Cyclacel(US:CYCC)2019-05-14 23:21Financial Data and Key Metrics Changes - Cash and cash equivalents totaled $17.9 million as of March 31, 2019, compared to $17.4 million as of December 31, 2018, reflecting an increase of $0.4 million primarily due to net proceeds from a Common Stock Sales Agreement [28] - Net loss for the three months ended March 31, 2019, was $1.8 million compared to $1.3 million for the same period in 2018 [31] - Research and development expenses were $1 million for the first quarter of 2019, up from $0.8 million for the same period in 2018 [29] Business Line Data and Key Metrics Changes - The company is evaluating three clinical stage drugs, with CYC065 being a CDK 2/9 inhibitor involved in six clinical studies [7][8] - CYC065-02, a Phase 1 combination study with venetoclax in relapsed/refractory CLL, has treated two patients without dose-limiting toxicity [17] - CYC140-01, a first-in-human Phase 1 study of CYC140, has dosed two patients with no observed dose-limiting toxicities [19] Market Data and Key Metrics Changes - The company is focusing on addressing cancer resistance, particularly through the suppression of pro-survival proteins like Mcl-1 and Bcl-2, which are critical in cancer treatment resistance [9][11] - The competitive landscape includes a race to market drugs that inhibit Mcl-1 function, with Cyclacel positioned as a leader in this area [13][14] Company Strategy and Development Direction - The company aims to enhance the efficacy of standard care drugs by targeting inherited mutations in DNA damage pathways, particularly in BRCA mutant cancers [14][15] - Key milestones include initiating studies for CYC065 and venetoclax in AML and MDS, and reporting initial data from ongoing clinical studies [26][27] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence that cash and marketable securities will be sufficient to finance operations through the end of 2020, supported by projected cash-sparing benefits from the MD Anderson alliance [31] - The company expects to enroll the first patient in the CYC065 and venetoclax study by summer 2019, pending IRB approval [34] Other Important Information - The company has made progress in developing oral formulations of CYC065, with capsules now available for clinical trials [23] - The ongoing combination study of sapacitabine and olaparib has shown promising results, with initial patients achieving tumor shrinkage [25] Q&A Session Summary Question: Timeline for initiating CYC065 with venetoclax in AML and sapacitabine with venetoclax in ML - Management expects IRB approval within four weeks, aiming to enroll the first patient by summer 2019 [33][34] Question: Clarification on the amendment for the Part 3 of the CYC065 oral formulation monotherapy - The amendment was to add evaluation of oral capsules, which was not included in the previous protocol [36][37]