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Bio Green Med Solution, Inc. Announces Closing of Strategic Acquisition of Fitters Sdn. Bhd.
Globenewswire· 2025-09-12 10:00
Core Viewpoint - Bio Green Med Solution, Inc. has successfully completed the acquisition of Fitters Sdn. Bhd., enhancing its business portfolio by entering the fire protection and safety sector while maintaining its pharmaceutical interests [1][3][4]. Company Overview - Bio Green Med Solution, Inc. (formerly Cyclacel Pharmaceuticals, Inc.) is a diversified company engaged in both the fire protection and biopharmaceutical industries, focusing on long-term value creation for shareholders [5]. - Fitters Sdn. Bhd. specializes in the supply and trading of protective and fire safety equipment, including fire extinguishers, foam systems, and personal protective equipment, and has a strong reputation for reliability and compliance with regulatory standards [2][6]. Transaction Details - The Exchange Transaction involved Bio Green Med issuing 699,158 shares of its common stock, representing 19.99% of the outstanding shares, to FITTERS Diversified Berhad in exchange for all equity interests of Fitters [4]. - Following the transaction, Fitters became a wholly-owned subsidiary of Bio Green Med, and the company's ticker symbols changed from CYCC and CYCCP to BGMS and BGMSP, respectively [3][4]. Strategic Implications - The acquisition allows Bio Green Med to diversify its business interests and explore opportunities across multiple industries, positioning the company for long-term growth [4]. - The integration of Fitters' established operations is expected to create synergies and enhance the company's market presence in the fire safety sector [4].
Cyclacel(CYCC) - 2025 Q2 - Quarterly Report
2025-08-14 01:45
[PART I - FINANCIAL INFORMATION](index=6&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) This section presents Cyclacel Pharmaceuticals, Inc.'s unaudited consolidated financial statements and management's analysis [Item 1. Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) Presents Cyclacel's unaudited consolidated financial statements, highlighting improved equity, reduced net loss, and a deconsolidation gain [Consolidated Balance Sheets](index=6&type=section&id=Balance%20Sheets%20as%20of%20June%2030%2C%202025%20and%20December%2031%2C%202024%20%28unaudited%29) Cash and cash equivalents increased, total liabilities decreased, and stockholders' equity shifted from deficit to positive | Metric | June 30, 2025 ($000s) | December 31, 2024 ($000s) | Change ($000s) | Change (%) | | :-------------------------------- | :--------------------- | :------------------------ | :-------------- | :--------- | | Cash and cash equivalents | 4,275 | 3,137 | 1,138 | 36.28% | | Total current assets | 4,383 | 3,674 | 709 | 19.29% | | Total assets | 4,401 | 4,094 | 307 | 7.50% | | Accounts payable | 221 | 4,599 | (4,378) | -95.20% | | Accrued and other current liabilities | 539 | 1,669 | (1,130) | -67.70% | | Total current liabilities | 760 | 6,268 | (5,508) | -87.88% | | Total liabilities | 770 | 6,268 | (5,498) | -87.71% | | Total stockholders' equity (deficit) | 3,631 | (2,174) | 5,805 | 267.02% | - The company's total stockholders' equity shifted from a deficit of **$2.174 million** at December 31, 2024, to a positive equity of **$3.631 million** at June 30, 2025, indicating a significant improvement in financial position[18](index=18&type=chunk) [Consolidated Statements of Operations](index=8&type=section&id=Statements%20of%20Operations%20for%20the%20three%20and%20six%20months%20ended%20June%2030%2C%202025%20and%20the%20three%20and%20six%20months%20ended%20June%2030%2C%202024%20%28unaudited%29) The company reported no revenue, significantly reduced net loss due to a deconsolidation gain, and decreased R&D expenses | Metric ($000s) | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | Change (3 Months) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Change (6 Months) | | :-------------------------------- | :--------------------------- | :--------------------------- | :---------------- | :--------------------------- | :--------------------------- | :---------------- | | Revenues | — | 4 | (4) | — | 33 | (33) | | Research and development | 68 | 2,023 | (1,955) | 890 | 4,825 | (3,935) | | General and administrative | 1,249 | 1,625 | (376) | 5,463 | 3,207 | 2,256 | | Operating loss | (1,317) | (3,644) | 2,327 | (6,353) | (7,999) | 1,646 | | Gain on deconsolidation of subsidiary | — | — | — | 4,947 | — | 4,947 | | Net loss | (1,318) | (3,257) | 1,939 | (1,399) | (6,203) | 4,804 | | Net loss per share – basic and diluted | (0.98) | (172.18) | 171.2 | (1.62) | (509.96) | 508.34 | - The company reported **$0 revenue** for both the three and six months ended June 30, 2025, a decrease from **$4 thousand** and **$33 thousand** respectively in the prior year periods[21](index=21&type=chunk) - Net loss significantly decreased for the six months ended June 30, 2025, to **$(1.399) million** from **$(6.203) million** in the prior year, primarily due to a **$4.947 million** gain on deconsolidation of a subsidiary[21](index=21&type=chunk) [Consolidated Statements of Comprehensive Loss](index=9&type=section&id=Consolidated%20Statements%20of%20Comprehensive%20Loss) Comprehensive loss significantly decreased for the six months ended June 30, 2025, driven by lower net loss and positive translation adjustment | Metric ($000s) | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | Change (3 Months) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Change (6 