Warrants
April 2024 Warrants
As of September 30, 2024, warrants to purchase a total of
A total of
December 2023 Warrants
As of September 30, 2024, warrants to purchase a total of
There were
December 2020 Warrants
As of September 30, 2024, warrants to purchase
There were
April 2020 Warrants
As of September 30, 2024,
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stock dividends, stock splits, reorganizations or similar events affecting the Company’s common stock. The common warrants were issued separately from the common stock and were eligible for transfer immediately after issuance. A common warrant to purchase
The common warrants are exercisable, at the option of each holder, in whole or in part, by delivering to the Company a duly executed exercise notice accompanied by payment in full for the number of shares of the Company’s common stock purchased upon such exercise (except in the case of a cashless exercise). A holder (together with its affiliates) may not exercise any portion of the common warrant to the extent that the holder would own more than
There were
Series B Preferred Stock
A total of
Holders of Series B Preferred Stock are entitled to receive dividends on shares of Series B Preferred Stock equal, on an as-if-converted-to-common-stock basis, and in the same form as dividends actually paid on shares of the common stock. Except as otherwise required by law, the Series B Preferred Stock does not have voting rights. However, as long as any shares of Series B Preferred Stock are outstanding, the Company will not, without the affirmative vote of the holders of a majority of the then outstanding shares of the Series B Preferred Stock, (a) alter or change adversely the powers, preferences or rights given to the Series B Preferred Stock, (b) alter or amend the Certificate of Designation, (c) amend its certificate of incorporation or other charter documents in any manner that adversely affects any rights of the holders of Series B Preferred Stock, (d) increase the number of authorized shares of Series B Preferred Stock, (e) pay certain dividends or (f) enter into any agreement with respect to any of the foregoing. The Series B Preferred Stock does not have a preference upon any liquidation, dissolution or winding-up of the Company. The Purchaser may convert shares of Series B Preferred Stock through a conversion into shares of common stock if and solely to the extent that such conversion would not result in the Purchaser beneficially owning in excess of
During the year ended December 31, 2023,
Series A Preferred Stock
A total of
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As of September 30, 2024 and December 31, 2023,
In the event of a liquidation, the holders of shares of the Series A Preferred Stock may participate on an as-converted-to-common-stock basis in any distribution of assets of the Company. The Company shall not pay any dividends on shares of common stock (other than dividends in the form of common stock) unless and until such time as dividends on each share of Series A Preferred Stock are paid on an as-converted basis. There is no restriction on the Company’s ability to repurchase shares of Series A Preferred Stock while there is any arrearage in the payment of dividends on such shares, and there are no sinking fund provisions applicable to Series A Preferred Stock.
Subject to certain conditions, at any time following the issuance of the Series A Preferred Stock, the Company has the right to cause each holder of the Series A Preferred Stock to convert all or part of such holder’s Series A Preferred Stock in the event that (i) the volume weighted average price of our common stock for
The Series A Preferred Stock has no maturity date, will carry the same dividend rights as the common stock, and with certain exceptions contains no voting rights. In the event of any liquidation or dissolution of the Company, the Series A Preferred Stock ranks senior to the common stock in the distribution of assets, to the extent legally available for distribution.
As of September 30, 2024, there were
The Company may automatically convert the
The
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The Company may, at its option, redeem the
The
11. Subsequent Events
Dividends on
On September 4, 2024, the board of directors of the Company passed a resolution to suspend payment of the quarterly cash dividend on the Company’s
On October 15, 2024,
As of October 23, 2024, all of the remaining
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q, including, without limitation, Management’s Discussion and Analysis of Financial Condition and Results of Operations, contains “forward-looking statements” within the meaning of Section 27A of the Securities Exchange Act of 1933 as amended and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). We intend that the forward-looking statements be covered by the safe harbor for forward-looking statements in the Exchange Act. The forward-looking information is based on various factors and was derived using numerous assumptions. All statements, other than statements of historical fact, that address activities, events or developments that we intend, expect, project, believe or anticipate will or may occur in the future are forward-looking statements. Such statements are based upon certain assumptions and assessments made by our management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These forward-looking statements are usually accompanied by words such as “believe,” “anticipate,” “plan,” “seek,” “expect,” “intend” and similar expressions.
