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Cyclacel Pharmaceuticals, Inc.(CYCCP) - 2025 Q2 - Quarterly Report
2025-08-14 01:45
PART I - FINANCIAL INFORMATION [Item 1. Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) The unaudited consolidated financial statements for the period ended June 30, 2025, reflect significant corporate changes, including the deconsolidation of the UK subsidiary, resulting in a **$5.0 million** gain, and a shift from a **$2.2 million** stockholders' deficit to a **$3.6 million** equity, with net loss improving to **$1.4 million** from **$6.2 million** [Consolidated Balance Sheets](index=6&type=section&id=Consolidated%20Balance%20Sheets) As of June 30, 2025, total assets were **$4.4 million**, liabilities **$0.77 million**, and stockholders' equity **$3.6 million**, a significant improvement from a **$2.2 million** deficit in 2024 due to reduced liabilities and increased cash Consolidated Balance Sheet Summary (in $000s) | Balance Sheet Item | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $4,275 | $3,137 | | Total current assets | $4,383 | $3,674 | | Total assets | $4,401 | $4,094 | | **Liabilities & Equity** | | | | Accounts payable | $221 | $4,599 | | Total current liabilities | $760 | $6,268 | | Total liabilities | $770 | $6,268 | | Total stockholders' equity (deficit) | $3,631 | $(2,174) | [Consolidated Statements of Operations](index=8&type=section&id=Consolidated%20Statements%20of%20Operations) For the six months ended June 30, 2025, the company reported zero revenue and a net loss of **$1.4 million**, a substantial improvement from **$6.2 million** in 2024, driven by a **$4.9 million** deconsolidation gain and reduced R&D expenses Consolidated Statements of Operations Highlights (in $000s, except per share data) | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Revenues | $0 | $33 | | Research and development | $890 | $4,825 | | General and administrative | $5,463 | $3,207 | | Operating loss | $(6,353) | $(7,999) | | Gain on deconsolidation of subsidiary | $4,947 | $0 | | Net loss | $(1,399) | $(6,203) | | Net loss per share – basic and diluted | $(1.62) | $(509.96) | [Consolidated Statements of Cash Flows](index=13&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2025, net cash used in operating activities was **$4.3 million**, offset by **$5.5 million** from financing, leading to a net increase of **$1.1 million** and an ending cash balance of **$4.3 million** Cash Flow Summary (in $000s) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(4,303) | $(3,567) | | Net cash used in investing activities | $0 | $0 | | Net cash provided by financing activities | $5,526 | $6,210 | | Net increase in cash and cash equivalents | $1,138 | $2,622 | | Cash and cash equivalents, end of period | $4,275 | $6,000 | [Notes to Unaudited Consolidated Financial Statements](index=14&type=section&id=Notes%20to%20Unaudited%20Consolidated%20Financial%20Statements) The notes detail the deconsolidation of the UK subsidiary, generating a **$5.0 million** gain, two reverse stock splits, and management's substantial doubt about the company's going concern ability, with **$4.3 million** cash only funding operations into Q4 2025 - The company's UK subsidiary, Cyclacel Limited, entered into creditors voluntary liquidation and was deconsolidated as of January 24, 2025, resulting in a gain of approximately **$5.0 million**[34](index=34&type=chunk) - The company executed a **1-for-16 reverse stock split** on May 12, 2025, and a further **1-for-15 reverse stock split** on July 7, 2025, with all share and per-share data retroactively adjusted[37](index=37&type=chunk) - Management has concluded there is substantial doubt about the company's ability to continue as a going concern, as its cash and cash equivalents of **$4.3 million** as of June 30, 2025, are only sufficient to meet liquidity requirements into the fourth quarter of 2025[39](index=39&type=chunk) - In June 2025, the company raised **$3.0 million** in gross proceeds through the sale of **3,000,000 shares** of Series F Convertible Preferred Stock and associated warrants to accredited investors[82](index=82&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=31&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the strategic shift to focus solely on the plogosertib clinical program, highlighting a significant going concern risk with **$4.3 million** cash expected to last only into Q4 2025, while exploring a potential business combination with FITTERS Diversified Berhad - Following the liquidation of its UK subsidiary, the company has focused its development efforts exclusively on the plogosertib ('Plogo') clinical program, having repurchased the related assets for approximately **$0.3 million**[145](index=145&type=chunk) - The company has substantial doubt about its ability to continue as a going concern, with cash of **$4.3 million** as of June 30, 2025, expected to fund operations only into Q4 2025[149](index=149&type=chunk) - The company has entered into an Exchange Agreement with FITTERS Diversified Berhad, which, if completed, will result in a business combination where Cyclacel stockholders will own approximately **80.01%** of the combined entity, and the company will