Months) | | :-------------------------------- | :--------------------------- | :--------------------------- | :---------------- | :--------------------------- | :--------------------------- | :---------------- | | Net loss | (1,318) | (3,257) | 1,939 | (1,399) | (6,203) | 4,804 | | Translation adjustment | — | (521) | 521 | 3,271 | 1,619 | 1,652 | | Unrealized foreign exchange gain (loss) on intercompany loans | — | 504 | (504) | (2,380) | (1,626) | (754) | | Comprehensive loss | (1,318) | (3,274) | 1,956 | (508) | (6,210) | 5,702 | - Comprehensive loss for the six months ended June 30, 2025, significantly decreased to **$(508) thousand** from **$(6.210) million** in the prior year, driven by a lower net loss and a positive translation adjustment[24](index=24&type=chunk) [Consolidated Statements of Stockholders' Equity (Deficit)](index=10&type=section&id=Statements%20of%20Changes%20in%20Stockholders%27%20Equity%20%28Deficit%29%20for%20the%20three%20and%20six%20months%20ended%20June%2030%2C%202025%20and%20the%20three%20and%20six%20months%20ended%20June%2030%2C%202024%20%28unaudited%29) Total stockholders' equity shifted from a deficit to positive equity due to new preferred stock issuances and conversions | Metric ($000s) | December 31, 2024 | June 30, 2025 | | :-------------------------------- | :------------------ | :------------ | | Total Stockholders' Equity (Deficit) | (2,174) | 3,631 | | Additional Paid-in Capital | 438,211 | 445,405 | | Accumulated Deficit | (439,494) | (441,779) | - Total stockholders' equity shifted from a deficit of **$2.174 million** at December 31, 2024, to a positive equity of **$3.631 million** at June 30, 2025, primarily due to new preferred stock issuances and conversions, and the deconsolidation of a foreign operation[26](index=26&type=chunk)[28](index=28&type=chunk) - Significant activities in the first six months of 2025 included the issuance of Series C, D, E, and F preferred stock, and the conversion of Series C, D, and E preferred stock into common stock[26](index=26&type=chunk)[28](index=28&type=chunk) [Consolidated Statements of Cash Flows](index=13&type=section&id=Statements%20of%20Cash%20Flows%20for%20the%20six%20months%20ended%20June%2030%2C%202025%20and%20the%20six%20months%20ended%20June%2030%2C%202024%20%28unaudited%29) Net cash used in operating activities increased, while net cash provided by financing activities decreased | Metric ($000s) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Change ($000s) | | :-------------------------------- | :--------------------------- | :--------------------------- | :------------- | | Net cash used in operating activities | (4,303) | (3,567) | (736) | | Net cash used in investing activities | — | — | — | | Net cash provided by financing activities | 5,526 | 6,210 | (684) | | Net increase (decrease) in cash and cash equivalents | 1,138 | 2,622 | (1,484) | | Cash and cash equivalents, end of period | 4,275 | 6,000 | (1,725) | - Net cash used in operating activities increased by **$0.7 million** to **$4.3 million** for the six months ended June 30, 2025, compared to the same period in 2024[31](index=31&type=chunk)[161](index=161&type=chunk) - Net cash provided by financing activities decreased by **$0.7 million** to **$5.5 million** for the six months ended June 30, 2025, primarily from preferred stock issuances, offset by warrant payments[31](index=31&type=chunk)[163](index=163&type=chunk) [Notes to Unaudited Consolidated Financial Statements](index=14&type=section&id=Notes%20to%20Financial%20Statements%20%28Unaudited%29) This section provides detailed notes explaining the accounting policies and specific financial statement items [1. Company Overview](index=14&type=section&id=1.%20Company%20Overview) Cyclacel is a clinical-stage biopharmaceutical company focused on cancer medicines, with its UK subsidiary entering liquidation - Cyclacel Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing cancer medicines based on cell cycle, transcriptional regulation, epigenetics, and mitosis control biology[33](index=33&type=chunk) - The company's wholly-owned UK subsidiary, Cyclacel Limited, entered creditors voluntary liquidation on January 24, 2025, leading to its deconsolidation and a gain of approximately **$5.0 million** on the income statement[34](index=34&type=chunk) [2. Summary of Significant Accounting Policies](index=14&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) This section outlines the key accounting principles and policies applied in preparing the consolidated financial statements [Basis of Presentation](index=14&type=section&id=Basis%20of%20Presentation) The unaudited consolidated financial statements are prepared in accordance with GAAP for interim financial information and SEC rules - The consolidated financial statements are unaudited and prepared in accordance with GAAP for interim financial information and SEC rules, not including all disclosures required for a complete set of annual financial statements[36](index=36&type=chunk) [Reverse Stock Splits](index=14&type=section&id=Reverse%20Stock%20Splits) The Company effected two reverse stock splits in May and July 2025, retrospectively adjusting all share data - The Company effected a one-for-sixteen reverse stock split on May 12, 2025, and a further one-for-fifteen reverse stock split on July 7, 2025. All share and per share data have been retrospectively adjusted[37](index=37&type=chunk) [Going Concern](index=15&type=section&id=Going%20Concern%20%28Accounting%20Policy%29) Management has substantial doubt about the Company's ability to continue as a going concern due to losses and