Investors
News Release
Cyclacel Pharmaceuticals Reports Second Quarter 2019 Financial Results
Aug 13 2019
- Conference Call Scheduled
“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
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.
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
Research and development expenses were
General and administrative expenses were
Other income, net for the three months ended
The United Kingdom R&D tax credit was
Net loss for the three months ended
Conference call information:
US/
US/
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.
About
Forward-looking Statements
This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, the efficacy, safety and intended utilization of Cyclacel's product candidates, the conduct and results of future clinical trials, plans regarding regulatory filings, future research and clinical trials and plans regarding partnering activities. Factors that may cause actual results to differ materially include the risk that product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials, trials may have difficulty enrolling, Cyclacel may not obtain approval to market its product candidates, the risks associated with reliance on outside financing to meet capital requirements, and the risks associated with reliance on collaborative partners for further clinical trials, development and commercialization of product candidates. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal," or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties the Company faces, please refer to our most recent Annual Report on Form 10-K and other periodic and other filings we file with the
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© Copyright 2019 Cyclacel Pharmaceuticals, Inc. All Rights Reserved. The Cyclacel logo and Cyclacel® are trademarks of Cyclacel Pharmaceuticals, Inc.
CYCLACEL PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(In $000s, except share and per share amounts)
(Unaudited)
| Three Months Ended | ||||||||||||||
| June 30, | ||||||||||||||
| 2018 | 2019 | |||||||||||||
| Revenues: | ||||||||||||||
| Total revenues | - | - | ||||||||||||
| Operating expenses: | ||||||||||||||
| Research and development | 1,182 | 1,153 | ||||||||||||
| General and administrative | 1,283 | 1,184 | ||||||||||||
| Total operating expenses | 2,465 | 2,337 | ||||||||||||
| Operating loss | (2,465 | ) | (2,337 | ) | ||||||||||
| Other income (expense): | ||||||||||||||
| Foreign exchange gains (losses) | (39 | ) | 21 | |||||||||||
| Interest income | 84 | 56 | ||||||||||||
| Other income, net | 66 | 170 | ||||||||||||
| Total other income (expense), net | 111 | 247 | ||||||||||||
| Loss before taxes | (2,354 | ) | (2,090 | ) | ||||||||||
| Income tax benefit | 502 | 307 | ||||||||||||
| Net loss | (1,852 | ) | (1,783 | ) | ||||||||||
| Dividend on convertible exchangeable preferred shares | (50 | ) | (50 | ) | ||||||||||
| Net loss applicable to common shareholders | $ | (1,902 | ) | $ | (1,833 | ) | ||||||||
| Basic and diluted earnings per common share: | ||||||||||||||
| Net loss per share – basic and diluted | $ | (0.16 | ) | $ | (0.11 | ) | ||||||||
| Weighted average common shares outstanding | 11,997,447 | 17,199,974 | ||||||||||||
CYCLACEL PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEET
(In $000s, except share, per share, and liquidation preference amounts)
(Unaudited)
| December 31, | June 30, | ||||
| 2018 | 2019 | ||||
| ASSETS | |||||
| Current assets: | |||||
| Cash and cash equivalents | $ | 17,504 | $ | 15,159 | |
| Prepaid expenses and other current assets | 2,283 | 2,991 | |||
| Total current assets | 19,787 | 18,150 | |||
| Property and equipment, net | 36 | 29 | |||
| Right-of-use lease asset | - | 1,285 | |||
| Total assets | $ | 19,823 | $ | 19,464 | |
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||
| Current liabilities: | |||||
| Accounts payable | $ | 2,719 | $ | 1,106 | |
| Accrued and other current liabilities | 1,732 | 1,394 | |||
| Total current liabilities | 4,451 | 2,500 | |||
| Lease liability | - | 1,233 | |||
| Other liabilities | 100 | - | |||
| Total liabilities | 4,551 | 3,733 | |||
| Stockholders’ equity | 15,272 | 15,731 | |||
| Total liabilities and stockholders’ equity | $ | 19,823 | $ | 19,464 | |
SOURCE: Cyclacel Pharmaceuticals, Inc.
