[Part I. Financial Information](index=3&type=section&id=Part%20I.%20Financial%20Information) [Item 1. Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Cyclacel Pharmaceuticals reported no revenue and a net loss of $4.1 million for Q1 2022, with cash decreasing to $29.6 million due to increased R&D expenses [Consolidated Balance Sheets](index=3&type=section&id=Consolidated%20Balance%20Sheets) Total assets decreased to $39.6 million as of March 31, 2022, primarily due to a reduction in cash and cash equivalents | Financial Metric | March 31, 2022 ($000s) | December 31, 2021 ($000s) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | 29,639 | 36,559 | | Total current assets | 36,577 | 40,942 | | Total assets | 39,629 | 42,587 | | **Liabilities & Equity** | | | | Total current liabilities | 6,204 | 5,294 | | Total liabilities | 6,219 | 5,324 | | Total stockholders' equity | 33,410 | 37,263 | | Total liabilities and stockholders' equity | 39,629 | 42,587 | [Consolidated Statements of Operations](index=4&type=section&id=Consolidated%20Statements%20of%20Operations) The company reported no revenue and an increased net loss of $4.1 million for Q1 2022, driven by higher research and development expenses | Metric | Three Months Ended March 31, 2022 ($000s) | Three Months Ended March 31, 2021 ($000s) | | :--- | :--- | :--- | | Revenues | 0 | 0 | | Research and development | 4,954 | 2,566 | | General and administrative | 1,605 | 1,739 | | Total operating expenses | 6,559 | 4,305 | | Operating loss | (6,559) | (4,305) | | Net loss | (4,108) | (3,478) | | Net loss applicable to common shareholders | (4,158) | (3,528) | | Net loss per share – basic and diluted | $(0.42) | $(0.50) | [Consolidated Statements of Cash Flows](index=7&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to $6.8 million in Q1 2022, resulting in a $6.9 million net decrease in cash and cash equivalents | Cash Flow Activity ($000s) | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | (6,775) | (3,566) | | Net cash used in investing activities | (4) | (78) | | Net cash (used in) provided by financing activities | (50) | 17,997 | | Net (decrease) increase in cash and cash equivalents | (6,920) | 14,371 | | Cash and cash equivalents, end of period | 29,639 | 47,777 | [Notes to Unaudited Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Consolidated%20Financial%20Statements) The company, a clinical-stage biopharmaceutical firm, has $29.6 million in cash, sufficient to fund operations through June 2023, and recognized $1.3 million in other income - The company is a clinical-stage biopharmaceutical firm focused on developing cancer medicines based on cell cycle, transcriptional regulation, and mitosis control biology[26](index=26&type=chunk) - Management asserts that the company's cash of approximately **$29.6 million** as of March 31, 2022, is sufficient to fund operations and capital expenditures through June 30, 2023, with future viability dependent on raising additional capital[29](index=29&type=chunk)[32](index=32&type=chunk) - The company recognized **$1.3 million** of other income during Q1 2022 related to royalty payments receivable under a December 2005 Asset Purchase Agreement with Thermo Fisher Scientific Company[56](index=56&type=chunk) - As of March 31, 2022, the company had sold **752,425 shares** for gross proceeds of approximately **$4.0 million** under its August 2021 Controlled Equity Offering Sales Agreement[75](index=75&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=30&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's clinical-stage programs, fadraciclib and CYC140, highlighting a 93% increase in R&D expenses and the need for future capital [Overview](index=30&type=section&id=Overview) Cyclacel, a clinical-stage biopharmaceutical company, focuses on fadraciclib and CYC140, with the first patient in the CYC140 study dosed in April 2022 - The company's primary focus is on its transcriptional regulation program evaluating fadraciclib (CDK2/9 inhibitor) and its anti-mitotic program evaluating CYC140 (PLK1 inhibitor)[114](index=114&type=chunk) - Fadraciclib is in ongoing Phase 1/2 studies for advanced solid tumors/lymphomas (065-101) and hematological malignancies (065-102)[115](index=115&type=chunk)[117](index=117&type=chunk) - The first patient was dosed in the CYC140 Phase 1/2 study for hematological malignancies (140-101) in April 