Bio Green Med Solution Narrows Focus, Secures Funding Amid Re-Audit

TL;DR

**BGMSP is making a desperate, last-ditch effort to survive by focusing on one drug and raising capital, but the going concern warning makes it a high-risk bet.**

AI Summary

Bio Green Med Solution, Inc. (formerly Cyclacel Pharmaceuticals, Inc.) filed a 10-K/A on November 26, 2025, primarily to incorporate a re-audit report for the full fiscal years 2024 and 2023 by a single independent registered public accounting firm, aiming for future cost efficiencies. The company also underwent significant corporate changes, including a 1-for-16 stock split effective May 7, 2025, and a subsequent 1-for-15 stock split effective July 2, 2025. Furthermore, on September 12, 2025, the company officially changed its name to Bio Green Med Solution Inc. from Cyclacel Pharmaceuticals, Inc. Strategically, the company is narrowing its focus to the development of its plogosertib (plogo) clinical program only, following the liquidation of its wholly-owned United Kingdom subsidiary, Cyclacel Limited, announced on January 31, 2025. This deconsolidation is anticipated to increase stockholders' equity by approximately $5.0 million. The company also secured $3.1 million in gross proceeds from investor David Lazar through the sale of Series C and Series D Convertible Preferred Stock on January 2, 2025, to settle liabilities and for general corporate purposes. The fadraciclib drug development program is being marketed for sale by the joint liquidator and is no longer part of the company's assets as of January 2025.

Why It Matters

This 10-K/A signals a significant strategic pivot for Bio Green Med Solution, Inc., focusing solely on its plogosertib program and shedding other assets like fadraciclib. For investors, the $3.1 million capital injection from David Lazar and the anticipated $5.0 million increase in stockholders' equity from deconsolidation provide a much-needed financial boost, potentially stabilizing the highly speculative investment. However, the history of operating losses and substantial doubt about its going concern status, coupled with intense competition in the biopharmaceutical space, means the company faces an uphill battle. Employees and customers of the divested fadraciclib program will see a clear shift, while the plogo program's future hinges on successful clinical trials and market acceptance against established competitors.

Risk Assessment

Risk Level: high — The filing explicitly states, "There is substantial doubt regarding our ability to continue as a going concern." This, combined with a "history of operating losses" and the need to "raise additional capital in upcoming periods," indicates significant financial instability. The aggregate market value of voting and non-voting common stock held by non-affiliates was only $2,523,882 as of June 30, 2024, reflecting a small market capitalization for a clinical-stage biopharmaceutical company.

Analyst Insight

Investors should approach BGMSP with extreme caution due to the explicit going concern warning and history of losses. While the $3.1 million capital raise and strategic focus on plogosertib offer a glimmer of hope, the high risk of failure in clinical trials and intense competition suggest that this is a highly speculative investment suitable only for those with a high-risk tolerance and a long-term horizon, prepared for potential total loss.

Key Numbers

• $3.1 million — Gross proceeds from securities purchase agreement (Received from investor David Lazar for Series C and D Convertible Preferred Stock)
• $5.0 million — Anticipated increase in stockholders' equity (Resulting from the deconsolidation of Cyclacel Limited)
• 1-for-16 — Common stock split ratio (Effective May 7, 2025)
• 1-for-15 — Common stock split ratio (Effective July 2, 2025)
• $2,523,882 — Aggregate market value of common stock held by non-affiliates (As of June 30, 2024, based on a closing price of $388.80)
• 863,901 — Shares of common stock outstanding (As of March 27, 2025)
• 3 nM — PLK1 IC50 for Plogo (Indicates potent and selective target inhibition)

Key Players & Entities

• Bio Green Med Solution, Inc. (company) — Registrant, formerly Cyclacel Pharmaceuticals, Inc.
• Cyclacel Pharmaceuticals, Inc. (company) — Former name of the registrant
• David Lazar (person) — Investor from Activist Investing, LLC
• Activist Investing, LLC (company) — Investment firm led by David Lazar
• Cyclacel Limited (company) — Wholly owned United Kingdom subsidiary undergoing liquidation
• SEC (regulator) — Securities and Exchange Commission
• Nasdaq Capital Market (regulator) — Exchange where common and preferred stock are registered
• Professor David Glover, PhD (person) — Former Chief Scientist, discovered Polo Kinases
• Hilco Appraisals Limited (company) — Firm marketing fadraciclib for sale

