Full Press Release Details
Pharmaceuticals Reports SECOND Quarter 2021 Financial Results
PROVIDES BUSINESS UPDATE
Patients with Solid Tumors Dosed with Oral Fadraciclib -
1/2 Trials for Fadraciclib and CYC140 Expected to Follow -
Scheduled August 11, 2021 at 4:30 p.m. ET -
Berkeley Heights, NJ, August 11, 2021
- Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical
company developing innovative medicines based on cancer cell biology, today reported its financial results for the second quarter 2021.
The quarter's business highlights included an update on the Company's progress with fadraciclib and CYC140, Cyclacel's novel
CDK2/9 and PLK1 inhibitors, respectively.
"After announcing In July that the
first patient had been dosed with oral fadraciclib, two additional patients with advanced solid tumors have been treated, completing
enrolment of the first dose level," said Spiro Rombotis, President and Chief Executive Officer. "We are encouraged by investigator
interest in our fadraciclib 065-101 solid tumor study. In earlier clinical studies fadraciclib has demonstrated single-agent activity,
including durable PR. We believe that fadraciclib is a leading, transcriptionally-active CDK inhibitor with a differentiated product
profile. Pipeline momentum will continue to build with the planned opening of protocol 065-102, an oral fadraciclib study in patients
with hematological malignancies, and later with the initiation of two similar protocols in solid tumors and hematological malignancies
for our novel PLK1 inhibitor, CYC140. The second half of 2021 is an exciting period for Cyclacel, as we expand our clinical programs
and increase our visibility as an oncology leader focused on cell cycle inhibition for the treatment of cancer. We look forward to reporting
further updates as data from these studies become available."
Key Corporate Highlights
Connell Drive, Suite 1500, Berkeley Heights, NJ 07922, USA Tel +1 908 517 7330 Fax +1 866 271 3466
Key Near-Term Business Objectives and Expected Timeline
Financial Highlights
As of June 30, 2021, cash and cash equivalents
totaled $43.6 million, compared to $47.8 million as of March 31, 2021. The decrease of $4.2 million was primarily due to net cash used
in operating activities. The Company estimates that the cash resources will fund currently planned programs through early 2023.
Research and development expenses were $4.1 million for the three
months ended June 30, 2021 as compared to $1.2 million for the same period in 2020. Research and development (R&D) expenses relating
to fadraciclib increased by approximately $1.9 million for the three months ended June 30, 2021 with the start of the CYC065-101
study of fadraciclib in solid tumors and preparations for opening the 065-102 study of fadraciclib in leukemias. Additionally, R&D
expenses related to CYC140 increased $1.0 million for the quarter as IND-directed activities are approaching completion and clinical
trial supplies are being manufactured.
General and administrative expenses for the three months ended June
30, 2021 were $2.0 million, compared to $1.3 million for the same period of the previous year due to costs of approximately $0.4 million
related to exiting a long-term facility lease, increased legal and professional expenses and recruitment costs.
United Kingdom research & development
tax credits were $1.0 million for the three months ended June 30, 2021, as compared to $0.3 million for the same period in 2020 due to
the increase in R&D expenditure.
Net loss for the three months ended June
30, 2021 was $5.1 million, compared to $2.2 million for the same period in 2020.
Conference call information:
Conference ID: CYCCQ221
US call: (866) 342-8591/
international call: +1 (203) 518-9713
Replay: US: (800) 839-5109
/ international archive: +1 (402) 220-2688
Code for live and replay conference call
is CYCCQ221 Webcast link.
For the live and archived webcast, please
visit the Corporate Presentations page on the Cyclacel website at www.cyclacel.com.
About Cyclacel Pharmaceuticals, Inc.
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 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.
| Company: | Paul McBarron, (908) 517-7330, pmcbarron@cyclacel.com |
| Investor Relations: | LifeSci Advisors, LLC, Irina Koffler, (646) 970-4681, ikoffler@lifesciadvisors.com |
The Cyclacel logo and Cyclacel are trademarks of Cyclacel.
CYCLACEL PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS (LOSS)
(In $000s, except share and per share amounts)
| Three Months Ended | ||||||||
| June 30, | ||||||||
| 2020 | 2021 | |||||||
| Revenues: | ||||||||
| Total revenues | - | - | ||||||
| Operating expenses: | ||||||||
| Research and development | 1,163 | 4,101 | ||||||
| General and administrative | 1,309 | 1,999 | ||||||
| Total operating expenses | 2,472 | 6,100 | ||||||
| Operating loss | (2,472 | ) | (6,100 | ) | ||||
| Other income (expense): | ||||||||
| Foreign exchange gains (losses) | (2 | ) | (13 | ) | ||||
| Interest income | 4 | 4 | ||||||
| Other income, net | 18 | 18 | ||||||
| Total other income (expense), net | 20 | 9 | ||||||
| Loss before taxes | (2,452 | ) | (6,091 | ) | ||||
| Income tax benefit | 286 | 964 | ||||||
| Net loss | (2,166 | ) | (5,127 | ) | ||||
| Dividend on convertible exchangeable preferred shares | (50 | ) | (50 | ) | ||||
| Beneficial conversion feature of Series B preferred stock | - | - | ||||||
| Net loss applicable to common shareholders | $ | (2,216 | ) | $ | (5,177 | ) | ||
| Basic and diluted earnings per common share: | ||||||||
| Net loss per share - basic and diluted | $ | (0.58 | ) | $ | (0.56 | ) | ||
| Weighted average common shares outstanding | 3,850,228 | 9,234,110 |
SOURCE: Cyclacel Pharmaceuticals, Inc
CYCLACEL PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEET
(In $000s, except share, per share, and liquidation
| December 31, | June 30, | |||||||
| 2020 | 2021 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 33,406 | $ | 43,639 | ||||
| Prepaid expenses and other current assets | 2,063 | 2,564 | ||||||
| Total current assets | 35,469 | 46,203 | ||||||
| Property and equipment, net | 106 | 73 | ||||||
| Right-of-use lease asset | 1,227 | 58 | ||||||
| Total assets | $ | 36,802 | $ | 46,334 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 514 | $ | 1,197 | ||||
| Accrued and other current liabilities | 1,972 | 1,921 | ||||||
| Total current liabilities | 2,486 | 3,118 | ||||||
| Lease liability | 1,057 | - | ||||||
| Total liabilities | 3,543 | 3,118 | ||||||
| Stockholders' equity | 33,259 | 43,216 | ||||||
| Total liabilities and stockholders' equity | $ | 36,802 | $ | 46,334 |
SOURCE: Cyclacel Pharmaceuticals, Inc