2022[118](index=118&type=chunk) [Results of Operations](index=32&type=section&id=Results%20of%20Operations) For Q1 2022, the company reported no revenue, a 93% increase in R&D expenses, and a significant rise in other income from royalty payments | R&D Expense Breakdown ($000s) | Q1 2022 | Q1 2021 | Change (%) | | :--- | :--- | :--- | :--- | | Transcriptional Regulation (fadraciclib) | 3,645 | 1,662 | 119% | | Anti-mitotic (CYC140) | 1,122 | 679 | 65% | | **Total R&D Expenses** | **4,954** | **2,566** | **93%** | - The increase in R&D expenses was driven by a **$1.7 million** rise in clinical trial costs for fadraciclib and a **$0.4 million** increase for CYC140 trial site openings[125](index=125&type=chunk) - General and administrative expenses decreased by **8%** to **$1.6 million** in Q1 2022 from **$1.7 million** in Q1 2021, due to lower professional and recruitment costs[128](index=128&type=chunk) - Total other income increased to **$1.3 million** in Q1 2022 from **$140,000** in Q1 2021, mainly due to **$1.3 million** in royalty income from a 2005 asset sale agreement[130](index=130&type=chunk) [Liquidity and Capital Resources](index=37&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2022, the company had $29.6 million in cash, sufficient through June 2023, but acknowledges the need for additional future funding | Liquidity Metric ($000s) | March 31, 2022 | March 31, 2021 | | :--- | :--- | :--- | | Cash and cash equivalents | 29,639 | 47,777 | | Total working capital | 30,373 | 47,691 | - Net cash used in operating activities increased to **$6.8 million** in Q1 2022 from **$3.6 million** in Q1 2021, primarily due to increased clinical activities[140](index=140&type=chunk) - Existing funds are expected to be sufficient to satisfy working capital and capital expenditure needs through June 30, 2023[144](index=144&type=chunk) - The company will require additional funding to complete the development and commercialization of any of its drug candidates, which it may seek through equity offerings, debt financings, or strategic collaborations[148](index=148&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=43&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Cyclacel is exempt from providing quantitative and qualitative disclosures about market risk - As a smaller reporting company, Cyclacel is not required to provide quantitative and qualitative disclosures about market risk[153](index=153&type=chunk) [Item 4. Controls and Procedures](index=43&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2022, with no significant changes in internal control over financial reporting - The company's management, including the CEO and principal financial officer, concluded that disclosure controls and procedures were effective as of March 31, 2022[154](index=154&type=chunk) - There were no significant changes in the company's internal controls over financial reporting during the quarter ended March 31, 2022[155](index=155&type=chunk) [Part II. Other Information](index=43&type=section&id=Part%20II.%20Other%20Information) [Item 1. Legal Proceedings](index=43&type=section&id=Item%201.%20Legal%20Proceedings) The company reported no legal proceedings during the period - There are no legal proceedings to report[157](index=157&type=chunk) [Item 1A. Risk Factors](index=43&type=section&id=Item%201A.%20Risk%20Factors) No material changes have occurred in the company's risk factors since its Annual Report on Form 10-K for the year ended December 31, 2021 - No material changes have occurred in the company's risk factors since its Annual Report on Form 10-K for the year ended December 31, 2021[158](index=158&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=43&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - None[160](index=160&type=chunk) [Item 3. Defaults Upon Senior Securities](index=45&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - None[161](index=161&type=chunk) [Item 4. Mine Safety Disclosures](index=45&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[162](index=162&type=chunk) [Item 5. Other Information](index=45&type=section&id=Item%205.%20Other%20Information) The company reported no other information - None[163](index=163&type=chunk) [Item 6. Exhibits](index=45&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including certifications by the Principal Executive Officer and Principal Financial Officer and iXBRL financial statements - Exhibits filed include CEO and CFO certifications (31.1, 31.2, 32.1, 32.2) and iXBRL formatted financial data (101, 104)[164](index=164&type=chunk)

