What changed in this filing

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Item 2. Management’s Discussion and Analysis

2022-11-10 compared with 2022-08-11 · 74 added, 51 removed, 119 unchanged (51% of the section changed)

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Forward-looking statements necessarily involve risks and uncertainties, and our actual results could differ materially from those anticipated in the forward-looking statements due to a number of factors, including those set forth in Part I, Item 1A, entitled “Risk Factors,” of our Annual Report on Form 10-K for the year ended December 31, 2021, as updated and supplemented by Part II, Item 1A, entitled “Risk Factors,” of our Quarterly Reports on Form 10-Q, and elsewhere in this report.

In addition, while we expect the coronavirus pandemic to have an impact on our business operations and financial results, the extent of the impact on our clinical development and regulatory efforts, our corporate development objectives, our financial position and the value of and market for our common stock will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time, such as the ultimate duration of the pandemic, the emergence of new geographic hotspots, the re-emergence of subsequent outbreaks, travel restrictions, quarantines, social distancing and business closure requirements in the United States and in other countries, and the effectiveness of actions taken globally to contain and treat the disease.

In addition, while we expect the coronavirus pandemic to have an ongoing impact on our business operations and financial results, the extent of the impact on our clinical development and regulatory efforts, our corporate development objectives, our financial position and the value of and market for our common stock will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time, such as the ultimate duration of the pandemic, the emergence of new geographic hotspots, the re-emergence of subsequent outbreaks, travel restrictions, quarantines, social distancing and business closure requirements in the United States and in other countries, and the effectiveness of actions taken globally to contain and treat the disease.

These factors as well as other cautionary statements made in this Quarterly Report on Form 10-Q, should be read and understood as being applicable to all related forward-looking statements wherever they appear herein.

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In this report, “Cyclacel,” the “Company,” “we,” “us,” and “our” refer to Cyclacel Pharmaceuticals, Inc.

We are a clinical-stage biopharmaceutical company working to develop innovative cancer medicines based on cell cycle, transcriptional regulation and mitosis control biology.

We are a pioneer company in the field of cancer cell cycle biology with a vision to improve patient healthcare by translating insights in cancer biology into medicines that can overcome resistance and ultimately increase a patient’s overall survival.

We are a clinical-stage biopharmaceutical company developing innovative cancer medicines based on cell cycle, transcriptional regulation and mitosis control biology.

We are a pioneer in the field of cancer cell cycle biology with a vision to improve patient healthcare by translating insights in cancer biology into medicines that can overcome resistance and ultimately increase a patient’s overall survival rate.

Our primary focus has been on our transcriptional regulation program, which is evaluating fadraciclib, a CDK2/9 inhibitor, in solid tumors and hematological malignancies .

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NCT#04983810 )

In this ongoing study, seventeen patients have been treated in five dose escalation levels so far.

The proof-of-concept stage includes 7 histologically defined cohorts thought to be sensitive to the drug’s mechanism:

colorectal (including KRAS mutant), endometrial/ uterine, hepatobiliary, ovarian cancers and lymphomas.

In this ongoing study, eighteen patients have been treated in the first five dose escalation levels.

Following a protocol amendment, we are enrolling dose level six.

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.

An additional basket cohort will enroll patients regardless of histology with biomarkers relevant to the drug’s mechanism, including MCL1, MYC and/or cyclin E amplified.

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NCT#05168904 )

In this ongoing study six patients have been treated in the first dose escalation level.

The proof-of-concept stage, where fadraciclib will be administered both as a single agent as well as in combination, includes 7 histologically defined cohorts which will include patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) who have an inadequate response or have progressed on venetoclax combinations with hypomethylating agent (HMA) or low dose Ara C;

relapsed/refractory AML or MDS patients.

The trial will also include patients with CLL who have progressed after at least two lines of therapy including a BTK inhibitor and/or venetoclax.

