Item 8. Financial Statements and Supplementary Data
Item
8. Financial Statements and Supplementary Data
INDEX
TO CYCLACEL PHARMACEUTICALS, INC. FINANCIAL STATEMENTS
Page
Report of Independent Registered Public Accounting Firm (PCAOB ID: 7167)
79
Consolidated Balance Sheets as of December 31, 2024 and 2023
81
Consolidated Statements of Operations (Loss) for the years ended December 31, 2024 and 2023
82
Consolidated Statements of Comprehensive Loss for the years ended December 31, 2024 and 2023
83
Consolidated Statements of Stockholders’ Equity for the years ended December 31, 2024 and 2023
84
Consolidated Statements of Cash Flows for the years ended December 31, 2024 and 2023
85
Notes to Consolidated Financial Statements
86
78
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REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To
the Board of Directors and the Stockholders of Bio Green Med Solution, Inc. (Formerly known as Cyclacel Pharmaceuticals, Inc.)
Opinion
on the Consolidated Financial Statements
We
have audited the accompanying consolidated balance sheet of Bio Green Med Solution, Inc. (Formerly known as Cyclacel Pharmaceuticals,
Inc.) and its subsidiary (collectively, the “Company”) as of December 31, 2024 and 2023, and the related consolidated statements
of operations (loss) and other comprehensive loss, stockholders’ equity and cash flows for each of the years ended December 31,
2024 and 2023, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion,
the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December
31, 2024 and 2023, and the results of its operations and its cash flows for each of the years ended December 31, 2024 and 2023, in conformity
with accounting principles generally accepted in the United States of America.
Substantial
doubt about the Company’s ability to continue as a going concern
The
accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed
in Note 1 to the financial statements, the Company does not currently have sufficient funds to complete development and commercialization
and has a limited cash balance as of December 31, 2024 and 2023. This raises substantial doubt about the Company’s ability to continue
as a going concern. Management’s plans in regard to these matters are also described in Note 1. The financial statements do not
include any adjustments that might result from the outcome of this uncertainty.
Basis
for Opinion
These
consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion
on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public
Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company
in accordance with the United States federal securities laws and the applicable rules and regulations of the Securities and Exchange
Commission and the PCAOB.
We
conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud.
The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part
of our audits, we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing
an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our
audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether
due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence
regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles
used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements.
We believe that our audits provide a reasonable basis for our opinion.
Critical
Audit Matters
The
critical audit matter communicated below is a matter arising from the current period audit of the financial statements that were communicated
or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the financial
statements and (2) involved our especially challenging, subjective or complex judgments. The communication of critical audit matters
does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit
matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.
79
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CRITICAL
TRIAL ACCRUAL AND EXPENSES
As
discussed in Notes 2 and 9 of the consolidated financial statements, the Company’s total accrued expenses for research and development
were $1.3 million at December 31, 2024, which included the estimated obligation for pre-clinical and clinical trial expenses incurred
as of December 31, 2024, but not paid as of that date. The Company’s clinical trial expenses are based on the Company’s estimates
of the level of services performed each period pursuant agreements with third parties that conduct research and development on the Company’s
behalf, which results in an accrual or prepaid at period end.
We
identified the Company’s accrued clinical trial expenses as a critical audit matter because auditing the application of significant
management judgment over the estimate of services provided but not yet invoiced required significant audit effort and a high degree of
auditor judgment and subjectivity to evaluate the audit evidence obtained. Specifically, the amount of accrued clinical trial expenses
recognized is dependent on the availability of information to make the estimate, including information from multiple sources, the level
of effort expended as of the balance sheet date and the associated cost of such services. Additionally, due to the timing of invoicing
received from third parties, the actual amounts incurred are not typically known on the date the Company issues its financial statements.
Our
audit procedures to evaluate the Company’s estimate of services incurred as of period end pursuant to its clinical trials included,
among others:
● We
tested the accuracy and completeness of the underlying data used in the estimates and evaluated
the significant assumptions stated above that are used by management to estimate the recorded
amounts.