[PART I](index=6&type=section&id=PART%20I) - The company is a clinical-stage biopharmaceutical firm developing cancer medicines based on cell cycle, transcriptional regulation, and mitosis control biology[14](index=14&type=chunk) - The main clinical programs are evaluating fadraciclib (CDK2/9 inhibitor) and CYC140 (PLK1 inhibitor) in various cancers[15](index=15&type=chunk) - Cyclacel's strategy involves building a diversified pipeline, retaining commercialization rights, and entering into selective partnerships[16](index=16&type=chunk) [Business](index=6&type=section&id=Item%201.%20Business) Cyclacel is a clinical-stage biopharmaceutical company developing cancer medicines focused on cell cycle, transcriptional regulation, and mitosis control biology [Clinical Development Pipeline](index=8&type=section&id=Clinical%20Development%20Pipeline) The company's pipeline focuses on oral formulations of fadraciclib and CYC140 in Phase 1/2 studies for various cancers Clinical Development Pipeline Summary | Program | Drug Candidate | Indication | Phase | | :--- | :--- | :--- | :--- | | Transcriptional Regulation | Fadraciclib (oral) | Solid tumors | Phase 1/2 (in progress) | | | Fadraciclib (oral) | Leukemias | Phase 1/2 (in progress) | | Mitosis Regulation | CYC140 (oral) | Solid tumors | Phase 1/2 (in progress) | | | CYC140 (oral) | Leukemias | Phase 1/2 (in planning) | | DNA Damage Response | Sapacitabine (oral) | AML/MDS with venetoclax | Phase 1/2 (recruitment completed) | - The company has transitioned its lead drug candidates, fadraciclib and CYC140, from intravenous to oral administration for current and planned Phase 1/2 clinical studies[24](index=24&type=chunk) - Cyclacel **retains all global marketing rights** for its clinical-stage compounds, with the exception of sapacitabine in Japan[26](index=26&type=chunk) [Transcriptional Regulation Program - Fadraciclib](index=8&type=section&id=Transcriptional%20Regulation%20Program%20-%20Fadraciclib) Fadraciclib is a selective CDK2/9 inhibitor targeting cancer pathways, with two oral Phase 1/2 trials underway for solid tumors and leukemias - Fadraciclib is a **selective CDK2/9 inhibitor** that causes apoptotic death in cancer cells by suppressing the MCL1-mediated survival pathway and can reverse drug resistance associated with cyclin E addiction[38](index=38&type=chunk) - A Phase 1/2 trial (CYC065-101) is evaluating oral fadraciclib in patients with various solid tumors and lymphomas, including breast, colorectal, and ovarian cancers, with a basket cohort for patients with specific biomarkers (MCL1, MYC, cyclin E)[41](index=41&type=chunk) - A separate Phase 1/2 trial (CYC065-102) is evaluating oral fadraciclib in patients with leukemias (AML, CLL) and MDS, both as a single agent and in combination with other therapies[50](index=50&type=chunk)[51](index=51&type=chunk)[53](index=53&type=chunk) - Preclinical data indicate fadraciclib may be effective against KRAS-mutated cancers (colorectal, lung, pancreatic) and can synergize with venetoclax in leukemia models[58](index=58&type=chunk)[61](index=61&type=chunk) [Mitosis Regulation Program - CYC140](index=17&type=section&id=Mitosis%20Regulation%20Program%20-%20CYC140) CYC140 is a novel, selective PLK1 inhibitor with potent anti-cancer activity, currently in a Phase 1/2 trial for solid tumors - CYC140 is a novel, **selective PLK1 inhibitor** with potent anti-cancer activity demonstrated in preclinical models[66](index=66&type=chunk) - A Phase 1/2 registration-directed trial (CYC140-101) is underway to evaluate oral CYC140 in advanced solid tumors and lymphomas, with plans for a subsequent study in hematological malignancies[68](index=68&type=chunk)[69](index=69&type=chunk) - Preclinical data show CYC140 preferentially induces growth inhibition and cell death in malignant cells compared to non-malignant cells[71](index=71&type=chunk)[72](index=72&type=chunk) [DNA Damage Response Program - Sapacitabine](index=19&type=section&id=DNA%20Damage%20Response%20Program%20-%20Sapacitabine) Sapacitabine is an orally available nucleoside analog, with a Phase 3 trial not meeting its primary endpoint but showing subgroup potential, and a Phase 1/2 combination study completed - The