Cyclacel Pharmaceuticals Reports Third Quarter Financial Results and Provides Business Update
Rhea-AI Summary
Cyclacel Pharmaceuticals reported Q3 2024 financial results, highlighting initial safety and efficacy data from twelve patients in Phase 2 study of fadraciclib. Cash equivalents were $3.0 million as of September 30, 2024, down from $3.4 million at end-2023. Net loss decreased to $2.0 million from $6.0 million year-over-year. R&D expenses reduced to $1.0 million from $5.2 million in Q3 2023. The company faces potential Nasdaq delisting unless it meets minimum stockholders' equity requirement by December 24, 2024. Current cash is expected to fund operations into Q4 2024, with substantial doubt about continuing as a going concern.
Positive
- Net loss decreased by 67% to $2.0 million from $6.0 million YoY
- R&D expenses reduced by 81% to $1.0 million from $5.2 million YoY
- Operating cash burn reduced to $6.6 million from $12.2 million for nine months
Negative
- Cash position declined to $3.0 million from $3.4 million at end-2023
- Risk of Nasdaq delisting if minimum stockholders' equity requirement not met by December 24, 2024
- Substantial doubt about company's ability to continue as going concern
- Current cash only sufficient to fund operations into Q4 2024
- Potential bankruptcy risk if additional funding not secured
News Market Reaction 1 Alert
On the day this news was published, CYCC gained 9.76%, reflecting a notable positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
BERKELEY HEIGHTS, N.J., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines, today announced third quarter financial results and provided a business update.
“We were pleased to report initial safety and efficacy data from twelve patients with advanced solid tumors enrolled in the Phase 2 part of the 065-101, proof of concept, clinical study of fadraciclib as a single agent as a poster presentation at the 2024 EORTC-NCI-AACR 36th Symposium on Molecular Targets and Cancer Therapeutics (“Triple Meeting”), in Barcelona, Spain. The patients were enrolled in the biomarker-enriched, Cohort 8 of the study and were preselected for CDKN2A and/or CDKN2B abnormalities,” said Spiro Rombotis, President and Chief Executive Officer. “Nasdaq has granted the Company an extension until December 24, 2024, to regain compliance with Nasdaq’s minimum stockholders’ equity requirement and we continue to pursue opportunities to obtain additional funding for our programs. If we do not secure such additional funding in an amount that allows us to meet or exceed Nasdaq’s minimum stockholders’ equity requirement, our securities will be delisted from Nasdaq.”
Financial Highlights
As of September 30, 2024, cash equivalents totaled
Although the Company has made substantial reductions in its expenses, there remains substantial doubt about our ability to continue as a going concern. We are currently investigating ways to raise additional capital through private equity financing or by entering into a strategic transaction. In the event that we are not able to secure such additional funding, we may be forced to curtail operations, delay or stop ongoing development activities, cease operations altogether, and/or file for bankruptcy. In such events, our stockholders may lose their entire investment in the Company.
Research and development (R&D) expenses were
General and administrative expenses for the three months ended September 30, 2024 were
Total other income, net, for the three months ended September 30, 2024 was
United Kingdom research & development tax credits for the three months ended September 30, 2024 were
Net loss for the three months ended September 30, 2024 was
About Cyclacel Pharmaceuticals, Inc.