FAQ

Risk Factors

• Clinical Trial Delays and Funding [high — operational]: The company faces risks associated with the cost, time, and potential delays in clinical trials. There is uncertainty regarding the ability to raise sufficient funds to complete development and commercialization of remaining product candidates, which may require funding beyond available resources.
• Clinical Trial Setbacks and Biomarker Reliance [high — operational]: Significant delays, setbacks, or negative results in clinical trials are a risk. Furthermore, reliance on biomarkers that are not scientifically validated could lead to inefficient resource allocation.
• Third-Party Reliance for Clinical Trials and Manufacturing [medium — operational]: The company relies on contract research organizations and third parties for the conduct of clinical trials and manufacturing. This lack of direct control over timing, conduct, and expense, as well as manufacturing capacity, poses an operational risk.
• Regulatory Approval Uncertainty [high — regulatory]: Drug candidates are subject to extensive regulation, which is costly and time-consuming. There is no guarantee that the company will obtain the necessary approvals for commercialization of any of its drug candidates.
• Intense Competition [medium — market]: The company faces intense competition from other companies that may develop drugs that are less expensive, safer, or more effective than its drug candidates. This competitive landscape could adversely affect market adoption.
• Strategic Alliance Dependence [medium — financial]: Failure to enter into and maintain successful strategic alliances for drug candidates could force the company to reduce or delay development or increase expenditures, impacting financial flexibility.
• Growth and Expansion Management [low — operational]: The company may encounter difficulties in managing its growth and expanding operations successfully as it transitions from a discovery and development focus to commercialization.
• License Agreement Breaches [medium — legal]: Breach of existing license agreements or failure to obtain necessary licenses for technology required for development, testing, and commercialization could seriously harm the business.

Industry Context

Bio Green Med Solution, Inc. operates in the highly competitive biopharmaceutical industry, specifically focusing on oncology drug development. The industry is characterized by long development cycles, significant R&D investment, and stringent regulatory hurdles. Key trends include a growing emphasis on targeted therapies and precision medicine, as well as increasing reliance on strategic partnerships and collaborations to share risk and accelerate development.

Regulatory Implications

The company's drug candidates are subject to extensive regulatory review by bodies like the FDA. The process is costly and time-consuming, with no guarantee of approval. Failure to navigate these regulatory pathways effectively poses a significant risk to commercialization and market access.

What Investors Should Do

1. Monitor progress and funding for the plogosertib clinical program closely, as it is the sole focus and critical for future value.
2. Evaluate the impact of the recent stock splits on share price and liquidity, and assess if they are precursors to further corporate actions.
3. Assess the company's ability to secure future funding, given the historical reliance on external capital and the high costs associated with drug development.
4. Understand the implications of the fadraciclib program's divestment and the potential impact on the company's overall strategic direction and asset base.
5. Review the updated risk factors in the 10-K/A filing, paying close attention to operational, financial, and regulatory risks associated with the narrowed focus.

Key Dates

• 2025-01-31: Liquidation of wholly-owned UK subsidiary, Cyclacel Limited, announced — This deconsolidation is expected to increase stockholders' equity by approximately $5.0 million and allows the company to narrow its focus to the plogosertib program.
• 2025-01-02: Secured $3.1 million in gross proceeds from investor David Lazar — Funds raised through the sale of Series C and D Convertible Preferred Stock are intended to settle liabilities and for general corporate purposes.
• 2025-05-07: 1-for-16 stock split effective — This reverse stock split adjusted the number of outstanding shares, likely to meet exchange listing requirements or improve per-share price.
• 2025-07-02: 1-for-15 stock split effective — Another reverse stock split further adjusted the share count, indicating ongoing efforts to manage share price and structure.
• 2025-09-12: Official name change to Bio Green Med Solution Inc. — Reflects a strategic shift or rebranding, moving away from the previous identity as Cyclacel Pharmaceuticals, Inc.
• 2025-11-26: 10-K/A filing incorporating re-audit report — This amended filing addresses audit requirements for fiscal years 2024 and 2023, aiming for future cost efficiencies in auditing.

Glossary

10-K/A

An amended annual report filed with the SEC, used to correct or supplement information previously filed in a 10-K. (This filing is an amended annual report, indicating updates or corrections to the company's financial and operational disclosures.)