randomized **Phase 3 SEAMLESS trial** of sapacitabine in elderly AML patients did not meet its primary endpoint of overall survival, but showed a trend toward improvement in a subgroup with low baseline white blood cell counts[81](index=81&type=chunk) - The company has received consistent scientific advice from three European regulatory authorities regarding a potential approval pathway for sapacitabine based on subgroup analyses from the SEAMLESS trial[83](index=83&type=chunk) - A Phase 1/2 study evaluating an oral combination of sapacitabine with venetoclax in patients with relapsed or refractory AML or MDS has dosed 13 patients[77](index=77&type=chunk) [Competition](index=33&type=section&id=Competition) The company faces intense competition from large pharmaceutical and biotech firms with greater resources in the highly competitive biopharmaceutical industry - The company faces **intense competition** from commercial, pharmaceutical, and biotechnology companies, many of which have significantly greater financial and development resources[128](index=128&type=chunk) - Competitors with CDK or MCL1 inhibitors include Amgen, AstraZeneca, Eli Lilly, Pfizer, and Novartis. Cardiff Oncology has a competing PLK1 inhibitor in trials[129](index=129&type=chunk) [Risk Factors](index=37&type=section&id=Item%201A.Risk%20Factors) The company faces significant risks including uncertain clinical trial outcomes, reliance on third parties, extensive regulation, financial losses, and intellectual property challenges [Risks Associated with Development and Commercialization of Our Drug Candidates](index=37&type=section&id=Risks%20Associated%20with%20Development%20and%20Commercialization%20of%20Our%20Drug%20Candidates) Success depends on clinical trial outcomes, third-party reliance, regulatory approvals, market acceptance, and intense competition, all posing significant risks - Clinical trials are expensive, time-consuming, and subject to delays and uncertain outcomes. The SEAMLESS Phase 3 study failing to meet its primary endpoint is cited as an example of negative results[142](index=142&type=chunk) - The company has no manufacturing capacity and relies on third-party manufacturers for clinical and potential commercial supply, creating dependence and risk of delays or shortages[148](index=148&type=chunk) - Drug candidates are subject to extensive, costly, and time-consuming regulation by the FDA and EMA, with no guarantee of approval[151](index=151&type=chunk) - The company faces **intense competition** from numerous companies with greater resources, and its drug candidates may be rendered obsolete or noncompetitive[155](index=155&type=chunk) [Risks Related to Our Business and Financial Condition](index=59&type=section&id=Risks%20Related%20to%20Our%20Business%20and%20Financial%20Condition) The company has a history of operating losses, requires substantial additional funding, and faces risks from economic conditions and the COVID-19 pandemic - The company has a history of operating losses, with an accumulated deficit of **$385.0 million** as of December 31, 2021, and may never become profitable[179](index=179&type=chunk) - Substantial additional capital will be required to complete drug development. Future financing may not be available on reasonable terms and could cause significant stockholder dilution[173](index=173&type=chunk) - The COVID-19 pandemic has adversely affected clinical trials by delaying operations and impacting patient recruitment and enrollment[188](index=188&type=chunk) - The United Kingdom's withdrawal from the European Union (Brexit) could disrupt markets, change tax benefits, and lead to legal uncertainty and increased regulatory complexity[176](index=176&type=chunk) [Risks Related to our Intellectual Property](index=67&type=section&id=Risks%20Related%20to%20our%20Intellectual%20Property) Commercial success relies on obtaining and defending patent and trade secret protection, but faces risks of invalidation, infringement claims, and difficulty protecting proprietary information - Commercial success depends on obtaining and maintaining patent and trade secret protection, but legal protections are limited and may not provide a competitive advantage[191](index=191&type=chunk)[193](index=193&type=chunk) - The company may be subject to costly litigation or other proceedings relating to intellectual property rights, which could result in substantial damages or prevent commercialization of products[197](index=197&type=chunk) - Third-party intellectual property rights could increase costs or prevent the commercialization of drug candidates, potentially requiring the company to obtain licenses or redesign products[195](index=195&type=chunk) [Properties](index=84&type=section&id=Item%202.