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, 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 of Incorp ...

Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC) Q4 2019 Results Conference Call February 26, 2020 4:30 PM ET Company Participants Jan Medina - Investor Relations Spiro Rombotis - President and Chief Executive Officer Paul McBarron - Executive Vice President, Finance and Chief Operating Officer Dr. Judy Chiao - Vice President of Clinical Development and Regulatory Affairs Conference Call Participants Wangzhi Li - Ladenburg Thalmann Operator Good afternoon, and welcome to the Cyclacel Pharmaceuticals Fourth Quar ...

Translating cancer biology into medicines NASDAQ CYCC – BIOCEO Conference February 10, 2020 Disclaimer | --- | --- | |-------------------------------------------------------------------------------------|---------------| | | | | This presentation contains forward-looking statements | within the | | meaning of the "safe harbor" provisions of the Private Securities | Litigation | | Reform Act of 1995 about financial results and estimates, | business | | strategy, clinical trial plans and research and developm ...

Translating cancer biology into medicines NASDAQ CYCC Biotech Showcase - January 13, 2020 Disclaimer | --- | --- | |------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------| | | | | This presentation contains forward-looking statements within | the meaning | | of the "safe harbor" provisions of the Private Securities | Litigation Reform | | Act of 1995 about financi ...

Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC) Q3 2019 Earnings Conference Call November 13, 2019 4:30 PM ET Company Participants Jan Medina – Russo Partners LLC Spiro Rombotis – President and Chief Executive Officer Paul McBarron – Executive Vice President-Finance and Chief Operating Officer Judy Chiao – Vice President-Clinical Development and Regulatory Affairs Conference Call Participants Wangzhi Li – Ladenburg Operator Good afternoon, and welcome to the Cyclacel Pharmaceuticals Third Quarter 2019 Results ...

Revenue Generation - Revenues for the three months ended September 30, 2018 and 2019 were $0, indicating no revenue generation during this period[115] Research and Development Expenses - Research and development expenses decreased by $0.1 million from $1.2 million for the three months ended September 30, 2018 to $1.1 million for the same period in 2019, representing a 12% decrease[121] - Research and development expenses related to transcriptional regulation remained flat at $726,000 for both periods, while expenses for sapacitabine decreased by $249,000, or 79%[119] - Total research and development expenses represented 49% and 45% of operating expenses for the three months ended September 30, 2018 and 2019, respectively[120] - The company anticipates an increase in overall research and development expenses for the year ended December 31, 2019 compared to 2018 as clinical development progresses[122] - Total research and development expenses remained relatively flat at $3.2 million for the nine months ended September 30, 2018 and 2019, representing 45% and 47% of operating expenses respectively[136] General and Administrative Expenses - General and administrative expenses increased slightly from $1.25 million in 2018 to $1.285 million in 2019, a 3% increase[123] - General and administrative expenses decreased by $0.2 million from $3.9 million for the nine months ended September 30, 2018 to $3.7 million for the nine months ended September 30, 2019[140] - General and administrative expenses represented 51% and 55% of operating expenses for the three months ended September 30, 2018 and 2019, respectively[123] Clinical Studies and Collaborations - The company is evaluating CYC065 in combination with venetoclax in two clinical studies for patients with relapsed refractory chronic lymphocytic leukemia and acute myeloid leukemia[107] - A Phase 1/2 study of sapacitabine in combination with venetoclax is intended to enroll up to 40 patients with relapsed or refractory AML or myelodysplastic syndromes[110] - The company entered into a Clinical Collaboration Agreement with MD Anderson Cancer Center to evaluate the safety and efficacy of three Cyclacel medicines in patients with hematological malignancies, with a total projected enrollment of up to 170 patients[113] Income and Cash Flow - Total other income increased by approximately $0.1 million from $0.1 million for the three months ended September 30, 2018 to $0.2 million for the three months ended September 30, 2019[126] - Foreign exchange gains increased by approximately $78,000, from a gain of $1,000 for the three months ended September 30, 2018, to a gain of $79,000 for the three months ended September 30, 2019[127] - Total income tax benefit decreased by $0.1 million from $1.0 million for the nine months ended September 30, 2018 to $0.9 million for the nine months ended September 30, 2019[147] - Total other income decreased by approximately $0.3 million, from $0.8 million for the nine months ended September 30, 2018 to $0.5 million for the nine months ended September 30, 2019[142] - Net cash used in operating activities increased by $3.6 million, from $4.7 million for the nine months ended September 30, 2018 to $8.3 million for the nine months ended September 30, 2019[152] - Net cash provided by financing activities increased by $4.1 million for the nine months ended September 30, 2019 due to approximately $4.1 million in net proceeds from the issuance of common stock[154] - Cash and cash equivalents decreased from $18.973 million as of September 30, 2018 to $12.967 million as of September 30, 2019[149] Financial Position and Future Funding - The accumulated deficit as of September 30, 2019 was $355.3 million[149] - The company expects to continue incurring substantial operating losses in the future and cannot guarantee significant product revenues until FDA or EMA approval and successful commercialization[155] - Existing funds, along with cash generated from operations and recent financing activities, are deemed sufficient to meet planned working capital and capital expenditures through the end of 2020, but the company lacks sufficient funds for drug candidate development and commercialization[156] - Future funding requirements will depend on various factors, including clinical trial costs, manufacturing capabilities, and costs associated with acquiring businesses or technologies[157] - The company plans to evaluate in-licensing and acquisition opportunities to access new drugs or drug targets, which may increase future funding needs[156] - Future cash needs are expected to be financed primarily through public or private equity offerings, debt financings, or strategic collaborations[159] - The company is not reliant on institutional credit finance, but it is dependent on the availability of funds and activity in equity markets[159] - If additional funding is not secured when needed, the company may have to delay or reduce clinical trials or research programs[159] - The company may need to partner product candidate programs at earlier stages of development, potentially lowering their economic value[159] - The costs of filing and enforcing patent claims and obtaining FDA and EMA approvals will impact future funding requirements[158] - The company is not required to provide market risk disclosures as a smaller reporting company[160]