● To
evaluate the completeness and valuation of the accrual clinical trial expenses, we compared
invoices received by the Company subsequent to December 31, 2024, to the amounts recognized
by the Company as of that date.
● We
inspected the Company’s contracts with third parties and any pending change orders
to assess the impact to the amounts recorded.
/s/
SFAI Malaysia PLT
We
have served as the Company’s auditor since 2025.
Malaysia
November
26, 2025
PCAOB
ID Number 7167
80
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CYCLACEL
PHARMACEUTICALS, INC.
CONSOLIDATED
BALANCE SHEETS
(In
thousands, except share and per share amounts)
December 31,
December 31,
2024
2023
ASSETS
Current assets:
Cash and cash equivalents
$ 3,137
$ 3,378
Prepaid expenses and other current assets
537
4,066
Total current assets
3,674
7,444
Property and equipment, net
3
9
Right-of-use lease asset
5
93
Non-current deposits
412
1,259
Total assets
$ 4,094
$ 8,805
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
Current liabilities:
Accounts payable
$ 4,599
$ 3,543
Accrued and other current liabilities
1,669
4,618
Total current liabilities
6,268
8,161
Lease liability
—
37
Total liabilities
6,268
8,198
Stockholders’ equity (deficit):
Preferred stock, $ 0.001 par value; 5,000,000 shares authorized at December 31, 2024 and December 31,
2023; 6 % Convertible Exchangeable preferred stock; 135,273 shares issued and outstanding at December 31, 2024 and 335,273
shares issued and outstanding at December 31, 2023. Aggregate preference in liquidation of $ 1,697,676 as of December 31,
2024 and $ 4,006,512 as of December 31, 2023
—
—
Series A convertible preferred stock, $ 0.001 par value; 264 shares issued and outstanding at December 31, 2024 and
December 31, 2023
—
—
Series B convertible preferred stock, $ 0.001 par value; 0 shares issued and outstanding at December 31, 2024 and 119,000
shares issued and outstanding at December 31, 2023
—
—
Preferred stock, value
—
—
Common stock, $ 0.001 par value; 100,000,000 shares authorized at December 31, 2024 and December 31, 2023; 36,913
shares issued and outstanding at December 31, 2024 and 4,412 shares issued and outstanding at December 31, 2023
—
—
Additional paid-in capital
438,211
429,797
Accumulated other comprehensive loss
( 891 )
( 908 )
Accumulated deficit
( 439,494 )
( 428,282 )
Total stockholders’ equity (deficit)
( 2,174 )
607
Total liabilities and stockholders’ equity (deficit)
$ 4,094
$ 8,805
The
accompanying notes are an integral part of these consolidated financial statements.
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CYCLACEL
PHARMACEUTICALS, INC.
CONSOLIDATED
STATEMENTS OF OPERATIONS (LOSS)
(In
thousands, except share and per share amounts)
2024
2023
Year Ended
December 31,
2024
2023
Revenues:
Clinical trial supply
$ 43
$ 420
Revenues
43
420
Operating expenses:
Research and development
6,655
19,155
General and administrative
5,392
6,718
Total operating expenses
12,047
25,873
Operating loss
( 12,004 )
( 25,453 )
Other expense:
Foreign exchange losses
( 54 )
( 414 )
Interest income
12
266
Other income, net
52
50
Total other income (expense), net
10
( 98 )
Loss before taxes
( 11,994 )
( 25,551 )
Income tax benefit
782
2,996
Net loss
( 11,212 )
( 22,555 )
Dividend on convertible exchangeable preferred shares
—
( 201 )
Net loss applicable to common shareholders
$ ( 11,212 )
$ ( 22,756 )
Basic and diluted earnings per common share:
Net loss per share – basic and diluted (common shareholders)
$ ( 504.30 )
$ ( 6,419.18 )
The
accompanying notes are an integral part of these consolidated financial statements.
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CYCLACEL
PHARMACEUTICALS, INC.
