Cyclacel Pharmaceuticals Q1 2024 Earnings Report

Cyclacel Pharmaceuticals EPS Results

• Actual EPS: -$544.80
• Consensus EPS: -$1,183.20
• Beat/Miss: Beat by +$638.40
• One Year Ago EPS: -$1,692.00

Cyclacel Pharmaceuticals Revenue Results

• Actual Revenue: $0.03 million
• Expected Revenue: N/A
• Beat/Miss: N/A
• YoY Revenue Growth: N/A

Cyclacel Pharmaceuticals Announcement Details

• Quarter: Q1 2024
• Date: 5/14/2024
• Time: After Market Closes
• Conference Call Date: Tuesday, May 14, 2024
• Conference Call Time: 4:30PM ET

Cyclacel Pharmaceuticals (NASDAQ:CYCC) is a clinical-stage biopharmaceutical company focused on the discovery and development of novel cancer therapies that target key mechanisms of cell division. Founded in 1996, the company has built a pipeline of experimental small-molecule inhibitors designed to disrupt the activity of cyclin-dependent kinases (CDKs) and other cell cycle regulators. These targeted agents are intended to selectively halt the proliferation of tumor cells while minimizing effects on healthy tissue.

The company’s most advanced programs include fadraciclib (formerly CYC065), an oral CDK2/9 inhibitor in Phase 1/2 studies for advanced solid tumors and hematologic malignancies, and CYC140, a novel allosteric inhibitor of aurora kinases under early clinical evaluation. Cyclacel’s research and development efforts leverage in-house discovery platforms as well as strategic collaborations with academic institutions and contract research organizations. This collaborative model supports rapid translation of laboratory findings into clinical candidates.

Cyclacel is headquartered in Berkeley Heights, New Jersey, with additional research operations in Dundee, Scotland, reflecting its UK-US footprint. Over the years, the company has advanced multiple compounds into human trials, demonstrating its ability to move promising molecules through preclinical stages. Under its experienced management team, Cyclacel continues to explore combination regimens and biomarker-driven approaches to enhance the therapeutic potential of its pipeline agents for patients with hard-to-treat cancers.

Cyclacel Pharmaceuticals Q1 2024 Earnings Call Transcript

Key Takeaways

• Cyclacel raised $8 million in a private placement, resulting in $9.9 million pro forma cash, expected to fund operations into Q4 2024.
• The company initiated dosing of first patients in the Phase 2 proof-of-concept part of the 65-101 study of oral fadraciclib (FADRA) in cohorts with CDKN2A/CDKN2B abnormalities and T-cell lymphoma, with initial activity data due in H2 2024.
• In the completed Phase 1 dose escalation, FADRA achieved a recommended Phase 2 dose of 100 mg BID orally for five days per week in four-week cycles, with no dose-limiting toxicities observed.
• Retrospective Phase 1 analyses showed clinical benefit in all eight patients with CDKN2A/B alterations, including 22% tumor shrinkage in refractory squamous NSCLC and a complete response in an endometrial cancer patient.
• Q1 2024 R&D expenses decreased to $2.8 million (from $5.7 million in Q1 2023), and net loss narrowed to $2.9 million (from $5.8 million), aided by UK R&D tax credits.

Presentation

[Operator]

Good afternoon and welcome to the Cyclacel Pharmaceuticals' first quarter 2024 results conference call and webcast. At this time, all participants are in a listen-only mode. After today's call, members of the financial community will have an opportunity to ask questions. If you would like to ask a question at that time, please press Star one on your telephone keypad. If at any point your question has been answered, you may remove yourself from the queue by pressing Star two. In posing your question, we ask that you please pick up your handset to allow optimal sound quality. Lastly, if at any time during the call you should require operator assistance, please press Star zero. Please note today's call is being recorded. I will now turn the conference call over to the company. Please go ahead.

[Grace Kim, Head of Investor Relations at Cyclacel Pharmaceuticals]

Good afternoon, everyone, and thank you for joining today's conference call to discuss Cyclacel's financial results and business highlights for the first quarter ending March 31st, 2024. 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.

