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]

Revenues - Revenues for the three and nine months ended September 30, 2021 and 2022 were $0, with no anticipated revenues for the foreseeable future[124][125] Research and Development Expenses - Research and development expenses increased by $2.7 million from $10.9 million for the nine months ended September 30, 2021 to $13.6 million for the same period in 2022[130] - Total research and development expenses for the three months ended September 30, 2022 were $4.4 million, representing a 5% increase compared to $4.2 million in the same period of 2021[129] - The transcriptional regulation program (fadraciclib) incurred $2.5 million in expenses for the three months ended September 30, 2022, a decrease of 25% from $3.3 million in the same period of 2021[129] - CYC140 research and development expenses increased by 157% to $1.7 million for the three months ended September 30, 2022, compared to $664,000 in the same period of 2021[129] - The company anticipates an increase in overall research and development expenses for the year ended December 31, 2022 compared to 2021 as it progresses its clinical development programs[133] General and Administrative Expenses - General and administrative expenses for the three months ended September 30, 2022 were $2.1 million, a 15% increase from $1.8 million in the same period of 2021[134] Income and Other Financial Metrics - Total other income increased by $1.7 million from $0.2 million for the nine months ended September 30, 2021 to $1.9 million for the same period in 2022[137] - Foreign exchange gains increased by $0.5 million, from $5,000 for the nine months ended September 30, 2021, to $0.5 million for the nine months ended September 30, 2022[140] - Total income tax benefit increased by approximately $0.5 million from $2.6 million for the nine months ended September 30, 2021, to $3.1 million for the nine months ended September 30, 2022, representing an 18% increase[143] Cash and Cash Equivalents - Cash and cash equivalents decreased from $40.2 million as of September 30, 2021, to $23.7 million as of September 30, 2022[145] - Net cash used in operating activities increased by $1.7 million, from $14.0 million for the nine months ended September 30, 2021, to $15.7 million for the nine months ended September 30, 2022[150] - Net cash provided by financing activities was $2.9 million for the nine months ended September 30, 2022, compared to $20.9 million for the same period in 2021[152][153] Accumulated Deficit and Future Outlook - The accumulated deficit as of September 30, 2022, was $398.7 million[147] - The company expects to incur substantial operating losses in the future and does not guarantee significant product revenues until FDA or EMA approval[156] - Future funding requirements will depend on various factors, including clinical trial costs and the impact of COVID-19 on operations[158] Strategic Plans - The company plans to evaluate in-licensing and acquisition opportunities to access new drugs or drug targets[157] Impact of COVID-19 - The COVID-19 pandemic has negatively impacted clinical trials and the availability of materials, affecting the company's operations[162] - The company will not pursue further development of sapacitabine and has notified the licensor of the termination of the license agreement effective March 23, 2023[127]

Corporate Presentation September 2022 Translating cancer biology into medicines Disclaimer This presentation contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forwardlooking statements. Such forward-looking statements include statements regarding, among other things, the efficacy, safety and intended utilization of Cyclacel's product candid ...

Financial Data and Key Metrics Changes - As of June 30, 2022, cash and cash equivalents totaled $29.1 million, down from $36.6 million as of December 31, 2021, with available cash resources expected to fund planned programs into the second half of 2023 [31] - Research and development (R&D) expenses were $4.2 million for Q2 2022, slightly up from $4.1 million in Q2 2021 [31] - Net loss for Q2 2022 was $4.6 million, compared to $5.1 million for the same period in 2021 [34] Business Line Data and Key Metrics Changes - R&D expenses related to the lead product candidate, oral fadraciclib (fadra), were $2.6 million for Q2 2022, down from $2.8 million in Q2 2021, attributed to increased clinical trial costs [32] - R&D expenses for CYC140 were $1.5 million for Q2 2022, compared to $1.1 million in Q2 2021, due to the initiation of the CYC140 Phase 1/2 study [33] Market Data and Key Metrics Changes - The 065-101 study of oral fadra is enrolling well at four sites in the US, South Korea, and Spain, with 17 patients enrolled in the dosage escalation part of the study [9][10] - The company is also testing oral fadra for leukemia and myelodysplastic syndromes in study 065-102, which is currently enrolling patients [23] Company Strategy and Development Direction - The company aims to establish oral fadra as a best-in-class CDK inhibitor, focusing on its dual targeting of CDK2 and CDK9, good tolerability, and preliminary anti-cancer activity [11][12] - The company plans to hold an R&D day in the fall to provide updates on clinical programs and preclinical work [29] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the safety and anti-cancer activity of oral fadra, noting the encouraging results in heavily pretreated patients [7][8] - The company anticipates building momentum as the fadra solid tumor trial progresses, along with other clinical stage programs [48] Other Important Information - The company has made progress in advancing its novel PLK1 inhibitor, CYC140, into a Phase 1/2 study for solid tumors and lymphomas, with no dose-limiting toxicities observed so far [27][28] Q&A Session Summary Question: Plans for R&D Day and safety data from fadra program - Management confirmed that updates, including safety data, will be presented during the R&D Day event in Q3 [35][36] Question: Synergistic toxicity of inhibiting CDK2 and CDK9 - Management indicated that no toxicity has been observed in the study so far [37] Question: Indications for CYC140 and enrollment rates - Management discussed ongoing dose escalation and indicated that solid tumors and lymphomas are currently the focus, with plans to activate the leukemia part of the study later [41][42] Question: Upcoming conferences and data presentations - Management mentioned that an abstract has been submitted for an upcoming oncology conference, with expectations for data updates in the second half of the year [43][45]

