Full Press Release Details
Pharmaceuticals Reports SECOND quarter 2022 financial results
provides business update
Oral fadraciclib demonstrated good tolerability with continuous dosing;
entering Phase 2 POC stage in 2H 2022 -
- Demonstrated evidence of target
engagement for CDK2 and CDK9 -
Company to host R&D day in fall of 2022 to highlight data updates
fadraciclib and CYC140 in solid tumor Phase 1/2 studies
Cash runway into 2H 2023 -
- Conference call scheduled for
August 10, 2022 at 4:30 pm ET -
HEIGHTS, NJ, August 10, 2022 - Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"),
a biopharmaceutical company developing innovative medicines based on cancer cell biology, today announced second quarter 2022 financial
results and provided a business update.
"In the first half of 2022 we have established
that oral fadraciclib, our CDK2 and CDK9 inhibitor, is well-tolerated and demonstrated single-agent, anticancer activity across multiple
solid tumor and lymphoma patients in our 065-101 study," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel.
"In the second half of 2022 we are optimizing the dosing schedule to maximize target coverage and determine recommended Phase 2
dose (RP2D). We then anticipate advancing into Phase 2 proof of concept stage of 065-101. We believe that daily dosing of oral fadraciclib
targeting both CDK2 and CDK9 at efficacious doses without dose limiting toxicities may represent best-in-class properties. We look forward
to reporting additional clinical and preclinical data at our upcoming R&D Day for both fadraciclib and CYC140, our differentiated
PLK1 inhibitor, also in a Phase 1/2 study."
are excited with the progress of oral fadraciclib in our Phase 1/2 solid tumor and lymphoma study because of the promising safety and
early efficacy results we are seeing in a challenging Phase 1 population," said Mark Kirschbaum, M.D., Chief Medical Officer of
Cyclacel. "As fadraciclib has been relatively well tolerated, 065-101 principal investigators agreed to continue dose escalation
with the current 4-week schedule. Following Food and Drug Administration (FDA) clearance of a protocol amendment, we are recruiting patients
at the sixth dose level of 065-101. We have previously observed partial response and anticancer activity including tumor shrinkage in
endometrial, lymphoma and pancreatic cancer patients. In parallel we are determining which tumor types to prioritize for the Phase 2 stage
of 065-101 informed by preclinical modeling and data from our clinical collaborators. The 065-102 study of fadraciclib in advanced leukemias
continues to enroll at the 100mg twice a day dose level after clearance of a protocol amendment that allowed us to skip two dose levels.
We are also encouraged that the 140-101 dose escalation study of CYC140 is now recruiting patients with solid tumors and lymphomas for
the second dose level."
key efficacy, safety and PK findings to date:
065-101 study is enrolling at four sites. Several additional sites are in start-up preparations to
join the Phase 2 proof-of-concept stage of this registration-directed study. The Phase 2 part of 065-101 includes seven histologically
defined cohorts thought to be sensitive to the drug's mechanism: breast, colorectal (including KRAS mutant), endometrial/uterine,
hepatobiliary, ovarian cancers and lymphomas. The study also includes an eighth basket cohort which will enroll patients regardless of
histology with biomarkers relevant to the drug's mechanism, including MCL1, MYC and/or cyclin E amplified.
April, the Company announced a publication in the journal, Leukemia, confirming fadraciclib
suppresses MCL1 and synergizes with venetoclax in chronic lymphocytic leukemia. Results from the study confirmed that fadraciclib
inhibited CDK9-mediated transcription, reduced levels of the short-lived, anti-apoptotic protein MCL1, and induced apoptosis in primary
CLL cells. The data highlighted the importance of continuous treatment to prevent recovery of MCL1 protein levels. Furthermore,
fadraciclib was shown to combine synergistically with the BCL2 antagonist, venetoclax, and demonstrated even greater synergy when targeted
against 17p deleted CLL cells which were not sensitive to either agent alone.
of key efficacy, safety and PK findings to date:
study uses a streamlined design and will initially determine RP2D for single-agent oral CYC140. Following RP2D, the trial will immediately
enter into proof-of-concept, cohort stage, using a Simon 2-stage design. In this stage CYC140 will be administered to patients in up to
seven mechanistically relevant cohorts including patients with bladder, breast, colorectal (including KRAS mutant), hepatocellular and
biliary tract, and lung cancers (both small cell and non-small cell), as well as lymphomas plus an eighth basket cohort which will enroll
patients with biomarkers relevant to the drug's mechanism.
As of June 30, 2022, cash and cash equivalents
totaled $29.1 million, compared to $36.6 million as of December 31, 2021. Net cash used in operating activities was $8.7 million for the
six months ended June 30, 2022 compared to $7.8 million for the same period of 2021. The Company estimates
that its available cash will fund currently planned programs into the second half of 2023.
Research and development (R&D) expenses were $4.2 million for the
three months ended June 30, 2022, as compared to $4.1 million for the same period in 2021. R&D expenses relating to fadraciclib were
$2.6 million for the three months ended June 30, 2022, as compared to $2.8 million for the same period in 2021 due to increased clinical
trial costs of $0.5 million associated with ongoing clinical trials evaluating fadraciclib in Phase 1/2 studies offset by a reduction
of $0.7 million in non-clinical expenditures. R&D expenses related to CYC140 were $1.5 million for the three months ended June 30,
2022, as compared to $1.1 million for the same period in 2021 due to clinical trial costs associated with the start of the CYC140 Phase
General and administrative expenses for the three months ended June
30, 2022, were $1.6 million, compared to $2.0 million for the same period of the previous year due to a decrease in facilities, professional
and recruitment costs
Total other income, net, for the three months ended June 30, 2022,
was $0.2 million, compared to $9,000 for the same period of the previous year. The increase of $0.2 million for the three months ended
June 30, 2022, is primarily related to foreign exchange gains.
United Kingdom research & development
tax credits were $1.0 million for each of the three months ended June 30, 2022 and June 30, 2021 and are directly correlated to qualifying
research and development expenditure. Tax credit receipts of $3.3 million in respect of the financial year ended December 31, 2021, were
received in April 2022.
Net loss for the three months ended June 30,
2022, was $4.6 million, compared to $5.1 million for the same period in 2021.
(800) 225-9448 / international call: (203) 518-9708
(888) 269-5330 / international archive: (402) 220-7326
for live and archived conference call is CYCCQ222. Webcast Link.
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.
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
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, the potential effects of the COVID-19 pandemic, 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