financing dependence - Management has assessed that there is substantial doubt about the Company's ability to continue as a going concern for at least twelve months from the issuance date of the financial statements, due to a history of losses, negative cash flows, and dependence on additional financing[39](index=39&type=chunk) - Cash and cash equivalents of **$4.3 million** as of June 30, 2025, are anticipated to meet liquidity requirements only into the fourth quarter of 2025[39](index=39&type=chunk) - The Company regained compliance with Nasdaq's equity requirement on February 25, 2025, but is subject to a Mandatory Panel Monitor for one year[40](index=40&type=chunk) [Newly Adopted Accounting Pronouncements](index=15&type=section&id=Newly%20Adopted%20Accounting%20Pronouncements) The Company adopted ASU 2023-09 on January 1, 2025, requiring specified captions for tax rate reconciliation and disaggregated income taxes paid - On January 1, 2025, the Company adopted ASU 2023-09, 'Income Taxes (Topic 740): Improvements to Income Tax Disclosures,' which requires specified captions for tax rate reconciliation and disaggregated income taxes paid[42](index=42&type=chunk) [Recently Issued Accounting Pronouncements](index=16&type=section&id=Recently%20Issued%20Accounting%20Pronouncements) The FASB issued ASU 2024-03, effective after December 15, 2026, which the Company is currently evaluating - The FASB issued ASU 2024-03, 'Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses,' effective for annual periods after December 15, 2026, which the Company is currently evaluating[43](index=43&type=chunk) [Fair Value of Financial Instruments](index=16&type=section&id=Fair%20Value%20of%20Financial%20Instruments) The carrying amounts of cash equivalents, accounts payable, and accrued liabilities approximate their fair values - The carrying amounts of cash equivalents, accounts payable, and accrued liabilities approximate their fair values due to their short maturities[44](index=44&type=chunk) [Comprehensive Income (Loss)](index=16&type=section&id=Comprehensive%20Income%20%28Loss%29) Upon deconsolidation of the UK subsidiary, **$0.9 million** of accumulated comprehensive income (loss) was reclassified into earnings - Upon deconsolidation of the UK subsidiary on January 24, 2025, **$0.9 million** of accumulated comprehensive income (loss) was reclassified into earnings as part of the gain on deconsolidation[45](index=45&type=chunk) [Foreign Currency and Currency Translation](index=16&type=section&id=Foreign%20Currency%20and%20Currency%20Translation) Foreign currency-denominated assets and liabilities are remeasured at current exchange rates, with gains or losses recognized in operations - Foreign currency-denominated monetary assets and liabilities are remeasured at current exchange rates, with gains or losses recognized in the statement of operations[46](index=46&type=chunk) - Prior to January 24, 2025, translation adjustments and unrealized foreign exchange gains/losses on long-term intercompany loans were recorded in other comprehensive loss[47](index=47&type=chunk) [Leases](index=16&type=section&id=Leases%20%28Accounting%20Policy%29) The Company accounts for operating leases under ASC 842, recognizing right-of-use assets and lease liabilities - The Company accounts for lease contracts under ASC 842, classifying outstanding leases as operating leases and recognizing a right-of-use asset and lease liabilities based on the present value of lease payments[48](index=48&type=chunk)[49](index=49&type=chunk) [Revenue Recognition](index=17&type=section&id=Revenue%20Recognition%20%28Accounting%20Policy%29) Revenue is recognized using the five-step model of ASC 606, with grant revenue presented as a reduction of R&D expenses - Revenue is recognized using the five-step model provided in ASC 606, with transaction prices including fixed payments and estimated variable consideration, subject to a constraint[52](index=52&type=chunk) - Grant revenue from non-customers (e.g., charitable foundations, government agencies) is presented as a reduction against related research and development expenses[58](index=58&type=chunk) [3. Revenue](index=18&type=section&id=3.%20Revenue%20%28Note%29) The Company recognized no revenue for the three and six months ended June 30, 2025, a decrease from the prior year | Period | Revenue ($000s) | | :--------------------------- | :---------------- | | 3 months ended June 30, 2025 | — | | 3 months ended June 30, 2024 | 4 | | 6 months ended June 30, 2025 | — | | 6 months ended June 30, 2024 | 33 | - The Company recognized **no revenue** for the three and six months ended June 30, 2025, a decrease from **$4 thousand** and **$33 thousand** respectively in the prior year, which was related to clinical manufacturing cost recovery[59](index=59&type=chunk) [4. Net Loss per Common Share](index=18&type=section&id=4.%20Net%20Loss%20per%20Common%20Share) Potentially dilutive securities were excluded from diluted net loss per share computation as their inclusion would be anti-dilutive - Potentially dilutive securities, including stock options, restricted stock units, preferred stock, and common stock warrants, were excluded from the computation of diluted net loss per share for the six months ended June 30, 2025 and 2024, as their inclusion would have been anti-dilutive[61](index=61&type=chunk) Potentially Dilutive Securities | Potentially Dilutive Securities | June 30, 2025 | June 30, 2024 | | :------------------------------ | :------------ | :------------ | | Stock options | 25,106 | 549 | | Restricted Stock Units | 10 | 171 | | Series A preferred stock | 2 | 2 | | Series F preferred stock | 654,000 | — | | Common stock warrants | 1,965,178 | 45,298 | | Total shares excluded | 2,644,296 | 46,020 | [5. Prepaid Expenses and Other Current Assets](index=18&type=section&id=5.