Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) Commission file number 000-50626 ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________________ to __________________ CYCLACEL PHARMACEUTICALS, INC. (Exact name of registrant as specif ...

Exhibit 99.1 Cyclacel Pharmaceuticals, Inc. CYCLACEL PHARMACEUTICALS REPORTS FIRST QUARTER FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE - New Clinical Data to be Presented at ASCO Annual Meeting Highlighting Potential Precision Medicine Strategy with Oral Fadraciclib - - First Patients Enrolled in Oral Fadraciclib Phase 2 Proof of Concept Study - - Balance Sheet Bolstered with $8.0 million Private Placement Priced At-The-Market Under Nasdaq Rules - - Management to Host Conference Call at 4:30 pm EDT Today ...

BERKELEY HEIGHTS, N.J., May 08, 2024 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, will announce first quarter 2024 financial results on Tuesday, May 14, 2024. The Company will host a conference call and live webcast at 4:30 p.m. Eastern Daylight Time on the same day. Conference call information: Call: (888) 632-3384 / international call: (785) 424-1794 A ...

BERKELEY HEIGHTS, N.J., May 08, 2024 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC, NASDAQ:CYCCP, ", Cyclacel", or the ", Company", ))), a biopharmaceutical company developing innovative medicines based on cancer cell biology, will announce first quarter 2024 financial results on Tuesday, May 14, 2024. The Company will host a conference call and live webcast at 4:30 p.m. Eastern Daylight Time on the same day. Conference call information: Call: (888) 632-3384 / international call: (785) 424 ...

BERKELEY HEIGHTS, N.J., May 02, 2024 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC, NASDAQ:CYCCP, ", Cyclacel", or the ", Company", ))), a biopharmaceutical company developing innovative medicines based on cancer cell biology, today announced that it has closed its previously announced private placement for the purchase and sale of 4,968,945 shares of common stock (or pre-funded warrants in lieu thereof), series A warrants to purchase up to 4,968,945 shares of common stock and short-term s ...

Cyclacel Pharmaceuticals (NASDAQ:CYCC) stock is rocketing higher on Tuesday after the clinical-stage biopharmaceutical company withdrew a proposed public offering. A filing with the Securities and Exchange Commission (SEC) has the company withdrawing its proposed public offering filed in March. Cyclacel Pharmaceuticals notes that it won’t be refunded the filing fees but seeks to have them applied to future filings. Here’s a portion of what the company said in its filing with the SEC withdrawing the offering ...

BERKELEY HEIGHTS, N.J., April 30, 2024 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC, NASDAQ:CYCCP, ", Cyclacel", or the ", Company", ))), a biopharmaceutical company developing innovative medicines based on cancer cell biology, today announced that it has entered into definitive agreements for the purchase and sale of an aggregate of 4,968,945 shares of common stock (or pre-funded warrant in lieu thereof), series A warrants to purchase up to 4,968,945 shares of common stock and short-term ...

- New clinical, PK and PD data from novel CDK2/9 inhibitor fadraciclib monotherapy studies support ongoing development program in patients with solid tumors and lymphoma - BERKELEY HEIGHTS, N.J., April 01, 2024 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, today announced that new clinical, pharmacokinetic (PK) and pharmacodynamic (PD) data from the CYC06 ...

