Investors
News Release
Cyclacel Pharmaceuticals Reports First Quarter 2019 Financial Results
May 14 2019
“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
Key Company Highlights
- Data was presented at the 2019 AACR Annual Meeting from the Company's DNA damage response program with an oral, sequential regimen of sapacitabine and seliciclib from an expansion cohort in patients with BRCA mutant metastatic breast cancer. The data demonstrated that the regimen was safe and led to a clinical benefit rate of 30%. All eight PARP inhibitor naïve patients, half of the patients previously treated with platinum agents and one on previous PARP inhibitor responded. Progression on previous platinum or PARP inhibitors was associated with lack of benefit. Both sapacitabine and PARP inhibitors are more effective in cancer cells with BRCA mutations or other homologous recombination repair deficiencies.
- Based on data from the above study, the investigators are enrolling a Phase 1b/2 study with an oral, concomitant regimen of sapacitabine and olaparib in patients with BRCA mutant breast cancer. According to the investigators three patients have been dosed. The first two achieved tumor shrinkage and continue on treatment and the third has completed first cycle without dose-limiting toxicity. Dual targeting of the DNA damage response pathway with sapacitabine and olaparib may improve the current standard of care for such patients.
- Two patients have been treated in the Phase 1, dose escalation clinical trial evaluating CYC065 in combination with venetoclax, a Bcl-2 inhibitor, in patients with relapsed/refractory CLL. Preclinical data presented at the 2018 AACR showed synergistic activity of CYC065 and venetoclax combination in CLL tumor samples, including those with 17p deletions. The combination was also active in CLL samples resistant to either agent alone, suggesting that dual targeting of Mcl-1 and Bcl-2 dependent mechanisms could overcome intrinsic resistance to each individual compound.
- Two patients have been dosed in the recently opened Phase 1, first-in-human, dose escalation study evaluating CYC140 monotherapy in patients with advanced leukemias. CYC140 is a small molecule, selective polo-like-kinase 1 (PLK1) inhibitor that has demonstrated potent and selective target inhibition and high activity in xenograft models of human cancers.
- The Company raised net proceeds of approximately
$4.1 million from its Common Stock Sales Agreement withH.C. Wainwright .
Key Upcoming Business Objectives
- Initiate CYC065-venetoclax Phase 1 study in patients with relapsed or refractory AML or MDS;
- Initiate sapacitabine-venetoclax Phase 1 study in patients with relapsed or refractory AML or MDS;
- Report initial data from the CYC065-venetoclax Phase 1 study in relapsed/refractory leukemias;
- 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 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 and tax credit was
Net loss for the three months ended
Conference call information:
US/
US/
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
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 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.