%20Prepaid%20Expenses%20and%20Other%20Current%20Assets) Prepaid expenses and other current assets significantly decreased from **$537 thousand** to **$108 thousand** by June 30, 2025 | Category | June 30, 2025 ($000s) | December 31, 2024 ($000s) | | :----------------------- | :-------------------- | :------------------------ | | Prepayments and VAT receivable | 50 | 237 | | Other current assets | 58 | 300 | | Total | 108 | 537 | - Prepaid expenses and other current assets decreased significantly from **$537 thousand** at December 31, 2024, to **$108 thousand** at June 30, 2025[62](index=62&type=chunk) [6. Non-Current Assets](index=18&type=section&id=6.%20Non-Current%20Assets) The Company had no non-current assets as of June 30, 2025, a decrease from **$0.4 million** at December 31, 2024 - The Company had **no non-current assets** as of June 30, 2025, a decrease from **$0.4 million** at December 31, 2024, which primarily consisted of deposits held by a contract research organization[63](index=63&type=chunk) [7. Accrued and Other Liabilities](index=19&type=section&id=7.%20Accrued%20and%20Other%20Liabilities) Accrued and other current liabilities decreased significantly due to a reduction in accrued research and development costs | Category | June 30, 2025 ($000s) | December 31, 2024 ($000s) | | :------------------------------ | :-------------------- | :------------------------ | | Accrued research and development | 1 | 1,299 | | Accrued legal and professional fees | 500 | 87 | | Other current liabilities | 38 | 283 | | Total | 539 | 1,669 | - Accrued and other current liabilities decreased from **$1.669 million** at December 31, 2024, to **$539 thousand** at June 30, 2025, primarily due to a significant reduction in accrued research and development costs[64](index=64&type=chunk) [8. Leases](index=19&type=section&id=8.%20Leases%20%28Note%29) The Company maintains an operating lease for its Kuala Lumpur facility, with lease expenses significantly decreasing after a headquarters lease termination - The Company currently has an operating lease liability for its Kuala Lumpur, Malaysia facility, with a remaining lease term of approximately **1.7 years** as of June 30, 2025[65](index=65&type=chunk)[66](index=66&type=chunk) - Operating lease expenses decreased significantly from **$38,062** for the six months ended June 30, 2024, to **$3,790** for the same period in 2025, following the termination of its New Jersey headquarters lease[65](index=65&type=chunk)[66](index=66&type=chunk) [9. Stock Based Compensation](index=19&type=section&id=9.%20Stock%20Based%20Compensation) Total stock-based compensation costs increased significantly, primarily driven by general and administrative expenses and new option grants | Expense Category | 3 Months Ended June 30, 2025 ($000s) | 3 Months Ended June 30, 2024 ($000s) | 6 Months Ended June 30, 2025 ($000s) | 6 Months Ended June 30, 2024 ($000s) | | :----------------------- | :----------------------------------- | :----------------------------------- | :----------------------------------- | :----------------------------------- | | General and administrative | 2 | 168 | 1,595 | 321 | | Research and development | 5 | 21 | 78 | 71 | | Total Stock-based compensation costs | 7 | 189 | 1,673 | 392 | - Total stock-based compensation costs increased significantly to **$1.673 million** for the six months ended June 30, 2025, from **$392 thousand** in the prior year, primarily driven by general and administrative expenses[69](index=69&type=chunk) - The Company granted **24,812 options** during the six months ended June 30, 2025, with a weighted average grant date fair value of **$70.79 per option**, and accelerated recognition of unrecognized compensation expense for restricted stock units due to impending cancellation from the July 2025 Reverse Stock Split[75](index=75&type=chunk)[76](index=76&type=chunk)[80](index=80&type=chunk) [10. Stockholders' Equity](index=22&type=section&id=10.%20Stockholders%27%20Equity%20%28Note%29) This section details changes in common stock, warrants, and preferred stock, including issuances, conversions, and exercises [Common Stock Equity Offerings](index=22&type=section&id=Common%20Stock%20Equity%20Offerings) The Company issued Series F Convertible Preferred Stock and Warrants in June 2025, raising **$3.0 million** for general corporate purposes - In June 2025, the Company issued **3,000,000 shares** of Series F Convertible Preferred Stock and **1,962,000 Warrants** for aggregate gross proceeds of **$3.0 million**, to be used for general corporate and operating purposes[82](index=82&type=chunk)[83](index=83&type=chunk) - In April 2024, the Company completed a private placement raising approximately **$8.0 million** gross proceeds from the issuance of common stock, pre-funded warrants, and common warrants[89](index=89&type=chunk)[92](index=92&type=chunk) - In December 2023, the Company completed a registered direct offering and concurrent private placement, raising approximately **$1.0 million** net proceeds from the sale of common stock, pre-funded warrants, and common warrants[97](index=97&type=chunk)[98](index=98&type=chunk) [Warrants](index=25&type=section&id=Warrants) **1,962,000 warrants** from the June 2025 financing remained outstanding, while **82,816 warrants** from November 2024 were exercised - As of June 30, 