Forward-looking statements necessarily involve risks and uncertainties, and our actual results could differ materially from those anticipated in the forward looking statements due to a number of factors, including those set forth in Part I, Item 1A, entitled “Risk Factors,” of our Annual Report on Form 10-K for the year ended December 31, 2023, as updated and supplemented by Part II, Item 1A, entitled “Risk Factors,” of our Quarterly Reports on Form 10-Q, and elsewhere in this report. These factors as well as other cautionary statements made in this Quarterly Report on Form 10-Q, should be read and understood as being applicable to all related forward-looking statements wherever they appear herein. The forward-looking statements contained in this Quarterly Report on Form 10-Q represent our judgment as of the date hereof. We encourage you to read those descriptions carefully. We caution you not to place undue reliance on the forward-looking statements contained in this report. These statements, like all statements in this report, speak only as of the date of this report (unless an earlier date is indicated) and we undertake no obligation to update or revise the statements except as required by law. Such forward-looking statements are not guarantees of future performance and actual results will likely differ, perhaps materially, from those suggested by such forward-looking statements. In this report, “Cyclacel,” the “Company,” “we,” “us,” and “our” refer to Cyclacel Pharmaceuticals, Inc.
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Overview
We are a clinical-stage biopharmaceutical company developing innovative cancer medicines based on cell cycle, transcriptional regulation, epigenetics and mitosis control biology. We reported revenue of $10,000 and $43,000 for the three and nine months ended September 30, 2024, respectively, and revenues of $16,000 and $389,000 for the comparable three and nine months ended September 30, 2023, respectively. We do not expect to report a significant amount of revenue for the foreseeable future.
Our primary focus has been on the development of our transcriptional regulation program, which is evaluating fadraciclib, a CDK2/9 inhibitor, in solid tumors and hematological malignancies. The anti-mitotic program is evaluating plogosertib, a PLK1 inhibitor, in advanced cancers.
We currently retain all marketing rights worldwide to the compounds associated with our drug programs.
Fadraciclib Phase 1/2 Study in Advanced Solid Tumors and Lymphoma (065-101; NCT#04983810)
In this ongoing study, a total of 47 heavily pretreated patients have been dosed in the Phase 1 part of the 065-101 study through eight dose levels. Clinical, pharmacokinetic (PK) and pharmacodynamic (PD) data from the study were presented at a poster at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.
Patients received a median of four prior lines of therapy. Fadraciclib was generally well tolerated with good compliance between dose levels 1 and 5. The most common treatment related adverse events reported were nausea (66.0%), vomiting (46.8%), diarrhea (31.9%) fatigue (25.5%), and hyperglycemia (21.3%). A total of 25 drug-related serious adverse events (SAE) were reported in 8 patients. The most common SAEs reported were hyperglycemia (n=4), platelet count decrease (n=3), and accidental overdose (n=3).
There were no drug-related SAEs at dose level 5 (100 mg bid, 5 days a week, for 4/4 weeks) which was selected for the Phase 2 proof of concept part of the 065-101 study. PKs were dose-proportional and exceeded the preclinical efficacy targets for both CDK2 and CDK9. PDs evaluated in peripheral blood showed suppression of CDKN2A/B by four hours post treatment in most patients who received 100 mg bid or higher.
A total of 34 patients had measurable target lesions at baseline. Two partial responses were reported in patients with T-cell lymphoma, one of whom had CDKN2A loss. A squamous non-small cell lung (NSCLC) cancer patient with CDKN2A and CDKN2B loss achieved 22% reduction in tumor burden at 4 weeks per RECIST 1.1 criteria. In addition, clinical benefit was reported in two patients with endometrial cancer and one each with ovarian and pancreatic cancers.
The primary objectives of the 065-101 study in the Phase 1 dose escalation stage are to determine maximum tolerated dose (MTD) and/or RP2D and in the Phase 2, Proof of Concept stage to evaluate preliminary efficacy of fadraciclib as measured by overall response rate (ORR). The secondary objectives in dose escalation are to assess safety and tolerability, pharmacokinetics, and ORR, while in Phase 2, Proof of Concept, to assess safety and tolerability, evaluate disease control rate (DCR), duration of response (DOR), progression free survival (PFS), and overall survival (OS). The study is utilizing a Simon two-stage optimal design to evaluate clinical activity. Exploratory objectives include investigation of clinical pharmacodynamics (PD) and pharmacogenomics (PGx).
