BERKELEY HEIGHTS, N.J., Jan. 30, 2024 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC, NASDAQ:CYCCP, ", Cyclacel", or the ", Company", ))), a biopharmaceutical company developing innovative medicines based on cancer cell biology, announced today that Brian Schwartz, M.D. will assume the role of interim Chief Medical Officer ("CMO") of the Company effective immediately. Dr. Schwartz will succeed Mark Kirschbaum, M.D., whose employment was terminated by the Company. "We are delighted to have B ...

Table of Contents 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, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________________ to __________________ Commission file number 000-50626 CYCLACEL PHARMACEUTICALS, INC. (Exact name of registrant as sp ...

Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC) Q3 2023 Results Conference Call November 13, 2023 4:30 PM ET Company Participants Grace Kim - IR Spiro Rombotis - President, CEO Paul McBarron - EVP, Finance & COO Mark Kirschbaum - SVP, CMO Conference Call Participants Ahu Demir - Ladenburg Thalmann Jonathan Aschoff - ROTH MKM Operator Good afternoon, and welcome to the Cyclacel Pharmaceuticals Third Quarter 2023 Results Conference Call and Webcast. [Operator Instructions] Please note, today's call is being reco ...

Cyclacel Pharmaceuticals Inc. (NASDAQ:CYCC) Q2 2023 Earnings Conference Call August 9, 2023 4:30 PM ET Company Participants Grace Kim - Investor Relations Spiro Rombotis - President and Chief Executive Officer Mark Kirschbaum - Senior Vice President and Chief Medical Officer Paul McBarron - Executive Vice President, Chief Financial Officer and Chief Operating Officer Conference Call Participants Ahu Demir - Ladenburg Thalmann Jeff Jones - Oppenheimer Kemp Dolliver - Brookline Capital Markets Operator Good a ...

Table of Contents 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 June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________________ to __________________ Commission file number 000-50626 CYCLACEL PHARMACEUTICALS, INC. (Exact name of registrant as specifi ...

Cyclacel Pharmaceuticals Inc. (NASDAQ:CYCC) Q1 2023 Results Conference Call May 11, 2023 4:30 PM ET Company Participants Grace Kim - IR Spiro Rombotis - CEO Mark Kirschbaum - CMO Paul McBarron - CFO Conference Call Participants Ahu Demir - Ladenburg Thalmann Shubhendu Sen Roy - Brookline Capital Markets Operator Good afternoon, and welcome to the Cyclacel Pharmaceuticals First Quarter 2023 Results Conference Call and Webcast. At this time, all participants are in a listen-only mode. After today’s call membe ...