%20Properties) The company leases its corporate headquarters in Berkeley Heights, New Jersey, and considers its current facilities adequate for business needs - The company **leases its corporate headquarters** in Berkeley Heights, New Jersey, and considers its current facilities adequate[222](index=222&type=chunk) [Legal Proceedings](index=84&type=section&id=Item%203.%20Legal%20Proceedings) As of December 31, 2021, Cyclacel Pharmaceuticals, Inc. was not a party to any material legal proceedings - As of December 31, 2021, the company was **not party to any material legal proceedings**[223](index=223&type=chunk) [PART II](index=84&type=section&id=PART%20II) [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=84&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on Nasdaq under 'CYCC', with no anticipated common stock dividends, but required preferred stock dividends - Common stock is traded on The **Nasdaq Capital Market** under the symbol "**CYCC**"; preferred stock trades under "**CYCCP**"[226](index=226&type=chunk) - As of March 24, 2022, there were **9,993,135 shares** of common stock outstanding[227](index=227&type=chunk) - The company has **never paid cash dividends on common stock** and does not plan to in the foreseeable future, but is required to pay dividends on its Preferred Stock[229](index=229&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=85&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The company reported a net loss of **$18.9 million** in 2021 due to increased R&D and G&A expenses, with existing cash sufficient into mid-2023 [Results of Operations](index=88&type=section&id=Results%20of%20Operations) In 2021, the company reported no revenues, a **225%** surge in R&D expenses, a **27%** rise in G&A expenses, and a significant increase in income tax benefit - There were **no revenues** for the years ended December 31, 2020 and 2021[246](index=246&type=chunk) Research and Development Expenses (in thousands) | Program | 2020 | 2021 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Transcriptional Regulation (fadraciclib) | $3,665 | $11,105 | $7,440 | 203% | | Anti-mitotic (CYC140) | $579 | $3,579 | $3,000 | 518% | | DNA Damage Response (sapacitabine) | $203 | $301 | $98 | 48% | | Other R&D | $312 | $492 | $180 | 58% | | **Total R&D Expenses** | **$4,759** | **$15,477** | **$10,718** | **225%** | General and Administrative Expenses (in thousands) | Period | Amount | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | | Year ended Dec 31, 2020 | $5,877 | | | | Year ended Dec 31, 2021 | $7,461 | $1,584 | 27% | Income Tax Benefit (in thousands) | Period | Amount | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | | Year ended Dec 31, 2020 | $1,236 | | | | Year ended Dec 31, 2021 | $3,847 | $2,611 | 211% | [Liquidity and Capital Resources](index=93&type=section&id=Liquidity%20and%20Capital%20Resources) As of December 31, 2021, the company had **$36.6 million** in cash, with net cash used in operations increasing, and believes existing funds are **sufficient through mid-2023** but not for full development Key Liquidity Measures (in thousands) | Measure | Dec 31, 2020 | Dec 31, 2021 | | :--- | :--- | :--- | | Cash and cash equivalents | $33,406 | $36,559 | | Total working capital | $32,983 | $35,648 | Summary of Cash Flows (in thousands) | Activity | 2020 | 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(7,934) | $(18,540) | | Net cash used in investing activities | $(96) | $(27) | | Net cash provided by financing activities | $29,504 | $21,737 | - Management believes existing funds are **sufficient to finance operations through mid-2023**, but are not sufficient to complete development and commercialization of any drug candidates[275](index=275&type=chunk) [Critical Accounting Policies and Estimates](index=97&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) Key accounting policies include **Accrued Research and Development Costs** and **Stock-based Compensation**, both requiring significant estimates and judgments - **Accrued