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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Cyclacel Pharmaceuticals Inc | NASDAQ:CYCC | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-0.11 | -6.87% | 1.49 | 1.49 | 1.51 | 1.56 | 1.46 | 1.55 | 181,642 | 00:07:34 |
“We continue to execute on our strategy to develop innovative therapies to overcome cancer resistance mechanisms through combinations of our candidates with approved drugs,” said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. “Two Phase 1, dose escalation studies evaluating CYC065 in combination with venetoclax in patients with relapsed/refractory CLL and CYC140 as single agent in a first-in-human trial are open for accrual and patients have been dosed on both studies. Two additional studies evaluating combinations of CYC065 and sapacitabine with venetoclax are under review by institutional review boards. The Phase 1 study of single agent CYC065 has been amended to evaluate an oral form of CYC065. We are pleased to report that the first two patients with BRCA mutant breast cancer treated in the IST evaluating sapacitabine and olaparib have achieved tumor shrinkage. During the quarter, we also extended our projected cash runway to the end of 2020 through our ATM equity sales agreement.”
Key Company Highlights
Key Upcoming Business Objectives
Financial Highlights
As of March 31, 2019, cash and cash equivalents totaled $17.9 million compared to $17.5 million as of December 31, 2018. The increase of $0.4 million in the three months was primarily due to net proceeds from a Common Stock Sales Agreement with H.C. Wainwright of $4.1m, offset by net cash used in operating activities of $3.7 million. The Sales Agreement was concluded in the first quarter 2019.
Research and development expenses were $1.0 million for the three months ended March 31, 2019 compared to $0.8 million for the same period in 2018.
General and administrative expenses were $1.2 million for the three months ended March 31, 2019 compared to $1.4 million for the same period in 2018.
Other income, net for the three months ended March 31, 2019 was $0.1 million compared to $0.6 million for the same period of the previous year.
The United Kingdom R&D and tax credit was $0.3 million for the three months ended March 31, 2019 compared to $0.2 million for the same period in 2018.
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. With the projected cash-sparing benefits accruing from the MD Anderson alliance the Company believes that cash and marketable securities, which were approximately $17.9 million as of March 31, 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 9383419
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 Cyclacel Pharmaceuticals, Inc.
Cyclacel Pharmaceuticals is a clinical-stage biopharmaceutical company using its expertise in cell cycle, transcriptional regulation and DNA damage response biology in cancer cells to develop innovative medicines. The transcriptional regulation program is evaluating CYC065, a CDK inhibitor, in patients with advanced solid cancers and in combination with venetoclax in patients with advanced hematological malignancies, including CLL and AML. The DNA damage response program is evaluating a sequential regimen of sapacitabine and seliciclib, a CDK inhibitor, in BRCA positive patients with advanced solid cancers and a concomitant regimen of sapacitabine and olaparib, a PARP inhibitor, in BRCA positive patients with breast cancer. CYC140, a PLK inhibitor, is in a Phase 1 first-in-human study in patients with advanced leukemias. Cyclacel's strategy is to build a diversified biopharmaceutical business focused in hematology and oncology based on a pipeline of novel drug candidates. For additional information, please visit www.cyclacel.com.
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 Securities and Exchange Commission and are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and we assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
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 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 | ||||||||||
March 31, | ||||||||||
2018 | 2019 | |||||||||
Revenues: | ||||||||||
Total revenues | - | - | ||||||||
Operating expenses: | ||||||||||
Research and development | 798 | 1,012 | ||||||||
General and administrative | 1,364 | 1,192 | ||||||||
Total operating expenses | 2,162 | 2,204 | ||||||||
Operating loss | (2,162 | ) | (2,204 | ) | ||||||
Other income (expense): | ||||||||||
Foreign exchange gains (losses) | (4 | ) | 15 | |||||||
Interest income | 69 | 79 | ||||||||
Other income, net | 566 | - | ||||||||
Total other income (expense), net | 631 | 94 | ||||||||
Loss from continuing operations before taxes | (1,531 | ) | (2,110 | ) | ||||||
Income tax benefit | 182 | 268 | ||||||||
Net loss from continuing operations | (1,349 | ) | (1,842 | ) | ||||||
Net loss | (1,349 | ) | (1,842 | ) | ||||||
Dividend on convertible exchangeable preferred shares | (50 | ) | (50 | ) | ||||||
Net loss applicable to common shareholders | $ | (1,399 | ) | $ | (1,892 | ) | ||||
Basic and diluted earnings per common share: | ||||||||||
Net loss per share – basic and diluted | $ | (0.12 | ) | $ | (0.14 | ) | ||||
Weighted average common shares outstanding | 11,997,447 | 13,638,271 | ||||||||
CYCLACEL PHARMACEUTICALS, INC. | ||||||||
CONSOLIDATED BALANCE SHEET | ||||||||
(In $000s, except share, per share, and liquidation preference amounts) | ||||||||
(Unaudited) | ||||||||
December 31, | March 31, | |||||||
2018 | 2019 | |||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 17,504 | $ | 17,934 | ||||
Prepaid expenses and other current assets | 2,283 | 2,190 | ||||||
Total current assets | 19,787 | 20,124 | ||||||
Property and equipment, net | 36 | 33 | ||||||
Right-of-use lease asset | - | 1,353 | ||||||
Total assets | $ | 19,823 | $ | 21,510 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 2,719 | $ | 1,284 | ||||
Accrued and other current liabilities | 1,732 | 1,203 | ||||||
Total current liabilities | 4,451 | 2,487 | ||||||
Lease liability | - | 1,468 | ||||||
Other liabilities | 100 | - | ||||||
Total liabilities | 4,551 | 3,955 | ||||||
Stockholders’ equity | 15,272 | 17,555 | ||||||
Total liabilities and stockholders’ equity | $ | 19,823 | $ | 21,510 | ||||
SOURCE: Cyclacel Pharmaceuticals, Inc.
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