be renamed Bio Green Med Solution, Inc[13](index=13&type=chunk) [Liquidity and Capital Resources](index=34&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2025, the company held **$4.3 million** in cash and **$3.6 million** in working capital, relying on equity financing with an accumulated deficit of **$441.8 million**, and faces uncertainty in raising additional capital for drug development Key Liquidity Measures (in $000s) | Measure | June 30, 2025 | June 30, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $4,275 | $6,000 | | Working capital | $3,623 | $521 | - As of June 30, 2025, the company had an accumulated deficit of **$441.8 million** and has historically relied on equity sales to finance operations[159](index=159&type=chunk) [Results of Operations](index=36&type=section&id=Results%20of%20Operations) For the six months ended June 30, 2025, R&D expenses decreased by **$3.9 million (82%)** to **$0.9 million**, while G&A expenses increased by **$2.3 million (70%)** to **$5.5 million** due to one-time costs, and other income surged by **$4.9 million** from a deconsolidation gain Research and Development Expenses by Program (in $000s) | Program | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Transcriptional Regulation (fadraciclib) | $389 | $3,244 | $(2,855) | (88)% | | Anti-mitotic (plogosertib) | $423 | $1,466 | $(1,043) | (71)% | | **Total R&D Expenses** | **$890** | **$4,825** | **$(3,935)** | **(82)%** | - General and administrative expenses increased by **$2.3 million** for the six months ended June 30, 2025, mainly due to one-time costs from two changes of control, including stock compensation (**$1.3M**), D&O insurance (**$0.7M**), and other compensation (**$0.3M**)[179](index=179&type=chunk) - Total other income increased by **$4.9 million** year-over-year, driven by a **$5.0 million** gain on the deconsolidation of the company's UK subsidiary in January 2025[181](index=181&type=chunk)[182](index=182&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=39&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, the company is exempt from providing quantitative and qualitative disclosures about market risk - As a smaller reporting company, Cyclacel is not required to provide quantitative and qualitative disclosures about market risk[189](index=189&type=chunk) [Item 4. Controls and Procedures](index=39&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2025, with the only change to internal control over financial reporting being the hiring of a new chief financial officer - Management concluded that as of June 30, 2025, the company's disclosure controls and procedures were effective[190](index=190&type=chunk) - The hiring of a new chief financial officer was the only change in internal control over financial reporting during the quarter ended June 30, 2025[191](index=191&type=chunk) PART II - OTHER INFORMATION [Item 1. Legal Proceedings](index=40&type=section&id=Item%201.%20Legal%20Proceedings) On August 6, 2025, a minority shareholder filed a lawsuit against the company and its CEO, alleging breach of fiduciary duty and contract, seeking over **$12.5 million** in damages, which the company deems meritless - A complaint was filed on August 6, 2025, by minority shareholder David Lazar against the company and its CEO, alleging breach of fiduciary duty, minority shareholder oppression, and breach of contract[193](index=193&type=chunk) - The lawsuit seeks damages of **$11,882,683.45** for the first two causes of action and **$629,501.36** for the third, plus interest and fees, with the company considering the claims meritless[193](index=193&type=chunk) [Item 1A. Risk Factors](index=40&type=section&id=Item%201A.%20Risk%20Factors) No material changes to the company's risk factors were reported from its Annual Report on Form 10-K for the year ended December 31, 2024 - No material changes to the company's risk factors from its 2024 Form 10-K were reported[194](index=194&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=40&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities or use of proceeds during the period - None reported[195](index=195&type=chunk)
Cyclacel Pharmaceuticals, Inc.(CYCCP) - 2025 Q2 - Quarterly Results
2025-08-13 21:27
[Cyclacel Pharmaceuticals Q2 2025 Earnings Release](index=1&type=section&id=Cyclacel%20Pharmaceuticals%20Q2%202025%20Earnings%20Release) [Business Highlights](index=1&type=section&id=Business%20Highlights) Cyclacel executed key corporate actions including dividend payments, a strategic acquisition, a private placement, and a reverse stock split to enhance compliance and capital structure - The company declared and paid quarterly cash dividends of **$0.15 per share** on its 6% Convertible Exchangeable Preferred Stock in April and June 2025[4](index=4&type=chunk) - Entered into 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**, later amended to include a **$1 million cash consideration** from Cyclacel, with the closing date extended to September 30, 2025[4](index=4&type=chunk)[5](index=5&type=chunk) - Raised **$3 million in gross proceeds** through a securities purchase agreement with accredited investors for **3,000,000 shares of Series F Convertible Preferred Stock** at **$1.00 per