Research and Development Costs** are a critical estimate, involving judgments about the level of services performed by CROs and other vendors before invoices are received. The accrual was $2.3 million as of Dec 31, 2021[284](index=284&type=chunk)[288](index=288&type=chunk)[289](index=289&type=chunk) - **Stock-based Compensation** is another critical policy, requiring the use of the Black-Scholes model to estimate the fair value of stock options, which involves assumptions for volatility, term, interest rates, and dividend yields[290](index=290&type=chunk) [Financial Statements and Supplementary Data](index=99&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents the company's audited consolidated financial statements and the independent auditor's **unqualified opinion**, highlighting clinical trial accrual as a **critical audit matter** Consolidated Balance Sheet Data (in thousands) | | Dec 31, 2020 | Dec 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $33,406 | $36,559 | | Total current assets | $35,469 | $40,942 | | Total assets | $36,802 | $42,587 | | **Liabilities & Equity** | | | | Total current liabilities | $2,486 | $5,294 | | Total liabilities | $3,543 | $5,324 | | Total stockholders' equity | $33,259 | $37,263 | Consolidated Statement of Operations Data (in thousands) | | Year Ended Dec 31, 2020 | Year Ended Dec 31, 2021 | | :--- | :--- | :--- | | Research and development | $4,759 | $15,477 | | General and administrative | $5,877 | $7,461 | | Operating loss | $(10,636) | $(22,938) | | Net loss | $(8,445) | $(18,887) | | Net loss per share | $(3.42) | $(2.14) | - The independent auditor, RSM US LLP, issued an **unqualified opinion**, stating the financial statements are fairly presented. The auditor identified 'Clinical Trial Accrual and Expenses' as a **critical audit matter**[299](index=299&type=chunk)[303](index=303&type=chunk)[304](index=304&type=chunk) [Controls and Procedures](index=139&type=section&id=Item%209A.Controls%20and%20Procedures) Management concluded that disclosure controls and internal control over financial reporting were **effective as of December 31, 2021**, with no material changes reported - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were **effective as of December 31, 2021**[487](index=487&type=chunk) - Based on an assessment using the COSO framework, management determined that the company's internal control over financial reporting was **effective as of December 31, 2021**[493](index=493&type=chunk) - This annual report does not include an attestation report from the independent public accounting firm regarding internal control over financial reporting, as permitted for smaller reporting companies[494](index=494&type=chunk) [PART III](index=140&type=section&id=PART%20III) [Directors, Executive Officers, Corporate Governance, Compensation, Security Ownership, and Accountant Fees](index=140&type=section&id=Items%2010-14) Information for these items is **incorporated by reference** from the company's definitive Proxy Statement for the 2022 Annual Meeting of Stockholders - Information for Items 10, 11, 12, 13, and 14 is **incorporated by reference** from the company's Proxy Statement for the 2022 Annual Meeting of Stockholders[499](index=499&type=chunk)[500](index=500&type=chunk)[502](index=502&type=chunk) [PART IV](index=142&type=section&id=PART%20IV) [Exhibits and Financial Statement Schedules](index=142&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists **all exhibits filed with the Form 10-K**, including financial statements, corporate governance documents, material contracts, and executive certifications - This section provides a list of **all exhibits filed with the Form 10-K**, including financial statements, corporate governance documents, material contracts, and executive certifications[508](index=508&type=chunk)[509](index=509&type=chunk)

Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC) Q4 2021 Results Conference Call March 28, 2022 4:30 PM ET Company Participants Spiro Rombotis - President and CEO Paul McBarron - EVP, Finance and COO Dr. Mark Kirschbaum - SVP and Chief Medical Officer Conference Call Participants Kevin DeGeeter - Oppenheimer Ahu Demir - Ladenburg Jonathan Aschoff - ROTH Capital Kumar Raja - Brookline Operator Good afternoon, and welcome to the Cyclacel Pharmaceuticals Fourth Quarter and Full Year 2021 Results Conference Call an ...

