Investors
News Release
Cyclacel Pharmaceuticals Reports Third Quarter 2018 Financial Results
Nov 12 2018
Conference Call Scheduled
“We continue to execute on our strategy to rapidly develop CYC065 and CYC140 in hematological malignancies and CYC065 in advanced solid tumors,” said
Key Company Highlights
- Announced a three-year strategic alliance agreement with
The University of Texas MD Anderson Cancer Center enabling clinical evaluation of three Cyclacel medicines in patients with hematological malignancies. MD Anderson will conduct four clinical studies, with a total projected enrollment of up to 170 patients, investigating CYC065, CYC140 and sapacitabine either as single agents or in combination with approved drugs. - Opened for enrollment the Phase 1 clinical trial evaluating CYC065 in combination with venetoclax, a Bcl-2 inhibitor, in patients with relapsed/refractory CLL. Preclinical data presented at AACR 2018 showed enhanced activity of CYC065 and venetoclax combination in CLL tumor samples, including those with 17p deletions. The combination also demonstrated activity in two CLL samples resistant to either agent alone, suggesting that dual targeting of Mcl-1 and Bcl-2 dependent mechanisms could induce synergistic cell death.
- First patient dosed in the Phase 1b/2 investigator-sponsored trial (IST) of sapacitabine with olaparib, an approved PARP inhibitor, in BRCA positive patients with breast cancer. Preclinical data support the hypothesis that dual targeting of the DNA damage response pathway by combining olaparib with sapacitabine may enhance the efficacy of standard of care treatment for BRCA positive patients with breast cancer.
- Activated the CYC140 first-in-human study in advanced leukemias. CYC140 is a novel, small molecule, selective polo-like-kinase 1 (PLK1) inhibitor. CYC140 is differentiated from other PLK1 inhibitors, demonstrating potent and selective target inhibition and high activity in xenograft models of human cancers when dosed orally at non-toxic doses.
- Progressed patient enrollment in part 2 of the Phase 1 study evaluating CYC065 monotherapy in patients with advanced solid tumors including those with Mcl-1, MYC or cyclin E amplified cancers relevant to CYC065’s mechanism of action. Part 2 is evaluating increased dosing frequency of two days per week for two weeks of a three-week cycle.
- Completed meetings with three European regulatory authorities with the objective of determining a potential regulatory pathway for sapacitabine in elderly AML. The regulators provided consistent guidance on next steps and Cyclacel is evaluating a potential request for a meeting with the
Scientific Advice Working Party of theEuropean Medicines Agency . - Appointed
Robert J. Spiegel , M.D. to the Board of Directors. Dr. Spiegel brings over 30 years of R&D and operational experience in the biopharmaceutical industry as well as advisory experience to venture capital and private equity funds. - Entered into a Common Stock Sales Agreement with
H.C. Wainwright & Co., LLC as sales agent, pursuant to which the agent may sell shares of common stock having an aggregate offering price of up to$5.0 million by any method that is deemed to be an “at the market offering” as defined in Rule 415 under the Securities Act of 1933 as amended.