[Grace Kim, Head of Investor Relations at Cyclacel Pharmaceuticals]

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. Brian Schwartz, Chief Medical Officer. Spiro will begin with an overview of our business strategy and progress. Brian will provide details on Cyclacel's clinical programs, and then Paul will provide financial highlights for the first quarter of 2024, which will be followed by a Q&A session. At this time, I would like to turn the call over to Spiro.

[Spiro Rombotis, President and CEO at Cyclacel Pharmaceuticals]

Thank you, Grace, and thank you, everyone, for joining us today for our first quarter 2024 business update. As previously reported, we have closed the financing for $8 million in gross proceeds in a private placement priced at the market per Nasdaq rules. With additional resources in place, we have begun dosing patients in the phase II proof-of-concept part of our 065-101 study evaluating fadraciclib, or Fadra for short, in patients with one or more chromosomal abnormalities, including CDKN2A and/or CDKN2B deep deletions or loss of function. You will recall that we are pursuing a potential precision medicine approach for Fadra oral CDK2/9 inhibitor, following findings in our clinical and preclinical data which suggest the hypothesis that patients with one or more of these chromosomal abnormalities may be sensitive to Fadra.

[Spiro Rombotis, President and CEO at Cyclacel Pharmaceuticals]

In the phase II part, we are evaluating patients selected for their mutational profile and/or phase I activity in various solid tumors and lymphoma. We're initially enrolling two patient cohorts, those with CDKN2A and/or CDKN2B abnormalities and also T-cell lymphoma, based on observation of anticancer activity, including responses, in multiple phase I patients. We believe that there is great unmet medical need and industry interest in the cancer patient populations identified by these abnormalities, which are closely located on chromosome nine and are often co-deleted. CDKN2A gene deletions occur in several solid tumors, including bladder, breast, endometrial, esophageal, glioma, head and neck, hepatobiliary, lung, including squamous, melanoma, ovarian, pancreatic, and also in certain T-cell lymphomas. CDKN2B deletions occur in several solid tumors, including bladder, breast, cholangiocarcinoma, endometrial, esophageal, glioma, head and neck, hepatobiliary, lung, including squamous and mesothelioma, melanoma, pancreatic, and others.

[Spiro Rombotis, President and CEO at Cyclacel Pharmaceuticals]

There are no approved drugs to treat patients with CDKN2A or CDKN2B abnormalities. We expect two key data readouts for Fadra this year. Final data for the dose escalation part of the 065-101 study to be presented at the ASCO 2024 annual meeting in a few weeks, and report on initial clinical activity from the phase II proof-of-concept part of the study in the second half of this year. I will now turn the call over to Brian to review our progress and discuss some of our clinical results in the Fadra study. Brian?

[Brian Schwartz, Chief Medical Officer at Cyclacel Pharmaceuticals]

Thank you, Spiro. In our recently completed 065-101 study, we determined the recommended phase II dose for Fadra. As a reminder, this is 100 milligrams b.i.d. dosed orally, five days per week, in a four-week cycle. No dose-limiting toxicities were observed on this schedule. We have now dosed the first patient in the phase II proof-of-concept part of the study, with the initial focus of the cohort in patients with CDKN2A or B alterations. In order to speed up enrollment, we have opened additional sites with up to seven participating in the phase II. We expect to deliver initial results by the second half of 2024. As we progress through the phase II study, let me summarize the rationale for our clinical strategy. We have observed CDKN2A or B alterations, including loss of function in multiple pre-treated phase Ipatients with various cancers.

