Cyclacel(CYCC)

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Cyclacel(CYCC) - 2025 Q2 - Quarterly Report
2025-08-14 01:45
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________________ to __________________ Commission file number 000-50626 CYCLACEL PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) (State or Other Jurisdiction Delaware 91-170 ...
Cyclacel(CYCC) - 2025 Q2 - Quarterly Results
2025-08-13 21:27
[Business Update and Highlights](index=1&type=section&id=Business%20Update%20and%20Highlights) Cyclacel executed key financing activities, including a reverse stock split, and advanced a strategic acquisition of FITTERS Sdn. Bhd. [Corporate and Financing Activities](index=1&type=section&id=Corporate%20and%20Financing%20Activities) During and shortly after the second quarter of 2025, Cyclacel executed several key corporate and financing actions, including dividend payments, a stock sale, and a reverse stock split - Declared and paid quarterly cash dividends of **$0.15 per share** on its 6% Convertible Exchangeable Preferred Stock in both April and June 2025[4](index=4&type=chunk) - In June, the company raised **$3.0 million** in gross proceeds by selling 3,000,000 shares of Series F Convertible Preferred Stock to accredited investors at $1.00 per share[4](index=4&type=chunk) - A **one-for-fifteen reverse stock split** was implemented, effective July 7, 2025, to meet the Nasdaq Capital Market's minimum share bid price requirement[4](index=4&type=chunk) [Strategic Transactions](index=1&type=section&id=Strategic%20Transactions) The company entered into a share exchange agreement to acquire FITTERS Sdn. Bhd., later amended to include a cash consideration and extended deadline, with a shareholder vote scheduled - Announced a share exchange agreement with FITTERS Diversified Berhad to acquire **100%** of FITTERS Sdn. Bhd. in exchange for approximately **19.99%** of Cyclacel's common stock[4](index=4&type=chunk) - The agreement was amended in July to include a **$1.0 million cash payment** from Cyclacel to FITTERS Parent and to extend the final closing date to September 30, 2025[5](index=5&type=chunk) - A special meeting is scheduled for September 4, 2025, for shareholders to vote on the approval of the transaction[5](index=5&type=chunk) [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) The company significantly reduced its net loss in Q2 2025 due to substantial decreases in operating expenses, improving its cash position [Cash Position and Liquidity](index=2&type=section&id=Cash%20Position%20and%20Liquidity) As of June 30, 2025, the company's cash and cash equivalents stood at $4.3 million, an increase from $3.2 million at the end of 2024, projected to fund expenditures into Q4 2025 | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $4.3 million | $3.2 million | - Net cash used in operating activities was **$1.1 million** for the three months ended June 30, 2025[6](index=6&type=chunk) - The company estimates its current cash resources will fund planned expenditures into the **fourth quarter of 2025**[6](index=6&type=chunk) [Operating Expenses](index=2&type=section&id=Operating%20Expenses) Total operating expenses saw a substantial year-over-year decrease, driven by significant reductions in both Research & Development and General & Administrative costs following strategic changes [Research and Development (R&D) Expenses](index=2&type=section&id=Research%20and%20Development%20(R%26D)%20Expenses) R&D expenses dramatically decreased to $0.1 million for Q2 2025 from $2.0 million in Q2 2024, primarily due to the cessation of the transcriptional regulation program after the UK subsidiary's liquidation | Expense Category | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | R&D Expenses | $0.1 million | $2.0 million | - The decrease was mainly due to the liquidation of the UK subsidiary, Cyclacel Limited, on January 24, 2025, which halted expenditure for the transcriptional regulation program[7](index=7&type=chunk) [General and Administrative (G&A) Expenses](index=2&type=section&id=General%20and%20Administrative%20(G%26A)%20Expenses) G&A expenses were reduced to $1.2 million in Q2 2025 from $1.6 million in the same period of 2024, reflecting lower operating costs partially offset by one-time legacy severance and higher legal fees | Expense Category | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | G&A Expenses | $1.2 million | $1.6 million | - The reduction was attributed to lower operating costs, with savings partially offset by one-off legacy severance costs and increased legal fees[8](index=8&type=chunk) [Net Loss](index=2&type=section&id=Net%20Loss) The company's net loss for Q2 2025 narrowed significantly to $1.3 million, compared to $3.3 million in Q2 2024, primarily due to reduced operating expenses despite the absence of UK R&D tax credits | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Net Loss | $1.3 million | $3.3 million | - There were **no research and development tax credits** in Q2 2025, compared to **$0.4 million** in Q2 2024, due to the liquidation of the UK subsidiary[9](index=9&type=chunk) | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Net Loss Per Share | ($0.98) | ($172.18) | [Financial Statements](index=4&type=section&id=Financial%20Statements) Detailed financial statements for Q2 2025 show a reduced operating loss and a positive shift in stockholders' equity [Consolidated Statements of Operations (Loss)](index=4&type=section&id=Consolidated%20Statements%20of%20Operations%20(Loss)) For the three months ended June 30, 2025, Cyclacel reported no revenue and a total operating loss of $1.32 million, a significant improvement from the $3.64 million operating loss in the same period of 2024 Q2 2025 vs Q2 2024 Statement of Operations (in $000s) | Line Item | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Revenues | $0 | $4 | | Research and development | $68 | $2,023 | | General and administrative | $1,249 | $1,625 | | **Operating loss** | **($1,317)** | **($3,644)** | | **Net loss** | **($1,318)** | **($3,257)** | | Net loss applicable to common shareholders | ($1,338) | ($3,257) | | Net loss per share – basic and diluted | ($0.98) | ($172.18) | [Consolidated Balance Sheet](index=5&type=section&id=Consolidated%20Balance%20Sheet) As of June 30, 2025, the company's balance sheet showed total assets of $4.4 million and total liabilities of $0.77 million, resulting in a positive stockholders' equity of $3.63 million Consolidated Balance Sheet Summary (in $000s) | Line Item | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Current Assets** | | | | Cash and cash equivalents | $4,275 | $3,137 | | Total current assets | $4,383 | $3,674 | | **Total Assets** | **$4,401** | **$4,094** | | **Current Liabilities** | | | | Accounts payable | $221 | $4,599 | | Total current liabilities | $760 | $6,268 | | **Total Liabilities** | **$770** | **$6,268** | | **Stockholders' Equity** | **$3,631** | **($2,174)** | [Company Overview and Forward-Looking Statements](index=2&type=section&id=Company%20Overview%20and%20Forward-Looking%20Statements) Cyclacel Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on cancer medicines, with forward-looking statements highlighting inherent risks [About Cyclacel Pharmaceuticals, Inc.](index=2&type=section&id=About%20Cyclacel%20Pharmaceuticals%2C%20Inc.) Cyclacel is a clinical-stage biopharmaceutical company developing cancer medicines based on cell cycle, epigenetics, and mitosis biology, with its primary program evaluating plogosertib - Cyclacel is a clinical-stage biopharmaceutical company focused on developing innovative cancer medicines[11](index=11&type=chunk) - The company's main program is evaluating plogosertib, a PLK1 inhibitor, in patients with solid tumors and hematological malignancies[11](index=11&type=chunk) [Forward-looking Statements](index=3&type=section&id=Forward-looking%20Statements) This section provides a standard safe harbor statement, cautioning that the press release contains forward-looking statements with inherent risks and uncertainties - Warns that statements regarding drug efficacy, future plans, cash runway, and clinical data timing are forward-looking and subject to risks[12](index=12&type=chunk) - Key risks include candidates failing in later-stage trials, difficulty in trial enrollment, reliance on outside financing, and maintaining Nasdaq listing requirements[12](index=12&type=chunk)
Cyclacel Pharmaceuticals Reports Second Quarter Financial Results and Provides Business Update
Globenewswire· 2025-08-13 20:05