Company Overview - Cyclacel is focused on converting cell cycle control biology into innovative oncology medicines[4] - The company has assets in mid-stage development targeting CDK2/9 and PLK1[4] - Cyclacel held a cash position of $40.2 million as of September 30, 2021, expected to finance operations through early 2023[4, 10] Clinical Programs - Fadraciclib (CYC065) is an oral CDK2/9 inhibitor with ongoing Phase 1/2 studies in solid tumors and leukemias, with data expected in 1H 2022 and 2H 2022 respectively[4] - CYC140 is an oral PLK1 inhibitor with IND cleared and Phase 1/2 in solid tumors to initiate in 1H 2022, with data expected in 1H 2023[4] - Fadraciclib has shown durable MCL1 suppression and anticancer activity in patients[7] Therapeutic Strategy - The company's therapeutic strategy involves suppressing multiple redundant mechanisms with a single drug to durably suppress cancer-promoting proteins/genes, enabling apoptosis[6] - Fadraciclib's mechanism of action includes durable suppression of anti-apoptotic proteins like MCL1, MYC, cyclin E, and KRAS mutant[12] - CYC140 has shown compelling preclinical data in liquid and solid cancers, including KRAS mutated cancers[7] Market Potential - Fadraciclib potentially addresses large markets, such as high-grade serous ovarian cancer where CCNE1 is amplified in over 20% of patients[28] - CCNE1 is amplified in 20% of high-grade serous endometrial/uterine cancers, which represents approximately 5,000 US incidence and 77,000 prevalence[28] - In breast cancer, CCNE1 is amplified in 30% of HR+ cases (56,000 US incidence, 735,000 prevalence) and 40% of BRCA1/2+ cases (18,000 US incidence, 238,000 prevalence)[28]

Table of Contents 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 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, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECT ...

Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC) Q3 2021 Earnings Conference Call November 10, 2021 4:30 PM ET Company Participants Spiro Rombotis - President and Chief Executive Officer Paul McBarron - Executive Vice President, Finance and Chief Operating Officer Mark Kirschbaum - Senior Vice President and Chief Medical Officer Conference Call Participants Jonathan Aschoff - ROTH Capital Kumar Raja - Brookline Capital Suzanne Rismiller - Oppenheimer Operator Good afternoon and welcome to the Cyclacel Pharmaceu ...

Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC) Q2 2021 Earnings Conference Call August 11, 2021 4:30 PM ET Company Participants Spiro Rombotis - President and CEO Paul McBarron - EVP, Finance and COO Dr. Mark Kirschbaum - SVP and CMO Conference Call Participants Jonathan Aschoff - ROTH Capital Kumar Raja - Brooklyn Capital Markets Operator Good afternoon, and welcome to the Cyclacel Pharmaceuticals’ Second Quarter 2021 Results Conference Call and Webcast. At this time, all participants are in a listen-only mo ...