Part I. Financial Information [Item 1. Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Unaudited Q1 2023 financials show no revenue, increased net loss, and significant cash decline, raising going concern doubts [Consolidated Balance Sheets](index=3&type=section&id=Consolidated%20Balance%20Sheets) Total assets declined to **$22.1 million** by March 31, 2023, driven by reduced cash, while equity decreased Consolidated Balance Sheet Summary (in $000s) | Account | March 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $11,435 | $18,345 | | Total current assets | $18,974 | $24,411 | | Total assets | $22,060 | $27,501 | | **Liabilities & Equity** | | | | Total current liabilities | $7,338 | $7,392 | | Total liabilities | $7,418 | $7,498 | | Total stockholders' equity | $10,148 | $15,509 | | Total liabilities and stockholders' equity | $22,060 | $27,501 | [Consolidated Statements of Operations](index=5&type=section&id=Consolidated%20Statements%20of%20Operations) Q1 2023 saw no revenue, with net loss widening to **$5.9 million** due to higher R&D and lower other income Consolidated Statement of Operations Summary (in $000s, except per share data) | Metric | Q1 2023 | Q1 2022 | | :--- | :--- | :--- | | Revenues | $0 | $0 | | Research and development | $5,674 | $4,954 | | General and administrative | $1,645 | $1,605 | | Operating loss | ($7,319) | ($6,559) | | Net loss | ($5,804) | ($4,108) | | Net loss applicable to common shareholders | ($5,854) | ($4,158) | | Net loss per share – basic and diluted | ($0.47) | ($0.42) | [Consolidated Statements of Cash Flows](index=8&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations was **$6.9 million** in Q1 2023, leading to a significant drop in cash to **$11.4 million** Consolidated Statement of Cash Flows Summary (in $000s) | Cash Flow Activity | Q1 2023 | Q1 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($6,861) | ($6,775) | | Net cash used in investing activities | ($6) | ($4) | | Net cash provided by financing activities | ($50) | ($50) | | Net (decrease) in cash and cash equivalents | ($6,910) | ($6,920) | | Cash and cash equivalents, end of period | $11,435 | $29,639 | [Notes to Unaudited Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Consolidated%20Financial%20Statements) Notes highlight clinical stage, going concern doubts, no revenue, and potential rescission risk for **3.1 million** shares - Management concluded there is substantial doubt about the Company's ability to continue as a going concern, with cash and cash equivalents of **$11.4 million** as of March 31, 2023, plus **$4.7 million** in R&D tax credits received in April 2023, expected to fund operations only through the end of 2023[27](index=27&type=chunk) - The company recognized no revenue in the first quarters of 2023 and 2022[42](index=42&type=chunk) - The company sold **3.1 million** shares for approximately **$4.5 million** under an expired registration statement, which may be subject to potential rescission rights and reclassified outside of stockholders' equity[62](index=62&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses clinical drug candidates, increased R&D, and significant going concern doubts from limited cash [Overview](index=27&type=section&id=Overview) Clinical-stage biopharmaceutical firm developing cancer medicines, fadraciclib and plogosertib, in Phase 1/2 studies - The company's primary focus is on its transcriptional regulation program with fadraciclib (CDK2/9 inhibitor) and its anti-mitotic program with plogosertib (PLK1 inhibitor)[93](index=93&type=chunk) - Fadraciclib is being evaluated in two Phase 1/2 studies: one for advanced solid tumors and lymphoma (065-101) and another for hematological malignancies (065-102)[95](index=95&type=chunk)[97](index=97&type=chunk) - Plogosertib is being evaluated in a Phase 1/2 registration-directed trial (140-101) for advanced solid tumors and lymphoma, with the first patient dosed in April 2022[98](index=98&type=chunk) [Results of Operations](index=29&type=section&id=Results%20of%20Operations) Q1 2023 reported no revenue, R&D expenses increased **15%** to **$5.7 million**, and other income significantly decreased Research and Development Expenses (in $000s) | Program | Q1 2023 | Q1 2022 | Change (%) | | :--- | :--- | :--- | :--- | | Transcriptional Regulation (fadraciclib) | $4,087 | $3,645 | 12% | | Anti-mitotic (plogosertib) | $1,351 | $1,122 | 20% | | **Total R&D Expenses** | **$5,674** | **$4,954** | **15%** | - General and administrative expenses were consistent at **$1.6 million** for both Q1 2023 and Q1 2022[111](index=111&type=chunk) - Total other income decreased by **85%** to **$0.2 million** in Q1 2023 from **$1.3 million** in Q1 2022, mainly due to a reduction in royalty income from an asset sale agreement with ThermoFisher Scientific[113](index=113&type=chunk) [Liquidity and Capital Resources](index=33&type=section&id=Liquidity%20and%20Capital%20Resources) Cash and equivalents of **$11.4 million** as of March 31, 2023, projected to last only through 2023, raise going concern doubts - The company's cash and cash equivalents as of March 31, 2023, were **$11.4 million**, down from **$29.6 million** a year prior[119](index=119&type=chunk) - Net cash used in operating activities was **$6.9 million** for Q1 2023, slightly higher than the **$6.8 million** used in Q1 2022[122](index=122&type=chunk)[123](index=123&type=chunk) - The company explicitly states that its cash on hand, including tax credits received in April 2023, will only fund operations through the end of 2023, resulting in substantial doubt about its ability to continue as a going concern[131](index=131&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=39&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 - The company is not required to provide information for this item as it qualifies as a smaller reporting company[136](index=136&type=chunk) [Item 4. Controls and Procedures](index=39&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2023, with no significant changes - Management concluded that as of March 31, 2023, the company's disclosure controls and procedures were effective[137](index=137&type=chunk) - No significant changes were made to internal controls over financial reporting during the quarter[138](index=138&type=chunk) Part II. Other Information [Item 1. Legal Proceedings](index=40&type=section&id=Item%201.%20Legal%20Proceedings) No legal proceedings were reported by the company during the period - There are no legal proceedings to report[140](index=140&type=chunk) [Item 1A. Risk Factors](index=40&type=section&id=Item%201A.%20Risk%20Factors) No material changes to previously disclosed risk factors were reported from the 2022 Annual Report - No material changes to the risk factors from the Annual Report on Form 10-K for the year ended December 31, 2022, were reported[141](index=141&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=40&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities or use of proceeds were reported during the period - None reported[142](index=142&type=chunk) [Item 6. Exhibits](index=41&type=section&id=Item%206.%20Exhibits) Exhibits filed with Form 10-Q include Sarbanes-Oxley certifications and financial statements in iXBRL format - Exhibits filed include CEO and CFO certifications pursuant to Sarbanes-Oxley Act Sections 302 and 906[147](index=147&type=chunk) - The filing includes financial statements and notes formatted in Inline eXtensible Business Reporting Language (iXBRL)[147](index=147&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, 2022 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 2022 Earnings Conference Call March 6, 2023 4:30 PM ET Company Participants Irina Koffler - Investor Relations 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 MKM Ahu Demir - Ladenburg Jeff Jones - Oppenheimer Kemp Dolliver - Brookline Capital Markets Operator ...

