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Item 2. Management’s Discussion and Analysis

2024-11-12 compared with 2024-08-14 · 86 added, 49 removed, 136 unchanged (50% of the section changed)

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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 reported revenue of $10,000 and $43,000 for the three and nine months ended September 30, 2024, respectively, and revenues of $16,000 and $389,000 for the comparable three and nine months ended September 30, 2023, respectively.

We do not expect to report a significant amount of revenue for the foreseeable future.

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

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

The anti-mitotic program is evaluating plogosertib, a PLK1 inhibitor, in advanced cancers.

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The most common treatment related adverse events reported were nausea (66.0%), vomiting (46.8%), diarrhea (31.9%) fatigue (25.5%), and hyperglycemia (21.3%).

A total of 25 drug-related

serious adverse events (SAE) were reported in 8 patients.

A total of 25 drug-related serious adverse events (SAE) were reported in 8 patients.

The most common SAEs reported were hyperglycemia (n=4), platelet count decrease (n=3), and accidental overdose (n=3).

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In addition, clinical benefit was reported in two patients with endometrial cancer and one each with ovarian and pancreatic cancers.

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 deletion or T-cell lymphoma.

The primary objectives of the 065-101 study in the Phase 1 dose escalation stage are to determine maximum tolerated dose (MTD) and/or RP2D and in the Phase 2, Proof of Concept stage to evaluate preliminary efficacy of fadraciclib as measured by overall response rate (ORR).

The secondary objectives in dose escalation are to assess safety and tolerability, pharmacokinetics, and ORR, while in Phase 2, Proof of Concept, to assess safety and tolerability, evaluate disease control rate (DCR), duration of response (DOR), progression free survival (PFS), and overall survival (OS).

The study is utilizing a Simon two-stage optimal design to evaluate clinical activity.

Exploratory objectives include investigation of clinical pharmacodynamics (PD) and pharmacogenomics (PGx).

The Phase 2, part of the study is ongoing and two dose expansion cohorts are enrolling patients with mechanistically relevant biomarkers, including CDKN2A and/or CDKN2B mutation or deletion or T-cell lymphoma.

Cohort 8 prospectively enrolled 12 patients with known CDKNA/B genetic alterations between April and September 2024.

The rationale was to further evaluate observations of clinical activity in Phase 1 patients with known CDNK2A or CDKN2B genetic alterations.

Cohort 6 is enrolling patients with T-cell Lymphoma with two patients treated so far.

The rationale was to further evaluate observations of partial response (PR) in 2/3 Phase 1 patients with T-cell lymphoma.

Certain T-Cell lymphomas are known to harbor CDNK2A genetic alterations.

All patients were treated with oral fadraciclib 100mg BID, M-F, week 1-4 in 28-day cycles which was the Recommended Phase 2 dose (RP2D).

Interim data from the Phase 2 was presented as a poster at the 2024 EORTC-NCI-AACR 36 th Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, Spain in October, 2024.

The data showed that fadraciclib was well tolerated in Cohort 8.

Most common drug-related adverse events included diarrhea, nausea, vomiting and were similar to those seen at this dose in Phase 1.

There were no Grade 3 or higher treatment-emergent adverse events in the Phase 2 study this far, consistent with the Phase 1 data.

The majority of patients (12/14) had ECOG performance status of 1 and median number of prior therapies was 3.

In Cohort 8, four patients had pancreatic cancer, and one each cholangiocarcinoma, duodenal, melanoma, cervical, laryngeal, ovarian, squamous cell cancer with unknown primary (CUP) and thymus cancer.

Out of six patients evaluable for efficacy, two achieved stable disease:

a melanoma patient whose treatment duration was 125 days and a squamous cell CUP patient who achieved 11% tumor shrinkage in the sum of all lesions on first scan with treatment duration of over 85 days (ongoing).

Two additional patients with ovarian and laryngeal cancer are ongoing but have not had their first scan yet.

The most common molecular characteristics of Cohort 8 patients were loss of function or deletion of CDKN2A and/or CDKN2B tumor suppressor genes.

Other pharmacogenomic observations included CDKN2A/B, KRAS and/or TP53 mutations.

Fadraciclib tablets can be given orally with repeat dosing which has led to transient suppression of anti-apoptosis proteins with generally good tolerability and no Grade 3 or higher hematological toxicity in the first cycle.

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A new, alternative salt, oral formulation of plogosertib with improved bioavailability is under development.

We plan to recruit further patients to the 140-101 study after the new formulation becomes available.

Going Concern

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.

For the nine months ended September 30, 2024, we used net cash of $6.6 million to fund our operating activities.

We have cash and cash equivalents of $3.0 million as of September 30, 2024, will allow it to meet its 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 following Liquidity and Capital Resources section for additional information.

We are currently investigating ways to raise additional capital through private equity financing or by entering into a strategic transaction.

In the event that we are not able to secure funding, we may be forced to curtail operations, delay or stop ongoing development activities, cease operations altogether, and/or file for bankruptcy.

On August 26, 2024, the Staff of Nasdaq determined that we were not in compliance with the Equity Rule because we reported stockholders’ equity of less than $2.5 million as of June 30, 2024.

The notice from the Staff further stated that unless we timely requested a hearing before a Panel, our securities would be subject to delisting.

As of September 30, 2024, we had a stockholders equity deficit of approximately $0.97 million which is not in compliance with the Equity Rule.

On October 15, 2024, we met with the Panel regarding our potential delisting from Nasdaq as a result of our violation of the Equity Rule.

On October 22, 2024, we received the Panel’s decision which granted us until

December 24, 2024 to regain compliance with the Equity Rule and all applicable criteria for continued listing on Nasdaq.

If we are unable to regain compliance with the listing standards of the Nasdaq Capital Market by December 24, 2024, our securities may be delisted from Nasdaq.

Liquidity and Capital Resources

The following is a summary of our key liquidity measures as of June 30, 2024 and 2023 (in $000s):

The following is a summary of our key liquidity measures as of September 30, 2024 and 2023 (in $000s):

September 30,

Cash and cash equivalents

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We have incurred significant losses since our inception.

As of June 30, 2024, we had an accumulated deficit of $434.5 million.

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

Six Months Ended June 30,

As of September 30, 2024, we had an accumulated deficit of $436.4 million.

Cash from operating, investing and financing activities for the nine months ended September 30, 2024 and 2023 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 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.

Net cash used in operating activities decreased by $5.6 million, from $12.2 million for the nine months ended September 30, 2023 to $6.6 million for the nine months ended September 30, 2024.

The decrease in cash used by operating activities was primarily the result of a decrease in net loss of $9.1 million, brought about by a reduction in clinical trial supply and non-clinical activities, offset by a change in working capital of $2.9 million.

Investing activities

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.

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

Financing activities

Net cash provided by financing activities was $6.3 million for the six months ended June 30, 2024 as a direct result of receiving approximately $6.3 million, net of expenses, from the issuance of common stock and warrants under a Securities Purchase Agreement with an institutional investor.

Net cash used in financing activities was $0.1 million for the six months ended June 30, 2023 as a result of dividend payments of approximately $0.1 million to the holders of our 6% Preferred Stock.

Net cash provided by financing activities was $6.2 million for the nine months ended September 30, 2024 as a direct result of receiving approximately $6.2 million, net of expenses, from the issuance of common stock and warrants under a Securities Purchase Agreement with an institutional investor.

Net cash used in financing activities was $0.2 million for the nine months ended September 30, 2023 as a result of dividend payments of approximately $0.2 million to the holders of our 6% Preferred Stock.

Funding Requirements and Going Concern

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.

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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.

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

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Additional funding has come through research and development tax credits, government grants, the sale of product rights, interest on investments, licensing revenue, royalty income, and a limited amount of product revenue from operations discontinued in September 2012.

As discussed in Note 2 of the Notes to the Consolidated Financial Statements accompanying this Quarterly Report on Form 10-Q, under ASC Topic 205-40, Presentation of Financial Statements - Going Concern , management is required at each reporting period to evaluate whether there are conditions and events, considered in the aggregate, that raise substantial doubt about an entity’s ability to continue as a going concern within one year after the date that the financial statements are issued.

financial statements are issued.

This evaluation initially does not take into consideration the potential mitigating effect of management’s plans that have not been fully implemented as of the date the financial statements are issued.

Our history of losses, our negative cash flows from operations, our liquidity resources currently on hand, and our dependence on the ability to obtain additional financing to fund our operations after the current resources are exhausted, about which there can be no certainty, have resulted in our assessment that there is substantial doubt about our ability to continue as a going concern for a period of at least twelve months from the issuance date of this Quarterly Report on Form 10-Q.