CONSOLIDATED
STATEMENTS OF COMPREHENSIVE LOSS
(In
thousands)
2024
2023
Year Ended
December 31,
2024
2023
Net loss
$ ( 11,212 )
$ ( 22,555 )
Translation adjustment
2,916
( 12,142 )
Unrealized foreign exchange gain (loss) on intercompany loans
( 2,899 )
12,550
Comprehensive loss
$ ( 11,195 )
$ ( 22,147 )
The
accompanying notes are an integral part of these consolidated financial statements.
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CYCLACEL
PHARMACEUTICALS, INC.
CONSOLIDATED
STATEMENTS OF STOCKHOLDERS’ EQUITY
(In
thousands, except share amounts)
Shares
Amount
Shares
Amount
Capital
Loss
Deficit
Equity
Additional
Accumulated
Other
Total
Preferred Stock
Common Stock
Paid-in
Comprehensive
Accumulated
Stockholders’
Shares
Amount
Shares
Amount
Capital
Loss
Deficit
Equity
Balances at December 31, 2022
573,282
$ —
2,617
$ 0
$ 422,982
$ ( 1,316 )
$ ( 405,727 )
$ 15,939
Issue of common stock and pre-funded warrants in
Securities Purchase Agreement In Registered
—
—
735
—
1,049
—
—
1,049
Direct Offering, net of expenses
Issue of common stock and pre-funded warrants in Securities Purchase Agreement In
Registered Direct Offering, net of expenses
—
—
735
—
1,049
—
—
1,049
Conversion of series B Preferred stock
( 118,745 )
—
165
—
—
—
—
—
Reclassification of redeemable common stock
—
—
866
—
4,494
—
—
4,494
Stock-based compensation
—
—
29
—
1,473
—
—
1,473
Preferred stock dividends
—
—
—
—
( 201 )
—
—
( 201 )
Unrealized foreign exchange on intercompany
—
—
—
—
—
12,550
—
12,550
loans
Translation adjustment
—
—
—
—
—
( 12,142 )
—
( 12,142 )
Loss for the period
—
—
—
—
—
—
( 22,555 )
( 22,555 )
Balances at December 31, 2023
454,537
$ —
4,412
$ 0
$ 429,797
$ ( 908 )
$ ( 428,282 )
$ 607
Balance
454,537
$ —
4,412
$ 0
$ 429,797
$ ( 908 )
$ ( 428,282 )
$ 607
Issue of common stock, preferred stock and
associated warrants on underwritten offering, net of
—
—
2,944
-
6,209
—
—
6,209
expenses
Issue of common stock, preferred stock and associated warrants on underwritten
offering, net of expenses
—
—
2,944
-
6,209
—
—
6,209
Conversion of series B Preferred stock
( 119,000 )
—
165
—
—
—
—
—
Conversion of series 6 % Convertible Exchangeable
( 200,000 )
—
-
—
—
—
—
—
Preferred
Conversion of series 6%
Convertible Exchangeable Preferred
( 200,000 )
—
-
—
—
—
—
—
Warrant Exercises
—
—
29,391
-
1,613
—
—
1,613
Stock-based compensation
—
—
—
—
592
—
—
592
Unrealized foreign exchange on intercompany
—
—
—
—
—
( 2,899 )
—
( 2,899 )
loans
Unrealized foreign exchange on intercompany loans
—
—
—
—
—
( 2,899 )
—
( 2,899 )
Translation adjustment
—
—
—
—
—
2,916
—
2,916
Loss for the period
—
—
—
—
—
—
( 11,212 )
( 11,212 )
Balances at December 31, 2024
135,537
$ —
36,913
$ -
$ 438,211
$ ( 891 )
$ ( 439,494 )
$ ( 2,174 )
Balance
135,537
$ —
36,913
$ -
$ 438,211
$ ( 891 )
$ ( 439,494 )
$ ( 2,174 )
The
accompanying notes are an integral part of these consolidated financial statements.
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CYCLACEL
PHARMACEUTICALS, INC.