CYC 682 Translating cancer biology into medicines NASDAQ CYCC September 2019 Disclaimer | --- | --- | |--------------------------------------------------------------------------------------|---------------| | | | | This presentation contains forward-looking statements | within the | | meaning of the "safe harbor" provisions of the Private | Securities | | Litigation Reform Act of 1995 about financial results and | estimates, | | business strategy, clinical trial plans and research and | development | | prog ...

Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC) Q2 2019 Results Earnings Conference Call August 13, 2019 4:30 PM ET Company Participants Paul McBarron - Executive VP of Finance, CFO, COO, Secretary & Executive Director Spiro Rombotis - President, CEO & Executive Director Alexander Fudukidis - IR, Russo Partners LLC Conference Call Participants Operator Good afternoon, and welcome to the Cyclacel Pharmaceuticals Second Quarter 2019 Results Conference Call and Webcast. (Operator Instructions) The company will al ...

Part I. Financial Information [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) Unaudited H1 2019 financial statements show decreased cash and assets, a $3.6 million net loss, and increased operating cash outflow [Consolidated Balance Sheets](index=4&type=section&id=Consolidated%20Balance%20Sheets) Total assets decreased to $19.5 million by June 30, 2019, driven by reduced cash, while liabilities also decreased, and new lease accounting recognized ROU assets and liabilities Consolidated Balance Sheet Highlights (in $000s) | Account | Dec 31, 2018 | June 30, 2019 | Change | | :--- | :--- | :--- | :--- | | **Assets** | | | | | Cash and cash equivalents | $17,504 | $15,159 | ($2,345) | | Total current assets | $19,787 | $18,150 | ($1,637) | | Right-of-use lease asset | $0 | $1,285 | +$1,285 | | **Total assets** | **$19,823** | **$19,464** | **($359)** | | **Liabilities & Equity** | | | | | Total current liabilities | $4,451 | $2,500 | ($1,951) | | Lease liability | $0 | $1,233 | +$1,233 | | **Total liabilities** | **$4,551** | **$3,733** | **($818)** | | **Total stockholders' equity** | **$15,272** | **$15,731** | **+$459** | [Consolidated Statements of Operations](index=5&type=section&id=Consolidated%20Statements%20of%20Operations) The company reported no revenue, with a Q2 2019 net loss of $1.8 million and a six-month net loss increasing to $3.7 million due to higher operating losses Statement of Operations Summary (in $000s, except per share data) | Metric | Q2 2018 | Q2 2019 | YTD 2018 | YTD 2019 | | :--- | :--- | :--- | :--- | :--- | | Total Revenues | $0 | $0 | $0 | $0 | | R&D Expenses | $1,182 | $1,153 | $1,980 | $2,165 | | G&A Expenses | $1,283 | $1,184 | $2,647 | $2,376 | | Operating Loss | ($2,465) | ($2,337) | ($4,627) | ($4,541) | | Net Loss | ($1,852) | ($1,783) | ($3,201) | ($3,625) | | Net Loss per Share | ($0.16) | ($0.11) | ($0.28) | ($0.24) | [Consolidated Statements of Cash Flows](index=9&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations increased to $6.3 million for H1 2019, partially offset by $4.0 million from financing activities, leading to a $2.3 million cash decrease Cash Flow Summary for the Six Months Ended June 30 (in $000s) | Activity | 2018 | 2019 | | :--- | :--- | :--- | | Net cash used in operating activities | ($3,942) | ($6,319) | | Net cash provided by (used in) investing activities | ($31) | $26 | | Net cash provided by (used in) financing activities | ($101) | $3,955 | | **Net (decrease) in cash and cash equivalents** | **($4,086)** | **($2,345)** | - The company received net proceeds of approximately **$4.1 million** from the issuance of common stock in the first six months of 2019[26](index=26&type=chunk) [Notes to Unaudited Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Unaudited%20Consolidated%20Financial%20Statements) Notes detail the company's biopharmaceutical focus, cash sufficiency through 2020 with future capital needs, ASC 842 adoption, and details on dilutive securities and warrants - The company is a clinical-stage biopharmaceutical company focused on developing targeted medicines for cancer using cell cycle control, transcriptional regulation, and DNA damage response biology[29](index=29&type=chunk) - Management believes its cash of **$15.2 million** as of June 30, 2019, is **sufficient to fund operations through the end of 2020**, but notes that its future viability depends on raising additional capital[32](index=32&type=chunk)[34](index=34&type=chunk) - On January 1, 2019, the company adopted the new lease accounting standard (ASC 842), resulting in the recognition of a **$1.5 million** lease liability and a corresponding right-of-use asset[36](index=36&type=chunk)[38](index=38&type=chunk) - As of June 30, 2019, there were **7,490,500 warrants** outstanding with an exercise price of **$2.00**, expiring in 