On August 13, 2019 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported financial results and business highlights for the second quarter 2019 (Press release, Cyclacel, AUG 13, 2019, View Source [SID1234538641]). The Company’s net loss applicable to common shareholders for the three months ended June 30, 2019 was $1.8 million. As of June 30, 2019 cash and cash equivalents totaled $15.2 million.
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"We are excited to report new evidence of anticancer activity for CYC065. In part 2 of our Phase 1 study of CYC065 as a single agent, a patient with endometrial cancer with MCL1 amplification treated on the fourth dose level achieved tumor shrinkage. This patient was previously treated with liposomal doxorubicin, carboplatin, and multiple investigational therapies," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "Following our recent announcement of the first patient dosed in a Phase 1/2 study with an oral combination of sapacitabine and venetoclax in relapsed or refractory AML or MDS, we are now dosing patients in five clinical studies in pursuit of our strategy of overcoming cancer resistance mechanisms through combinations of our candidates with approved drugs. The first two patients in the relapsed or refractory CLL study evaluating the combination of CYC065 and venetoclax remain on treatment for 4 and 6 cycles respectively. A total of 4 patients with BRCA mutant breast cancer have been treated in the Phase 1/2 investigator sponsored trial (IST) evaluating sapacitabine and olaparib and one patient has achieved partial response (PR). With projected cash to the end of 2020 we look forward to delivering on multiple data outcomes from our ongoing studies."
Key Company Highlights
·Reported first evidence of anticancer activity in part 2 of the Phase 1 study (065-01) as a single agent testing a frequent dosing schedule of four, one-hour infusions every three weeks in which a patient with endometrial cancer with MCL1 amplification treated on the fourth dose level of 213mg achieved tumor shrinkage;
·Reported that patients with relapsed/refractory CLL treated in the 065-02 study with CYC065 plus venetoclax are continuing treatment after ibrutinib front-line failure;
Announced treatment of the first patient in a Phase 1 study (065-03) evaluating the safety and effectiveness of CYC065, a CDK2/9 inhibitor shown to durably suppress MCL1, in combination with venetoclax, a BCL2 inhibitor, in patients with relapsed or refractory AML or MDS. Preclinical data confirmed synergy of CYC065 and venetoclax, suggesting that the suppression of both BCL2 and MCL1 may be more beneficial than inhibiting either one alone;
·Announced treatment of the first patient in part 2 of a Phase 1/2 study (682-11) evaluating the safety and effectiveness of an oral regimen of sapacitabine in combination with venetoclax in patients with relapsed or refractory AML or MDS. Sapacitabine is a nucleoside analogue that is active in AML and MDS relapsed or refractory to prior therapy such as cytarabine or hypomethylating agents. Combining sapacitabine with venetoclax may offer an effective, oral treatment regimen for patients who have failed front-line therapy;
·Following an amendment of the Phase 1 study (065-01) of single agent CYC065 in patients with advanced cancers part 3 of the study will evaluate an oral form of CYC065.
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¨ 1 James Lindsay Place, Dundee, DD1 5JJ, UK Tel +44 1382 206 062 Fax +44 1382 206 067
www.cyclacel.com – [email protected]
Key Upcoming Business Objectives
·Report initial data from the CYC065-venetoclax Phase 1 studies in relapsed/refractory leukemias;
·Report initial data from the sapacitabine-venetoclax Phase 1 study in patients with relapsed or refractory AML or MDS;
·Report initial data from the CYC140 Phase 1 First-in-Human study;
·Report initial data and bioavailability from the Phase 1 study of an oral formulation of CYC065;
·Report updated CYC065 Phase 1 data with frequent dosing schedule in patients with advanced solid cancers;
·Report data from the IST Phase 1b/2 trial of sapacitabine-olaparib combination in patients with BRCA mutant metastatic breast cancer when reported by the investigators;
·Determine regulatory pathway and submissibility of sapacitabine in elderly AML patients.
Financial Highlights
As of June 30, 2019, cash and cash equivalents totaled $15.2 million compared to $17.5 million as of December 31, 2018. The decrease of $2.3 million was primarily due to net cash used in operating activities of $6.3 million, offset by net proceeds from a Common Stock Sales Agreement with H.C. Wainwright of $4.1m.
Research and development expenses were $1.2 million for the three months ended June 30, 2019 compared to $1.2 million for the same period in 2018.
General and administrative expenses were $1.2 million for the three months ended June 30, 2019 compared to $1.3 million for the same period in 2018.
Other income, net for the three months ended June 30, 2019 was $0.2 million compared to $0.1 million for the same period of the previous year.
The United Kingdom R&D tax credit was $0.3 million for the three months ended June 30, 2019 compared to $0.5 million for the same period in 2018.
Net loss for the three months ended June 30, 2019 was $1.8 million compared to $1.9 million for the same period in 2018. With the projected cash-sparing benefits accruing from the MD Anderson alliance the Company believes that cash and marketable securities, which were approximately $15.2 million as of June 30, 2019, will be sufficient to finance operations through the end of 2020.
Conference call information:
US/Canada call: (877) 493-9121 / international call: (973) 582-2750
US/Canada archive: (800) 585-8367 / international archive: (404) 537-3406
Code for live and archived conference call is 7654539
For the live and archived webcast, please visit the Corporate Presentations page on the Cyclacel website at www.cyclacel.com. The webcast will be archived for 90 days and the audio replay for 7 days.