The Phase 2, part of the study is ongoing and two dose expansion cohorts are enrolling patients with mechanistically relevant biomarkers, including CDKN2A and/or CDKN2B mutation or deletion or T-cell lymphoma. Cohort 8 prospectively enrolled 12 patients with known CDKNA/B genetic alterations between April and September 2024. The rationale was to further evaluate observations of clinical activity in Phase 1 patients with known CDNK2A or CDKN2B genetic alterations. Cohort 6 is enrolling patients with T-cell Lymphoma with two patients treated so far. The rationale was to further evaluate observations of partial response (PR) in 2/3 Phase 1 patients with T-cell lymphoma. Certain T-Cell lymphomas are known to harbor CDNK2A genetic alterations. All patients were treated with oral fadraciclib 100mg BID, M-F, week 1-4 in 28-day cycles which was the Recommended Phase 2 dose (RP2D).
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Interim data from the Phase 2 was presented as a poster at the 2024 EORTC-NCI-AACR 36th Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, Spain in October, 2024. The data showed that fadraciclib was well tolerated in Cohort 8. Most common drug-related adverse events included diarrhea, nausea, vomiting and were similar to those seen at this dose in Phase 1. There were no Grade 3 or higher treatment-emergent adverse events in the Phase 2 study this far, consistent with the Phase 1 data. The majority of patients (12/14) had ECOG performance status of 1 and median number of prior therapies was 3.
In Cohort 8, four patients had pancreatic cancer, and one each cholangiocarcinoma, duodenal, melanoma, cervical, laryngeal, ovarian, squamous cell cancer with unknown primary (CUP) and thymus cancer. Out of six patients evaluable for efficacy, two achieved stable disease: a melanoma patient whose treatment duration was 125 days and a squamous cell CUP patient who achieved 11% tumor shrinkage in the sum of all lesions on first scan with treatment duration of over 85 days (ongoing). Two additional patients with ovarian and laryngeal cancer are ongoing but have not had their first scan yet.
The most common molecular characteristics of Cohort 8 patients were loss of function or deletion of CDKN2A and/or CDKN2B tumor suppressor genes. Other pharmacogenomic observations included CDKN2A/B, KRAS and/or TP53 mutations.
Fadraciclib tablets can be given orally with repeat dosing which has led to transient suppression of anti-apoptosis proteins with generally good tolerability and no Grade 3 or higher hematological toxicity in the first cycle. We believe that fadraciclib’s inhibition of CDK2 and CDK9 may be superior to inhibiting either CDK2 or CDK9 alone.
Plogosertib Phase 1/2 Study in Advanced Solid Tumors and Lymphoma (140-101; NCT#05358379)
This open-label Phase 1/2 registration-directed study uses a streamlined design and initially seeks to determine the RP2D for single-agent oral plogosertib in a dose escalation stage. Once RP2D has been established, the study will enter into proof-of-concept, cohort stage, using a Simon 2-stage design. In this stage plogosertib will be administered to patients in up to seven mechanistically relevant cohorts including patients with bladder, breast, colorectal (including KRAS mutant), hepatocellular and biliary tract, and lung cancers (both small cell and non-small cell), as well as lymphomas. An additional basket cohort will enroll patients with biomarkers relevant to the drug’s mechanism, including MYC amplified tumors. The protocol allows for expansion of individual cohorts based on response which may allow acceleration of the clinical development and registration plan for plogosertib.
Fifteen patients have been treated at the first five dose escalation levels with no dose limiting toxicities observed. Stable disease has been observed in pretreated patients with gastrointestinal, lung, and ovarian cancers. A new, alternative salt, oral formulation of plogosertib with improved bioavailability is under development.
Going Concern
For the nine months ended September 30, 2024, we used net cash of $6.6 million to fund our operating activities. We have cash and cash equivalents of $3.0 million as of September 30, 2024, will allow it to meet its liquidity requirements into the fourth quarter of 2024. However, there remains substantial doubt about our ability to continue as a going concern. We are currently investigating ways to raise additional capital through private equity financing or by entering into a strategic transaction. In the event that we are not able to secure funding, we may be forced to curtail operations, delay or stop ongoing development activities, cease operations altogether, and/or file for bankruptcy.