Clinical Trials and Product Development - The company has no products approved for sale and cannot guarantee that it will ever have marketable products [182]. - Clinical trials are expensive and time-consuming, with potential delays that may extend beyond available funding [175]. - The company has experienced clinical trial failures, such as the SEAMLESS Phase 3 study, which did not reach its primary endpoint [178]. - There is a risk of delays in securing clinical investigators or trial sites, which could hinder the progress of clinical trials [178]. - The company relies on biomarkers that are not scientifically validated, which may lead to inefficient resource allocation [187]. - Regulatory approval processes are lengthy and unpredictable, potentially harming the company's business if approvals are not obtained [190]. - The company has not submitted any marketing applications for its drug candidates, which may limit its ability to commercialize products [192]. - Undesirable side effects from product candidates could delay or prevent marketing approval, impacting commercial potential [197]. - The company faces competition for patient enrollment in clinical trials, which may limit the number of suitable participants [180]. - The outcome of preclinical testing may not predict the success of later clinical trials, leading to potential failures [185]. - The company is transitioning from discovery and development to commercialization, which may lead to difficulties in managing growth and operations [200]. - Regulatory approvals for product candidates may be delayed or denied due to issues with preclinical studies conducted by third parties [203]. - Even with regulatory approval, ongoing compliance with manufacturing, labeling, and post-marketing requirements is mandatory [204]. - The company is prioritizing its clinical development strategy on two ongoing hemato-oncology clinical programs, focusing on transcriptional regulation and mitosis control biology, due to funding constraints [305]. 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 [282]. - The company had cash and cash equivalents of $3.4 million as of December 31, 2023, raising substantial doubt about its ability to continue as a going concern for the next year [284]. - The company has incurred operating losses every year since 1996, primarily due to research and development costs, and may never achieve profitability [282]. - The company plans to fund the development and commercialization of drug candidates, which will require substantial additional funding [300]. - The company expects to incur continued losses for several years as it continues research and development and seeks regulatory approvals [282]. - The company may face significant dilution of existing stockholders' interests if additional funding is raised through equity or convertible debt securities [283]. - The company may be forced to delay or terminate clinical trials if it is unable to obtain additional funding [286]. Competition and Market Dynamics - The company faces intense competition from other pharmaceutical and biotechnology firms with potentially greater resources and experience [219]. - Future product candidates may encounter competition from generic drugs sooner than anticipated, impacting market share [220]. - Market acceptance of drug candidates will depend on factors such as safety, efficacy, pricing, and reimbursement policies [229]. - Reimbursement decisions by third-party payors could adversely affect pricing and market acceptance of the company's products [233]. - The company faces significant competition in negotiating strategic alliances, which may impact its ability to fund and advance drug development programs [326]. Regulatory and Compliance Risks - The company must adapt to changing regulatory requirements to maintain marketing approvals and profitability [211]. - Failure to secure intellectual property rights or minimize adverse side effects could materially affect the company's financial condition [218]. - The company may need to conduct additional costly post-marketing studies to monitor safety and efficacy of approved products [206]. - Legislative discussions at the federal level may require manufacturers to pay higher rebates in Medicare Part D, impacting reimbursement for products [236]. - The company faces risks from government and third-party payors aiming to reduce healthcare costs, which could adversely affect its financial condition [237]. - The evolving regulatory landscape for privacy and data security may lead to increased compliance costs and potential liabilities for the company [276]. - The interplay of federal and state laws creates complex compliance issues, potentially exposing the company to additional expenses and adverse publicity [276]. Intellectual Property and Legal Risks - The company faces uncertainties in obtaining and maintaining patent protections, which may limit competitive advantages [331]. - There is a risk that issued patents for drug candidates could be challenged by competitors, potentially leading to invalidation [332]. - Proprietary trade secrets are crucial for the company, but protecting them is challenging due to potential disclosures by employees and collaborators [333]. - The company may incur substantial costs from litigation related to patent and intellectual property rights, which could divert management's focus [341]. - Non-compliance with patent agency requirements could lead to loss of patent rights, allowing competitors to enter the market [346]. Operational and Management Challenges - The company is highly dependent on skilled personnel for drug development and commercialization, and competition for such talent is intense [238]. - Labor shortages and increased turnover rates could lead to higher operational costs, including overtime and wages [239]. - The company does not currently own manufacturing facilities and relies on third-party contract manufacturing organizations (CMOs) for product supplies, which may be limited or interrupted [319]. - Compliance with FDA and other regulatory manufacturing requirements is critical, and any failure by the company or its CMOs could result in significant regulatory actions and impact product development [323]. - The company must ensure that third-party manufacturers comply with quality standards, as any non-compliance could adversely affect the ability to develop and market product candidates [324]. Stock and Market Performance - The company's common stock may experience high volatility due to small trading volumes and market conditions, with significant fluctuations often unrelated to its operating performance [355]. - The lack of research or reports from securities analysts could lead to a decline in stock price and trading volume, particularly if operating results do not meet expectations [358]. - Anti-takeover provisions in the company's charter and Delaware law may complicate acquisition efforts and entrench management [359]. - The market price of the company's common and preferred stock may fluctuate significantly due to various factors, including technological announcements and changes in regulatory guidelines [373].

Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC) Q4 2023 Earnings Call Transcript March 19, 2024 4:30 PM ET Company Participants Grace Kim - IR Spiro Rombotis - President and CEO Brian Schwartz - CMO Paul McBarron - EVP, Finance & COO Conference Call Participants Ahu Demir - Ladenburg Thalmann Kemp Dolliver - Brookline Capital Markets Operator Good afternoon and welcome to the Cyclacel Pharmaceuticals Fourth Quarter and Full Year 2023 Earnings Conference Call and Webcast. At this time all participants are in a ...