share**[4](index=4&type=chunk) - Implemented a **one-for-fifteen reverse stock split**, effective July 7, 2025, to regain compliance with Nasdaq's minimum bid price requirement[4](index=4&type=chunk) [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) Cyclacel reported a significantly reduced net loss in Q2 2025, driven by decreased R&D and G&A expenses, improving its cash position and extending its cash runway [Financial Position](index=2&type=section&id=Financial%20Position) The company's cash and cash equivalents increased, with an estimated cash runway extending into the fourth quarter of 2025 Financial Position (In millions of US dollars) | Metric | Q2 2025 | Q4 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $4.3 | $3.2 | - 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) Operating expenses significantly decreased in Q2 2025, primarily due to reduced research and development activities and lower general and administrative costs Operating Expenses (In millions of US dollars) | Expense Category | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | Research and development | $0.1 | $2.0 | -$1.9 | | General and administrative | $1.2 | $1.6 | -$0.4 | - The decrease in R&D expenses is primarily due to the cessation of the transcriptional regulation program after the liquidation of the UK subsidiary, Cyclacel Limited, on January 24, 2025[7](index=7&type=chunk) - G&A expenses decreased due to lower operating costs under current management, 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 significantly reduced its net loss in Q2 2025 compared to the prior year, despite receiving no research and development tax credits Net Loss (In millions of US dollars) | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Net Loss | $1.3 | $3.3 | - The company received **no research & development tax credits** in Q2 2025, compared to **$0.4 million** in Q2 2024, due to the liquidation of its UK subsidiary[9](index=9&type=chunk) [Financial Statements](index=4&type=section&id=Financial%20Statements) This section presents the unaudited consolidated financial statements for Q2 2025, including the Statements of Operations detailing the net loss and the Balance Sheet outlining assets and stockholders' equity [Consolidated Statements of Operations (Loss)](index=4&type=section&id=Consolidated%20Statements%20of%20Operations%20(Loss)) This statement details the company's revenues, operating expenses, and net loss for the three months ended June 30, 2025 and 2024 Consolidated Statements of Operations (Loss) (In thousands of US dollars) | | Three Months Ended June 30, | | | :--- | :--- | :--- | | | **2025** | **2024** | | **Revenues** | **$ -** | **$ 4** | | Operating expenses: | | | | Research and development | 68 | 2,023 | | General and administrative | 1,249 | 1,625 | | **Total operating expenses** | **1,317** | **3,648** | | **Operating loss** | **(1,317)** | **(3,644)** | | Total other income (expense), net | 1 | (25) | | Loss before taxes | (1,316) | (3,669) | | Income tax benefit | (2) | 412 | | **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) This statement presents the company's financial position, including assets, liabilities, and stockholders' equity, as of June 30, 2025 and December 31, 2024 Consolidated Balance Sheet (In thousands of US dollars) | | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **ASSETS** | | | | Cash and cash equivalents | $ 4,275 | $ 3,137 | | Total current assets | 4,383 | 3,674 | | **Total assets** | **$ 4,401** | **$ 4,094** | | **LIABILITIES AND STOCKHOLDERS' EQUITY** | | | | Total current liabilities | 760 | 6,268 | | **Total liabilities** | **770** | **6,268** | | **Stockholders' equity** | **3,631** | **(2,174)** | | **Total liabilities and stockholders' equity** | **$ 4,401** | **$ 4,094** | [Company Information and Disclosures](index=2&type=section&id=Company%20Information%20and%20Disclosures) This section outlines Cyclacel's business as a clinical-stage biopharmaceutical company and includes standard forward-looking statements regarding potential risks and uncertainties [About Cyclacel Pharmaceuticals, Inc.](index=2&type=section&id=About%20Cyclacel%20Pharmaceuticals%2C%20Inc.) Cyclacel is a clinical-stage biopharmaceutical company focused on developing cancer medicines based on cell cycle, epigenetics, and mitosis biology - Cyclacel is a clinical-stage biopharmaceutical company focused on developing cancer medicines based on cell cycle, epigenetics, and mitosis biology[11](index=11&type=chunk) - The company's epigenetic/anti-mitotic 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 contains disclaimers regarding forward-looking statements, highlighting inherent risks and uncertainties that could impact future results - The press release contains forward-looking statements regarding the company's plans, prospects, cash runway, and clinical development, which are subject to risks and uncertainties including clinical trial outcomes, market conditions, financing needs, and Nasdaq listing compliance[12](index=12&type=chunk)
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 $3 Million Private Placement Offering of Convertible Preferred Stock
GlobeNewswire News Room· 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].
