Cyclacel Pharmaceuticals Inc

Previous wording

We are a clinical-stage biopharmaceutical company developing innovative cancer medicines based on cell cycle, transcriptional regulation, epigenetics and mitosis control biology. We reported revenue of $29,000 for the three months ended March 31, 2024 and no revenues for the comparable quarter ended March 31, 2023. We do not expect to report a significant amount of revenue for the foreseeable future.

Current wording

We are a clinical-stage biopharmaceutical company developing innovative cancer medicines based on cell cycle, transcriptional regulation, epigenetics and mitosis control biology. We reported revenue of $4,000 and $33,000 for the three and six months ended June 30, 2024, respectively, and revenues of $373,000 and $373,000 for the comparable three and six months ended June 30, 2023, respectively. We do not expect to report a significant amount of revenue for the foreseeable future.

Previous wording

Our primary focus has been on our transcriptional regulation program, which isevaluating fadraciclib, a CDK2/9 inhibitor, insolid tumors and hematological malignancies. The epigenetic/anti-mitotic program is evaluating plogosertib, a PLK1 inhibitor, in advanced cancers.

Current wording

Our primary focus has been on our transcriptional regulation program, which isevaluating fadraciclib, a CDK2/9 inhibitor, insolid tumors and hematological malignancies. The anti-mitotic program is evaluating plogosertib, a PLK1 inhibitor, in advanced cancers.

Previous wording

We plan to enroll patients in the Phase 2 proof-of-concept stage beginning with the basket cohort which will enroll patients with mechanistically relevant biomarkers, including CDKN2A and/or CDKN2B mutation or deletion. Additional cohorts will be enrolled as resources allow. The proof-of-concept stage 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 basket cohort will enroll patients regardless of histology with biomarkers relevant to the drug’s mechanism, including CDKN2A/B, MCL1, MYC and/or cyclin E amplified.

Current wording

The Phase 2, proof of concept part of the study is now enrolling patients with mechanistically relevant biomarkers, including CDKN2A and/or CDKN2B mutation or deletionor T-cell lymphoma.

Previous wording

This ongoing open-label Phase 1/2 registration-directed study uses a streamlined design and initially seeks to determine the RP2D for single-agent oral plogosertib in a dose escalation stage. Once RP2D has been established, the study will enter into proof-of-concept, cohort stage, using a Simon 2-stage design. In this stage plogosertib 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. An additional basket cohort will enroll patients with biomarkers relevant to the drug’s mechanism, including MYC amplified tumors. The protocol allows for expansion of individual cohorts based on response which may allow acceleration of the clinical development and registration plan for plogosertib.

Current wording

This open-label Phase 1/2 registration-directed study uses a streamlined design and initially seeks to determine the RP2D for single-agent oral plogosertib in a dose escalation stage. Once RP2D has been established, the study will enter into proof-of-concept, cohort stage, using a Simon 2-stage design. In this stage plogosertib 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. An additional basket cohort will enroll patients with biomarkers relevant to the drug’s mechanism, including MYC amplified tumors. The protocol allows for expansion of individual cohorts based on response which may allow acceleration of the clinical development and registration plan for plogosertib.

Previous wording

For the three months ended March 31, 2024, we used net cash of $0.6 million to fund our operating activities. We have cash and cash equivalents of $2.8 million as of March 31, 2024, which together with the $8.0 million gross proceeds from equity financing received in May 2024 will allow it to meet our liquidity requirements into the fourth quarter of 2024. However, there remains substantial doubt about our ability to continue as a going concern. We are currently investigating ways to raise additional capital through a combination of public or private equity, debt financing or by entering into partnership agreements for further development of our drug candidates. Please refer to the followingLiquidity and Capital Resourcessection for additional information.