Based on good tolerability in the 065-101 study and following FDA clearance of a protocol amendment we have has accelerated dose progression by omitting dose levels two and three and enrolling patients at dose level four .

The proof-of-concept stage, where fadraciclib will be administered both as a single agent and in combination, includes seven histologically defined cohorts which will include patients with acute myeloid leukemia (or AML) or myelodysplastic syndromes (or MDS) who have an inadequate response or have progressed on venetoclax combinations with hypomethylating agent (or HMA) or low dose Ara C.

The trial will also include patients with chronic lymphocytic leukemia or CLL who have progressed after at least two lines of therapy including a BTK inhibitor and/or venetoclax.

CYC140 Phase 1/2 Study in Advanced Solid Tumors and Lymphomas (140-101;

NCT# 05358379 )

The first patient was dosed in this study in April 2022, with a total of three patients treated in the first dose escalation level .

Similar to fadraciclib this Phase 1/2 registration-directed trial uses a streamlined design and will first determine in a dose escalation stage the recommended Phase 2 dose (RP2D) for single-agent CYC140.

The first patient was dosed in this study in April 2022 and treated at the second dose escalation level.

Similar to fadraciclib this Phase 1/2 registration-directed trial uses a streamlined design and will first determine in a dose escalation stage the recommended Phase 2 dose (or RP2D) for single-agent CYC140.

Once RP2D has been established, 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 7 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.

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.

An additional basket cohort will enroll patients with biomarkers relevant to the drug’s mechanism, including MYC amplified tumors.

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Results of Operations

Three and Six Months Ended June 30, 2021 and 2022

Revenues for each of the three and six months ended June 30, 2021 and 2022 were $0.

Three and Nine Months Ended September 30, 2021 and 2022

Revenues for each of the three and nine months ended September 30, 2021 and 2022 were $0.

There are no active collaboration, licensing, or clinical supply agreements and we do not anticipate any revenues for the foreseeable future.

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From our inception, we have focused on drug discovery and development programs, with a particular emphasis on orally available anticancer agents, and our research and development expenses have represented costs incurred to discover and develop novel small molecule therapeutics, including clinical trial costs for fadraciclib and CYC140, as well as other compounds such as sapacitabine and seliciclib.

We will not be pursuing further development of sapacitabine and have notified Daiichi Sankyo Co., Ltd., the licensor, that we wishe to terminate the sapacitabine license agreement for commercial reasons.

The termination is expected to be effective as of March 23, 2023.

We have also incurred costs in the advancement of product candidates toward clinical and preclinical trials and the development of in-house research to advance our biomarker program and technology platforms.

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● Rent and facility expenses for our offices.

The following table provides information with respect to our research and development expenditures for the three and six months ended June 30, 2021 and 2022 (in $000s except percentages):

The following table provides information with respect to our research and development expenditures for the three and nine months ended September 30, 2021 and 2022 (in $000s except percentages):

Three Months Ended

Six Months Ended

Nine Months Ended

September 30,

Transcriptional Regulation (fadraciclib)

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Total research and development expenses

Total research and development expenses for the three and six months ended June 30, 2022 represented 73% and 74% of our operating expenses respectively, representing an increase over the respective prior periods.

Research and development expenses increased by $2.5 million from $6.7 million for the six months ended June 30, 2021 to $9.2 million for the six months ended June 30, 2022.

Expenditure for the transcriptional regulation program increased by $1.8 million for the six months ended June 30, 2022, relative to the respective comparative period.

Total research and development expenses for the three and nine months ended September 30, 2022 represented 68% and 72% of our operating expenses respectively, compared to 70% and 66% in the respective prior periods.

Research and development expenses increased by $2.7 million from $10.9 million for the nine months ended September 30, 2021 to $13.6 million for the nine months ended September 30, 2022.

Expenditure for the transcriptional regulation program increased by $1.0 million for the nine months ended September 30, 2022, relative to the respective comparative period.