2025, **1,962,000 warrants** from the June 2025 financing transaction remained outstanding, with exercise prices ranging from **$7.65 to $10.20 per share** and a five-year expiration[104](index=104&type=chunk)[105](index=105&type=chunk) - All **82,816 warrants** from the November 2024 agreement were exercised during the six months ended June 30, 2025, resulting in a **$1.1 million** cash payment by the Company[107](index=107&type=chunk)[108](index=108&type=chunk) - A total of **20,704 Series A warrants** from the April 2024 financing were exercised during the six months ended June 30, 2025[110](index=110&type=chunk) [Preferred Stock](index=27&type=section&id=Preferred%20Stock) **3,000,000 shares** of Series F Preferred Stock were issued, while Series C, D, and E Preferred Stock were fully converted - **3,000,000 shares** of Series F Preferred Stock were issued in June 2025 for **$3.0 million**, convertible into **0.218 shares of common stock** each, with all shares remaining outstanding as of June 30, 2025[116](index=116&type=chunk)[117](index=117&type=chunk)[118](index=118&type=chunk) - All **1,000,000 shares** of Series E Preferred Stock, issued in March 2025 for **$1.0 million**, were converted into **458,333 shares of Common Stock** during the six months ended June 30, 2025[119](index=119&type=chunk)[120](index=120&type=chunk)[122](index=122&type=chunk) - Series C and D Preferred Stock, issued in January 2025 for **$3.1 million**, were fully converted into common stock by April 2, 2025, with no shares remaining outstanding as of June 30, 2025[123](index=123&type=chunk)[126](index=126&type=chunk)[127](index=127&type=chunk) - **No Series B Preferred Stock** remained outstanding as of June 30, 2025, following conversions during the year ended December 31, 2024[129](index=129&type=chunk) - **264 shares** of Series A Preferred Stock remain outstanding as of June 30, 2025, convertible into **2 shares of common stock**, and rank senior to common stock in liquidation[131](index=131&type=chunk)[134](index=134&type=chunk) - **135,273 shares** of 6% Convertible Exchangeable Preferred Stock remain outstanding, with a liquidation preference of **$10.00 per share** plus accrued and unpaid dividends[135](index=135&type=chunk) [11. Subsequent Events](index=29&type=section&id=11.%20Subsequent%20Events) The board declared a quarterly cash dividend on the 6% Convertible Exchangeable Preferred Stock, paid on August 1, 2025 - On June 3, 2025, the board declared a quarterly cash dividend on the 6% Convertible Exchangeable Preferred Stock, paid on August 1, 2025[139](index=139&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=31&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the Company's financial condition, strategic shifts, and operational results, highlighting reduced net loss, going concern issues, and a proposed merger [Recent Developments](index=4&type=section&id=Recent%20Developments) The Company underwent a change of control, liquidated its UK subsidiary, repurchased plogosertib assets, and is exploring a merger - In December 2024, the Company began exploring strategic alternatives, including a potential transaction with investor David E. Lazar, leading to a securities purchase agreement on January 2, 2025, for **$3.1 million** in preferred stock[8](index=8&type=chunk) - On February 11, 2025, Datuk Dr. Doris Wong Sing Ee acquired Lazar's preferred stock, resulting in her holding **70%** of the fully diluted shares, and subsequently converted Series C and D shares into **810,952 shares of common stock**[9](index=9&type=chunk)[10](index=10&type=chunk) - Cyclacel Limited, the Company's UK subsidiary, entered liquidation on January 31, 2025, leading to its deconsolidation and a **$5.0 million** increase in stockholders' equity[11](index=11&type=chunk) - The Company repurchased assets related to the plogosertib ('Plogo') clinical program for approximately **$0.3 million**, focusing solely on its development, while fadraciclib is being marketed for sale by the liquidator[12](index=12&type=chunk) - An Exchange Agreement was entered into with FITTERS Diversified Berhad to acquire its wholly-owned subsidiary, Fitters Sdn. Bhd., in exchange for up to **$1.0 million cash** and **19.99%** of Cyclacel's common stock, with Cyclacel to be renamed Bio Green Med Solution, Inc. (BGMS) and listed on Nasdaq[13](index=13&type=chunk) - The Company effected a one-for-sixteen reverse stock split on May 12, 2025, and a further one-for-fifteen reverse stock split on July 7, 2025[14](index=14&type=chunk) [Overview](index=31&type=section&id=Overview) Cyclacel is a clinical-stage biopharmaceutical company with **$0 revenue**, focusing solely on the plogosertib program after deconsolidating its UK subsidiary - Cyclacel is a clinical-stage biopharmaceutical company developing cancer medicines, reporting **$0 revenue** for the six months ended June 30, 2025, and not expecting significant revenue from R&D activities in the foreseeable future[143](index=143&type=chunk) - The deconsolidation of the UK subsidiary on January 24, 2025, resulted in a **$5.0 million** gain on deconsolidation[144](index=144&type=chunk) - The Company has decided to focus solely on the plogosertib ('Plogo') clinical program to reduce operating costs[145](index=145&type=chunk) [Plogosertib Phase 1/2 Study](index=32&type=section&id=Plogosertib%20Phase%201%2F2%20Study%20in%20Advanced%20Solid%20Tumors%20and%20Lymphoma%20%28140-101%3B%20NCT%2305358379%29) The Plogosertib Phase 1/2 study for advanced solid tumors and lymphoma is progressing, with stable disease observed and a new oral