Current wording

For the six months ended June 30, 2024, we used net cash of $3.6 million to fund our operating activities. We have cash and cash equivalents of $6.0 million as of June 30, 2024, which we believe will allow us to meet our liquidity requirements into the fourth quarter of 2024. However, there remains substantial doubt about our ability to continue as a going concern. We are currently investigating ways to raise additional capital through a combination of public or private equity, debt financing or by entering into partnership agreements for further development of our drug candidates. Please refer to the followingLiquidity and Capital Resourcessection for additional information.

Previous wording

Since our inception, we have relied primarily on the proceeds from sales of common and preferred equity securities to finance our operations and internal growth. Additional funding has come through research and development tax credits, government grants, the sale of product rights, interest on investments and licensing revenue. We have incurred significant losses since our inception. As of March 31, 2024, we had an accumulated deficit of $431.2 million.

Current wording

Since our inception, we have relied primarily on the proceeds from sales of common and preferred equity securities to finance our operations and internal growth. Additional funding has come through research and development tax credits, government grants, the sale of product rights, interest on investments and licensing revenue. We have incurred significant losses since our inception. As of June 30, 2024, we had an accumulated deficit of $434.5 million.

Previous wording

Cash used in operating, investing and financing activities for the three months ended March 31, 2024 and 2023 is summarized as follows (in $000s):

Current wording

Cash from operating, investing and financing activities for the six months ended June 30, 2024 and 2023 is summarized as follows (in $000s):

Previous wording

Net cash used in operating activities decreased by $6.4 million, from $6.9 million for the three months ended March 31, 2023 to $0.5 million for the three months ended March 31, 2024. The decrease in cash used by operating activities was primarily the result of a decrease in net loss of $2.9 million, brought about by a reduction in manufacturing and non-clinical activities, and a change in working capital of $3.5 million, due mainly to the receipt of research and development tax credits of $2.9 million during the three months ended March 31, 2024.

Current wording

Net cash used in operating activities decreased by $4.6 million, from $8.2 million for the six months ended June 30, 2023 to $3.6 million for the six months ended June 30, 2024. The decrease in cash used by operating activities was primarily the result of a decrease in net loss of $5.0 million, brought about by a reduction in clinical trial supply and non-clinical activities, offset by a change in working capital of $0.4 million.

Previous wording

Net cash used in investing activities remained relatively small for each of the three months ended March 31, 2024 and 2023 and consisted of IT-related capital expenditure in 2023.

Current wording

Net cash used by investing activities remained inconsequential for each of the six months ended June 30, 2024 and 2023 and consisted of IT-related capital expenditure in 2023.

Previous wording

We do not currently have sufficient funds to complete development and commercialization of any of our drug candidates. Current business and capital market risks could have a detrimental effect on the availability of sources of funding and our ability to access them in the future, which may delay or impede our progress of advancing our drugs currently in the clinical pipeline to approval by the Food and Drug Administration (“FDA”) or European Medicines Agency (“EMA”) for commercialization. Additionally, we plan to continue to evaluate in-licensing and acquisition opportunities to gain access to new drugs or drug targets that would fit with our strategy. Any such transaction would likely increase our funding needs in the future.

Current wording

We do not currently have sufficient funds to complete development and commercialization of any of our drug candidates. Current business and capital market risks could have a detrimental effect on the availability of sources of funding and our ability to access them in the future, which may delay or impede our progress of advancing our drugs currently in the clinical pipeline to approval by the Food and Drug Administration (“FDA”) or European Medicines

Previous wording

The Company recognized $29,000 of revenue for the three months ended March 31, 2024, relating to recovery of clinical manufacturing costs associated with an investigator sponsored. There were no revenues recognized for the comparative period in 2023.

Current wording

We recognized $4,000 and $33,000 of revenue for the three and six months ended June 30, 2024, respectively. This revenue related to recovery of clinical manufacturing costs associated with an investigator sponsored study managed by Cedar-Sinai Medical Center. Revenues recognized for both the three and six months ended June 30, 2023 were approximately $373,000.

Previous wording

We expect to completely fulfill our obligations under this agreement by the second quarter of 2024 and further recognize a small amount of revenues at that time. The associated clinical manufacturing costs are presented as a component of research & development.