2024[78](index=78&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) MD&A highlights clinical program progress, no revenue, increased R&D expenses, decreased G&A, and the need for additional capital beyond 2020 despite current cash [Overview](index=20&type=section&id=Overview) The company's H1 2019 focus was on clinical programs, including CYC065, sapacitabine, and CYC140, alongside a collaboration with MD Anderson Cancer Center - The company's main focus is on its clinical programs: **CYC065** (transcriptional regulation), **sapacitabine** (DNA damage response), and **CYC140** (anti-mitotic)[97](index=97&type=chunk) - A clinical collaboration with **MD Anderson Cancer Center** was established to evaluate three of the company's medicines in up to 170 patients with hematological malignancies[108](index=108&type=chunk) [Results of Operations](index=23&type=section&id=Results%20of%20Operations) Q2 2019 R&D expenses were flat, G&A decreased 8%; H1 2019 R&D increased 9% due to clinical progress, while G&A decreased 10% R&D Expenses by Program - Three Months Ended June 30 (in $000s) | Program | 2018 | 2019 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Transcriptional Regulation | $637 | $684 | $47 | 7% | | Sapacitabine | $340 | $109 | ($231) | (68%) | | Other R&D | $205 | $360 | $155 | 76% | | **Total R&D** | **$1,182** | **$1,153** | **($29)** | **(2%)** | R&D Expenses by Program - Six Months Ended June 30 (in $000s) | Program | 2018 | 2019 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Transcriptional Regulation | $1,106 | $1,304 | $198 | 18% | | Sapacitabine | $482 | $211 | ($271) | (56%) | | Other R&D | $392 | $650 | $258 | 66% | | **Total R&D** | **$1,980** | **$2,165** | **$185** | **9%** | - General and administrative expenses decreased by **8%** for the three-month period and **10%** for the six-month period ended June 30, 2019, compared to the same periods in 2018, primarily due to reduced legal and professional costs[118](index=118&type=chunk)[133](index=133&type=chunk) [Liquidity and Capital Resources](index=30&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2019, the company had $15.2 million in cash, sufficient through 2020, but requires additional capital for full drug development and commercialization - The company expects its existing cash of **$15.2 million** (as of June 30, 2019) to be **sufficient to fund operating expenses and capital requirements through the end of 2020**[32](index=32&type=chunk)[149](index=149&type=chunk) - The company does not currently have sufficient funds to complete the development and commercialization of any of its drug candidates and will need to raise **additional capital**[149](index=149&type=chunk) Key Liquidity Measures (in $000s) | Metric | June 30, 2018 | June 30, 2019 | | :--- | :--- | :--- | | Cash and cash equivalents | $19,824 | $15,159 | | Working capital | $18,693 | $15,650 | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=32&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is exempt from market risk disclosures as it qualifies as a smaller reporting company - The company is not required to provide information on quantitative and qualitative disclosures about market risk because it qualifies as a **smaller reporting company**[154](index=154&type=chunk) [Item 4. Controls and Procedures](index=32&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of June 30, 2019, with no significant changes due to ASC 842 adoption - Management concluded that the company's disclosure controls and procedures were **effective** as of June 30, 2019[155](index=155&type=chunk) - The company implemented the new lease accounting standard (ASU 2016-02, Topic 842) on January 1, 2019, with **no significant changes** to internal controls over financial reporting[156](index=156&type=chunk) Part II. Other Information [Item 1. Legal Proceedings](index=33&type=section&id=Item%201.%20Legal%20Proceedings) No legal proceedings were reported during the period - There are **no legal proceedings** to report[159](index=159&type=chunk) [Item 1A. Risk Factors](index=33&type=section&id=Item%1A.%20Risk%20Factors) No material changes to previously disclosed risk factors were reported - **No material changes** have occurred in the company's risk factors since the filing of its 2018 Form 10-K[160](index=160&type=chunk) [Other Items (2, 3, 4, 5, 6)](index=33&type=section&id=Other%20Items%20(2%2C%203%2C%204%2C%205%2C%206)) The company reported no unregistered equity sales, no defaults on senior securities, and no other material information, with mine safety disclosures not applicable - Item 2: **No unregistered sales** of equity securities and use of proceeds were reported[161](index=161&type=chunk) - Item 3: **No defaults** upon senior securities were reported[162](index=162&type=chunk) - Item 4: **Mine Safety Disclosures are not applicable**[163](index=163&type=chunk)