[Brian Schwartz, Chief Medical Officer at Cyclacel Pharmaceuticals]

These included gynecological, hepatobiliary, lung, pancreatic, and recently testicular, who benefited from fadraciclib monotherapy. These patient groups are associated with a high unmet need and often have poor clinical outcomes. As an illustration, we were excited to see shrinkage of 22% in the sum of all target lesions of the one cycle of oral Fadra monotherapy in a squamous, non-small cell lung cancer patient with CDKN2B deletions refractory to standard-of-care chemo and immunotherapy. A recently enrolled patient with advanced testicular cancer post-surgery achieved a 12% reduction in the sum of all target lesions in the first cycle and continues on therapy now at cycle 3. After retrospectively analyzing a subset of previously treated phase I patients, we found a total of eight patients with CDKN2A or 2B alterations, all of whom experienced clinical benefit after Fadra monotherapy.

[Brian Schwartz, Chief Medical Officer at Cyclacel Pharmaceuticals]

These included an endometrial cancer patient who achieved a CR and over three years of treatment for the previous IV Fadra monotherapy study and was found to have CDKN2A and CDKN2B loss. We are also encouraged by phase I anticancer activity observed in T-cell lymphoma patients, including PRs in two out of three patients treated, one of whom had loss of CDKN2A. Literature suggests that a large percentage of T-cell lymphoma patients have loss of CDKN2A. Although the phase I hypothesis-generating data are limited and cannot be generalized, we believe that the data supports evaluating patients with these cancer types in phase II proof-of-concept part of the study. I will now turn the call over to Paul to review our first quarter results.

[Paul McBarron, EVP, Finance and COO at Cyclacel Pharmaceuticals]

Thank you, Brian. As of March 31st, 2024, pro forma cash and cash equivalents totaled $9.9 million, which includes proceeds from this month's private placement and $0.8 million cash received for the second and final part of the United Kingdom Research and Development Tax Credit claim for 2023. Cash and cash equivalents as of March 31st, 2024 totaled $2.8 million, compared to $3.4 million as of December 31st, 2023. Net cash used in operating activities was $0.5 million for the three months ended March 31st, 2024, which includes $2.9 million received in March in respect to the first part of the 2023 R&D Tax Credit claim, compared to $6.9 million for the same period of 2023. Research and Development, or R&D, expenses were $2.8 million for the three months ended March 31st, 2024, as compared to $5.7 million for the same period in 2023.

[Paul McBarron, EVP, Finance and COO at Cyclacel Pharmaceuticals]

R&D expenses relating to Fadra were $1.8 million for the three months ended March 31st, 2024, as compared to $4.1 million for the same period in 2023 due to a decrease in clinical trial and other non-clinical expenditures. R&D expenses related to Plogo were $1 million for the three months ended March 31st, 2024, as compared to $1.4 million for the same period in 2023 due to a decrease in manufacturing and other non-clinical expenditures. Expenses related to Plogo will be greatly reduced in 2024 as we have paused the 140-101 study while a new salt formulation becomes available. General and administrative expenses remain relatively flat at approximately $1.6 million for each of the three months ended March 31st, 2024, and 2023. Total other expenses net for the three months ended March 31st, 2024 were $0.1 million, compared to $0.2 million for the same period of the previous year.

[Paul McBarron, EVP, Finance and COO at Cyclacel Pharmaceuticals]

United Kingdom Research and Development Tax Credits for the three months ended March 31st, 2024 were $1.4 million, which includes $0.8 million related to the 2023 claim, which, as I mentioned previously, we have now received payment, compared to $1.3 million for the same period of the previous year and are directly correlated to qualifying Research and Development expenditure. Net loss for the three months ended March 31st, 2024, were $2.9 million, which includes stock-based compensation expense of $0.2 million, compared to $5.8 million, including stock-based compensation expense of $0.4 million for the same period in 2023. As we concentrate our resources on recruiting patients in the specific cohorts in the Fadra phase II study, we anticipate that our expenditures in 2024 will continue to decrease.

[Paul McBarron, EVP, Finance and COO at Cyclacel Pharmaceuticals]

The company estimates that its current cash resources will fund currently planned programs into the fourth quarter of 2024. Operator, we are now ready to take questions.