On August 26, 2024, the Staff of Nasdaq determined that we were not in compliance with the Equity Rule because we reported stockholders’ equity of less than $2.5 million as of June 30, 2024. The notice from the Staff further stated that unless we timely requested a hearing before a Panel, our securities would be subject to delisting. As of September 30, 2024, we had a stockholders equity deficit of approximately $0.97 million which is not in compliance with the Equity Rule. On October 15, 2024, we met with the Panel regarding our potential delisting from Nasdaq as a result of our violation of the Equity Rule. On October 22, 2024, we received the Panel’s decision which granted us until
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December 24, 2024 to regain compliance with the Equity Rule and all applicable criteria for continued listing on Nasdaq. If we are unable to regain compliance with the listing standards of the Nasdaq Capital Market by December 24, 2024, our securities may be delisted from Nasdaq.
Liquidity and Capital Resources
The following is a summary of our key liquidity measures as of September 30, 2024 and 2023 (in $000s):
September 30, | ||||||
| 2024 |
| 2023 | |||
Cash and cash equivalents | $ | 2,982 | $ | 5,944 | ||
Working capital: | ||||||
Current assets | $ | 4,913 | $ | 11,113 | ||
Current liabilities |
| (6,351) |
| (8,148) | ||
Total working capital | $ | (1,438) | $ | 2,965 |
Since our inception, we have relied primarily on the proceeds from sales of common and preferred equity securities to finance our operations and internal growth. Additional funding has come through research and development tax credits, government grants, the sale of product rights, interest on investments and licensing revenue. We have incurred significant losses since our inception. As of September 30, 2024, we had an accumulated deficit of $436.4 million.
Cash Flows
Cash from operating, investing and financing activities for the nine months ended September 30, 2024 and 2023 is summarized as follows (in $000s):
Nine Months Ended September 30, | ||||||
| 2024 |
| 2023 | |||
Net cash used in operating activities | $ | (6,634) | $ | (12,202) | ||
Net cash used in investing activities |
| — |
| (6) | ||
Net cash provided by (used in) financing activities |
| 6,209 |
| (151) |
Operating activities
Net cash used in operating activities decreased by $5.6 million, from $12.2 million for the nine months ended September 30, 2023 to $6.6 million for the nine months ended September 30, 2024. The decrease in cash used by operating activities was primarily the result of a decrease in net loss of $9.1 million, brought about by a reduction in clinical trial supply and non-clinical activities, offset by a change in working capital of $2.9 million.
Investing activities
Net cash used by investing activities remained inconsequential for each of the nine months ended September 30, 2024 and 2023 and consisted of IT-related capital expenditure in 2023.
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Financing activities
Net cash provided by financing activities was $6.2 million for the nine months ended September 30, 2024 as a direct result of receiving approximately $6.2 million, net of expenses, from the issuance of common stock and warrants under a Securities Purchase Agreement with an institutional investor.
Net cash used in financing activities was $0.2 million for the nine months ended September 30, 2023 as a result of dividend payments of approximately $0.2 million to the holders of our 6% Preferred Stock.
Funding Requirements and Going Concern
We do not currently have sufficient funds to complete development and commercialization of any of our drug candidates. Current business and capital market risks could have a detrimental effect on the availability of sources of funding and our ability to access them in the future, which may delay or impede our progress of advancing our drugs currently in the clinical pipeline to approval by the Food and Drug Administration (“FDA”) or European Medicines Agency (“EMA”) for commercialization. Additionally, we plan to continue to evaluate in-licensing and acquisition opportunities to gain access to new drugs or drug targets that would fit with our strategy. Any such transaction would likely increase our funding needs in the future.
Our future funding requirements will depend on many factors, including but not limited to:
● | the rate of progress and cost of our clinical trials, preclinical studies and other discovery and research and development activities; |
● | the costs associated with establishing manufacturing and commercialization capabilities; |
● | the costs of acquiring or investing in businesses, product candidates and technologies; |
● | the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; |
● | the costs and timing of seeking and obtaining FDA and EMA approvals; |
● | the effect of competing technological and market developments; and |
● | the economic and other terms and timing of any collaboration, licensing or other arrangements into which we may enter. |
Until we can generate a sufficient amount of product revenue to finance our cash requirements, which we may never do, we expect to finance future cash needs primarily through public or private equity offerings, debt financings or strategic collaborations. Although we are not reliant on institutional credit finance and therefore not subject to debt covenant compliance requirements or potential withdrawal of credit by banks, we are reliant on the availability of funds and activity in equity markets. We do not know whether additional funding will be available on acceptable terms, or at all. If we are not able to secure additional funding when needed, we may have to delay, reduce the scope of or eliminate one or more of our clinical trials or research and development programs or make changes to our operating plan, which may include ceasing operations altogether and/or filing for bankruptcy. In addition, we may have to partner one or more of our product candidate programs at an earlier stage of development, which would lower the economic value of those programs to us.
