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Dear Fellow Stockholders, the Global Pandemic Caused by the Novel Coronavirus and COVID-19 Disease That Began in Late 2019 Is At

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Dear Fellow Stockholders, the Global Pandemic Caused by the Novel Coronavirus and COVID-19 Disease That Began in Late 2019 Is At Cyclacel Pharmaceuticals, Inc. Dear Fellow Stockholders, The global pandemic caused by the novel coronavirus and COVID-19 disease that began in late 2019 is at the time of this writing affecting nearly all human activity and creating uncertainty in every business sector. At the same time, it has elevated the importance of high value medicines to the forefront of public awareness and ensured that innovative science will play a critical role to help humanity find its way out of the crisis. At Cyclacel, we remain committed to our mission of serving cancer patients by developing novel treatment alternatives, ensuring patient safety and availability of clinical supplies and maintaining the integrity of our clinical research. We take our social responsibility of protecting the health and safety of our employees and the communities in which we live and work very seriously. To this end, we have redesigned our work flow and business processes in line with current standards and government recommendations. Cyclacel's business strategy is to build an innovative pipeline addressing the rising problem of cancer resistance to available drugs that have stopped working. We are studying the ability of our agents alone or in combinations with such drugs to restore anticancer effectiveness and improve treatment outcomes. We are pleased to report a productive year during which we achieved multiple milestones and made substantial progress in executing our business strategy. Fadraciclib (CYC065), our second generation CDK inhibitor, is establishing a leadership position among MCL1 suppressing compounds in clinical development. We have enrolled approximately 65 patients to date with multiple dose escalating schedules in three Phase 1 studies in patients with relapsed or refractory (R/R) cancers. Interim data from these ongoing studies have demonstrated safety, proof of mechanism, and anticancer activity of fadraciclib as a single agent and in combinations. Pharmacologic proof of mechanism was shown by means of durable suppression of MCL1 in the majority of patients at the recommended Phase 2 dose, which was well tolerated. More recently, we were encouraged by a durable response after fadraciclib monotherapy in a heavily pretreated patient with MCL1 amplified endometrial cancer. This patient achieved a confirmed partial response (PR) after three months, and is still on treatment after nine months with 79% reduction in her target tumor lesions at the last restaging. An additional patient in the same study with cyclin E amplified ovarian cancer achieved stable disease after three months with 29% tumor shrinkage. Based on data thus far, we are developing a precision medicine strategy to further evaluate fadraciclib as monotherapy and in combinations in patients with advanced solid tumors. Turning to our leukemia programs, we have been treating patients with R/R acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), or chronic lymphocytic leukemia (CLL) with escalating doses of a combination of fadraciclib and the approved drug venetoclax. Evidence of antileukemic activity included reductions in leukemic blasts in peripheral blood and achievement of minimal residual disease negative status in patients who had already received venetoclax ramp-up. Both of these studies are part of our risk-sharing alliance with The University of Texas MD Anderson Cancer Center, whereby MD Anderson assumes the patient costs for all studies and we provide investigational drugs and other limited support. The MD Anderson alliance also includes our two other clinical stage programs: sapacitabine in combination with venetoclax and our PLK1 inhibitor CYC140. As part of our DNA damage response program, an investigator sponsored trial (IST) of a combination of sapacitabine with the approved drug olaparib is enrolling at the Dana Farber Cancer Institute in patients with BRCA mutant breast cancer. Two additional ISTs are evaluating seliciclib, our first generation CDK inhibitor, outside oncology in patients with Cushing's disease and rheumatoid arthritis. Like many of our peer biopharmaceutical companies, we have responded to society's call by volunteering our medicines for testing in specific indications where they may be helpful to patients affected by the coronavirus. To this end, we have recently announced a collaboration with The University of Edinburgh to evaluate the potential of our CDK inhibitors, fadraciclib and seliciclib, for reducing runaway inflammation and subsequent lung injury in patients with COVID-19 disease. Following receipt of net proceeds of $18.4 million from an equity financing in April 2020, we have strengthened our balance sheet to support planned spending until the end of 2022. In light of the pandemic and to ensure the health and wellbeing of our employees and stockholders, this year's Annual Meeting will be held virtually over the Internet. Details will be communicated in the proxy material filed with the SEC. During 2019, we laid the foundations for multiple data outcomes over the next two years consistent with our strategy: Near Term Outlook Report updated fadraciclib Phase 1 safety and efficacy data with frequent i.v. dosing schedule in patients with advanced solid cancers; Report initial safety and PK data from Phase 1 study of fadraciclib oral formulation; First patient treated in fadraciclib Phase 1/2 precision medicine study; Report initial data from fadraciclib-venetoclax Phase 1 in R/R AML/MDS & CLL; Report initial data from sapacitabine-venetoclax Phase 1 study in R/R AML/MDS; Report initial data from CYC140 Phase 1 First-in-Human study in R/R leukemias; and Report data from Phase 1b/2 sapacitabine-olaparib IST in BRCA mutant metastatic breast cancer when reported by the investigators. We look forward to reporting data from our ongoing clinical programs and potentially realizing stockholder value from our targeted drug pipeline. On behalf of Cyclacel and its Board of Directors, we sincerely thank our employees for their devoted work, our stockholders for their ongoing support, and our patients, their families and healthcare professionals whose participation in our clinical research makes our work possible. Spiro Rombotis President & CEO May 14, 2020 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, 2019 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 (I.R.S. Employer of Incorporation or Organization) Identification No.) 200 Connell Drive Suite 1500 Berkeley Heights, New Jersey 07922 (Address of principal executive offices) (Zip Code) Registrant’s telephone number, including area code: (908) 517-7330 Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, par value $0.001 per share CYCC The Nasdaq Stock Market LLC Preferred Stock, $0.001 par value CYCCP The Nasdaq Stock Market LLC Securities registered pursuant to section 12(g) of the Act: None. Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒ Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒ Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐ Indicate by check mark whether the registrant has submitted electronically, every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act: Large accelerated filer ☐ Accelerated filer ☐ Non-accelerated filer ☒ Smaller reporting company ☒ Emerging growth company ☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒ The aggregate market value of the registrant’s voting and non-voting common stock held by non-affiliates of the registrant (without admitting that any person whose shares are not included in such calculation is an affiliate), as of June 28, 2019 (based upon the closing sale price of $0.5405 of such shares on The NASDAQ Capital Market on June 28, 2019), the last business day of the registrant’s most recently completed second fiscal quarter, was $9,278,819. As of March 4, 2020, there were 17,199,974 shares of the registrant’s common stock outstanding. DOCUMENTS INCORPORATED BY REFERENCE None TABLE OF CONTENTS Page PART I Item 1. Business 3 Item 1A. Risk Factors 24 Item 1B. Unresolved Staff Comments 50 Item 2. Properties 51 Item 3. Legal Proceedings 51 Item 4. Mine Safety Disclosures 51 PART II Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity 51 Securities Item 6. Selected Financial Data 51 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 51 Item 7A.
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