Cyclacel Pharmaceuticals, Inc.(CYCCP) - 2025 Q1 - Quarterly Results
2025-05-15 20:05
Financial Performance - Net cash used in operating activities was $8.0 million for the twelve months ended December 31, 2024, compared to $16.1 million for the same period of 2023, representing a 50.3% decrease[5]. - Net loss for the three months and year ended December 31, 2024, was $3.0 million and $11.2 million, compared to $5.3 million and $22.6 million for the same period in 2023, showing a 43.4% and 50.5% reduction respectively[10]. - Total liabilities decreased from $8.2 million as of December 31, 2023, to $6.3 million as of December 31, 2024, a reduction of approximately 23.2%[21]. Research and Development Expenses - Research and development (R&D) expenses were $0.9 million and $6.7 million for the three months and year ended December 31, 2024, compared to $3.5 million and $19.2 million for the same period in 2023, indicating a 74.3% and 65.1% decrease respectively[6]. - R&D expenses related to plogosertib were $0.1 million and $1.6 million for the three months and year ended December 31, 2024, compared to $0.7 million and $5.0 million for the same period in 2023, indicating a 85.7% and 68.0% decrease respectively[6]. - Collaboration and research and development revenue was $0 for the three months ended December 31, 2024, compared to $31,000 for the same period in 2023[20]. Cash Position - As of December 31, 2024, pro forma cash and cash equivalents totaled $7.2 million, including $4.1 million of equity financing received after the end of the year[5]. - The company estimates that its available cash will fund currently planned activities into the second quarter of 2025[5]. General and Administrative Expenses - General and administrative expenses for the three months and year ended December 31, 2024, were $0.9 million and $5.4 million, compared to $1.9 million and $6.7 million for the same period of the previous year, reflecting a 52.6% and 19.4% decrease respectively[7]. Equity Impact - The deconsolidation of Cyclacel Limited is anticipated to increase stockholders' equity by approximately $5.0 million[4].