formulation under development - The Plogosertib Phase 1/2 study (140-101; NCT05358379) is an open-label, registration-directed study for advanced solid tumors and lymphoma, aiming to determine the RP2D and then enter a proof-of-concept cohort stage[147](index=147&type=chunk) - **Fifteen patients** have been treated across five dose escalation levels with no dose-limiting toxicities, and stable disease has been observed in pretreated patients with gastrointestinal, lung, and ovarian cancers[148](index=148&type=chunk) - A new, alternative salt, oral formulation of plogosertib with improved bioavailability is currently under development[148](index=148&type=chunk) [Going Concern](index=32&type=section&id=Going%20Concern%20%28MD%26A%29) Substantial doubt exists about the Company's ability to continue as a going concern due to insufficient funding, necessitating strategic alternatives - The Company used **$4.3 million** in net cash for operating activities during the six months ended June 30, 2025, and its cash and cash equivalents of **$4.3 million** are expected to meet liquidity requirements only into the fourth quarter of 2025[149](index=149&type=chunk) - There is substantial doubt about the Company's ability to continue as a going concern, as indicated by its auditors, due to a lack of revenues and insufficient funding to complete drug development[149](index=149&type=chunk)[151](index=151&type=chunk) - The Board of Directors is actively analyzing strategic alternatives, including additional debt or equity financing, mergers, acquisitions, or share exchanges, to ensure the Company's continuation[152](index=152&type=chunk)[153](index=153&type=chunk) - The Company plans to acquire and consolidate complementary industrial assets, focusing on bulk commodity minerals and chemicals, to generate scalable enterprises and capitalize on valuation differentials[154](index=154&type=chunk) [Liquidity and Capital Resources](index=34&type=section&id=Liquidity%20and%20Capital%20Resources) Cash and cash equivalents decreased, but working capital improved significantly due to reduced current liabilities, with operations historically funded by equity sales | Metric ($000s) | June 30, 2025 | June 30, 2024 | | :----------------------- | :------------ | :------------ | | Cash and cash equivalents | 4,275 | 6,000 | | Current assets | 4,383 | 7,707 | | Current liabilities | (760) | (7,186) | | Total working capital deficit | 3,623 | 521 | - The Company's cash and cash equivalents decreased to **$4.275 million** as of June 30, 2025, from **$6.0 million** as of June 30, 2024[159](index=159&type=chunk) - Working capital improved significantly to a surplus of **$3.623 million** as of June 30, 2025, compared to a surplus of **$521 thousand** in the prior year, primarily due to a substantial reduction in current liabilities[159](index=159&type=chunk) - Since inception, the Company has primarily relied on proceeds from sales of common and preferred equity securities to finance operations, accumulating a deficit of **$441.8 million** as of June 30, 2025[159](index=159&type=chunk) [Cash Flows](index=34&type=section&id=Cash%20Flows%20%28MD%26A%29) Net cash used in operating activities increased, while net cash provided by financing activities decreased due to preferred stock issuances and warrant payments | Activity ($000s) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------------------- | :--------------------------- | :--------------------------- | | Net cash used in operating activities | (4,303) | (3,567) | | Net cash used in investing activities | — | — | | Net cash provided by financing activities | 5,526 | 6,210 | - Net cash used in operating activities increased by **$0.7 million** to **$4.3 million** for the six months ended June 30, 2025, primarily due to an **$11.8 million** change in working capital, partially offset by a decrease in net loss and an increase in non-cash stock compensation expense[161](index=161&type=chunk) - Net cash provided by financing activities decreased to **$5.5 million** for the six months ended June 30, 2025, from **$6.2 million** in the prior year, mainly from preferred stock issuances offset by a **$1.1 million** warrant payment[163](index=163&type=chunk)[164](index=164&type=chunk) [Funding Requirements and Going Concern](index=35&type=section&id=Funding%20Requirements%20and%20Going%20Concern%20%28MD%26A%29) The Company lacks sufficient funds for drug development and faces substantial doubt about its going concern ability, necessitating future funding - The Company lacks sufficient funds to complete the development and commercialization of its drug candidates and is reliant on future funding through equity offerings, debt financings, or strategic collaborations[165](index=165&type=chunk)[166](index=166&type=chunk) - Substantial doubt exists about the Company's ability to continue as a going concern for at least twelve months, with a risk of curtailing operations, delaying development, ceasing operations, or filing for bankruptcy if additional funding is not secured[169](index=169&type=chunk) - Future funding requirements are dependent on factors such as the rate and cost of clinical trials, manufacturing and commercialization capabilities, acquisition costs, intellectual property, and regulatory approvals[170](index=170&type=chunk) [Results of Operations](index=36&type=section&id=Results%20of%20Operations) This section analyzes the Company's revenues, R&D, G&A expenses, and other income/expense [Revenues](index=36&type=section&id=Revenues%20%28MD%26A%29) The Company recognized **$0 revenue** for the three