Since our inception, we have relied primarily on the proceeds from sales of common and preferred equity securities to finance our operations and internal growth. Additional funding has come through research and development tax credits, government grants, the sale of product rights, interest on investments, licensing revenue, royalty income, and a limited amount of product revenue from operations discontinued in September 2012.
As discussed in Note 2 of the Notes to the Consolidated Financial Statements accompanying this Quarterly Report on Form 10-Q, under ASC Topic 205-40, Presentation of Financial Statements - Going Concern, management is required at each reporting period to evaluate whether there are conditions and events, considered in the aggregate, that raise substantial doubt about an entity’s ability to continue as a going concern within one year after the date that the
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financial statements are issued. This evaluation initially does not take into consideration the potential mitigating effect of management’s plans that have not been fully implemented as of the date the financial statements are issued.
Our history of losses, our negative cash flows from operations, our liquidity resources currently on hand, and our dependence on the ability to obtain additional financing to fund our operations after the current resources are exhausted, about which there can be no certainty, have resulted in our assessment that there is substantial doubt about our ability to continue as a going concern for a period of at least twelve months from the issuance date of this Quarterly Report on Form 10-Q. We are currently investigating ways to raise additional capital through private equity financing or by entering into a strategic transaction. In the event that we are not able to secure funding, we may be forced to curtail operations, delay or stop ongoing development activities, cease operations altogether, and/or file for bankruptcy. In such event, our stockholders may lose their entire investment in our company.
Results of Operations
Three and Nine Months Ended September 30, 2024 and 2023
Revenues
We recognized $10,000 and $43,000 of revenue for the three and nine months ended September 30, 2024, respectively. This revenue is related to recovery of clinical manufacturing costs associated with an investigator sponsored study managed by Cedars-Sinai Medical Center. Revenues recognized for the three and nine months ended September 30, 2023 were approximately $16,000 and $389,000 respectively.
The future
We expect to completely fulfill our obligations under this agreement by the fourth quarter of 2024. The associated clinical manufacturing costs are presented as a component of research and development expenses.
Research and Development Expenses
From our inception, we have focused on drug discovery and development programs, with a particular emphasis on orally available anticancer agents, and our research and development expenses have represented costs incurred to discover and develop novel small molecule therapeutics, including clinical trial costs for fadraciclib and plogosertib. We have also incurred costs in the advancement of product candidates toward clinical and preclinical trials and the development of in-house research to advance our biomarker program and technology platforms. We expense all research and development costs as they are incurred. Research and development expenses primarily include:
● | Clinical trial and regulatory-related costs; |
● | Payroll and personnel-related expenses, including consultants and contract research organizations; |
● | Preclinical studies, supplies and materials; |
● | Technology license costs; |
● | Stock-based compensation; and |
● | Rent and facility expenses for our offices. |
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The following table provides information with respect to our research and development expenditures for the three and nine months ended September 30, 2024 and 2023 (in $000s except percentages):
Three Months Ended | Nine Months Ended | |||||||||||||||||||||
September 30, | Difference | September 30, | Difference | |||||||||||||||||||
2024 |
| 2023 |
| $ |
| % | 2024 |
| 2023 |
| $ |
| % | |||||||||
Transcriptional Regulation (fadraciclib) | $ | 884 | $ | 3,554 | $ | (2,670) | (75) | $ | 4,128 | $ | 10,683 | $ | (6,555) | (61) | ||||||||
Anti-mitotic (plogosertib) | 116 | 1,540 | (1,424) | (92) | 1,582 | 4,249 | (2,667) | (63) | ||||||||||||||
Other research and development expenses | (50) | 142 | (192) | (135) | 65 | 705 | (640) | (91) | ||||||||||||||
Total research and development expenses | $ | 950 | $ | 5,236 | $ | (4,286) | (82) | $ | 5,775 | $ | 15,637 | $ | (9,862) | (63) |
Total research and development expenses represented 56% and 76% of our operating expenses for the nine months ended September 30, 2024 and 2023 respectively.