CYCLACEL PHARMACEUTICALS REPORTS FIRST QUARTER FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE
GlobeNewswire News Room· 2025-05-15 04:50
Core Viewpoint - Cyclacel Pharmaceuticals is focusing on the development of its plogosertib clinical program while undergoing significant operational changes due to the liquidation of its UK subsidiary, Cyclacel Limited, which has impacted its financial results and strategic direction [2][4][7]. Financial Highlights - As of March 31, 2025, cash and cash equivalents increased to $3.5 million from $3.2 million as of December 31, 2024 [3]. - Net cash used in operating activities for the first quarter of 2025 was $3.3 million, with current cash resources expected to fund planned programs into the second quarter of 2025 [3]. - Research and development expenses were $0.8 million for the first quarter of 2025, a decrease from $2.8 million in the same period of 2024, primarily due to the cessation of expenditures related to the transcriptional regulation program following the liquidation of Cyclacel Limited [4]. - General and administrative expenses rose to $4.2 million for the first quarter of 2025, up from $1.6 million in the same period of 2024, attributed to one-time costs associated with the change of control [5]. - The company reported a net loss of $0.1 million for the first quarter of 2025, a significant improvement compared to a net loss of $2.9 million in the same period of 2024 [7]. Strategic Developments - The company has decided to focus solely on the plogosertib program and has repurchased related assets for approximately $0.3 million to enhance the development of an alternative salt, oral formulation with improved bioavailability [2]. - Following the liquidation of Cyclacel Limited, the company lost operational control over the subsidiary, leading to a gain on deconsolidation of approximately $5.0 million, which increased stockholders' equity [2][6]. - The company is exploring strategic alternatives to ensure its continued operation, including raising additional debt or equity financing or pursuing a merger or acquisition [2]. Research and Development Focus - Cyclacel is concentrating on the plogosertib program, which is a PLK1 inhibitor being evaluated for treating solid tumors and hematological malignancies [8]. - The company has ceased expenditures related to the fadraciclib program due to the liquidation of Cyclacel Limited, which has allowed for a reallocation of resources towards plogosertib [4][6]. Summary of Financial Performance - Total operating expenses for the first quarter of 2025 were $5.0 million, compared to $4.4 million in the same period of 2024 [11]. - The company reported total other income of $5.0 million for the first quarter of 2025, primarily due to the gain on deconsolidation of the UK subsidiary [6]. - The total assets as of March 31, 2025, were $3.7 million, a decrease from $4.1 million as of December 31, 2024, reflecting the impact of the subsidiary's liquidation [12][13].
Cyclacel Pharmaceuticals, Inc.(CYCCP) - 2025 Q1 - Quarterly Report
2025-05-14 20:10
Revenue and Financial Performance - The company reported revenue of $0 for the three months ended March 31, 2025, compared to $29,000 for the same period in 2024, and does not expect significant revenue in the foreseeable future [137]. - Revenue for the three months ended March 31, 2025 was $0, compared to $29,000 for the same period in 2024, related to recovery of clinical manufacturing costs [162]. - The accumulated deficit as of March 31, 2025, was $440.5 million, indicating significant financial losses since inception [151]. Cash Flow and Operating Activities - The company used net cash of $8.2 million to fund operating activities for the three months ended March 31, 2025, with cash and cash equivalents of $3.5 million remaining [143]. - Net cash used in operating activities increased by $2.8 million from $0.5 million in Q1 2024 to $3.2 million in Q1 2025, primarily due to a change in working capital [153]. Research and Development - Research and development expenses decreased by $2.0 million from $2.8 million in Q1 2024 to $0.8 million in Q1 2025, representing a 71% reduction [166]. - Total research and development expenses accounted for 16% of operating expenses in Q1 2025, down from 64% in Q1 2024 [165]. - Future research and development expenses are expected to decrease significantly for the year ending December 31, 2025, focusing solely on the anti-mitotic program [167]. - The company has initiated a Phase 1/2 study for plogosertib, with 15 patients treated at the first five dose escalation levels and no dose limiting toxicities observed [141][142]. General and Administrative Expenses - General and administrative expenses increased by approximately $2.6 million from $1.6 million in Q1 2024 to $4.2 million in Q1 2025, a 166% increase [171]. - Total general and administrative expenses represented 84% of operating expenses in Q1 2025, up from 36% in Q1 2024 [170]. Strategic Alternatives and Future Funding - The company plans to evaluate strategic alternatives, including raising additional capital or pursuing mergers and acquisitions, due to substantial doubt about its ability to continue as a going concern [145][146]. - The company is exploring ways to raise additional capital through private equity financing or strategic transactions due to substantial doubt about its ability to continue as a going concern [161]. - Future funding requirements will depend on various factors, including clinical trial costs, manufacturing capabilities, and potential acquisitions [157]. Other Financial Information - Total other income increased by $4.9 million from $55,000 in Q1 2024 to $5.0 million in Q1 2025, primarily due to a gain on deconsolidation of a subsidiary [173]. - The company no longer qualifies for research and development tax credits following the liquidation of its UK subsidiary, resulting in a tax benefit decrease from $1.4 million in Q1 2024 to $0 in Q1 2025 [177]. - The liquidation of the UK subsidiary has resulted in the forgiveness of intercompany loans and reclassification of accumulated translation adjustments [176]. Asset Management - The company repurchased certain assets related to the plogosertib clinical program for approximately $0.3 million in cash on March 10, 2025 [138]. - The company has no plans to repurchase rights to the fadraciclib program, which is being marketed for sale by the joint liquidator [138]. Compliance and Control - The company regained compliance with Nasdaq's equity requirement on February 25, 2025, following a change of control [144].