and six months ended June 30, 2025, with anticipated growth if a merger is completed | Period | Revenue ($000s) | | :--------------------------- | :---------------- | | 3 months ended June 30, 2025 | — | | 3 months ended June 30, 2024 | 4 | | 6 months ended June 30, 2025 | — | | 6 months ended June 30, 2024 | 33 | - The Company recognized **$0 revenue** for the three and six months ended June 30, 2025, a decrease from **$4 thousand** and **$33 thousand** respectively in the prior year, which was related to clinical manufacturing cost recovery[171](index=171&type=chunk) - Revenue growth is anticipated in the fourth quarter of 2025 if the Exchange Agreement with FITTERS Diversified Berhad is successfully completed[172](index=172&type=chunk) [Research and Development Expenses](index=36&type=section&id=Research%20and%20Development%20Expenses%20%28MD%26A%29) Total R&D expenses decreased significantly due to the liquidation of the UK subsidiary and a focus on the anti-mitotic program | Program ($000s) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Change ($) | Change (%) | | :------------------------------ | :--------------------------- | :--------------------------- | :--------- | :--------- | | Transcriptional Regulation (fadraciclib) | 389 | 3,244 | (2,855) | -88% | | Anti-mitotic (plogosertib) | 423 | 1,466 | (1,043) | -71% | | Other research and development expenses | 78 | 115 | (37) | -32% | | Total research and development expenses | 890 | 4,825 | (3,935) | -82% | - Total research and development expenses decreased by **$3.9 million (82%)** to **$0.9 million** for the six months ended June 30, 2025, compared to **$4.8 million** in the prior year[174](index=174&type=chunk)[176](index=176&type=chunk) - Expenditure for the transcriptional regulation program ceased due to the liquidation of the UK subsidiary, and plogosertib R&D decreased while developing an alternative oral formulation[176](index=176&type=chunk) - Overall R&D expenses for the year ended December 31, 2025, are anticipated to decrease significantly due to the focus solely on the anti-mitotic program[177](index=177&type=chunk) [General and Administrative Expenses](index=37&type=section&id=General%20and%20Administrative%20Expenses%20%28MD%26A%29) General and administrative expenses increased significantly due to one-time costs associated with two changes of control | Metric ($000s) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Change ($) | Change (%) | | :-------------------------------- | :--------------------------- | :--------------------------- | :--------- | :--------- | | Total general and administrative expenses | 5,463 | 3,207 | 2,256 | 70% | - General and administrative expenses increased by approximately **$2.3 million (70%)** to **$5.5 million** for the six months ended June 30, 2025, from **$3.2 million** in the prior year[178](index=178&type=chunk)[179](index=179&type=chunk) - This increase was primarily due to one-time costs associated with two changes of control, including **$1.3 million** in stock compensation expense, **$0.7 million** in D&O insurance, and **$0.3 million** in compensation expense[179](index=179&type=chunk) - G&A expenditures for the full year 2025 are expected to be higher than 2024, with further increases anticipated if the Exchange Agreement with FITTERS Diversified Berhad is completed[180](index=180&type=chunk) [Other (expense) income, net](index=37&type=section&id=Other%20%28expense%29%20income%2C%20net%20%28MD%26A%29) Total other income increased significantly due to a **$5.0 million** gain on the deconsolidation of the UK subsidiary | Metric ($000s) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Change ($) | Change (%) | | :-------------------------------- | :--------------------------- | :--------------------------- | :--------- | :--------- | | Foreign exchange gains (losses) | (11) | 4 | (15) | -375% | | Interest (expense) income | 8 | (26) | 34 | -131% | | Gain on deconsolidation of subsidiary | 4,947 | — | 4,947 | — | | Other income (expense), net | 12 | 52 | (40) | -77% | | Total other (expense) income, net | 4,956 | 30 | 4,926 | 16420% | - Total other income increased by **$4.9 million** to **$4.9 million** for the six months ended June 30, 2025, primarily due to a **$5.0 million** gain on the deconsolidation of the UK subsidiary[182](index=182&type=chunk) - Foreign exchange losses increased by **$15 thousand**, from a gain of **$4 thousand** in 2024 to a loss of **$11 thousand** in 2025[183](index=183&type=chunk) - The liquidation of the UK subsidiary in January 2025 resulted in the forgiveness of intercompany loans and the reclassification of accumulated translation adjustments into earnings[185](index=185&type=chunk) [Income Tax Benefit](index=38&type=section&id=Income%20Tax%20Benefit%20%28MD%26A%29) The Company recorded an income tax charge of **$2 thousand**, a significant decrease from a tax benefit of **$1.8 million** in the prior year | Metric ($000s) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Change ($) | Change (%) | | :-------------------------------- | :--------------------------- | :--------------------------- | :--------- | :--------- | | Total income tax benefit | (2) | 1,766 | (1,768) | -100% | - The Company recorded an income tax charge of **$2 thousand** for the six months ended June 30, 2025, a significant decrease from a tax benefit of **$1.8 million** in the prior year[186](index=186&type=chunk) - This change is due to the liquidation of the UK subsidiary, which resulted in the loss of eligibility for recoverable UK research and development tax credits[186](index=186&type=chunk)[187](index=187&type=chunk) [Critical Accounting Policies and Estimates](index=39&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) There have been no material changes to the Company's critical accounting policies during the six months ended June 30, 2025 - There have been no material changes to the Company's critical accounting policies during the six months ended June 30, 2025[188](index=188&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, Cyclacel Pharmaceuticals, Inc. is not required to provide specific quantitative and qualitative disclosures about market risk - The Company is exempt from providing quantitative and qualitative disclosures about market risk as it qualifies as a smaller reporting company[189](index=189&type=chunk) [Item 4. Controls and Procedures](index=39&type=section&id=Item%204.