Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC) Q3 2023 Earnings Call Transcript
Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC) Q3 2023 Earnings Call Transcript November 13, 2023
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 recorded. I would now like to turn the conference call over to the company. Please go ahead.
Grace Kim: Good afternoon, everyone, and thank you for joining today's conference call to discuss Cyclacel's financial results and business highlights for the third quarter of 2023. Before turning the call over to management, I would like to remind everyone that during this conference call, forward-looking statements made by management are intended to fall within the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and Section 21E of the Securities Exchange Act of 1934 as amended. As set forth in our press release, forward-looking statements involve risks and uncertainties that may affect the company's business and prospects, including those discussed in our filings with the Securities and Exchange Commission, which include, among other things, our Forms 10-Q and 10-K.
All of our projections and other forward-looking statements represent our judgment as of today, and Cyclacel does not take any responsibility to update such information. With us today are Spiro Rombotis, President and Chief Executive Officer; Paul McBarron, Executive Vice President, Finance and Chief Operating Officer; and Dr. Mark Kirschbaum, Senior Vice President and Chief Medical Officer. Spiro will begin with an overview of our business strategy and progress. Mark will provide details on Cyclacel's clinical programs, and then Paul will provide financial highlights for the third quarter of 2023 which will be followed by a Q&A session. At this time, I would like to turn the call over to Spiro.
Spiro Rombotis : Thank you, Grace, and thank you, everyone, for joining us today for our quarterly business update. Both our clinical stage cell cycle programs with fadraciclib or fadra and plogosertib or plogo are progressing well. We expect to shortly report complete dose escalation data with fadra and determination of the recommended Phase II dose or RP2D to be used in subsequent studies. We also expect to report interim dose escalation data from the plogo study and disclose the preclinical data supporting its novel epigenetic mechanism. Both fadra and plogo have demonstrated single agent anticancer activity. With oral fadra, we have observed complete response, partial response and stable disease in patients across a number of solid tumors and lymphoma with good tolerability.
With oral plogo, we have seen stable disease in several patients with various solid tumors at low dosing levels, which is novel for this class of medicines. We believe that based on the innovative properties and demonstrated clinical activity, both fadra and plogo have the potential to be best-in-class in their respective classes. Based on encouraging results in the fadra program, we have implemented a capsule-to-tablet switch, with patients now receiving the more convenient tablet form of the drug. We expect that the tablet is more convenient for patients and reduces the burden of taking many capsules by mouth. As the tablet would ultimately be used in a commercial put up of fadra if it reaches the market, the switch also represents strategic value to an acquirer or licensee.
At the present time, small-cap biotech companies are not in favor by the investment community. However, the Cyclacel team has been hard at work building pharmaceutical value for the long term. This is attested by the enthusiasm demonstrated by our clinical investigators across the globe and their interest in doing the clinical work and offering our medicines as clinical trial options to patients in their care. By developing 2 innovative, high-value medicines, both of which were discovered by Cyclacel, we hope to offer our stockholders the opportunity to realize strategic value. I will now turn the call over to Mark to review our progress in the fadra and plogo studies and discuss some of the clinical results. Mark?
Mark Kirschbaum : Thank you, Spiro. In the 065-101 Phase I/II study with fadra, we have enrolled 26 patients so far. Fadra has been well tolerated, and anticancer activity has been observed, including PR in 2 out of 3 T-cell lymphoma patients, treated and stable disease in 15 solid tumor patients. Of these 15 patients, 4 out of 4 had gynecological cancer, including endometrial, ovarian and cervical; 2 out of 2, cholangiocarcinoma or biliary tract cancers; 2 out of 2, hepatocellular; 2 out of 2, prostate; 1 out of 2, head and neck; 1 out of 1, pancreatic; and 1 out of 1, colorectal cancer. Fadra has a unique activity profile inhibiting both CDK2 and CDK9, which together complement one another, leading to enhanced antitumor activity compared to either CDK2 or CDK9 alone.
