Cyclacel(US:CYCC)2022-11-10 01:06Financial 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]