Yahoo Finance Cyclacel Pharmaceuticals Inc (CYCC) Q1 2024 Earnings Call Transcript Highlights: Navigating ...
Pro Forma Cash and Cash Equivalents: $9.9 million as of March 31, 2024.
Cash and Cash Equivalents: $2.8 million as of March 31, 2024, down from $3.4 million as of December 31, 2023.
Net Cash Used in Operating Activities: $0.5 million for Q1 2024.
Research and Development Expenses: $2.8 million for Q1 2024, down from $5.7 million in Q1 2023.
General and Administrative Expenses: Stable at $1.6 million for Q1 2024.
Total Other Expenses: $0.1 million for Q1 2024, reduced from $0.2 million in Q1 2023.
UK Research Development Tax Credits: $1.4 million for Q1 2024, including $0.8 million related to the 2023 claim.
Net Loss: $2.9 million for Q1 2024, including stock-based compensation expense of $0.2 million.
Release Date: May 14, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
Cyclacel Pharmaceuticals Inc (NASDAQ:CYCC) successfully closed financing for $8 million in gross proceeds, enhancing their financial resources.
The company has initiated the Phase 2 proof of concept part of the 065-101 study, focusing on patients with specific chromosomal abnormalities, potentially addressing unmet medical needs.
No dose-limiting toxicities were observed in the recommended Phase 2 dose for Fadraciclib, indicating a favorable safety profile.
Cyclacel Pharmaceuticals Inc (NASDAQ:CYCC) reported significant clinical benefits in Phase 1 patients with various cancers who received Fadraciclib, including cases of tumor shrinkage and prolonged treatment response.
The company has expanded its trial sites to seven for the Phase 2 study, potentially speeding up patient enrollment and data collection.
Negative Points
Despite the recent financing, Cyclacel Pharmaceuticals Inc (NASDAQ:CYCC)'s cash reserves of $9.9 million, including recent proceeds, might only fund operations into the fourth quarter of 2024, indicating a potential need for further funding.
Research and Development expenses, although lower than the previous year, still constitute a significant portion of the company's expenditures, which could impact financial stability if additional funding is not secured.
The company has paused the 140-101 study due to the need for a new salt formulation, potentially delaying progress in other research areas.
The specific patient population with CDKN2A or CDKN2B abnormalities might be limited, which could restrict the market size for Fadraciclib if approved.
There are no approved drugs for patients with CDKN2A or B abnormalities, which while representing an opportunity, also suggests a higher risk and uncertainty in regulatory approval and market acceptance.
Q & A Highlights
Q: 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. A: (Brian Schwartz, Interim Chief Medical Officer, Director) We plan 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 a full dataset around the Phase 1 dose escalation portion, including both the safety and efficacy seen so far. There will also be PK and PD included.
Q: On the proof of concept Phase 2 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? A: (Brian Schwartz, Interim Chief Medical Officer, Director) We've just opened the T-cell lymphoma slightly starting to open slightly different from the Phase 1 solid tumor sites. The solid tumor sites, we had already four sites enrolling so it's just opening an additional three in terms of timing. These new to these known mutations are sometimes difficult to determine the frequency, but we quite encouraged at the moment of patients being identified. We anticipate most probably by the end of the year, we've enrolled both cohorts.
Q: Could you elaborate on how the mutations related to the study are identified and the availability of a companion diagnostic? A: (Spiro Rombotis, President, Chief Executive Officer, Director) These mutations are readily available as part of standard panels and do not need a companion diagnostic to identify the patients. The company is collecting data for future regulatory discussions, but the important part is that they are amply available and there is no approved drug to treat these patients once they're identified with the abnormality.
Q: Can you provide an update on the financial results for the first quarter of 2024? A: (Paul Mcbarron, Chief Financial Officer, Chief Operating Officer, Executive Vice President - Finance) As of March 31, 2024, pro forma cash and cash equivalents totaled $9.9 million. Net cash used in operating activities was $0.5 million for the three months ended March 31, 2024. Research and Development expenses were $2.8 million for the three months ended March 31, 2024. General and administrative expenses remained relatively flat at approximately $1.6 million for each of the three months ended March 31, 2024 and 2023.
Q: What are the key milestones for Cyclacel Pharmaceuticals in 2024? A: (Spiro Rombotis, President, Chief Executive Officer, Director) Our upcoming key milestones include reporting data from the dose escalation stage of the O65-101 study, overall Fadra in patients with advanced solid tumors and lymphoma at the ASCO 2024 Annual meeting. We will also report interim data from initial cohorts in Phase 2, open-label proof-of-concept part of O65-101 study with oral Fadraciclib in patients with advanced solid tumors and lymphoma.
Q: How has the company's financial position changed compared to the previous year? A: (Paul Mcbarron, Chief Financial Officer, Chief Operating Officer, Executive Vice President - Finance) The company's financial position has shown improvement with a decrease in net loss for the three months ended March 31, 2024, which was $2.9 million compared to $5.8 million for the same period in 2023. This includes stock-based compensation expense of $0.2 million compared to $0.4 million for the same period in 2023.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
This article first appeared on GuruFocus.