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(In
thousands)
2024
2023
Year Ended December 31,
2024
2023
Operating activities:
Net loss
$ ( 11,212 )
$ ( 22,555 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation
6
31
Stock-based compensation
592
1,473
Changes in lease liability
( 37 )
( 69 )
Changes in operating assets and liabilities:
Prepaid expenses and other assets
4,472
4,712
Accounts payable, accrued and other current liabilities
( 1,811 )
296
Net cash used in operating activities
( 7,990 )
( 16,112 )
Investing activities:
Purchase of property, plant and equipment
—
( 6 )
Net cash used in investing activities
—
( 6 )
Financing activities:
Proceeds, net of issuance costs, from issuing common stock and pre-funded warrants, net
6,209
1,049
Proceeds from the exercise of stock options and warrants, net of issuance costs
1,613
—
Payment of preferred stock dividend
—
( 201 )
Net cash provided by (used) in financing activities
7,822
848
Effect of exchange rate changes on cash and cash equivalents
( 73 )
303
Net increase (decrease) in cash and cash equivalents
( 241 )
( 14,967 )
Cash and cash equivalents, beginning of period
3,378
18,345
Cash and cash equivalents, end of period
$ 3,137
$ 3,378
Supplemental cash flow information:
Cash received during the period for:
Interest
$ 96
$ 266
Research & development tax credits
$ 3,715
$ 4,846
Cash paid during the period for:
Taxes
$ 2
$ 2
Non cash financing activities:
Accrual of preferred stock dividends
$ —
$ 50
The
accompanying notes are an integral part of these consolidated financial statements.
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CYCLACEL
PHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
Subsequent
Events
Preferred
Stock
On
January 29, 2025, the Board of Directors of Cyclacel Pharmaceuticals, Inc. (the “Company”) passed a resolution to suspend
payment of the quarterly cash dividend on the Company’s 6 % Convertible Exchangeable Preferred Stock (the “Preferred Stock”)
scheduled for February 1, 2025. The Board of Directors will continue to evaluate the payment of a quarterly cash dividend on a quarterly
basis.
Financing
and Restructuring Activities
On
January 2, 2025 the Company entered into a securities purchase agreement with investor David Lazar, pursuant to which he agreed to purchase
from the Company 1,000,000 shares of Series C Convertible Preferred Stock and 2,100,000 shares of Series D Convertible Preferred Stock
of Cyclacel at a purchase price of $ 1.00 per share for aggregate gross proceeds of $ 3.1 million, subject to the terms and conditions
of the Agreement. The proceeds of the transaction will be used to settle outstanding liabilities of the Company and other general corporate
and operating purposes.
On
January 31, 2025, the creditors voluntary liquidation of Cyclacel Limited was announced in the London Gazette, one of the official public
records of the government of the United Kingdom. As part of the Company’s efforts to reduce operating costs it has determined to
focus on the development of the Plogo clinical program only. Therefore fadraciclib, the Subsidiary’s other drug development program,
is being marketed for sale by the liquidators through Hilco Appraisals Limited, a firm of professional valuation agents and will no longer
be part of the assets of the Company as of January 2025. With the commencement of the liquidation of the Subsidiary, the Company will
no longer be considered to have control over the Subsidiary and the financial results of the Subsidiary will be deconsolidated from those
of the Company. The deconsolidation, which is anticipated to increase stockholders’ equity by approximately $ 5.6 million, will
be reported in the Company’s Form 10-Q for the three months ended March 31, 2025.
On
February 4, 2025, the Company entered into a securities purchase agreement with investor David Lazar, for the issuance and sale in a
private placement of up to $ 8,000,000 of shares of common stock, par value $ 0.001 per share of the Company. The Company shall have the
right, but not the obligation, to direct the Purchaser, by delivering written notice thereof from time to time and until September 30,
2026, to purchase up to the Aggregate Purchase Price of Shares at a purchase price equal to the greater of (i) the consolidated closing
bid price immediately prior to the entry of this Agreement and (ii) the consolidated closing bid price on the business day immediately
preceding the applicable purchase date. Unless otherwise agreed by the Company and the Purchaser, the Company’s right to cause
the Purchaser to purchase the Shares pursuant to the Lazar Purchase Agreement must be exercised in either $ 1,000,000 or $ 2,000,000 increments.