Cyclacel Pharmaceuticals, Inc.(CYCCP) - 2024 Q4 - Annual Report
2025-04-02 21:00
Clinical Development and Regulatory Challenges - The company is currently in clinical development with one product candidate, plogosertib, a PLK 1 inhibitor for esophageal cancer and acute leukemia [132]. - Clinical trials for plogosertib may require several more years to complete and could extend beyond available funding [132]. - The company has faced challenges in clinical trials, including a failed SEAMLESS Phase 3 study that did not meet its primary endpoint [133]. - Delays in securing clinical investigators or trial sites could impact the timeline for clinical trials and regulatory approvals [135]. - The company may experience increased development costs due to enrollment delays in clinical trials, potentially harming commercial prospects for plogosertib [138]. - The FDA and other regulatory authorities have substantial discretion in the approval process, which can be lengthy and unpredictable [146]. - The company has not yet submitted a marketing application for plogosertib and has limited experience in conducting the necessary clinical trials [146]. - The use of biomarkers in drug development is not scientifically validated, which may lead to inefficient resource allocation [142]. - The company has not obtained regulatory approval for any drug candidate, and future candidates may also face significant hurdles [146]. - The company may face delays in receiving regulatory approval for plogosertib due to various factors, including disagreements with regulatory authorities on trial design [148]. - Delays in clinical trials may harm the approval and commercial prospects of the product candidate, potentially increasing costs and delaying revenue generation [149]. - Regulatory authorities may approve drug candidates for fewer indications than requested, impacting commercial potential [150]. - Undesirable side effects from the product candidate could lead to delays in marketing approval and limit commercial potential [151]. - The FDA and other regulatory authorities may require costly post-marketing studies or impose restrictions on the product's marketing [157]. - Regulatory approvals may be subject to limitations and ongoing compliance requirements, which could affect market acceptance [163]. - The time required for regulatory approval is unpredictable and can take many years, influenced by various factors [160]. Competition and Market Dynamics - Competition is intense, with numerous drug candidates in development that may be more effective or less expensive [171]. - The company is highly dependent on market acceptance among healthcare providers and payors, which is influenced by factors such as safety, efficacy, and pricing [178]. - Reimbursement decisions by third-party payors may adversely affect pricing and market acceptance of the company's products, potentially limiting commercialization [180]. - Future product candidates may face competition from generic and follow-on drug products sooner than anticipated, impacting potential revenue [172]. - The FDA's approval process for generic drugs allows competitors to enter the market, which could negatively affect the company's future revenue and profitability [174]. Financial Condition and Capital Requirements - The company has incurred operating losses since its inception in 1996, with an accumulated deficit of $439.5 million as of December 31, 2024 [229]. - The net loss for the year ended December 31, 2024, was $11.2 million, compared to a net loss of $22.5 million for the year ended December 31, 2023 [229]. - As of December 31, 2024, the company's cash and cash equivalents were $3.1 million, raising substantial doubt about its ability to continue as a going concern for the next year [232]. - The company expects to incur significant losses for several years as it continues research and development of drug candidates and seeks regulatory approvals [229]. - The company may face challenges in raising additional capital, which could lead to further dilution of existing stockholders' interests [233]. - The company faces substantial additional funding requirements to support research, clinical trials, and commercialization efforts, which may be impacted by current economic conditions [250][251]. Legislative and Regulatory Environment - Legislative and regulatory changes in healthcare could continue to impact the business and financial condition of the company [182]. - The Affordable Care Act (ACA) has significantly impacted the U.S. pharmaceutical industry, increasing Medicaid rebates and establishing a 70% point-of-sale discount for Medicare Part D beneficiaries during coverage gaps [196]. - The American Rescue Plan Act of 2021 eliminates the statutory cap on Medicaid