A biotechnology laboratory with several scientists in white coats studying a microscope.
We have been able to maintain continuous inhibitory pressure on the tumor cells with twice daily dosing 5 days a week without hematologic toxicity at the current dose level. We are one patient away from completing the dose escalation segment of the study and expect to declare the RP2D shortly. We are also studying the PK and PD results and have identified mutational and molecular patterns on NGS and RNA-Seq that may be predictive of clinical activity. This exciting data may guide patient selection for the Phase II segment of the study. The mutational profile we identified is frequently observed in many large tumor populations. The design of the 065-101 study provides for a rapid transition to Phase II and the opportunity for multiple catalysts through 2024, leading to registration pathways.
As a reminder, the protocol provides for 7 independent cohorts by tumor type and an eighth basket cohort defined by relevant biomarkers. We have added major clinical sites in the U.S. and one more overseas to our current Phase I sites in order to rapidly achieve our enrollment objectives. Let us now turned to our PLK1 inhibitor program. We are very excited that plogo has emerged as a new oral PLK1 inhibitor with novel epigenetic activity when given continuously at low doses. In our 140-101 study, we are evaluating plogo in escalating doses as a treatment for patients with advanced solid tumors and lymphomas. We have enrolled 14 patients so far, currently enrolling dose level 5. In dose levels 1 through 5, plogo is administered once daily by mouth for 5 consecutive days, either for 2 weeks out of 3 or 3 weeks out of 3.
With this novel dosing approach, we have observed anticancer activity in patients with biliary tract non-small cell lung, ovarian and other tumor types, with no drug-related SAEs thus far. In our preclinical program, we have identified that plogo acts through a novel epigenetic mechanism. This epigenetic activity may have a crucial role in the presence of certain common tumor mutations. Patients carrying these mutations are frequent in several large tumor populations. Following these findings, we have entered into scientific collaborations with major global research centers to help further characterize this novel activity of plogo and define the tumor subsets that will benefit the most from this approach. As additional data corroborate these findings, we may enroll in the future, possibly as an expansion of our current Phase I/II study, 1 or more patient cohorts specifically selected on the basis of such biomarkers.
I will now turn the call over to Paul to review our second quarter and financial results.
Paul McBarron : Thank you, Mark. As of September 30, 2023, cash equivalents totaled $5.9 million compared to $18.3 million as of December 31, 2022. Net cash used in operating activities was $12.2 million for the 9 months ended September 30, 2023, compared to $15.7 million for the same period of 2022. The company estimates that its available cash will fund currently planned programs through the end of 2023. The operating plan includes discretionary expenditures, which have not incurred, and taken together with the anticipated receipt of research and development tax credits of approximately $3.1 million in the first quarter of 2024, could extend available cash into the second quarter. Research and development or R&D expenses were $5.2 million for the 3 months ended September 30, 2023, as compared to $4.4 million for the same period in 2022.
R&D expenses relating to fadra were $3.6 million for the 3 months ended September 30, 2023, and as compared to $2.5 million for the same period in 2022 due to increased costs associated with manufacture scale-up and introduction of the tablet form. R&D expenses related to plogo were $1.5 million for the 3 months ended September 30, 2023, as compared to $1.7 million for the same period in 2022. General and administrative expenses for the 3 months ended September 30, 2023, were $1.6 million as compared to $2.1 million for the same period in 2022 due to nonrecurring professional fees of $0.4 million last year. Total other income net for the 3 months ended September 30, 2023, was $0.1 million compared to an income of $0.4 million for the same period of the previous year.
United Kingdom research and development tax credits for the 3 months ended September 30, 2023, were $0.6 million compared to $1 million for the same period of the previous year. The decrease is due to legislative changes that took effect in April 2023, which reduced the amount of tax credit which could be claimed. The R&D tax credits are directly correlated to qualifying research and development expenditure. Net loss for the 3 months ended September 30, 2023, was $6.1 million compared to $5.1 million for the same period in 2022. Operator, we're now ready to take questions.
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