Financial Results - As of June 30, 2025, cash and cash equivalents totaled $4.3 million, an increase from $3.2 million as of December 31, 2024 [1] - Net cash used in operating activities was $1.1 million for the three months ended June 30, 2025, with current cash resources expected to fund planned expenditures into the fourth quarter of 2025 [2] - Research and development expenses were $0.1 million for the three months ended June 30, 2025, a significant decrease from $2.0 million for the same period in 2024 [3] - General and administrative expenses decreased from $1.6 million for the three months ended June 30, 2024, to $1.2 million for the same period in 2025 [5] - Net loss for the three months ended June 30, 2025, was $1.3 million, compared to $3.3 million for the same period in 2024 [7] Business Developments - The Company declared a quarterly cash dividend of $0.15 per share on its 6% Convertible Exchangeable Preferred Stock, paid on May 1, 2025, and again on August 1, 2025 [4] - In May 2025, the Company entered into a share exchange agreement with FITTERS Diversified Berhad, resulting in FITTERS Sdn. Bhd. becoming a wholly-owned subsidiary of the Company [4] - A one-for-fifteen reverse stock split was implemented on July 7, 2025, to meet Nasdaq Capital Market share bid price requirements [4] - The Company entered into a securities purchase agreement in June 2025, raising $3 million through the sale of Series F Convertible Preferred Stock [4] Tax Credits and Other Income - The Company did not receive any research and development tax credits for the three months ended June 30, 2025, following the liquidation of its UK subsidiary [6] - Total other income (expenses), net, for the three months ended June 30, 2025, were broadly flat year on year [5]
CYCLACEL PHARMACEUTICALS HIGHLIGHTS PRECLINICAL DATA SHOWING THAT CANCER OF THE BILIARY TRACT IS SENSITIVE TO PLOGOSERTIB
Globenewswire· 2025-08-04 22:50
Core Insights - Cyclacel Pharmaceuticals is advancing plogosertib, a PLK1 inhibitor, showing promising preclinical results in biliary tract cancer (BTC) with BUBR1 as a potential biomarker for treatment efficacy [1][2][6] Company Overview - Cyclacel Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing innovative cancer medicines based on cell cycle and mitosis biology [8] - The company is evaluating plogosertib in both solid tumors and hematological malignancies, aiming to build a diversified biopharmaceutical business [8][9] Biliary Tract Cancer (BTC) Insights - BTC, also known as cholangiocarcinoma, is a rare and aggressive cancer with an annual incidence of 4.4 per 100,000 in the US, and a poor prognosis with a 5-year overall survival rate of approximately 10-40% [3] - Current treatment strategies for BTC include chemotherapy, surgery, radiation, and targeted medicines, but there is an urgent need for effective therapies for relapsed, refractory, and unresectable cases [4] Plogosertib and PLK1 Inhibition - Plogosertib is a selective and potent PLK1 inhibitor that has shown impressive efficacy in human tumor xenografts at nontoxic doses [6] - The drug has demonstrated clinical benefits in patients with various cancers, including BTC, and is particularly effective in cancer cells with KRAS mutations and p53 deficiencies [5][7] Research Findings - A preclinical study indicated that BTC cells with high BUBR1 expression are more sensitive to plogosertib, suggesting that targeting PLK1 could be an effective treatment strategy [2] - The study also found that plogosertib combined with an ATR inhibitor showed synergistic effects, indicating potential for optimal combination therapies [2]
CYCLACEL PHARMACEUTICALS COMMENTS ON RECENT STOCK PRICE VOLATILITY
Globenewswire· 2025-07-16 13:00
Core Viewpoint - Cyclacel Pharmaceuticals, Inc. has addressed recent stock price volatility, stating that there are no material developments affecting its operating or financial condition that would explain the price movements observed on July 15, 2025 [2]. Company Overview - Cyclacel Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing innovative cancer medicines based on cell cycle, epigenetics, and mitosis biology [3]. - The company's epigenetic/anti-mitotic program is evaluating plogosertib, a PLK1 inhibitor, in patients with solid tumors and hematological malignancies [3]. - Cyclacel aims to build a diversified biopharmaceutical business with a pipeline of novel drug candidates targeting oncology and hematology indications [3]. Recent Developments - The company announced an amendment to the Exchange Agreement with FITTERS Diversified Berhad on July 7, 2025, which is the only disclosed change affecting its business strategy or prospects [2].