drug rebates, effective January 1, 2024, which could affect pricing strategies [198]. - Starting in 2023, manufacturers must pay a rebate to the federal government if drug prices increase faster than inflation, with negotiations for select Medicare Part D drugs beginning in 2026 [203]. - The Inflation Reduction Act of 2022 allows the Secretary of HHS to implement provisions through guidance, creating uncertainty about its effects on drug pricing [203]. - Increased scrutiny over pharmaceutical pricing has led to Congressional inquiries and proposed legislation aimed at enhancing transparency and reforming reimbursement methodologies [200]. - The U.S. Supreme Court's decision in December 2020 allows states to regulate pharmaceutical benefit managers, potentially leading to more aggressive state-level regulations [206]. - Legislative changes at both federal and state levels may limit government payments for healthcare products, impacting demand and pricing pressures on the company's products [209]. - The company anticipates that future healthcare reforms could have a material adverse effect on the U.S. healthcare industry, particularly regarding access and financing [199]. Operational Risks and Compliance - The company is experiencing a tight labor market with an unemployed-to-job-openings ratio of 0.9, leading to increased costs and challenges in recruitment [186]. - The commercialization of products will depend on the ability to develop effective sales and marketing capabilities, which are currently lacking [192]. - The company may face delays in product supply if third-party manufacturers do not meet quality or timeliness standards [189]. - Regulatory compliance costs are increasing due to evolving privacy laws, which may adversely affect the company's financial condition [225]. - The company has not yet self-certified under the newly adopted EU-U.S. Data Privacy Framework, which may complicate data transfer processes [217]. - The company is vulnerable to economic instability, which could adversely impact its business strategy and financial performance [234]. - The company may be subject to significant penalties for noncompliance with privacy regulations, including fines of up to €20 million or 4% of annual global revenues [218]. - Cybersecurity incidents pose a risk to the company's sensitive data and operations, with potential legal and reputational consequences [256][258]. - Disruptions at the FDA and other agencies could adversely affect the company's ability to review and approve new products, impacting business operations [238][239]. Intellectual Property and Legal Risks - Intellectual property rights are crucial for commercial success; inadequate enforcement could harm the company's competitive position [275]. - The company may be subject to claims regarding the wrongful use of trade secrets from former employers of its employees, which could lead to litigation and loss of valuable rights [281]. - The company relies on trade secret protection for its proprietary technology and processes, but enforcing these protections can be difficult and costly [282]. - There are risks of infringing on third-party intellectual property rights, which could delay or prevent the commercialization of drug candidates [283]. - The company is aware of several published patent applications that could potentially restrict its research and development operations [284]. - The company may incur substantial costs due to litigation related to patent and intellectual property rights, which could divert management's attention from business operations [285]. Stock and Market Considerations - The company executed a 15:1 reverse stock split on December 18, 2023, to regain compliance with Nasdaq's minimum bid price requirements [246]. - Nasdaq notified the company on February 25, 2025, that it has regained compliance with the equity requirement in Listing Rule 5550(b)(1) [247]. - The company does not anticipate paying cash dividends on its common stock in the foreseeable future, relying instead on capital appreciation for returns [325]. - The number of shares of common stock registered for resale is significant and could exert downward pressure on the market price of the common stock [326]. - The company is exposed to risks related to marketable securities, which may be impacted by market volatility and credit restrictions [328]. - The company may face substantial costs and management distraction from potential litigation related to its securities [320]. - The automatic conversion of convertible preferred stock could lead to significant fluctuations in the price of common stock [324]. - The company’s ability to pay cash dividends on preferred stock is limited by Delaware law and its current financial condition [314].