[Operator]

Yes, sir. At this time, if you would like to ask a question, please press the Star and one on your telephone keypad. You may remove yourself from the queue at any time by pressing Star two. Once again, that is Star one to ask a question. We will pause for a moment to allow questions to queue. Our first question comes from Ahu Demir with Ladenburg Thalmann.

[Ahu Demir, Managing Director and Senior Research Analyst at Ladenburg Thalmann]

Thank you very much for taking my questions. Two from us. First one is, what are we expecting to see at ASCO from the fadraciclib 101 study? Could you provide more color? How many patients are we going to see? Subset analysis and any additional information would be very helpful.

[Spiro Rombotis, President and CEO at Cyclacel Pharmaceuticals]

Thank you for your question, Ahu. I will turn over to Brian to answer the question on the ASCO content.

[Brian Schwartz, Chief Medical Officer at Cyclacel Pharmaceuticals]

Ahu, we're basically planning to present almost the totality of the dose escalation portion of the study. The data cut was a couple of weeks ago, but we should have full data set around the phase I dose escalation portion, including both the safety and efficacy seen so far. There'll also be PK/PD included.

[Ahu Demir, Managing Director and Senior Research Analyst at Ladenburg Thalmann]

Thank you, Brian. Nice to chat with you again. Another question I have is on the proof-of-concept phase II portion of the same study. We are expecting to see data later this year. Curious, what is the timeline? What are you going to present? And currently, how many sites are open, and what are your thoughts on the enrollment? How fast that might move forward?

[Spiro Rombotis, President and CEO at Cyclacel Pharmaceuticals]

Brian?

[Brian Schwartz, Chief Medical Officer at Cyclacel Pharmaceuticals]

We've just opened the T-cell lymphoma site. They're starting to open slightly different from the phase I solid tumor sites. The solid tumor sites, we had already 4 sites enrolling, so it's just opening an additional 3. In terms of timing, these known mutations are sometimes difficult to determine the frequency, but we quite encourage at the moment of patients being identified. We anticipate most probably by the end of the year, we've enrolled both cohorts.

[Spiro Rombotis, President and CEO at Cyclacel Pharmaceuticals]

And we also add to Brian's color, Ahu, that these mutations are readily available as part of standard panels. We do not need a companion diagnostic to identify the patients, although the company is collecting data for future regulatory discussions. But the important point is that they are amply available, and there is no approved drug to treat these patients once they're identified with the abnormality.

[Ahu Demir, Managing Director and Senior Research Analyst at Ladenburg Thalmann]

Very helpful. Thank you, Spiro. Thanks, Brian.

[Spiro Rombotis, President and CEO at Cyclacel Pharmaceuticals]

Thank you, Ahu.

[Operator]

We have no further questions in the queue at this time. I'd now like to turn the call back over to today's speakers for any additional or closing remarks.

[Spiro Rombotis, President and CEO at Cyclacel Pharmaceuticals]

Thank you, Operator. Thanks to all of you for joining Cyclacel's first quarter 2024 earnings call. Fadraciclib has achieved a key milestone with the first patient dosed in the phase II proof-of-concept stage, with important catalysts anticipated in 2024 and a strong competitive profile in its therapeutic class. As a reminder, our upcoming key milestones are: report data from the dose escalation stage of the 065-101 study of oral Fadra in patients with advanced solid tumors and lymphoma at the ASCO 2024 annual meeting. Report interim data from initial cohorts in phase II open-label proof-of-concept part of 065-101 study with oral fadraciclib in patients with advanced solid tumors and lymphoma. We look forward to providing you with further updates and hope to meet some of you at upcoming conferences. Operator, at this time, you may end the call.

[Operator]

Thank you, sir. This does conclude today's program. Thank you for your participation. You may disconnect at any time.

Participants

Executives

• Brian Schwartz, Chief Medical Officer
• Grace Kim, Head of Investor Relations
• Paul McBarron, EVP, Finance and COO
• Spiro Rombotis, President and CEO

Analysts

• Ahu Demir, Managing Director and Senior Research Analyst at Ladenburg Thalmann