This was due to an increase in clinical trial costs of $1.2 million associated with the progression of clinical trials for the evaluation of fadraciclib in Phase 1/2 studies, offset by a decrease in non-clinical expenditure of $0.2 million.

Research and development expenses relating to CYC140 increased by $0.8 million for the six months ended June 30, 2022, relative to the respective comparative period.

Research and development expenses relating to CYC140 increased by $1.8 million for the nine months ended September 30, 2022, relative to the respective comparative period.

This was due to an increase in clinical trial costs of $2.4 million associated with the progression of clinical trials for the evaluation of CYC140 in Phase 1/2 studies, offset by a decrease in non-clinical expenditure of $0.6 million.

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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, 2021 and 2022 (in $000s except percentages):

The following table summarizes the general and administrative expenses for the three and nine months ended September 30, 2021 and 2022 (in $000s except percentages):

Three Months Ended

Six Months Ended

Nine Months Ended

September 30,

Total general and administrative expenses

Total general and administration expenses for the three and six months ended June 30, 2022 represented 27% and 26% of our operating expenses respectively representing a decrease over the respective prior periods.

During both the three and six months ended June 30, 2022, the decrease in general and administrative expenses was primarily due to a $0.4 million reverse premium in relation to assignation of the lease facility in Dundee, Scotland which was recognized during the second quarter of 2021.

The decrease in general and administrative expenses during the six months ended June 30, 2022 relative to the corresponding prior year period was also a result of reductions in legal, professional and recruitment costs relating to expansion of the clinical team that were incurred in the first half of 2021.

We expect general and administrative expenditures for the year ended December 31, 2022 to reduce slightly compared to our expenditures for the year ended December 31, 2021, due to lower recruitment and professional costs.

Total general and administrative expenses for the three and nine months ended September 30, 2022 represented 32% and 28% of our operating expenses respectively, compared to 30% and 34% in the respective prior periods.

During the three months ended September 30, 2022, the increase in general and administrative expenses was primarily due to a $0.4 million cost associated with the Controlled Equity Offering Sales Agreement with Cantor Fitzgerald & Co.

(the “Sales Agreement”).

The decrease in general and administrative expenses during the nine months ended September 30, 2022 relative to the corresponding prior year period was due to reductions in legal and professional expenses and recruitment costs relating to expansion of the clinical team that were incurred in the first half of 2021 along with a one-time $0.4 million reverse premium charge in relation to assignation of the lease facility in Dundee, Scotland which was recognized during the second quarter of 2021.

We expect general and administrative expenditures for the year ended December 31, 2022 to decrease slightly compared to our expenditures for the year ended December 31, 2021, due to lower recruitment and professional costs.

Other income (expense), net

The following table summarizes other income for the three and six months ended June 30, 2021 and 2022 (in $000 except percentages):

The following table summarizes other income for the three and nine months ended September 30, 2021 and 2022 (in $000 except percentages):

Three Months Ended

Six Months Ended

Nine Months Ended

September 30,

Foreign exchange gains

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Total other income

Total other income increased by $1.4 million from $0.1 million for the six months ended June 30, 2021 to $1.5 million for the six months ended June 30, 2022.

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 through the APA and other related agreements certain assets and intellectual property which are not related to our product development plans to ThermoFisher Scientific Company, or TSC .

Accordingly, we presented $1.3 million and $144,000 as other income received from TSC during the six months ended June 30, 2022 and 2021 respectively.

Total other income increased by $1.7 million from $0.2 million for the nine months ended September 30, 2021 to $1.9 million for the nine months ended September 30, 2022.

Other income primarily 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 through the APA and other related agreements certain assets and intellectual property which are not related to our product development plans to ThermoFisher Scientific Company, or TSC.

Accordingly, we presented $1.3 million and $144,000 as other income received from TSC during the nine months ended September 30, 2022 and 2021 respectively.

Foreign exchange gains (losses)

Foreign exchange gains increased by $0.2 million, from a loss of $3,000 for the six months ended June 30, 2021, to a gain of $0.2 million for the six months ended June 30, 2022.