Revenue and Income - Revenues for the three and six months ended June 30, 2021 and 2022 were $0, with no anticipated revenues for the foreseeable future[124][125]. - Total other income increased by $1.4 million from $0.1 million for the six months ended June 30, 2021 to $1.5 million for the six months ended June 30, 2022[136]. - Total income tax benefit increased by approximately $0.5 million from $1.6 million for the six months ended June 30, 2021 to $2.1 million for the six months ended June 30, 2022, representing a 29% increase[141]. Research and Development Expenses - Research and development expenses increased by $2.5 million from $6.7 million for the six months ended June 30, 2021 to $9.2 million for the six months ended June 30, 2022[129]. - Expenditure for the transcriptional regulation program increased by $1.8 million for the six months ended June 30, 2022, primarily due to a $2.2 million increase in clinical trial costs[129]. - Total research and development expenses represented 73% and 74% of operating expenses for the three and six months ended June 30, 2022, respectively[128]. - The company anticipates an increase in overall research and development expenses for the year ended December 31, 2022 compared to the previous year[131]. - The company expects eligible expenses for research and development to be higher in the fiscal year ended December 31, 2022, leading to an anticipated increase in tax credits recoverable[142]. Cash Flow and Financial Position - Cash and cash equivalents decreased from $43.6 million as of June 30, 2021 to $29.1 million as of June 30, 2022[143]. - Net cash used in operating activities increased by $0.9 million, from $7.8 million for the six months ended June 30, 2021 to $8.7 million for the six months ended June 30, 2022[146]. - Net cash provided by financing activities was $1.4 million for the six months ended June 30, 2022, compared to $17.9 million for the same period in 2021[148][149]. - The accumulated deficit as of June 30, 2022, was $393.6 million, indicating significant losses since inception[143]. Clinical Trials and Drug Development - The ongoing Phase 1/2 studies for fadraciclib and CYC140 aim to assess safety and identify signals of clinical activity[118][122]. - The COVID-19 pandemic has adversely affected clinical trials, particularly in patient enrollment and resource allocation[155]. - The company does not currently have sufficient funds to complete the development and commercialization of any drug candidates[151]. Future Funding and Opportunities - Future funding requirements will depend on various factors, including clinical trial costs and the impact of COVID-19 on operations[153][155]. - The company plans to evaluate in-licensing and acquisition opportunities to access new drugs or drug targets, which may increase future funding needs[151]. General and Administrative Expenses - General and administrative expenses decreased by 21% to $1.58 million for the three months ended June 30, 2022 compared to $1.99 million for the same period in 2021[133]. Marketing Rights - The company retains virtually all marketing rights worldwide to the compounds associated with its drug programs[123].

Financial Data and Key Metrics Changes - As of March 31, 2022, cash and cash equivalents totaled $29.6 million, down from $36.6 million as of December 31, 2021. After receiving $3.6 million in UK research and development tax credits and $1.3 million in royalty receipts post-quarter, cash and cash equivalents increased to $34.5 million [19] - Research and development (R&D) expenses were $5 million for Q1 2022, compared to $2.6 million for the same period in 2021, reflecting increased clinical trial costs [20] - The net loss for Q1 2022 was $4.1 million, compared to $3.5 million for the same period in 2021 [23] Business Line Data and Key Metrics Changes - R&D expenses related to fadraciclib were $3.6 million for Q1 2022, up from $1.7 million in Q1 2021, due to increased clinical trial costs [20] - R&D expenses for CYC140 were $1.1 million for Q1 2022, compared to $0.7 million in Q1 2021, attributed to costs associated with opening clinical trial sites [21] Market Data and Key Metrics Changes - The company is currently enrolling patients in three separate registration-directed Phase I/II clinical trials for its drug candidates fadraciclib and CYC140, despite challenges in patient enrollment faced by many biotechnology companies [5][6] Company Strategy and Development Direction - The company aims to meet key milestones for its drug candidates in 2022, including initial data for oral fadraciclib, and believes it has sufficient resources to fund operations through mid-2023 [7] - The clinical development plan for CYC140 will explore its potential for single-agent activity across various solid tumor types and hematological malignancies [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's competitive position and the potential for recovery in the biopharma market, emphasizing the importance of their clinical assets [7] - The management team highlighted the importance of continuous daily dosing for their drugs, which they believe provides a competitive advantage [14] Other Important Information - The company has established strong relationships with leading cancer centers in the U.S. and abroad, which is crucial for their clinical development efforts [6] - The company anticipates completing analyses related to fadraciclib in the coming weeks and remains on track to initiate the Phase II part of the study in the second half of 2022 [10] Q&A Session Summary Question: Update on oral fadraciclib cohort 5 and DLTs - Management confirmed that a patient has been dosed in cohort 5 and is doing well [25] Question: Timeline for updates on oral fadraciclib - Management expects to hold an R&D Day in early summer to provide updates [27] Question: Dosing strategy for the hematologic malignancy study - Management indicated that the dosing strategy for the leukemia trial is aligned with the solid tumor trial [29] Question: Active sites and dosing schedule for CYC140 - Management stated that they are starting with two initial sites for CYC140 and will proceed cautiously [31] Question: Differentiating factors of CYC140 compared to other PLK1 inhibitors - Management highlighted that CYC140 has a shorter half-life and is designed for oral administration, which may provide advantages over other PLK1 inhibitors [37] Question: Rationale behind indication selection for CYC140 - Management explained that all selected cohorts have a PLK1-related mechanism, supported by preclinical data [39] Question: Expectations for success across different tissue types in trials - Management noted that the trial design allows for flexibility to adapt based on emerging data from various tumor types [43]