Research and development expenses decreased by $9.9 million from $15.6 million for the nine months ended September 30, 2023 to $5.2 million for the nine months ended September 30, 2024. Expenditure for the transcriptional regulation program decreased by $6.6 million relative to the respective comparative period, primarily due to decreases in manufacturing and non-clinical expenditure. Research and development expenses relating to plogosertib decreased by $2.7 million relative to the respective comparative period due to decreases in manufacturing and non-clinical expenditure.
The future
We anticipate that overall research and development expenses for the year ended December 31, 2024 will decrease compared to the year ended December 31, 2023 as we do not expect to incur further manufacturing or preclinical costs. Expenditure will be primarily clinical trial costs related to our fadraciclib Phase 1/2 065-101 study in advanced solid tumors and lymphomas.
General and Administrative Expenses
General and administrative expenses include costs for administrative personnel, legal and other professional expenses and general corporate expenses. The following table summarizes the general and administrative expenses for the three and nine months ended September 30, 2024 and 2023 (in $000s except percentages):
Three Months Ended | Nine Months Ended | ||||||||||||||||||||
September 30, | Difference | September 30, | Difference | ||||||||||||||||||
2024 |
| 2023 |
| $ |
| % |
| 2024 |
| 2023 |
| $ |
| % | |||||||
Total general and administrative expenses | $ | 1,237 | $ | 1,625 | $ | (388) | (24) | $ | 4,444 | $ | 4,845 | $ | (401) | (8) |
Total general and administrative expenses represented 44% and 24% of our operating expenses for the nine months ended September 30, 2024 and 2023 respectively.
General and administrative expenses decreased by approximately $0.3 million from $4.8 million for the nine months ended September 30, 2023 to $4.5 million for the nine months ended September 30, 2024, due largely to reduction in stock compensation expense.
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The future
We expect general and administrative expenditures for the year ended December 31, 2024 to be lower than our expenditures for the year ended December 31, 2023, due to management efforts to lower costs across all departments.
Other (expense) income, net
The following table summarizes other (expense) income, net for the three and nine months ended September 30, 2024 and 2023 (in $000 except percentages):
Three Months Ended | Nine Months Ended | ||||||||||||||||||||
September 30, | Difference | September 30, | Difference | ||||||||||||||||||
2024 |
| 2023 |
| $ |
| % | 2024 |
| 2023 |
| $ |
| % | ||||||||
Foreign exchange gains (losses) | $ | 2 | $ | 104 | $ | (102) | (98) | $ | 6 | $ | (58) | $ | 64 | (110) | |||||||
Interest (expense) income |
| 8 |
| 50 |
| (42) | (84) |
| (18) |
| 243 |
| (261) | (107) | |||||||
Other income (expense), net |
| — |
| (9) |
| 9 | (100) |
| 52 |
| 50 |
| 2 | 4 | |||||||
Total other (expense) income, net | $ | 10 | 145 | $ | (135) | (93) | $ | 40 | 235 | $ | (195) | (83) |
Total other income decreased by $195,000 from $235,000 for the nine months ended September 30, 2023 to $40,000 for the nine months ended September 30, 2024. Other income for the nine months ended September 30, 2024 relates to royalties receivable under a December 2005 Asset Purchase Agreement, or APA, whereby Xcyte Therapies, Inc., or Xcyte (a business acquired by us in March 2006) sold certain assets and intellectual property to ThermoFisher Scientific Company, or TSC (formerly Invitrogen Corporation) through the APA and other related agreements. The assets and technology were not part of our product development plan following the transaction between Xcyte and Cyclacel in March 2006. Accordingly, we presented $52,000 and $50,000 as other income arising from royalties from the APA during each of the nine months ended September 30, 2024 and 2023 respectively.
Foreign exchange gains (losses)
Foreign exchange gains increased by $64,000, from a loss of $58,000 for the nine months ended September 30, 2023, to a gain of $6,000 for the nine months ended September 30, 2024.
The future
Other income (expense), net for the year ended December 31, 2024, will continue to be impacted by changes in foreign exchange rates and the receipt of income under the APA. As we are not in control of sales made by TSC, we are unable to estimate the level and timing of income under the APA, if any.