While we have plans in place to mitigate this risk, which primarily consist of raising additional capital through a combination of public or private equity or debt financings or by entering into partnership agreements for further development of our drug candidates, there is no guarantee that we will be successful in these mitigation efforts.

We are currently investigating ways to raise additional capital through private equity financing or by entering into a strategic transaction.

In the event that we are not able to secure funding, we may be forced to curtail operations, delay or stop ongoing development activities, cease operations altogether, and/or file for bankruptcy.

In such event, our stockholders may lose their entire investment in our company.

Results of Operations

Three and Six Months Ended June 30, 2024 and 2023

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.

We expect to completely fulfill our obligations under this agreement by the third quarter of 2024.

Three and Nine Months Ended September 30, 2024 and 2023

We recognized $10,000 and $43,000 of revenue for the three and nine months ended September 30, 2024, respectively.

This revenue is related to recovery of clinical manufacturing costs associated with an investigator sponsored study managed by Cedars-Sinai Medical Center.

Revenues recognized for the three and nine months ended September 30, 2023 were approximately $16,000 and $389,000 respectively.

We expect to completely fulfill our obligations under this agreement by the fourth quarter of 2024.

The associated clinical manufacturing costs are presented as a component of research and development expenses.

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

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.

Total research and development expenses represented 56% and 76% of our operating expenses for the nine months ended September 30, 2024 and 2023 respectively.

Research and development expenses decreased by $9.9 million from $15.6 million for the nine months ended September 30, 2023 to $5.2 million for the nine months ended September 30, 2024.

Expenditure for the transcriptional regulation program decreased by $6.6 million relative to the respective comparative period, primarily due to decreases in manufacturing and non-clinical expenditure.

Research and development expenses relating to plogosertib decreased by $2.7 million relative to the respective comparative period due to decreases in manufacturing and non-clinical expenditure.

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.

Expenditure will be primarily clinical trial costs related to our fadraciclib Phase 1/2 065-101 study in advanced solid tumors and lymphomas.

General and Administrative Expenses

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):

The following table summarizes the general and administrative expenses for the three and nine months ended September 30, 2024 and 2023 (in $000s except percentages):

Three Months Ended

Six Months Ended

Nine Months Ended

September 30,

Total general and administrative expenses

Total general and administrative expenses represented 40% and 24% of our operating expenses for the six months ended June 30, 2024 and 2023 respectively.

General and administrative expenses remained relatively consistent at $3.2 million for each of the six months ended June 30, 2024 and 2023.

Total general and administrative expenses represented 44% and 24% of our operating expenses for the nine months ended September 30, 2024 and 2023 respectively.

General and administrative expenses decreased by approximately $0.3 million from $4.8 million for the nine months ended September 30, 2023 to $4.5 million for the nine months ended September 30, 2024, due largely to reduction in stock compensation expense.

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.

Other (expense) income, net

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

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

Three Months Ended

Six Months Ended

Nine Months Ended

September 30,

Foreign exchange gains (losses)

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Total other (expense) income, net

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

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.

Total other income decreased by $195,000 from $235,000 for the nine months ended September 30, 2023 to $40,000 for the nine months ended September 30, 2024.

Other income for the nine months ended September 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 part of our product development plan following the transaction between Xcyte and Cyclacel in March 2006.

Accordingly, we presented $52,000 and $50,000 as other income arising from royalties from the APA during each of the nine months ended September 30, 2024 and 2023 respectively.

Foreign exchange gains (losses)

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.

Foreign exchange gains increased by $64,000, from a loss of $58,000 for the nine months ended September 30, 2023, to a gain of $6,000 for the nine months ended September 30, 2024.

Other income (expense), net for the year ended December 31, 2024, will continue to be impacted by changes in foreign exchange rates and the receipt of income under the APA.

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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, 2024 and 2023 (in $000s except percentages):

The following table summarizes total income tax benefit for the three and nine months ended September 30, 2024 and 2023 (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, 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 total income tax benefit, which comprised of research and development tax credits recoverable, decreased by approximately $0.6 million, from $2.6 million for the nine months ended September 30, 2023 to $2.0 million for the nine months ended September 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.

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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, 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.

There have been no material changes to our critical accounting policies during the nine months ended September 30, 2024.

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