Financial Data and Key Metrics Changes - As of September 30, 2022, cash and cash equivalents totaled $23.7 million, down from $36.6 million as of December 31, 2021 [28] - Net cash used in operating activities was $15.7 million for the nine months ended September 30, 2022, compared to $14 million for the same period in 2021 [28] - Net loss for the three months ended September 30, 2022, was $5.1 million, slightly higher than the $5 million loss for the same period in 2021 [32] Business Line Data and Key Metrics Changes - Research and development (R&D) expenses were $4.4 million for the three months ended September 30, 2022, compared to $4.2 million for the same period in 2021 [29] - R&D expenses related to fadraciclib were $2.5 million for the three months ended September 30, 2022, down from $3.3 million for the same period in 2021 [29] - R&D expenses related to CYC140 increased to $1.7 million for the three months ended September 30, 2022, compared to $0.7 million for the same period in 2021 [30] Market Data and Key Metrics Changes - The company is focusing on multiple indications for its drugs, particularly in lymphoma and women's cancers, based on initial clinical activity observed [33] - The company is also exploring the potential of its drugs in treating KRAS G12V mutations, which currently have no approved therapies [39] Company Strategy and Development Direction - The company aims to bring its two molecules, fadraciclib and CYC140, to proof-of-concept stage, with expectations for multiple data readouts in the next 12 months [10][54] - The strategy includes focusing on single-agent activity while also considering potential combinations with other therapies [49] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the promising clinical data for oral fadraciclib and the potential for both drugs to become important anticancer therapeutics [54] - The company anticipates providing further updates on clinical progress throughout 2023 [54] Other Important Information - The company reported that it expects its available cash to fund currently planned programs until the end of 2023 [28] - The company has seen early signs of clinical activity in its Phase 1 studies, which is encouraging for future development [54] Q&A Session Summary Question: Are there any indications that the company is particularly interested in for the proof-of-concept stage? - Management indicated that they are not prioritizing any one indication but noted high interest in lymphoma and women's cancers based on initial dialogues with Phase II sites [33] Question: What potential combinations and indications are being pursued for the 140 program? - Management stated that it is too early to predict specific combinations but is hopeful to replicate single-agent activity in various tumor types [34][35] Question: How many patients have been dosed in dose level 6 of the fadra trial? - Management responded that it is too early to disclose information regarding dose level 6, but patient accrual is ongoing [41][43] Question: What are the plans for escalating the dosing schedule in the 140 trial? - Management explained that they are following a straightforward dosing schedule with a 5-milligram increase for each dose level and are observing low toxicity so far [44][46] Question: What are the thoughts on possible combinations with targeted therapies for the 140 program? - Management emphasized the importance of seeing how the low-dose approach holds up before predicting specific combinations, but they are open to exploring various options [47][49] Question: Should general and administrative expenses be expected to grow from the current level? - Management indicated that the current G&A expense level is somewhat of an outlier and should trend similarly to prior quarters [50]