%20Controls%20and%20Procedures) Management evaluated disclosure controls and procedures as effective, with no material changes other than a new CFO [Evaluation of Disclosure Controls and Procedures](index=39&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) The Company's disclosure controls and procedures were deemed effective as of June 30, 2025, providing reasonable assurance of timely reporting - As of June 30, 2025, the Company's disclosure controls and procedures were deemed effective to provide reasonable assurance that required information is recorded, processed, summarized, and reported timely[190](index=190&type=chunk) [Changes in Internal Control over Financial Reporting](index=39&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) No material changes in internal control over financial reporting occurred during the quarter, other than the hiring of a new CFO - Other than the hiring of a new chief financial officer, there were no material changes in internal control over financial reporting during the quarter ended June 30, 2025[191](index=191&type=chunk) [Inherent Limitation on the Effectiveness of Internal Controls](index=39&type=section&id=Inherent%20Limitation%20on%20the%20Effectiveness%20of%20Internal%20Controls) Internal control systems have inherent limitations, providing only reasonable, not absolute, assurances of effectiveness - The effectiveness of any internal control system is subject to inherent limitations, providing only reasonable, not absolute, assurances, and is susceptible to changes in conditions or deterioration in compliance[192](index=192&type=chunk) [PART II - OTHER INFORMATION](index=40&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) This section provides other required information, including legal proceedings, risk factors, and exhibits [Item 1. Legal Proceedings](index=40&type=section&id=Item%201.%20Legal%20Proceedings) A minority shareholder filed a complaint against Cyclacel and its CEO, alleging breach of fiduciary duty and seeking over **$12 million** in damages - David Lazar filed a complaint on August 6, 2025, against Cyclacel and CEO Datuk Dr. Doris Wong, alleging breach of fiduciary duty, minority shareholder oppression, and breach of contract[193](index=193&type=chunk) - The complaint seeks damages of **$11.88 million** for the first two causes of action and **$629.5 thousand** for the third, plus interest and attorneys' fees[193](index=193&type=chunk) - The Company believes the claims are meritless and intends to vigorously defend the lawsuit[193](index=193&type=chunk) [Item 1A. Risk Factors](index=40&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes to the risk factors previously disclosed in the Company's Annual Report on Form 10-K for the year ended December 31, 2024 - No material changes to the Company's risk factors have occurred since the Annual Report on Form 10-K for the year ended December 31, 2024[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 - There were no unregistered sales of equity securities or use of proceeds to report[195](index=195&type=chunk) [Item 3. Defaults Upon Senior Securities](index=40&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The Company reported no defaults upon senior securities during the period - There were no defaults upon senior securities to report[196](index=196&type=chunk) [Item 4. Mine Safety Disclosures](index=40&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the Company - Mine Safety Disclosures are not applicable to the Company[197](index=197&type=chunk) [Item 5. Other Information](index=40&type=section&id=Item%205.%20Other%20Information) The Company reported no other information for the period - There is no other information to report[198](index=198&type=chunk) [Item 6. Exhibits](index=40&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Quarterly Report on Form 10-Q, including certifications from the Principal Executive Officer and Principal Financial Officer, and iXBRL formatted financial statements - Exhibits include certifications of the Principal Executive Officer and Principal Financial Officer pursuant to the Sarbanes-Oxley Act of 2002[199](index=199&type=chunk) - The financial statements for the period ended June 30, 2025, are filed in iXBRL (Inline eXtensible Business Reporting Language) format[199](index=199&type=chunk) [SIGNATURES](index=41&type=section&id=SIGNATURE%20PAGE) The Quarterly Report on Form 10-Q was duly signed on behalf of Cyclacel Pharmaceuticals, Inc. by Datuk Dr. Doris Wong, Chief Executive Officer and Executive Director, on August 13, 2025 - The report was signed by Datuk Dr. Doris Wong, Chief Executive Officer and Executive Director, on August 13, 2025[203](index=203&type=chunk)
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].