Because the nature of funding advanced through intercompany loans is that of a long-term investment, unrealized foreign exchange gains and losses on such funding will be recognized in other comprehensive income until repayment of the intercompany loan becomes foreseeable. Foreign exchange gains and losses relating to intercompany operating expenditure, which is expected to be settled in the foreseeable future, will be recognized within the statement of operations.
Income Tax Benefit
Credit is taken for research and development tax credits, which are claimed from the United Kingdom’s revenue and customs authority, or HMRC, in respect of qualifying research and development costs incurred.
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The following table summarizes total income tax benefit for the three and nine months ended September 30, 2024 and 2023 (in $000s except percentages):
Three Months Ended | Nine Months Ended | ||||||||||||||||||||
September 30, | Difference | September 30, | Difference | ||||||||||||||||||
2024 |
| 2023 |
| $ |
| % | 2024 |
| 2023 |
| $ |
| % | ||||||||
Total income tax benefit | $ | 210 | $ | 668 | $ | (458) | (69) | $ | 1,976 | $ | 2,574 | $ | (598) | (23) |
The total income tax benefit, which comprised of research and development tax credits recoverable, decreased by approximately $0.6 million, from $2.6 million for the nine months ended September 30, 2023 to $2.0 million for the nine months ended September 30, 2024. The level of tax credits recoverable is linked directly to qualifying research and development expenditure incurred in any one year and the availability of trading losses.
The future
We expect to continue to be eligible to receive United Kingdom research and development tax credits for the year ended December 31, 2024 and will continue to elect to receive payment of the tax credit. The amount of tax credits we will receive is entirely dependent on the amount of eligible expenses we incur and could be restricted by any future cap introduced by HMRC. Beyond 2024, we cannot be certain of our eligibility to receive this tax credit or if eligible, the amount that may be received, as a result of any future changes by HMRC to the eligibility criteria.
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Critical Accounting Policies and Estimates
Our critical accounting policies are those policies which require the most significant judgments and estimates in the preparation of our consolidated financial statements. We evaluate our estimates, judgments, and assumptions on an ongoing basis. Actual results may differ from these estimates under different assumptions or conditions. A summary of our critical accounting policies is presented in Part II, Item 7, of our Annual Report on Form 10-K for the year ended December 31, 2023 and Note 2 to our unaudited consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q. There have been no material changes to our critical accounting policies during the nine months ended September 30, 2024.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
As a smaller reporting company, we are not required to provide information in response to this item.
Item 4. Controls and Procedures
Under the supervision and with the participation of our management, including our chief executive officer and principal financial and accounting officer, we conducted an evaluation of the effectiveness, as of September 30, 2024, of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act. Based upon such evaluation, our chief executive officer and principal financial and accounting officer have concluded that, as of September 30, 2024, our disclosure controls and procedures to ensure that information required to be disclosed by us in reports we file or submit under the Exchange Act is (i) recorded, processed, summarized, evaluated and reported, as applicable, within the time periods specified in the SEC’s rules and forms and (ii) accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosures were not effective at the reasonable assurance level due to the material weakness in internal control over financial reporting.
Our remediation process is still ongoing and therefore cannot be considered fully complete at this time. There can be no assurance that we will be successful in remediating the material weaknesses. We plan to continue to assess internal controls and procedures and intend to take further action as necessary or appropriate to address any other matters as they are identified. Notwithstanding the identified material weakness in internal control over financial reporting, we have concluded that the consolidated financial statements in this Quarterly Report on Form 10-Q present fairly, in all material respects, our financial position, results of operations and cash flows as of the dates, and for the periods, presented, in conformity with GAAP.
Changes in Internal Control over Financial Reporting
There were no changes in internal control over financial reporting during the quarter ended September 30, 2024 that have materially affected, or are reasonably likely to materially affect, our internal controls over financial reporting.
Inherent Limitation on the Effectiveness of Internal Controls
The effectiveness of any system of internal control over financial reporting, including ours, is subject to inherent limitations, including the exercise of judgment in designing, implementing, operating, and evaluating the controls and procedures, and the inability to eliminate misconduct completely. Accordingly, any system of internal control over financial reporting, including ours, no matter how well designed and operated, can only provide reasonable, not absolute, assurances. In addition, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. We intend to continue to monitor and upgrade our internal controls as necessary or appropriate for our business but cannot ensure that such improvements will be sufficient to provide us with effective internal control over financial reporting.