Why Is Cyclacel Pharmaceuticals Stock Soaring On Tuesday?
Benzinga· 2025-07-15 16:17
Company Overview - Cyclacel Pharmaceuticals, Inc. (CYCC) stock is experiencing a significant increase, trading at $13.85, up 318.43% with a session volume of 21.9 million compared to an average volume of 206.9K [1][5] - The company recently amended its Exchange Agreement with FITTERS Diversified Berhad, which is involved in fire safety materials, "Waste-To-Resource" services, and real estate development [2] Research and Development - A publication in the journal Gut highlighted a study indicating that DNAJ-PKAc, a fusion oncoprotein, enhances the sensitivity of FLC (focal liver cancer) to treatment with plogosertib [3] - The study found that PLK1 is crucial for FLC cells, making them particularly sensitive to PLK1 loss, with a direct interaction between DNAJ-PKAc fusions and PLK1 promoting mitotic progression [3] Clinical Findings - Pharmacologic inhibitors of PLK1, such as plogosertib, have shown to significantly reduce FLC growth while sparing normal liver cells in both patient-derived in vitro and in vivo xenograft models [4] - Cyclacel has conducted two reverse stock splits, a 1-for-15 in July and a 1-for-16 in May, indicating a strategic move to manage stock price [4] Financial Activities - In June, Cyclacel completed a private placement that generated gross proceeds of $3.0 million, issuing series A, B, and C warrants for the purchase of 3.27 million shares at exercise prices of 51 cents, 60 cents, and 68 cents per share respectively [5]
CYCLACEL PHARMACEUTICALS ANNOUNCES AMENDMENT TO EXCHANGE AGREEMENT
Globenewswire· 2025-07-07 10:00
Core Viewpoint - Cyclacel Pharmaceuticals has amended its Exchange Agreement with FITTERS Diversified Berhad to facilitate the acquisition of Fitters Sdn. Bhd., a subsidiary of FITTERS, through the exchange of shares and a cash payment [1][2][3]. Company Overview - Cyclacel Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing innovative cancer medicines based on cell cycle, epigenetics, and mitosis biology [6]. - The company is evaluating plogosertib, a PLK1 inhibitor, in patients with solid tumors and hematological malignancies, aiming to build a diversified biopharmaceutical business [6]. Transaction Details - Under the amended Exchange Agreement, Cyclacel will exchange all ordinary shares of Fitters Sdn. Bhd. for common stock, representing 19.99% of Cyclacel's issued and outstanding shares at closing [2]. - Cyclacel will also pay USD 1,000,000 or a mutually agreed amount to FITTERS as part of the transaction [2]. - The final date for the transaction has been extended to September 30, 2025 [2]. Approval and Governance - The transaction is subject to approval from the stockholders of both Cyclacel and FITTERS, and has been unanimously approved by the Boards of Directors of Cyclacel, FITTERS, and Fitters Sub [3]. Fitters Sdn. Bhd. Overview - Fitters Sdn. Bhd. specializes in distributing, trading, and installing fire safety materials and equipment, with a strong reputation for reliability and compliance with regulatory standards [4][8]. - The company offers a wide range of fire safety products, including fire extinguishers, fire-resistant doors, and personal protective equipment [8].