Foreign exchange gains increased by $0.5 million, from $5,000 for the nine months ended September 30, 2021, to $0.5 million for the nine months ended September 30, 2022, primarily due to the weakening of the pound sterling relative to US dollar.

Other income (expense), net for the year ended December 31, 2022, will continue to be impacted by changes in foreign exchange rates and the receipt of income under the APA.

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Income Tax Benefit

Credit is taken for research and development tax credits, which are claimed from the United Kingdom’s revenue and customs authority, or HMRC, in respect of qualifying research and development costs incurred.

The following table summarizes total income tax benefit for the three and six months ended June 30, 2022 and 2021 (in $000s except percentages):

Credit is taken for research and development tax credits, which are claimed from the United Kingdom’s HM Revenue and Customs authority, or HMRC, in respect of qualifying research and development costs incurred.

The following table summarizes total income tax benefit for the three and nine months ended September 30, 2022 and 2021 (in $000s except percentages):

Three Months Ended

Six Months Ended

Nine Months Ended

September 30,

Total income tax benefit

The total income tax benefit, which comprised of research and development tax credits recoverable, increased by approximately $0.5 million from $1.6 million for the six months ended June 30, 2021 to $2.1 million for the six months ended June 30, 2022.

The total income tax benefit, which comprised of research and development tax credits recoverable, increased by approximately $0.5 million from $2.6 million for the nine months ended September 30, 2021 to $3.1 million for the nine months ended September 30, 2022.

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.

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Liquidity and Capital Resources

The following is a summary of our key liquidity measures as of June 30, 2021 and 2022 (in $000s):

The following is a summary of our key liquidity measures as of September 30, 2021 and 2022 (in $000s):

September 30,

Cash and cash equivalents

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We have incurred significant losses since our inception.

As of June 30, 2022, we had an accumulated deficit of $393.6 million.

Cash from operating, investing and financing activities for the six months ended June 30, 2022 and 2021 is summarized as follows (in $000s):

Six Months Ended June 30,

As of September 30, 2022, we had an accumulated deficit of $398.7 million.

On August 12, 2021, the Company entered into a Controlled Equity Offering Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co.

("Cantor"), pursuant to which the Company could issue and sell, from time to time, shares of its common stock having an aggregate offering price of up to $10.0 million through Cantor as the sales agent.

On August 12, 2022, the Company became aware that the shelf registration statement on Form S-3 (file number 333-231923) (the “Registration Statement”) associated with this Sales Agreement had expired on June 21, 2022.

Prior to becoming aware of the expiration, the Company sold an aggregate of 3,117,100 shares of its common stock following the expiration of the Registration Statement and through August 12, 2022, for an aggregate of approximately $4,494,496 under the Registration Statement pursuant to the Sales Agreement.

The sale of these shares may be subject to potential rescission rights by the shareholders, as described in more detail under “Risk Factors”.

As of September 30, 2022, there have been no claims or demands to exercise such rights.

Cash from operating, investing and financing activities for the nine months ended September 30, 2022 and 2021 is summarized as follows (in $000s):

Nine Months Ended September 30,

Net cash used in operating activities

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Operating activities

Net cash used in operating activities increased by $0.9 million, from $7.8 million for the six months ended June 30, 2021 to $8.7 million for the six months ended June 30, 2022.

Net cash used in operating activities increased by $1.7 million, from $14.0 million for the nine months ended September 30, 2021 to $15.7 million for the nine months ended September 30, 2022.

The increase in cash used by operating activities was primarily the result of a change in working capital of $1.6 million, a change in lease liability of $0.2 million, and an increase in net loss of $0.2 million, offset by an increase of stock compensation expense of $0.3 million.

Investing activities

Net cash used by investing activities decreased by $9,000 for the six months ended June 30, 2022 due to capital expenditures on information technology (IT) during the respective comparative period.