Plogosertib (plogo)

A specific drug candidate developed by Bio Green Med Solution, Inc. that targets cell cycle biology. (This is the company's sole remaining clinical program, making its development and potential commercialization critical to the company's future.)

Fadraciclib

Another drug development program previously held by the company, now being marketed for sale. (Its divestment signifies a strategic narrowing of focus and a reduction in the company's asset base.)

Deconsolidation

The process of removing a subsidiary from a parent company's consolidated financial statements. (The deconsolidation of Cyclacel Limited is expected to positively impact the company's stockholders' equity.)

Convertible Preferred Stock

A class of preferred stock that can be converted into a specified number of common stock shares. (The sale of Series C and D Convertible Preferred Stock provided crucial funding for the company.)

Joint Liquidators

Individuals appointed to manage the winding up of a company's affairs, including selling assets. (They are responsible for marketing and selling the fadraciclib drug development program.)

PLK1 IC50

The half-maximal inhibitory concentration (IC50) for Polo-like kinase 1 (PLK1), a measure of how much of a drug is needed to inhibit 50% of a specific enzyme's activity. (A low IC50 value, such as 3 nM for plogosertib, indicates high potency and selectivity for the target, which is a positive indicator in drug development.)

Epigenetics/Mitosis Control Biology

A field of study focused on changes in gene expression that do not involve alterations to the underlying DNA sequence, particularly related to cell division. (This is the company's core area of expertise and the focus of its remaining drug development program.)

Year-Over-Year Comparison

This 10-K/A filing primarily serves to incorporate a re-audit report for fiscal years 2024 and 2023, suggesting a need for enhanced financial reporting accuracy and potentially addressing prior audit issues. The company has undergone significant structural changes, including name and stock split adjustments, and a strategic narrowing of its drug development pipeline to focus solely on plogosertib. The divestment of fadraciclib and liquidation of its UK subsidiary indicate a move towards cost efficiency and a more streamlined operational model.

Key Financial Figures

• $0.001 — ch registered Common Stock, par value $0.001 per share CYCC The Nasdaq Capital M
• $388.80 — 24 (based upon the closing sale price of$388.80 of such shares on The NASDAQ Capital Ma
• $1.00 — tock of Cyclacel at a purchase price of $1.00 per share for aggregate gross proceeds
• $3.1 m — r share for aggregate gross proceeds of $3.1 million, subject to the terms and conditi
• $5.0 m — e stockholders' equity by approximately $5.0 million, will be reported in the Company'

Filing Documents

• form10-ka.htm (10-K/A) — 2357KB
• ex4-12.htm (EX-4.12) — 108KB
• ex19.htm (EX-19) — 65KB
• ex23-1.htm (EX-23.1) — 3KB
• ex31-1.htm (EX-31.1) — 12KB
• ex31-2.htm (EX-31.2) — 12KB
• ex32-1.htm (EX-32.1) — 4KB
• ex32-2.htm (EX-32.2) — 5KB
• ex97-1.htm (EX-97.1) — 30KB
• 0001493152-25-025179.txt ( ) — 10193KB
• bgms-20241231.xsd (EX-101.SCH) — 70KB
• bgms-20241231_cal.xml (EX-101.CAL) — 70KB
• bgms-20241231_def.xml (EX-101.DEF) — 327KB
• bgms-20241231_lab.xml (EX-101.LAB) — 567KB
• bgms-20241231_pre.xml (EX-101.PRE) — 443KB
• form10-ka_htm.xml (XML) — 1569KB

Business

Business 5 Item 1A.

Risk Factors

Risk Factors 24 Item 1B. Unresolved Staff Comments 63 Item 1C. Cybersecurity 64 Item 2.

Properties

Properties 65 Item 3.

Legal Proceedings

Legal Proceedings 65 Item 4. Mine Safety Disclosures 65 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 66 Item 6. Reserved 66 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 67 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 77 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 78 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 112 Item 9A.

Controls and Procedures

Controls and Procedures 112 Item 9B. Other Information 113 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 113 PART III Item 10. Directors, Executive Officers and Corporate Governance 114 Item 11.