Cyclacel is a clinical-stage, biopharmaceutical company developing innovative cancer medicines based on cell cycle, transcriptional regulation and mitosis biology. The transcriptional regulation program is evaluating fadraciclib, a CDK2/9 inhibitor, and the anti-mitotic program plogosertib, a PLK1 inhibitor, in patients with both solid tumors and hematological malignancies. Cyclacel's strategy is to build a diversified biopharmaceutical business based on a pipeline of novel drug candidates addressing oncology and hematology indications. 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, among other things, statements related to the efficacy and safety profile of fadraciclib in an incomplete clinical trial, Cyclacel’s future plans and prospects, Cyclacel’s anticipated cash runway and its ability to secure additional funding and the planned timing of data results and continued development of fadraciclib. Factors that may cause actual results to differ materially include market and other conditions, 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, the risks associated with reliance on collaborative partners for further clinical trials, development and commercialization of product candidates and Cyclacel’s ability to regain and maintain compliance with Nasdaq’s continued listing requirements, although no assurance to that effect can be given. 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 |
© Copyright 2024 Cyclacel Pharmaceuticals, Inc. All Rights Reserved. The Cyclacel logo and Cyclacel® are trademarks of Cyclacel Pharmaceuticals, Inc.
SOURCE: Cyclacel Pharmaceuticals, Inc.
| CYCLACEL PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS (LOSS) (In | |||||||||||
| Three Months Ended | |||||||||||
| September 30, | |||||||||||
| 2024 | 2023 | ||||||||||
| Revenues: | |||||||||||
| Collaboration and research and development revenue | 10 | 16 | |||||||||
| Revenues | $ | 10 | $ | 16 | |||||||
| Operating expenses: | |||||||||||
| Research and development | 950 | 5,236 | |||||||||
| General and administrative | 1,237 | 1,625 | |||||||||
| Total operating expenses | 2,187 | 6,861 | |||||||||
| Operating loss | (2,177 | ) | (6,845 | ) | |||||||
| Other income (expense): | |||||||||||
| Foreign exchange gains (losses) | 2 | 104 | |||||||||
| Interest income | 8 | 50 | |||||||||
| Other income, net | - | (9 | ) | ||||||||
| Total other income (expense), net | 10 | 145 | |||||||||
| Loss before taxes | (2,167 | ) | (6,700 | ) | |||||||
| Income tax benefit | 210 | 668 | |||||||||
| Net loss | (1,957 | ) | (6,032 | ) | |||||||
| Dividend on convertible exchangeable preferred shares | - | (50 | ) | ||||||||
| Net loss applicable to common shareholders | $ | (1,957 | ) | $ | (6,082 | ) | |||||
| Basic and diluted earnings per common share: | |||||||||||
| Net loss per share – basic and diluted (common shareholders) | $ | (0.18 | ) | $ | (0.48 | ) | |||||
| Net loss per share – basic and diluted (redeemable common shareholders) | $ | - | $ | (0.48 | ) | ||||||
| CYCLACEL PHARMACEUTICALS, INC. CONSOLIDATED BALANCE SHEET (In | |||||||||||
| September 30, | December 31, | ||||||||||
| 2024 | 2023 | ||||||||||
| ASSETS | |||||||||||
| Current assets: | |||||||||||
| Cash and cash equivalents | $ | 2,982 | $ | 3,378 | |||||||
| Prepaid expenses and other current assets | 1,931 | 4,066 | |||||||||
| Total current assets | 4,913 | 7,444 | |||||||||
| Property and equipment, net | 4 | 9 | |||||||||
| Right-of-use lease asset | 51 | 93 | |||||||||
| Non-current deposits | 413 | 1,259 | |||||||||
| Total assets | $ | 5,381 | $ | 8,805 | |||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||||||
| Current liabilities: | |||||||||||
| Accounts payable | $ | 4,126 | $ | 3,543 | |||||||
| Accrued and other current liabilities | 2,225 | 4,618 | |||||||||
| Total current liabilities | 6,351 | 8,161 | |||||||||
| Lease liability | - | 37 | |||||||||
| Total liabilities | 6,351 | 8,198 | |||||||||
| Stockholders’ equity | (970 | ) | 607 | ||||||||
| Total liabilities and stockholders’ equity | $ | 5,381 | $ | 8,805 | |||||||
FAQ
What is Cyclacel's (CYCC) cash position as of Q3 2024?
What was CYCC's net loss in Q3 2024?
When might CYCC face Nasdaq delisting?
How long will CYCC's current cash last?
