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]

[Part I. Financial Information](index=4&type=section&id=Part%20I.%20Financial%20Information) [Item 1. Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20%28Unaudited%29) Unaudited Q1 2019 financials reflect no revenue, increased net loss, and improved cash from financing, with new lease accounting adopted [Consolidated Balance Sheets](index=4&type=section&id=Consolidated%20Balance%20Sheets) Total assets increased to $21.5 million by March 31, 2019, driven by cash and new lease assets, while liabilities decreased, raising equity Consolidated Balance Sheet Highlights (in $000s) | Balance Sheet Item | Dec 31, 2018 | Mar 31, 2019 | | :--- | :--- | :--- | | Cash and cash equivalents | $17,504 | $17,934 | | Total current assets | $19,787 | $20,124 | | Right-of-use lease asset | $0 | $1,353 | | **Total assets** | **$19,823** | **$21,510** | | Total current liabilities | $4,451 | $2,487 | | Lease liability | $0 | $1,468 | | **Total liabilities** | **$4,551** | **$3,955** | | **Total stockholders' equity** | **$15,272** | **$17,555** | [Consolidated Statements of Operations](index=5&type=section&id=Consolidated%20Statements%20of%20Operations) Q1 2019 operations show no revenue, with net loss increasing to $1.9 million due to higher R&D and lower other income Consolidated Statements of Operations (in $000s, except per share data) | Metric | Q1 2018 | Q1 2019 | | :--- | :--- | :--- | | Total revenues | $0 | $0 | | Research and development | $798 | $1,012 | | General and administrative | $1,364 | $1,192 | | **Operating loss** | **($2,162)** | **($2,204)** | | Total other income, net | $631 | $94 | | **Net loss** | **($1,349)** | **($1,842)** | | **Net loss applicable to common stockholders** | **($1,399)** | **($1,892)** | | **Net loss per share – basic and diluted** | **($0.12)** | **($0.14)** | [Consolidated Statements of Cash Flows](index=8&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Q1 2019 saw increased cash used in operations ($3.7M), offset by $4.1M from financing, resulting in a net cash increase to $17.9M Consolidated Cash Flow Summary (in $000s) | Cash Flow Activity | Q1 2018 | Q1 2019 | | :--- | :--- | :--- | | Net cash used in operating activities | ($2,139) | ($3,684) | | Net cash (used in) / provided by investing activities | ($22) | $27 | | Net cash (used in) / provided by financing activities | ($50) | $4,056 | | **Net (decrease) / increase in cash** | **($2,185)** | **$430** | | **Cash and cash equivalents, end of period** | **$21,725** | **$17,934** | [Notes to Unaudited Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Consolidated%20Financial%20Statements) Notes detail clinical-stage status, going concern through 2020, ASC 842 adoption, no revenue, and $4.3 million raised from stock issuance - The company is a clinical-stage biopharmaceutical company focused on developing targeted medicines for cancer and other serious diseases, leveraging expertise in cell cycle, transcriptional regulation, and DNA damage response biology[30](index=30&type=chunk) - Management concluded that the company's cash of **$17.9 million** as of March 31, 2019, is sufficient to fund operations through the end of 2020, though future viability beyond 2020 depends on raising additional capital[33](index=33&type=chunk)[35](index=35&type=chunk) - On January 1, 2019, the company adopted lease accounting standard ASC 842, recognizing a lease liability of **$1.5 million** and a corresponding right-of-use asset, with prior period statements not recast[37](index=37&type=chunk)[39](index=39&type=chunk) - The "At Market Issuance" sales agreement with H.C. Wainwright concluded in Q1 2019, with the company selling **4,702,527 shares** for gross proceeds of approximately **$4.3 million**, and total net proceeds from the agreement approximately **$4.7 million**[77](index=77&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=17&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses CYC065 and sapacitabine programs, increased R&D, decreased G&A, no revenue, and cash sufficient through 2020 but needing more capital [Overview](index=17&type=section&id=Overview) The company focused on advancing clinical programs for CYC065, sapacitabine, and CYC140, including a collaboration with MD Anderson Cancer Center - The company's primary focus is on its transcriptional regulation program (evaluating CYC065, a CDK inhibitor) and its DNA damage response program (evaluating sapacitabine)[98](index=98&type=chunk) - A three-year Clinical Collaboration Agreement with MD Anderson Cancer Center is in place to evaluate the safety and efficacy of three Cyclacel medicines in up to **170 patients** with various hematological malignancies[108](index=108&type=chunk) - CYC140, a novel polo-like-kinase 1 (PLK1) inhibitor, is open for enrollment in a first-in-human study for patients with advanced leukemias and MDS[107](index=107&type=chunk) [Results of Operations](index=20&type=section&id=Results%20of%20Operations) Q1 2019 results show no revenue, increased R&D due to CYC065, decreased G&A, and significantly lower other income from reduced royalties Research and Development Expenses (in $000s) | Program | Q1 2018 | Q1 2019 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Transcriptional Regulation | $470 | $620 | $150 | 32% | | DNA Damage Response | $37 | $31 | ($6) | (16%) | | Sapacitabine | $141 | $102 | ($39) | (28%) | | Other R&D | $150 | $259 | $109 | 73% | | **Total R&D Expenses** | **$798** | **$1,012** | **$214** | **27%** | General and Administrative Expenses (in $000s) | Metric | Q1 2018 | Q1 2019 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Total G&A Expenses | $1,364 | $1,192 | ($172) | (13%) | - Total other income decreased by approximately **$0.5 million**, from **$0.6 million** in Q1 2018 to **$0.1 million** in Q1 2019, primarily due to lower royalties receivable from a 2005 asset purchase agreement with a third party[120](index=120&type=chunk) [Liquidity and Capital Resources](index=22&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2019, the company had $17.9 million cash, increased operating cash use, and raised $4.1 million from financing, sufficient through 2020 but requiring additional capital Key Liquidity Measures (in $000s) | Metric | Mar 31, 2018 | Mar 31, 2019 | | :--- | :--- | :--- | | Cash and cash equivalents | $21,725 | $17,934 | | Total working capital | $20,474 | $17,637 | Cash Flow Summary (in $000s) | Activity | Q1 2018 | Q1 2019 | | :--- | :--- | :--- | | Net cash used in operating activities | ($2,139) | ($3,684) | | Net cash provided by financing activities | ($50) | $4,056 | - The company believes existing funds are sufficient to satisfy planned working capital and capital expenditures through the end of 2020, but it does not have sufficient funds to complete development and commercialization of any drug candidates and will need to raise additional capital[133](index=133&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=24&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, the company is not required to provide market risk disclosures - As a smaller reporting company, Cyclacel is not required to provide information regarding quantitative and qualitative disclosures about market risk[137](index=137&type=chunk) [Item 4. Controls and Procedures](index=24&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of March 31, 2019, with no significant changes to internal controls from new lease accounting standards - Based on an evaluation as of March 31, 2019, the company's chief executive officer and principal financial officer concluded that disclosure controls and procedures were effective[138](index=138&type=chunk) - The company implemented ASU 2016-02, Leases (Topic 842) on January 1, 2019, with no significant changes made to internal controls over financial reporting as a result[139](index=139&type=chunk) [Part II. Other Information](index=25&type=section&id=Part%20II.%20Other%20Information) [Item 1. Legal Proceedings](index=25&type=section&id=Item%201.%20Legal%20Proceedings) The company reported no legal proceedings during the period - None[142](index=142&type=chunk) [Item 1A. Risk Factors](index=25&type=section&id=Item%201A.%20Risk%20Factors) No material changes to risk factors previously disclosed in the Annual Report on Form 10-K for 2018 - There have been no material changes to the risk factors contained in the Annual Report on Form 10-K for the year ended December 31, 2018[143](index=143&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=25&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities or use of proceeds - None[144](index=144&type=chunk) [Item 3. Defaults Upon Senior Securities](index=25&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - None[145](index=145&type=chunk) [Item 4. Mine Safety Disclosures](index=25&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[146](index=146&type=chunk) [Item 5. Other Information](index=25&type=section&id=Item%205.%20Other%20Information) The company reported no other information - None[147](index=147&type=chunk) [Item 6. Exhibits](index=25&type=section&id=Item%206.%20Exhibits) The report lists several exhibits filed with Form 10-Q, including employment agreements, SOX certifications, and XBRL data files - Exhibits filed include employment agreements, CEO and CFO certifications pursuant to Sarbanes-Oxley Act Sections 302 and 906, and XBRL formatted financial statements[148](index=148&type=chunk)

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, 2018 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 ...