On
February 5, 2025, the Company entered into a securities purchase agreement with Helena Special Opportunities 1 Ltd. (“Helena”),
pursuant to which the Company, subject to the restrictions and satisfaction of the conditions in the purchase agreement, has the right,
but not the obligation, to sell to Helena, and Helena is obligated to purchase, up to the lesser of (i) $ 25 million of newly issued shares
of the Company’s Common Stock and (ii) the Exchange Cap (as defined in the agreement).
The
Company held a special meeting of stockholders (the “ Special Meeting ”) on February 6, 2025 at which, among other matters,
the Company’s stockholders approved an amendment to the Company’s Amended and Restated Certificate of Incorporation to effect
a reverse stock split at a ratio not less than 1:4 and not more than 1:16 (the “2025 Reverse Stock Split”) such ratio and
the implementation and timing of such Reverse Stock Split to be determined in the discretion of the Company’s Board of Directors
(the “Board”). The 2025 Reverse Stock Split is expected to be implemented by the Board in or around May 2025.
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Table of Contents
On
February 26, 2025, David Lazar, the Company’s interim Chief Executive Officer, interim principal financial officer, interim principal
accounting officer, and Secretary, provided notice of his resignation as Chief Executive Officer and Secretary of the Company effective
February 26, 2025. Mr. Lazar will continue his role as co-principal financial officer and co-principal accounting officer to assist with
the transition of the Company’s new Chief Financial Officer, as discussed below. Mr Lazar’s resignation was not the result
of any disagreement between Mr. Lazar and the Company on any matter relating to the Company’s operations, policies or practices.
In connection with Mr. Lazar’s departure, he will not be eligible to receive any severance benefits or any performance based bonus
compensation for the 2025 partial year.
On
February 11, 2025, David E. Lazar (the “Seller”), the interim Chief Executive Officer and Secretary of the Company, entered
into a securities purchase agreement (the “Purchase Agreement”) with an investor, Datuk Dr. Doris Wong Sing Ee (the “Investor”)
pursuant to which the Investor agreed to purchase 1,000,000 shares of Series C Convertible Preferred Stock of the Company, $ 0.0001 par
value per share (the “Series C”) and such number of the 2,100,000 shares of Series D Convertible Preferred Stock of the Company,
$ 0.0001 par value per share (the “Series D”) currently held by Seller so that Purchaser shall hold seventy percent ( 70 %)
of the issued and outstanding shares of the Company, which resulted in the issuance of 1,745,262 shares of Series D (collectively, the
Series C and Series D are the “Securities”). The transaction contemplated by the Purchase Agreement closed on February 26,
2025 (the “Closing Date”). Additionally, the Investor purchased and succeeded to all of the Seller’s rights and interests
under that certain securities purchase agreement between the Seller and the Company dated January 2, 2025. On the Closing Date, the Seller
issued written notice to the Company to exercise the conversion rights related to the Series C and Series D shares into Common Stock
of the Company registered in the Investor’s name, as follows: (i) the conversion of 1,000,000 shares of Series C into 11,041 shares
of Common Stock of the Company; and (ii) the conversion of 1,745,262 shares of Series D into 799,911 shares of Common Stock of the Company.
Effective
as of February 26, 2025, the Board appointed Datuk Dr. Doris Wong Sing Ee, as Chief Executive Officer and, in such role, she will serve
as the Company’s principal executive officer. Datuk Dr. Doris Wong Sing Ee was also elected to the Board of the Company as of that
date.
Effective
as of February 26, 2025, the Board appointed Kiu Cu Seng, as Chief Financial Officer and, in such role, he will serve as the Company’s
co-principal financial officer and co-principal accounting officer along with David Lazar until the effective date of his resignation
on the earlier of the filing date of the Company’s annual report on Form 10-K for the fiscal year ended December 31, 2024 or March
31, 2025, as discussed above. The Company’s Board also appointed Mr. Kiu as Executive Director and Secretary.
On
March 10, 2025, the Company entered into an agreement for the Sale and Purchase of Certain Assets (the “Purchase Agreement”)
with Cyclacel Limited, a United Kingdom-based wholly owned subsidiary of the Company that is currently in liquidation (“Cyclacel
Limited”), along with the joint liquidator of Cyclacel Limited effective as of January 24, 2025 (the “Liquidators”).
Under the terms of the Purchase Agreement, the Company agreed to purchase, and Cyclacel Limited agreed to sell, with the approval of
the Liquidators, certain assets (the “Assets”) of Cyclacel Limited related to Plogosertib, a polo-like kinase 1 (PLK 1) inhibitor
for treatment of advanced cancers and hematological malignancies (“Plogo”), for a purchase price of £ 250,000 (exclusive
of VAT).
On
March 21, 2025 the Company entered into securities purchase agreements with a consortium of investors, pursuant to which they agreed
to purchase from the Company 1,000,000 shares of Series E Convertible Preferred Stock of Cyclacel at a purchase price of $ 1.00 per share
for aggregate gross proceeds of $ 1.0 million, subject to the terms and conditions of the Agreements. The proceeds of the transactions
will be used for general corporate and operating purposes.
Stock-Based
Compensation
On
January 2, 2025, Mr. Spiro Rombotis resigned as Chief Executive Officer of the Company and the Board of Directors appointed Mr. Lazar
as interim Chief Executive Officer of the Company, effective as of the signing of the Purchase Agreement. Mr. Lazar will serve as the
Company’s principal executive officer and principal financial officer until his successor is appointed. On this date, the Board
also appointed Messrs. David Natan and Avraham Ben-Tzvi as members of the Board of Directors. Dr. Robert Spiegel, Dr. Christopher Henney,
Dr. Brian Schwartz, Dr. Kenneth Ferguson and Ms. Karin Walker (together, the “Resigning Directors”) resigned effective as
of January 2, 2025.
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On
January 2, 2025, the Company entered into settlement agreements with the Resigning Directors effective as of the signing of the Purchase
Agreement. Pursuant to the terms of the Director Settlement Agreements, each Resigning Director resigned his or her position as a member
of the Board of Directors, and any positions held on committees of the Board of Directors. Each Resigning Director has received his or
her accrued Board fees in full consideration of the release of claims against the Company and other promises and covenants set forth
in the Director Settlement Agreements.
On
January 2, 2025, the Company entered into a settlement agreement with Mr. Spiro Rombotis (the “Rombotis Settlement Agreement”).
Pursuant to the terms of the Rombotis Settlement Agreement, Mr. Rombotis resigned his position as President and Chief Executive Officer
of the Company effective as of the signing of the Purchase Agreement, and agreed to provide transition services to the Company in his
capacity as a member of the Board of Directors through the filing of the Company’s Annual Report on Form 10-K for the year ended
2024. On January 2, 2025, the Company also entered into a settlement agreement with Paul McBarron (together with Mr. Rombotis, the “Resigning
Officers”) effective immediately following the Initial Closing, as such term is defined in the Purchase Agreement (the “McBarron
Settlement Agreement” and together with the Rombotis Settlement Agreement, the “Executive Officer Settlement Agreements”
and together with the Director Settlement Agreements, the “Settlement Agreements”). Pursuant to the terms of the McBarron
Settlement Agreement, Mr. McBarron agreed to provide transition services to the Company in his capacity as a member of the Board of Directors
through the filing of the Company’s Annual Report on Form 10-K for the year ended 2024.