Financial Data and Key Metrics Changes - Cash and cash equivalents totaled $17.9 million as of March 31, 2019, compared to $17.4 million as of December 31, 2018, reflecting an increase of $0.4 million primarily due to net proceeds from a Common Stock Sales Agreement [28] - Net loss for the three months ended March 31, 2019, was $1.8 million compared to $1.3 million for the same period in 2018 [31] - Research and development expenses were $1 million for the first quarter of 2019, up from $0.8 million for the same period in 2018 [29] Business Line Data and Key Metrics Changes - The company is evaluating three clinical stage drugs, with CYC065 being a CDK 2/9 inhibitor involved in six clinical studies [7][8] - CYC065-02, a Phase 1 combination study with venetoclax in relapsed/refractory CLL, has treated two patients without dose-limiting toxicity [17] - CYC140-01, a first-in-human Phase 1 study of CYC140, has dosed two patients with no observed dose-limiting toxicities [19] Market Data and Key Metrics Changes - The company is focusing on addressing cancer resistance, particularly through the suppression of pro-survival proteins like Mcl-1 and Bcl-2, which are critical in cancer treatment resistance [9][11] - The competitive landscape includes a race to market drugs that inhibit Mcl-1 function, with Cyclacel positioned as a leader in this area [13][14] Company Strategy and Development Direction - The company aims to enhance the efficacy of standard care drugs by targeting inherited mutations in DNA damage pathways, particularly in BRCA mutant cancers [14][15] - Key milestones include initiating studies for CYC065 and venetoclax in AML and MDS, and reporting initial data from ongoing clinical studies [26][27] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence that cash and marketable securities will be sufficient to finance operations through the end of 2020, supported by projected cash-sparing benefits from the MD Anderson alliance [31] - The company expects to enroll the first patient in the CYC065 and venetoclax study by summer 2019, pending IRB approval [34] Other Important Information - The company has made progress in developing oral formulations of CYC065, with capsules now available for clinical trials [23] - The ongoing combination study of sapacitabine and olaparib has shown promising results, with initial patients achieving tumor shrinkage [25] Q&A Session Summary Question: Timeline for initiating CYC065 with venetoclax in AML and sapacitabine with venetoclax in ML - Management expects IRB approval within four weeks, aiming to enroll the first patient by summer 2019 [33][34] Question: Clarification on the amendment for the Part 3 of the CYC065 oral formulation monotherapy - The amendment was to add evaluation of oral capsules, which was not included in the previous protocol [36][37]