Cyclacel Pharmaceuticals, Inc.(CYCCP) - 2024 Q3 - Quarterly Report
2024-11-12 22:10
Revenue Performance - Revenue for the three and nine months ended September 30, 2024, was $10,000 and $43,000, respectively, compared to $16,000 and $389,000 for the same periods in 2023, indicating a decline of 37.5% and 89.0% year-over-year [118]. - Revenue for the three months ended September 30, 2024, was $10,000, a decrease of 38% from $16,000 in the same period of 2023 [150]. Financial Position - As of September 30, 2024, the company had cash and cash equivalents of $2.98 million, down from $5.94 million in 2023, indicating a liquidity challenge [137]. - The accumulated deficit as of September 30, 2024, was $436.4 million, reflecting significant losses since inception [137]. - The company has received a notice from Nasdaq regarding non-compliance with the Equity Rule due to stockholders' equity being less than $2.5 million, with a stockholders' equity deficit of approximately $0.97 million as of September 30, 2024 [134][136]. Operating Activities - The company reported a net cash used in operating activities of $6.6 million for the nine months ended September 30, 2024, a decrease of $5.6 million from $12.2 million in the same period of 2023 [139]. - General and administrative expenses for the nine months ended September 30, 2024, were $4.4 million, down from $4.8 million in 2023, reflecting an 8% decrease [157]. Research and Development - Total research and development expenses decreased by $9.9 million from $15.6 million for the nine months ended September 30, 2023, to $5.8 million for the same period in 2024, representing a 63% reduction [154]. - Research and development expenses for the transcriptional regulation program decreased by $6.6 million, primarily due to decreases in manufacturing and non-clinical expenditure [154]. - The Phase 1/2 study of plogosertib has treated 15 patients with no dose-limiting toxicities observed, indicating potential for further development in various cancer types [131][132]. - Fadraciclib, a CDK2/9 inhibitor, is being evaluated in a Phase 1/2 study with 47 heavily pretreated patients dosed, showing good tolerability and preliminary efficacy in certain cancer types [120][121]. - In the ongoing Phase 2 study of fadraciclib, two partial responses were reported in patients with T-cell lymphoma, and a 22% reduction in tumor burden was observed in a patient with squamous non-small cell lung cancer [123]. Future Outlook - The company is currently investigating ways to raise additional capital through private equity financing or strategic transactions due to substantial doubt about its ability to continue as a going concern [133]. - The company has substantial doubt about its ability to continue as a going concern for at least twelve months from the issuance date of the Quarterly Report due to reliance on additional financing [149]. - Future funding requirements will depend on the ability to generate product revenue and the availability of funds in equity markets [144]. - Overall research and development expenses for the year ended December 31, 2024, are anticipated to decrease compared to 2023, focusing primarily on clinical trial costs [155]. - The company expects to fulfill its obligations under the clinical manufacturing agreement by the fourth quarter of 2024 [151]. Other Income - Other income decreased by $195,000 from $235,000 for the nine months ended September 30, 2023, to $40,000 for the same period in 2024 [159]. - Total income tax benefit for the nine months ended September 30, 2024, was $2.0 million, a decrease of 23% from $2.6 million in the same period of 2023 [164].
Cyclacel Pharmaceuticals, Inc.(CYCCP) - 2024 Q3 - Quarterly Results
2024-11-12 22:00
Financial Performance - The net loss for the three months ended September 30, 2024, was $2.0 million, compared to $6.0 million for the same period in 2023, reflecting improved financial performance[10] - Net cash used in operating activities was $6.6 million for the nine months ended September 30, 2024, compared to $12.2 million for the same period in 2023, indicating a reduction in cash burn[5] Cash and Liquidity - As of September 30, 2024, cash equivalents totaled $3.0 million, down from $3.4 million as of December 31, 2023[5] - The company is investigating ways to raise additional capital through private equity financing or strategic transactions to avoid potential delisting from Nasdaq[6] - The company has received an extension until December 24, 2024, to regain compliance with Nasdaq's minimum stockholders' equity requirement[4] Expenses - Research and development (R&D) expenses were $1.0 million for the three months ended September 30, 2024, a significant decrease from $5.2 million for the same period in 2023[7] - General and administrative expenses for the three months ended September 30, 2024, were $1.2 million, down from $1.6 million for the same period in 2023, primarily due to reduced stock compensation costs[8] Revenue - The company reported collaboration and research and development revenue of $10,000 for the three months ended September 30, 2024, compared to $16,000 for the same period in 2023[15] Tax Credits - United Kingdom research & development tax credits for the three months ended September 30, 2024, were $0.2 million, down from $0.7 million for the same period in the previous year[9] Liabilities - Total liabilities as of September 30, 2024, were $6.4 million, compared to $8.2 million as of December 31, 2023, indicating a decrease in liabilities[17]