Cyclacel Pharmaceuticals Reports First Quarter Financial Results and Provides Business Update
Cyclacel Pharmaceuticals (NASDAQ: CYCC) reported its first quarter 2024 financial results and provided a business update. Key highlights include enrolling patients in the Phase 2 proof-of-concept (PoC) study of oral fadraciclib, a CDK2/9 inhibitor, with data to be presented at the ASCO Annual Meeting. The company received $8.0 million from a private placement, bolstering its balance sheet. As of March 31, 2024, Cyclacel had $9.9 million in pro forma cash and cash equivalents, including $0.8 million from the UK R&D tax credit. The net loss for Q1 2024 was $2.9 million, a decrease from $5.8 million in Q1 2023. R&D expenses were $2.8 million compared to $5.7 million last year. The company plans to report key data from its ongoing clinical trials later this year.
- Enrolled first patients in Phase 2 PoC study of fadraciclib.
- Presentation of promising Phase 1 data at ASCO 2024.
- Secured $8.0 million from private placement, enhancing cash reserves.
- R&D expenses decreased by 50.9% year-over-year to $2.8 million.
- Net loss reduced by 50% year-over-year to $2.9 million.
- Cash and cash equivalents increased to $9.9 million due to private placement and UK tax credit.
- Cash and cash equivalents as of March 31, 2024, were $2.8 million, down from $3.4 million as of December 31, 2023.
- Net cash used in operating activities was $0.5 million for Q1 2024.
- R&D expenses for fadraciclib and plogosertib decreased, indicating reduced clinical and manufacturing activities.
- Significant reliance on private placement and tax credits for cash inflow.
- Current cash resources only expected to fund operations until Q4 2024.
Insights
Cyclacel Pharmaceuticals reported a notable decrease in R&D expenses for Q1 2024, down to
From a clinical perspective, the enrollment of the first patients in the Phase 2 PoC study for fadraciclib is a promising step forward. Fadraciclib's potential precision medicine application, especially given the lack of approved treatments for patients with CDKN2A/CDKN2B alterations, could position Cyclacel as a key player in the oncology market if the ongoing trials yield positive results. The Phase 1 data showing differentiation from other CDK inhibitors is encouraging, but the real test will come from the Phase 2 results. The upcoming presentation at the ASCO Annual Meeting is a critical milestone that could further validate fadraciclib’s efficacy and safety profile, potentially driving investor interest and stock performance. However, the risk remains high, as the biopharmaceutical landscape is competitive and success is contingent on favorable clinical outcomes.
- New Clinical Data to be Presented at ASCO Annual Meeting Highlighting Potential Precision Medicine Strategy with Oral Fadraciclib -
- First Patients Enrolled in Oral Fadraciclib Phase 2 Proof of Concept Study -
- Balance Sheet Bolstered with
- Management to Host Conference Call at 4:30 pm EDT Today -
BERKELEY HEIGHTS, N.J., May 14, 2024 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, announced today first quarter financial results and provided a business update.
“We are excited to report that we have begun enrolling patients in the Phase 2, proof of concept (PoC) stage of our 065-101 study of fadraciclib, our oral CDK2/9 inhibitor, and are on track to deliver key readouts this year,” said Spiro Rombotis, President and Chief Executive Officer. “Receipt of
“Having determined the recommended Phase 2 dose for fadraciclib we are now enrolling patients in the Phase 2 PoC stage of 065-101” said Brian Schwartz, M.D., interim Chief Medical Officer. “We are initially concentrating on the biomarker cohort which is enrolling patients prospectively selected for CDKN2A/CDKN2B alterations to be followed by patients with T-cell lymphoma. There are no approved medicines for patients with CDKN2A/CDKN2B alterations. Including currently opened trial sites, we expect a total of up to seven sites will participate with the majority in the United States. We are encouraged about fadra’s prospects and look forward to presenting emerging data from the 065-101 study later in the year.“
Key Upcoming Milestones for 2024
- Report final data from dose escalation stage and RP2D determination from the 065-101 study of oral fadraciclib in patients with advanced solid tumors and lymphoma at the ASCO 2024 Annual Meeting
- Report interim data from initial cohorts in Phase 2 proof-of-concept stage of 065-101 study with oral fadraciclib in patients with advanced solid tumors and lymphoma
Financial Highlights
As of March 31, 2024, pro forma cash and cash equivalents totalled
Net cash used in operating activities was
Research and development (R&D) expenses were
General and administrative expenses remained relatively flat at approximately
Total other expenses, net, for the three months and year ended March 31, 2024, were
United Kingdom research & development tax credits for the three months March 31, 2024, were
Net loss for the three months March 31, 2024, was
Conference call information:
Call: (888) 632-3384 / international call: (785) 424-1794
Archive: (800) 938-1584 / international archive: (402) 220-1542
Code for live and archived conference call is CYCCQ124. Webcast link
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 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 CYC140, 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 intended use of proceeds from the private placement, 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 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. 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: | Grace Kim, IR@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 | ||||||||
| March 31, | ||||||||
| 2024 | 2023 | |||||||
| Revenues | $ | 29 | $ | - | ||||
| Operating expenses: | ||||||||
| Research and development | 2,802 | 5,674 | ||||||
| General and administrative | 1,582 | 1,645 | ||||||
| Total operating expenses | 4,384 | 7,319 | ||||||
| Operating loss | (4,355 | ) | (7,319 | ) | ||||
| Other income (expense): | ||||||||
| Foreign exchange gains (losses) | 1 | (87 | ) | |||||
| Interest income | 2 | 116 | ||||||
| Other income, net | 52 | 166 | ||||||
| Total other income (expense), net | 55 | 195 | ||||||
| Loss before taxes | (4,300 | ) | (7,124 | ) | ||||
| Income tax benefit | 1,354 | 1,320 | ||||||
| Net loss | (2,946 | ) | (5,804 | ) | ||||
| Dividend on convertible exchangeable preferred shares | - | (50 | ) | |||||
| Net loss applicable to common shareholders | $ | (2,946 | ) | $ | (5,854 | ) | ||
| Basic and diluted earnings per common share: | ||||||||
| Net loss per share – basic and diluted (common shareholders) | $ | (2.27 | ) | $ | (7.00 | ) | ||
| Net loss per share – basic and diluted (redeemable common shareholders) | $ | - | $ | (7.00 | ) | |||
| Weighted average common shares outstanding | 1,296,547 | 835,946 | ||||||
| CYCLACEL PHARMACEUTICALS, INC. CONSOLIDATED BALANCE SHEET (In | ||||||||
| March 31, | December 31, | |||||||
| 2024 | 2023 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 2,798 | $ | 3,378 | ||||
| Prepaid expenses and other current assets | 2,037 | 4,066 | ||||||
| Total current assets | 4,835 | 7,444 | ||||||
| Property and equipment, net | 7 | 9 | ||||||
| Right-of-use lease asset | 79 | 93 | ||||||
| Non-current deposits | 1,244 | 1,259 | ||||||
| Total assets | $ | 6,165 | $ | 8,805 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 5,200 | $ | 3,543 | ||||
| Accrued and other current liabilities | 3,150 | 4,618 | ||||||
| Total current liabilities | 8,350 | 8,161 | ||||||
| Lease liability | 21 | 37 | ||||||
| Total liabilities | 8,371 | 8,198 | ||||||
| Stockholders’ equity | (2,206 | ) | 607 | |||||
| Total liabilities and stockholders’ equity | $ | 6,165 | $ | 8,805 | ||||
FAQ
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