Revenue and Income - Revenues for the three and six months ended June 30, 2021 were $0, with no active collaboration or licensing agreements, indicating no foreseeable revenue[120][121] - Total income tax benefit for the three months ended June 30, 2021 was $964, a 237% increase from $286 in the same period of 2020[136] - The company expects to incur substantial operating losses in the future and cannot guarantee significant product revenues until FDA or EMA approval[146] Research and Development Expenses - Total research and development expenses for the three months ended June 30, 2021 were $4.1 million, a 253% increase from $1.16 million in the same period of 2020[123] - Research and development expenses for the six months ended June 30, 2021 totaled $6.67 million, a 194% increase from $2.27 million in the same period of 2020[125] - The company anticipates an increase in overall research and development expenses for the year ended December 31, 2021 compared to 2020 as clinical development programs progress[127] General and Administrative Expenses - General and administrative expenses for the three months ended June 30, 2021 were $1.999 million, a 53% increase from $1.309 million in the same period of 2020[128] - General and administrative expenditures for the year ended December 31, 2021 are expected to increase by approximately 12% compared to 2020 due to lease assignation premium and increased legal and recruitment costs[130] Cash and Working Capital - Cash and cash equivalents as of June 30, 2021 were $43.639 million, up from $25.342 million as of June 30, 2020[139] - Total working capital as of June 30, 2021 was $43.085 million, compared to $26.421 million as of June 30, 2020[139] - Existing funds and cash generated from operations are expected to satisfy planned working capital and capital expenditures through early 2023, but not sufficient for drug candidate development[147] Cash Flow Activities - Net cash used in operating activities increased by $3.1 million, from $4.7 million in 2020 to $7.8 million in 2021[141] - Net cash used in investing activities increased by $12,000 primarily due to increased capital expenditures on IT[142] - Net cash provided by financing activities was $17.9 million in 2021, resulting from approximately $13.5 million in net proceeds from common stock issuance and $4.5 million from warrant exercises[143] Future Funding and Financial Strategy - Future funding requirements will depend on clinical trial costs, manufacturing capabilities, and the impact of COVID-19 on operations[148] - The company plans to finance future cash needs primarily through equity offerings, debt financings, or strategic collaborations[150] - The company is evaluating in-licensing and acquisition opportunities to access new drugs or drug targets, which may increase future funding needs[147] Accumulated Deficit - The accumulated deficit as of June 30, 2021 was $374.7 million, indicating significant losses since inception[139]

Financial Performance - The company reported no revenues for the three months ended March 31, 2020 and 2021, indicating a lack of active collaboration or licensing agreements[114][115]. - The accumulated deficit as of March 31, 2021, was $369.6 million, reflecting significant losses since inception[133]. - The company expects to incur substantial operating losses in the future and cannot guarantee significant product revenues until FDA or EMA approval and successful commercialization[139]. Research and Development Expenses - Research and development expenses increased by $1.5 million from $1.1 million in Q1 2020 to $2.6 million in Q1 2021, representing a 132% increase[120]. - Research and development expenses for transcriptional regulation (fadraciclib) increased by $0.8 million from $0.9 million in Q1 2020 to $1.7 million in Q1 2021, an 88% increase[120]. Cash Flow and Working Capital - Cash and cash equivalents increased significantly from $8.9 million in March 2020 to $47.8 million in March 2021[133]. - Total working capital improved from $10.3 million in March 2020 to $47.7 million in March 2021[133]. - Net cash used in operating activities increased by $0.8 million, from $2.8 million in Q1 2020 to $3.6 million in Q1 2021[135]. - Net cash provided by financing activities surged from a net outflow of $50,000 in Q1 2020 to a net inflow of $18.0 million in Q1 2021[134]. - Net cash provided by financing activities increased by approximately $18.0 million for the three months ended March 31, 2021, due to $13.5 million from common stock issuance and $4.5 million from warrant exercises[137]. Future Funding and Financial Strategy - Existing funds and cash generated from operations are expected to satisfy planned working capital and capital expenditures through early 2023, but the company lacks sufficient funds for drug candidate development and commercialization[140]. - Future funding requirements will depend on clinical trial costs, manufacturing capabilities, and the impact of COVID-19 on financial conditions and operations[141]. - The company plans to finance future cash needs primarily through public or private equity offerings, debt financings, or strategic collaborations[142]. - The company is not reliant on institutional credit finance, but it is dependent on the availability of funds and equity market activity[142]. Impact of COVID-19 - The impact of the COVID-19 pandemic on the company's financial condition and operations remains uncertain and could materially affect future capital raising and clinical studies[144].

Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC) Q1 2021 Earnings Conference Call May 12, 2021 4:30 PM ET Company Participants Spiro Rombotis - President and CEO Paul McBarron - EVP, Finance and COO Dr. Mark Kirschbaum - SVP and CMO Conference Call Participants Jonathan Aschoff - ROTH Capital Kevin DeGeeter - Oppenheimer Wangzhi Li - Ladenburg Operator Good afternoon, and welcome to the Cyclacel Pharmaceuticals First Quarter 2021 Results Conference Call and Webcast. At this time, all participants are in a liste ...