Executive Compensation

Executive Compensation 114 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 114 Item 13. Certain Relationships and Related Transactions, and Director Independence 114 Item 14. Principal Accountant Fees and Services 114 PART IV Item 15. Exhibits and Financial Statement Schedules 115 2 Table of Contents Summary of Principal Risk Factors This summary briefly lists the principal risks and uncertainties facing our business, which are only a select portion of those risks. A more complete discussion of those risks and uncertainties is set forth in Part I, Item 1A of this Annual Report, entitled "Risk Factors". Additional risks not presently known to us or that we currently deem immaterial may also affect us. If any of these risks occur, our business, financial condition or results of operations could be materially and adversely affected. Our business is subject to the following principal risks and uncertainties: Risks Associated with Development and Commercialization of Our Drug Candidates The cost, time, and possibility of delays associated with clinical trials, which may be required to continue beyond our available funding. We cannot be certain that we will be able to raise sufficient funds to complete the development and commercialize our remaining product candidates currently in clinical development, should they succeed. We may suffer significant delays, setbacks or negative results in, or termination of, our clinical trials. We are making use of biomarkers, which are not scientifically validated, and our reliance on biomarker data may thus cause us to direct our resources inefficiently. We may be unable to directly control the timing, conduct and expense of our clinical trials, due to our reliance on contract research organizations and other third parties to conduct clinical trials. We have no manufacturing capacity and will rely on third party manufacturers for the late-stage clinical trials, development and

, Item 1A of this Annual Report on Form 10-K. In this report, "Cyclacel," the "Company," "we,"

Part I, Item 1A of this Annual Report on Form 10-K. In this report, "Cyclacel," the "Company," "we," "us," and "our" refer to Cyclacel Pharmaceuticals, Inc. Recent Developments In December 2024 the Company announced that it was in the process of exploring and reviewing strategic alternatives on an expedited basis in order to preserve the Company's cash, including a potential transaction with investor David Lazar of Activist Investing, LLC, or "Lazar". The Company's Board of Directors reviewed a range of appropriate strategies to realize value from its assets. The Board directed management to reduce operating costs, which included the liquidation of the Company's wholly owned United Kingdom subsidiary Cyclacel Limited, or Subsidiary, while such alternatives were being explored. On January 2, 2025 the Company entered into a securities purchase agreement with investor Lazar, pursuant to which he agreed to purchase from the Company 1,000,000 shares of Series C Convertible Preferred Stock and 2,100,000 shares of Series D Convertible Preferred Stock of Cyclacel at a purchase price of $1.00 per share for aggregate gross proceeds of $3.1 million, subject to the terms and conditions of the Agreement. The proceeds of the transaction will be used to settle outstanding liabilities of the Company and other general corporate and operating purposes. On January 31, 2025, the creditors voluntary liquidation of Cyclacel Limited was announced in the London Gazette, one of the official public records of the government of the United Kingdom. As part of the Company's efforts to reduce operating costs it has determined to focus on the development of the plogo clinical program only. On March 10, 2025, the Company entered into an Agreement for the Sale and Purchase of certain assets related to plogo with Cyclacel Limited and the joint liquidator. Therefore, fadraciclib, the Subsidiary's other drug development program, is being marketed for sale by the joint liquidator through Hilco Ap

Business

Business Strategy Our clinical development strategy is focused on our program in epigenetics/mitosis control biology. As part of the Company's efforts to reduce operating costs it has determined to focus on the development of the plogo clinical program only. Fadraciclib, the Subsidiary's other drug development program, is being marketed for sale by the joint liquidators through Hilco Appraisals Limited, a firm of professional valuation agents and will no longer be part of the assets of the Company as of January 2025. We have retained worldwide rights to commercialize plogo. Focus on the cell cycle and cancer Our core area of expertise is in cell cycle biology and our senior management team has extensive experience in research, preclinical and clinical development and sales and marketing. The novel, mechanism-targeted cell cycle drugs we are developing are designed to be highly selective in comparison to conventional chemotherapies, potentially inducing death in cancer cells while sparing most normal cells which may give rise to fewer side-effects. Thus, we believe that we are well placed to exploit the significant opportunities that this area offers for new drug discovery and development. Develop anticancer drug candidates in all phases of the cell cycle and multiple compounds for particular cell cycle targets Targeting a broad development program focused on multiple phases of the cell cycle allows us to minimize risk while maximizing the potential for success, and also to develop products that are complementary to one another. Enter into partnering arrangements selectively, while developing our own sales and marketing capability We currently retain virtually all marketing rights to the compounds associated with our clinical-stage drug programs. To optimize our commercial return, we intend to enter into selected partnering arrangements and to retain co-promotion rights as appropriate. Generally we plan to develop compounds through the Phase 2 proof-o

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