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PART II. Other Information
Item 1. Legal Proceedings
None.
Item 1A. Risk Factors
Except as set forth below, there have been no material changes to our risk factors contained in our Annual Report on Form 10-K for the year ended December 31, 2023. For a further discussion of our Risk Factors, refer to Part I, Item 1A, “Risk Factors,” of our Annual Report on Form 10-K for the year ended December 31, 2023.
If we fail to comply with the continued listing requirements of the Nasdaq Capital Market, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted.
On March 27, 2024, we received a written notice (the “Notice”) from The Nasdaq Stock Market LLC (“Nasdaq”) indicating that we are not in compliance with Nasdaq Listing Rule 5550(b)(1), which requires companies listed on The Nasdaq Capital Market to maintain a minimum of $2,500,000 in stockholders’ equity for continued listing (the “Stockholders’ Equity Requirement”). Our stockholders’ equity was $607,000 as of December 31, 2023 and, as a result, we did not satisfy Listing Rule 5550(b)(1).
We submitted a plan to Nasdaq’s Listing Qualifications Staff (“Staff”) advising of actions we have taken or will take to regain compliance with Nasdaq Listing Rule 5550(b)(1). On August 26, 2024, the Listing Qualifications Staff (the “Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) determined that we were not in compliance with the Nasdaq Listing Rule 5550(b)(1) (the “Equity Rule”) because we reported stockholders’ equity of less than $2.5 million as of June 30, 2024. The notice from the Staff further stated that unless we timely requested a hearing before a Nasdaq Hearings Panel (the “Panel”), our securities would be subject to delisting. As of September 30, 2024, we had a stockholders equity deficit of approximately $1.02 million which is not in compliance with the Equity Rule. On October 15, 2024, we met with the Panel regarding our potential delisting from Nasdaq as a result of our violation of the Equity Rule. On October 22, 2024, we received the Panel’s decision which granted us until December 24, 2024 to regain compliance with the Equity Rule and all applicable criteria for continued listing on Nasdaq. If we are unable to regain compliance with the listing standards of the Nasdaq Capital Market by December 24, 2024, our securities may be delisted from Nasdaq.
If, for any reason, Nasdaq were to delist our securities from trading on its exchange and we are unable to obtain listing on another reputable national securities exchange, a reduction in some or all of the following may occur, each of which could materially adversely affect our stockholders:
| • |
| the liquidity and marketability of our common stock; |
| • |
| the market price of our common stock; |
| • |
| our ability to obtain financing for the continuation of our operations; |
| • |
| the number of institutional and general investors that will consider investing in our common stock; |
| • |
| the number of market makers in our common stock; |
| • |
| the availability of information concerning the trading prices and volume of our common stock; and |
| • |
| the number of broker-dealers willing to execute trades in shares of our common stock. |
In addition, if we cease to be eligible to trade on Nasdaq, we may have to pursue trading on a less recognized or accepted market, such as the over the counter markets, our stock may be traded as a “penny stock,” which would make transactions in our stock more difficult and cumbersome, and we may be unable to access capital on favorable terms or at all, as companies trading on alternative markets may be viewed as less attractive investments with higher associated
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risks, such that existing or prospective institutional investors may be less interested in, or prohibited from, investing in our common stock. This may also cause the market price of our common stock to decline.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3. Defaults upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
Item 6. Exhibits
Exhibit |
| Description |
101 | The following materials from Cyclacel Pharmaceuticals, Inc.’s Quarterly Report on Form 10-Q for the period ended September 30, 2024, formatted in iXBRL (Inline eXtensible Business Reporting Language): (i) the Consolidated Statements of Income, (ii) the Consolidated Balance Sheets, (iii) the Consolidated Statements of Cash Flows, and (iv) Notes to Consolidated Financial Statements. | |
104 | The cover page from the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, formatted in Inline eXtensible Business Reporting Language (included with Exhibit 101). | |
* # | Filed herewith. Management contract or compensatory plans or agreements. |
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned.
| CYCLACEL PHARMACEUTICALS, INC. | ||
Date: November 12, 2024 | By: | /s/ Paul McBarron | |
Paul McBarron | |||
Chief Operating Officer, Chief Financial Officer and Executive Vice President, Finance |
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