Net cash used by investing activities decreased by $18,000 for the nine months ended September 30, 2022 due to capital expenditures on information technology (IT) during the respective comparative period.

Financing activities

Net cash provided by financing activities was $1.4 million for the six months ended June 30, 2022 as a direct result of receiving approximately $1.5 million, net of expenses, from the issuance of common stock under the Sales Agreement with Cantor Fitzgerald & Co., offset by dividend payments of approximately $0.1 million to the holders of our 6% Preferred Stock.

Net cash provided by financing activities was $17.9 million for the six months ended June 30, 2021 as a direct result of receiving approximately $13.5 million in net proceeds from the issuance of common stock under an underwriting agreement with Oppenheimer & Co.

Inc., and approximately $4.5 million from warrant exercises associated with a co-placement agency agreement with Roth Capital Partners, LLC, Ladenburg Thalmann & Co.

Inc., and Brookline Capital Markets, a division of Arcadia Securities, LLC, offset by dividend payments of approximately $0.1 million to the holders of our 6% Preferred Stock.

Net cash provided by financing activities was $2.9 million for the nine months ended September 30, 2022 as a direct result of receiving approximately $3.1 million, net of expenses, from the issuance of common stock under the Sales Agreement, offset by dividend payments of approximately $0.2 million to the holders of our 6% Preferred Stock.

Net cash provided by financing activities was $20.9 million for the nine months ended September 30, 2021 as a direct result of receiving approximately:

● $13.5 million in net proceeds from the issuance of common stock under an underwriting agreement with Oppenheimer & Co.

● $4.5 million from warrant exercises associated with a co-placement agency agreement with Roth Capital Partners, LLC, Ladenburg Thalmann & Co.

Inc., and Brookline Capital Markets, a division of Arcadia Securities, LLC, and

● $3.0 million from the issuance of common stock under the Sales Agreement,

● offset by dividend payments of approximately $0.2 million to the holders of our 6% Preferred Stock.

Operating Capital and Capital Expenditure Requirements

We expect to continue to incur substantial operating losses in the future and cannot guarantee that we will generate any significant product revenues until a product candidate has been approved by the Food and Drug Administration (“FDA”) or European Medicines Agency (“EMA”) in other countries and successfully commercialized.

We believe that existing funds together with cash generated from operations, such as recent financing activities and the R&D tax credit, are sufficient to satisfy our planned working capital, capital expenditures and other financial commitments into the second half of 2023.

However, we do not currently have sufficient funds to complete development and commercialization of any of our drug candidates.

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We do not know whether additional funding will be available on acceptable terms, or at all.

If we are not able to secure additional funding when needed, we may have to delay, reduce the scope of or eliminate one or more of our clinical trials or research and development programs or make changes to our operating plan.

If we are not able to secure additional funding when needed, we may have to delay, reduce the scope of or eliminate

one or more of our clinical trials or research and development programs or make changes to our operating plan.

In addition, we may have to partner one or more of our product candidates at an earlier stage of development, which would lower the economic value of those programs to us.

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The extent to which COVID-19 will continue to impact our business will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the duration of the pandemic, the severity of COVID-19 or new variants or the effectiveness of actions to contain and treat COVID-19 and its variants, particularly in the geographies where we or our third-party suppliers, contract manufacturers, or contract research organizations operate.

At this time, we are unable to fully estimate the impact of the pandemic or current geopolitical turmoil on its financial condition or operations, but either or both could materially affect our ability to raise future capital or to conduct clinical studies on a timely basis.

At this time, we are unable to fully estimate the impact of the pandemic or current geopolitical turmoil on our financial condition or operations, but either or both could materially affect our ability to raise future capital or to conduct clinical studies on a timely basis.

Critical Accounting Policies and Estimates

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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, 2021 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 three months ended June 30, 2022.

There have been no material changes to our critical accounting policies during the three months ended September 30, 2022.

Quantitative and Qualitative Disclosures about Market Risk

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis