Clinical Trials and Drug Development - The company has no products approved for sale and cannot guarantee that it will ever have marketable products [177]. - Clinical trials are expensive and time-consuming, with potential delays that may extend beyond available funding [169]. - The company has experienced delays in clinical trials, including a failed SEAMLESS Phase 3 study that did not reach its primary endpoint [172]. - The approval process for drug candidates is lengthy and unpredictable, often taking many years and requiring extensive data submission [184]. - The company relies on biomarkers for drug development, but these biomarkers are not scientifically validated, which may lead to inefficient resource allocation [181]. - Undesirable side effects from product candidates could delay or prevent marketing approval, affecting patient recruitment and trial completion [190]. - The company has limited experience in planning and conducting clinical trials necessary for marketing approvals [185]. - The inability to enroll sufficient subjects in clinical trials could result in significant delays and increased development costs [176]. - The company may face competition for patient enrollment from other clinical trials targeting the same indications [175]. - The company must conduct significant additional clinical trials before seeking regulatory approvals for its drug candidates, which are currently in early to mid-stages of testing [271]. Regulatory and Compliance Challenges - Regulatory authorities may approve drug candidates for fewer or more limited indications than requested, impacting commercial prospects [187]. - Regulatory approvals for product candidates could be delayed or denied due to issues with preclinical studies conducted before in-licensing [196]. - Even with regulatory approval, the company will be subject to ongoing regulatory requirements, including manufacturing and post-marketing obligations [197]. - The company must ensure compliance with regulatory requirements in both domestic and international markets to avoid delays in product introduction [205]. - Regulatory changes and additional government regulations could hinder the approval process for product candidates [203]. - The company is subject to various federal and state healthcare fraud and abuse laws, which could result in substantial penalties if compliance is not achieved [253]. - Non-compliance with privacy and data protection laws could lead to liability, reputational harm, and increased compliance costs, particularly with the evolving regulatory landscape in the EU and UK [256]. - The General Data Protection Regulation (GDPR) imposes strict requirements on the processing of personal data, with potential fines of up to €20 million or 4% of annual global revenues for non-compliance [259]. - The California Consumer Privacy Act (CCPA) and the California Privacy Rights Act (CPRA) impose significant obligations on the handling of personal information, with penalties up to $250,000 for violations [264]. - The interplay of federal and state laws creates complex compliance issues that could expose the company to additional expenses and liabilities [265]. - The company’s operations involve the use of hazardous materials, which are subject to strict regulations and could lead to costly compliance issues and potential lawsuits [267]. - The company may incur significant costs related to compliance with evolving privacy and data security laws, which could negatively impact business operations [266]. - Future government enforcement actions could result in significant penalties and adverse publicity, affecting the company's business [266]. Financial Condition and Funding - As of December 31, 2023, the company's accumulated deficit was $428.3 million, with a net loss of $22.5 million for the year [271]. - The company has $3.4 million in cash and cash equivalents as of December 31, 2023, raising substantial doubt about its ability to continue as a going concern for the next year [273]. - The company has incurred operating losses every year since 1996, primarily due to research and development costs, and may never achieve profitability [271]. - The company plans to fund its operations through public equity, private placements, and other financing methods, but may face dilution of existing stockholders' interests [272]. - The company may need to raise substantial additional funding to support its research, development, and commercialization efforts [290]. - Funding constraints may delay the development of certain product candidates, impacting commercialization timelines [293]. - Economic disruptions and unstable market conditions could adversely affect the company's ability to secure necessary financing [276]. Market Competition and Acceptance - The company anticipates facing intense competition from other pharmaceutical and biotechnology companies with similar drug candidates [210]. - Future product candidates may encounter competition from generic drugs sooner than expected, impacting market share and revenue [211]. - Market acceptance of drug candidates will depend on factors such as safety, efficacy, pricing, and reimbursement policies from third-party payors [220][225]. - Failure to achieve market acceptance could significantly affect the company's ability to generate revenue and achieve profitability [222]. - The company faces challenges in determining the cost-effectiveness and reimbursement levels for its product candidates, which may affect competitive pricing [226]. - Legislative discussions at the federal level could require manufacturers to pay higher rebates in Medicare Part D, impacting reimbursement for products [227]. - The company is focusing its clinical development strategy on two ongoing hemato-oncology programs related to transcriptional regulation and mitosis