CYCLACEL PHARMACEUTICALS HIGHLIGHTS PUBLICATION OF PRECLINICAL DATA SHOWING THAT PLOGOSERTIB IS ACTIVE IN A HARD-TO-TREAT SUBTYPE OF LIVER CANCER
GlobeNewswire News Room· 2025-07-07 10:00
Core Insights - Cyclacel Pharmaceuticals is developing plogosertib, a PLK1 inhibitor, as a potential treatment for fibrolamellar hepatocellular carcinoma (FLC), a rare liver cancer with no approved therapies [1][2][5] Group 1: Disease Overview - FLC primarily affects adolescents and young adults, with an estimated annual incidence in the US of 0.02 per 100,000 [3] - The five-year survival rate for FLC patients is approximately 30%, and the disease is often misdiagnosed as hepatocellular carcinoma (HCC) [3] - FLC is characterized by the presence of a unique DNAJB1-PKAc gene fusion, which is a common driver of the disease [4] Group 2: Research Findings - A recent study published in the journal Gut indicates that the DNAJ-PKAc fusion oncoprotein increases sensitivity to PLK1 inhibitors like plogosertib in FLC cells [1][2] - PLK1 is essential for the growth of FLC cells, and its inhibition leads to significant reduction in FLC growth while sparing normal liver cells [2] - The study suggests further evaluation of plogosertib in preclinical and clinical studies for FLC treatment [2] Group 3: Drug Development - Plogosertib is a selective and potent PLK1 inhibitor that has shown efficacy in human tumor xenografts at non-toxic doses [7] - Initial Phase 1 clinical study data indicate that plogosertib is well tolerated with no dose-limiting toxicity observed [8] - Cyclacel's strategy includes developing plogosertib for various solid tumors and hematological malignancies, with a focus on cancers associated with DNAJ-PKAc fusions [10]
Cyclacel Pharmaceuticals Announces Stock Split
Globenewswire· 2025-07-02 13:00
Core Viewpoint - Cyclacel Pharmaceuticals, Inc. is implementing a 1-for-15 reverse stock split effective July 7, 2025, to enhance its stock price and maintain compliance with Nasdaq listing requirements [1][3]. Company Overview - Cyclacel is a clinical-stage biopharmaceutical company focused on developing innovative cancer medicines based on cell cycle, epigenetics, and mitosis biology [4]. - The company is evaluating plogosertib, a PLK1 inhibitor, in patients with solid tumors and hematological malignancies as part of its epigenetic/anti-mitotic program [4]. - Cyclacel aims to build a diversified biopharmaceutical business with a pipeline of novel drug candidates targeting oncology and hematology indications [4]. Reverse Stock Split Details - The reverse stock split will convert every 15 shares of common stock into one share, with no fractional shares issued; any fractions will be rounded to the nearest whole number [2]. - The board of directors and stockholders approved the reverse stock split, which will reduce the number of shares from 23,759,475 to 1,583,965 [3]. - The new CUSIP number for the shares post-split will be 23254L876, and trading will continue under the symbol "CYCC" on The Nasdaq Capital Market [1][3].
Cyclacel Pharmaceuticals Announces $3 Million Private Placement Offering of Convertible Preferred Stock
Globenewswire· 2025-06-20 20:30
Core Viewpoint - Cyclacel Pharmaceuticals has successfully completed a private placement of its convertible Series F Preferred Stock, raising gross proceeds of $3.0 million, which will be utilized for working capital and general corporate purposes [1][2]. Group 1: Financing Details - The private placement involved the issuance of convertible Series F Preferred Stock and warrants to purchase a total of 9,810,000 shares of common stock at varying exercise prices of $0.51, $0.60, and $0.68 per share [1]. - The offering closed on June 20, 2025, and the warrants will expire five years from the date of issuance [1]. - Each share of Preferred Stock is convertible into 3.27 shares of Common Stock, subject to stockholder approval as per Nasdaq listing rules [3]. Group 2: Use of Proceeds - The net proceeds from the offering are intended for working capital and general corporate purposes, which, along with existing cash, is expected to extend the company's cash runway into the third quarter of 2025 [2]. Group 3: Regulatory and Legal Aspects - The securities issued in the private placement have not been registered under the Securities Act of 1933 and were sold in reliance on Regulation S [4]. - The offering was conducted directly to investors without the involvement of a placement agent, underwriter, broker, or dealer [4]. Group 4: Company Overview - Cyclacel Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing innovative cancer medicines, particularly through its anti-mitotic program, plogosertib, which targets PLK1 in various cancer types [7].