Current wording

We expect to completely fulfill our obligations under this agreement by the third quarter of 2024. The associated clinical manufacturing costs are presented as a component of research and development expenses.

Previous wording

The following table provides information with respect to our research and development expenditures for the three months ended March 31, 2024 and 2023 (in $000s except percentages):

Current wording

The following table provides information with respect to our research and development expenditures for the three and six months ended June 30, 2024 and 2023 (in $000s except percentages):

Previous wording

Total research and development expenses represented 64% and 78% of our operating expenses for the three months ended March 31, 2024 and 2023, respectively.

Current wording

Total research and development expenses represented 60% and 76% of our operating expenses for the six months ended June 30, 2024 and 2023 respectively.

Previous wording

Research and development expenses decreased by $2.9 million from $5.7 million for the three months ended March 31, 2023 to $2.8 million for the three months ended March 31, 2024. Expenditure for the transcriptional regulation program decreased by $2.2 million relative to the respective comparative period, primarily due to decreases in manufacturing and non-clinical expenditure. Research and development expenses relating toplogosertib decreased by $0.4 million relative to the respective comparative period due to decreases in manufacturing and non-clinical expenditure.

Current wording

Research and development expenses decreased by $5.6 million from $10.4 million for the six months ended June 30, 2023 to $4.8 million for the six months ended June 30, 2024. Expenditure for the transcriptional regulation program decreased by $3.9 million relative to the respective comparative period, primarily due to decreases in manufacturing and non-clinical expenditure. Research and development expenses relating toplogosertib decreased by $1.2 million relative to the respective comparative period due to decreases in manufacturing and non-clinical expenditure.

Previous wording

We anticipate that overall research and development expenses for the year ended December 31, 2024 will decrease compared to the year ended December 31, 2023 as we focus on our Phase 1/2 programs in advanced solid tumors and lymphomas.

Current wording

We anticipate that overall research and development expenses for the year ended December 31, 2024 will decrease compared to the year ended December 31, 2023 as we do not expect to incur further manufacturing or preclinical costs and expenditure will be primarily clinical trial costs related to our fadraciclib Phase 1/2 065-101 study in advanced solid tumors and lymphomas.

Previous wording

General and administrative expenses include costs for administrative personnel, legal and other professional expenses and general corporate expenses. The following table summarizes the general and administrative expenses for the three months ended March 31, 2024 and 2023 (in $000s except percentages):

Current wording

General and administrative expenses include costs for administrative personnel, legal and other professional expenses and general corporate expenses. The following table summarizes the general and administrative expenses for the three and six months ended June 30, 2024 and 2023 (in $000s except percentages):

Previous wording

We expect general and administrative expenditures for the year ended December 31, 2024 to remain relatively flat compared to the year ended December 31, 2023.

Current wording

We expect general and administrative expenditures for the year ended December 31, 2024 to be lower than our expenditures for the year ended December 31, 2023, due to management efforts to lower costs across all departments.

Previous wording

The following table summarizes other income for the three months ended March 31, 2024 and 2023 (in $000 except percentages):

Current wording

The following table summarizes other (expense) income, net for the three and six months ended June 30, 2024 and 2023 (in $000 except percentages):

Previous wording

Total other income decreased by $0.1 million from $0.2 million for the three months ended March 31, 2023 to $0.1 million for the three months ended March 31, 2024. Other income relates to royalties receivable under a December 2005 Asset Purchase Agreement, or APA, whereby Xcyte Therapies, Inc., or Xcyte (a business acquired by us in March 2006) sold certain assets and intellectual property to ThermoFisher Scientific Company, or TSC (formerly Invitrogen Corporation) through the APA and other related agreements. The assets and technology were not part of our product development plan following the transaction between Xcyte and Cyclacel in March 2006. Accordingly, we