control biology [293]. Intellectual Property and Legal Risks - Intellectual property rights are critical for commercial success, and inadequate enforcement could harm the company's competitive position [317]. - The company may face challenges in patent protection, as competitors can argue for the invalidity of patents or create non-infringing versions of drug candidates [319]. - Trade secrets are crucial for the company, but they are difficult to protect, and unauthorized disclosures could harm competitive positioning [320]. - The company may not obtain patent term extensions under the Hatch-Waxman Act, potentially shortening the exclusive marketing period and reducing revenue [323]. - The company could incur substantial costs from litigation related to patent rights, which may divert management's attention and resources [328]. - The company is subject to various patent-related risks, including potential infringement claims that could delay or prevent commercialization of drug candidates [326]. - The patent application process is complex and uncertain, with potential challenges that could negatively impact the company's patent position [333]. Operational and Management Challenges - The company may face difficulties in managing growth and expanding operations as it transitions from discovery and development to commercialization of drugs and devices [193]. - The company is highly dependent on skilled personnel for drug development and commercialization, with competition for talent likely to continue [229]. - Labor shortages and increased turnover rates may lead to higher operational costs, including overtime and wages [230]. - The company does not own manufacturing facilities and relies on third-party contract manufacturing organizations (CMOs) for drug supplies, which may lead to supply interruptions [307]. - Compliance with FDA manufacturing regulations requires significant resources, and failure to meet these could result in regulatory actions that adversely affect product development [311]. - Strategic alliances are crucial for drug development; failure to secure these could lead to increased expenditures or delays in drug candidate development [313][314]. - The company faces significant competition in forming strategic alliances, which may impact the scope and timeline of drug development programs [314]. Stock and Market Risks - The market price of the company's common and preferred stock may experience significant fluctuations due to various factors, including regulatory developments and announcements of new products [358]. - The company’s operating losses may fluctuate significantly on a quarterly basis, which could impact stock price and investor expectations [343]. - The existence of anti-takeover provisions in the company's charter documents may make acquisitions more difficult and entrench management [345]. - If securities analysts downgrade the company's stock or fail to publish reports, it could lead to a decline in stock price and trading volume [344]. - The company may face substantial costs and management distraction from potential litigation related to stock price fluctuations [360]. - The future sale of common and convertible preferred stock could negatively affect stock price and cause dilution for existing shareholders [361]. - The company’s ability to pay cash dividends on preferred stock is limited by Delaware law and its current financial condition [356]. - Engaging in short sales of the company's common stock may lead to a decline in its market price [367]. - A significant number of short sales can create downward pressure on the market price of the security [367]. - The exercise of outstanding warrants could increase the number of shares available in the market, potentially causing further declines in stock price [367]. - Short sellers may lock in profits by covering through the exercise of options or warrants [367]. - The company warns that further sales of common stock could undermine the value of its shares [367]. - Investors could experience a decline in the value of their investment due to short sales [367].

As filed with the Securities and Exchange Commission on February 7, 2024 Registration Statement No. 333-276623 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 AMENDMENT NO. 1 TO FORM S-1 REGISTRATION STATEMENT under the SECURITIES ACT OF 1933 CYCLACEL PHARMACEUTICALS, INC. (Exact Name of Registrant as Specified in Its Charter) Delaware 3826 91-1707622 (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) (IRS Employer Id ...

As filed with the Securities and Exchange Commission on January 19, 2024 Registration Statement No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM S-1 REGISTRATION STATEMENT under the SECURITIES ACT OF 1933 CYCLACEL PHARMACEUTICALS, INC. (Exact Name of Registrant as Specified in Its Charter) (State or other jurisdiction of incorporation or organization) Delaware 3826 91-1707622 (Primary Standard Industrial Classification Code Number) (IRS Employer Identification No.) 200 Con ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________________ to __________________ Commission file number 000-50626 | Title of each class | Trading Symbol(s) | Name of each excha ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________________ to __________________ Commission file number 000-50626 CYCLACEL PHARMACEUTICALS, INC. (Exact name of registrant as specifi ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 | Delaware | 91-1707622 | | --- | --- | | (State or Other Jurisdiction | (I.R.S. Employer | of Incorporation or Organization) FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________ ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number 00-50626 CYCLACEL PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 91-1707622 (State or Other Jurisdiction of Incorp ...