Cyclacel(CYCC)

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Cyclacel(CYCC) - 2022 Q2 - Earnings Call Transcript
2022-08-11 00:16
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]
Cyclacel(CYCC) - 2022 Q2 - Quarterly Report
2022-08-10 16:00
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].
Cyclacel(CYCC) - 2022 Q1 - Earnings Call Transcript
2022-05-12 00:45
Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC) Q1 2022 Earnings Conference Call May 11, 2022 4:30 PM ET Company Participants Irina Koffler - LifeSci Advisors Spiro Rombotis - President, CEO & Executive Director Paul McBarron - EVP, CFO, COO, Secretary & Executive Director Mark Kirschbaum - SVP & Chief Medical Officer Conference Call Participants Kevin DeGeeter - Oppenheimer Ahu Demir - Ladenburg Thalmann & Co. Jonathan Aschoff - ROTH Capital Partners Operator Good afternoon, and welcome to the Cyclacel Pharma ...
Cyclacel(CYCC) - 2022 Q1 - Quarterly Report
2022-05-11 16:00
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 March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION ...
Cyclacel(CYCC) - 2021 Q4 - Annual Report
2022-03-29 16:00
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, 2021 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(CYCC) - 2021 Q4 - Earnings Call Transcript
2022-03-29 00:13
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 ...
Cyclacel Pharmaceuticals (CYCC) Investor Presentation - Slideshow
2022-03-20 10:09
Translating cancer biology into medicines Corporate Presentation February 2022 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 candida ...
Cyclacel(CYCC) - 2021 Q3 - Quarterly Report
2021-11-11 16:00
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(CYCC) - 2021 Q3 - Earnings Call Transcript
2021-11-11 01:49
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(CYCC) - 2021 Q2 - Earnings Call Transcript
2021-08-12 00:30
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 ...