Current wording

Total other income decreased by $60,000 from $90,000 for the six months ended June 30, 2023 to $30,000 for the six months ended June 30, 2024. Other income for the six months ended June 30, 2024 relates to royalties receivable under a December 2005 Asset Purchase Agreement, or APA, whereby Xcyte Therapies, Inc., or Xcyte (a business acquired by us in March 2006) sold certain assets and intellectual property to ThermoFisher Scientific Company, or TSC (formerly Invitrogen Corporation) through the APA and other related agreements. The assets and technology were not

Previous wording

presented $52,000 and $0 as other income arising from royalties from the APA during the three months ended March 31, 2024 and 2023 respectively.

Current wording

part of our product development plan following the transaction between Xcyte and Cyclacel in March 2006. Accordingly, we presented $52,000 as other income arising from royalties from the APA during each of the six months ended June 30, 2024 and 2023 respectively.

Previous wording

Foreign exchange gains increased by $88,000, from a loss of $87,000 for the three months ended March 31, 2023, to a gain of $1,000 for the three months ended March 31, 2024.

Current wording

Foreign exchange gains increased by $165,000, from a loss of $161,000 for the six months ended June 30, 2023, to a gain of $4,000 for the six months ended June 30, 2024.

Previous wording

The following table summarizes total income tax benefit for the three months ended March 31, 2024 and 2023 (in $000s except percentages):

Current wording

The following table summarizes total income tax benefit for the three and six months ended June 30, 2024 and 2023 (in $000s except percentages):

Previous wording

The total income tax benefit, which comprised of research and development tax credits recoverable, remained flat at approximately $1.3 million for each of the three months ended March 31, 2024 and 2023. The level of tax credits recoverable is linked directly to qualifying research and development expenditure incurred in any one year and the availability of trading losses.

Current wording

The total income tax benefit, which comprised of research and development tax credits recoverable, decreased by approximately $0.1 million, from $1.9 million for the six months ended June 30, 2023 to $1.8 million for the six months ended June 30, 2024. The level of tax credits recoverable is linked directly to qualifying research and development expenditure incurred in any one year and the availability of trading losses.

Previous wording

We expect to continue to be eligible to receive United Kingdom research and development tax credits for the year ended December 31, 2024 and will continue to elect to receive payment of the tax credit. The amount of tax credits we will receive is entirely dependent on the amount of eligible expenses we incur and could be restricted by any future cap introduced by HMRC. Beyond 2024, we cannot be certain of our eligibility to receive this tax credit or if eligible, the amount that may be received, due to proposed changes by HMRC to the eligibility criteria.

Current wording

We expect to continue to be eligible to receive United Kingdom research and development tax credits for the year ended December 31, 2024 and will continue to elect to receive payment of the tax credit. The amount of tax credits we will receive is entirely dependent on the amount of eligible expenses we incur and could be restricted by any future cap introduced by HMRC. Beyond 2024, we cannot be certain of our eligibility to receive this tax credit or if eligible, the amount that may be received, as a result of any future changes by HMRC to the eligibility criteria.

Previous wording

Our critical accounting policies are those policies which require the most significant judgments and estimates in the preparation of our consolidated financial statements. We evaluate our estimates, judgments, and assumptions on an ongoing basis. Actual results may differ from these estimates under different assumptions or conditions. A summary of our critical accounting policies is presented in Part II, Item 7, of our Annual Report on Form 10-K for the year ended December 31, 2023 and Note 2 to our unaudited consolidated financial statements included elsewhere in this Quarterly

Current wording

Our critical accounting policies are those policies which require the most significant judgments and estimates in the preparation of our consolidated financial statements. We evaluate our estimates, judgments, and assumptions on an ongoing basis. Actual results may differ from these estimates under different assumptions or conditions. A summary of our critical accounting policies is presented in Part II, Item 7, of our Annual Report on Form 10-K for the year ended December 31, 2023 and Note 2 to our unaudited consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q. There have been no material changes to our critical accounting policies during the six months ended June 30, 2024.