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 and tax credits were
Net loss for the three months ended
Conference call information:
US/
US/
Code for live and archived conference call is 3775807
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
| Contacts | ||
| Company: | Paul McBarron, (908) 517-7330, pmcbarron@cyclacel.com | |
| Investor Relations: | Russo Partners LLC, Alexander Fudukidis, (646) 942-5632, alex.fudukidis@russopartnersllc.com |
© Copyright 2018 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) | |||||||||||||||||||
| Three Months Ended September 30, |
Nine Months Ended September 30, |
||||||||||||||||||
| 2017 | 2018 | 2017 | 2018 | ||||||||||||||||
| Revenues: | |||||||||||||||||||
| Total revenues | $ | — | $ | — | $ | — | $ | — | |||||||||||
| Operating expenses: | |||||||||||||||||||
| Research and development | 958 | 1,205 | 3,491 | 3,185 | |||||||||||||||
| General and administrative | 1,154 | 1,250 | 3,802 | 3,898 | |||||||||||||||
| Total operating expenses | 2,112 | 2,455 | 7,293 | 7,083 | |||||||||||||||
| Operating loss | (2,112 | ) | (2,455 | ) | (7,293 | ) | (7,083 | ) | |||||||||||
| Other income (expense): | |||||||||||||||||||
| Foreign exchange gains (losses) | (22 | ) | 1 | (65 | ) | (42 | ) | ||||||||||||
| Interest income | 30 | 85 | 59 | 238 | |||||||||||||||
| Other income, net | 28 | - | 907 | 632 | |||||||||||||||
| Total other income | 36 | 86 | 901 | 828 | |||||||||||||||
| Loss before taxes | (2,076 | ) | (2,369 | ) | (6,392 | ) | (6,255 | ) | |||||||||||
| Income tax benefit | 219 | 301 | 793 | 985 | |||||||||||||||
| Net loss | (1,857 | ) | (2,068 | ) | (5,599 | ) | (5,270 | ) | |||||||||||
| Dividend on convertible exchangeable preferred shares | (50 | ) | (50 | ) | (151 | ) | (151 | ) | |||||||||||
| Beneficial conversion feature of Series A convertible stock | (3,638 | ) | - | (3,638 | ) | - | |||||||||||||
| Conversion of Series A convertible preferred stock | (3,373 | ) | - | (3,373 | ) | - | |||||||||||||
| Net loss applicable to common shareholders | $ | (8,918 | ) | $ | (2,118 | ) | $ | (12,761 | ) | $ | (5,421 | ) | |||||||
| Basic and diluted earnings per common share: | |||||||||||||||||||
| Net loss per share – basic and diluted | $ | (0.91 | ) | $ | (0.18 | ) | $ | (2.06 | ) | $ | (0.45 | ) | |||||||
| Weighted average common shares outstanding | 9,835,441 | 11,997,447 | 6,200,783 | 11,997,447 | |||||||||||||||
| CYCLACEL PHARMACEUTICALS, INC. | |||||||||||||
| CONSOLIDATED BALANCE SHEET | |||||||||||||
| (In $000s, except share, per share, and liquidation preference amounts) | |||||||||||||
| December 31, |
September 30, |
||||||||||||
| 2017 | 2018 | ||||||||||||
| ASSETS |
|||||||||||||
| Current assets: | |||||||||||||
| Cash and cash equivalents | $ | 23,910 | $ | 18,973 | |||||||||
| Prepaid expenses and other current assets | 2,064 | 1,696 | |||||||||||
| Total current assets | 25,974 | 20,669 | |||||||||||
| Property and equipment, net | 29 | 38 | |||||||||||
| Total assets | $ | 26,003 | $ | 20,707 | |||||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||||||||
| Current liabilities: | |||||||||||||
| Accounts payable | $ | 1,558 | $ | 1,411 | |||||||||
| Accrued and other current liabilities | 2,555 | 2,592 | |||||||||||
| Total current liabilities | 4,113 | 4,003 | |||||||||||
| Other liabilities | 124 | 106 | |||||||||||
| Total liabilities | 4,237 | 4,109 | |||||||||||
| Stockholders’ equity: | |||||||||||||
| Preferred stock, $0.001 par value; 5,000,000 shares authorized at December 31, 2017 and September 30, 2018; |
|||||||||||||
| 6% Convertible Exchangeable preferred stock; 335,273 shares issued and outstanding at | |||||||||||||
| December 31, 2017 and September 30, 2018. Aggregate preference in liquidation of $4,006,512 as | |||||||||||||
| of December 31, 2017 and September 30, 2018. | - | - | |||||||||||
| Series A convertible preferred stock, $0.001 par value; 264 shares issued and outstanding | |||||||||||||
| at December 31, 2017 and September 30, 2018. | - | - | |||||||||||
| Common stock, $0.001 par value; 100,000,000 shares authorized at December 31, 2017 and September 30, 2018; |
|||||||||||||
| 11,997,447 shares issued and outstanding at December 31, 2017 and September 30, 2018. | 12 | 12 | |||||||||||
| Additional paid-in capital | 365,057 | 365,160 | |||||||||||
| Accumulated other comprehensive loss | (794 | ) | (796 | ) | |||||||||
| Accumulated deficit | (342,509 | ) | (347,778 | ) | |||||||||
| Total stockholders’ equity |
21,766 | 16,598 | |||||||||||
| Total liabilities and stockholders’ equity |
$ | 26,003 | $ | 20,707 | |||||||||
SOURCE: Cyclacel Pharmaceuticals, Inc.