Pursuant
to the Executive Officer Settlement Agreements, and subject to the Purchase Agreement, the Company will pay to Mr. Rombotis and Mr. McBarron
payments of $ 279,415.50 and $ 165,164.50 , respectively, as soon as practicable, and three months later a further one-time payment of $ 279,415.50
and $ 165,164.50 either in cash or through the issuance of common stock, respectively, in full consideration of the release of claims
against the Company and other promises and covenants set forth in the Executive Officer Settlement Agreements (the “Settlement
Payments”) and the Purchase Agreement.
Pursuant
to the terms of the Settlement Agreements, the Company will provide continuing indemnification to the Resigning Directors and Resigning
Officers in a manner consistent with that which was in place as of the effective date of the Settlement Agreements, and will cause to
be maintained in effect the Company’s existing director and officer liability insurance pursuant to the Company’s tail insurance
coverage and will not modify its governing documents to modify the Resigning Directors’ and Resigning Officers’ rights under
such policy, as further set forth in the Settlement Agreements. The Settlement Agreements contain a mutual non-disparagement clause.
On
February 26, 2025, the Company entered into settlement agreements with Dr. Barker. Pursuant to the terms of the settlement agreement,
Dr. Barker resigned his position as a member of the Board of Directors, and any positions held on committees of the Board of Directors.
In addition, Dr. Barker will receive his accrued Board fees in full consideration of the release of claims against the Company and other
promises and covenants set forth in the settlement agreement. Pursuant to the terms of the settlement agreement, the Company will provide
continuing indemnification to Dr. Barker in a manner consistent with that which was in place as of the effective date of the settlement
agreement, and will cause to be maintained in effect the Company’s existing director and officer liability insurance pursuant to
the Company’s tail insurance coverage and will not modify its governing documents to modify Dr. Barker’s rights under such
policy, as further set forth in the settlement agreement. The settlement agreement contains a mutual non-disparagement clause.
On
February 26, 2025, the following directors of the Company tendered their resignation or notice of resignation from the Board: (i) Dr.
Samuel L. Barker resigned as an independent director effectively immediately; (ii) Avraham Ben-Tzvi provided notice that his resignation
as an independent director will be effective upon the earlier of the filing date of the Company’s annual report on Form 10-K for
the fiscal year ended December 31, 2024 or March 31, 2025; (iii) Paul McBarron resigned as a non-independent director effective immediately;
(iv) David Natan provided notice that his resignation as an independent director will be effective upon the earlier of the filing date
of the Company’s annual report on Form 10-K for the fiscal year ended December 31, 2024 or March 31, 2025; and (iv) Spiro Rombotis
resigned as a non-independent director effective immediately.
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All
nonvested stock based compensation awards were (or will be) forfeited immediately as of the dates of resignation. As the Company accounts
for forfeitures as they occur, the Company will report an adjustment to compensation expense in the first quarter of 2025 to reflect
the difference between the compensation expense recorded to date and the cost that should have been recorded given the number of awards
that ultimately vested. The Company does not expect the amount of this adjustment to be significant.
1. Organization of the Company and Basis of Presentation
Cyclacel
Pharmaceuticals, Inc. (“Cyclacel” or “the Company”) is a clinical-stage biopharmaceutical company developing
innovative cancer medicines based on cell cycle and mitosis control biology. Cyclacel is 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.
As
of December 31, 2024, substantially all efforts of the Company to date have been devoted to performing research and development, conducting
clinical trials, developing and acquiring intellectual property, raising capital and recruiting and training personnel.
The
Company is subject to risks and uncertainties common to early-stage companies in the biopharmaceutical industry, including, but not limited
to, the fact that drug candidates developed by the Company typically will require approvals or clearances from the U.S. Food and Drug
Administration, the European Medicines Agency or other similar regulatory agencies in other countries prior to commercial sales. There
can be no assurance that the Company’s drug candidates will receive any of the required approvals or clearances. If any of the
Company’s drug candidates are denied approval or clearance or such approval is delayed, or if the Company is unable to obtain the
necessary financing to complete development and approval, there will be a material adverse impact on the Company’s financial condition
and results of operations.
Through
December 31, 2024, the Company has funded all of its operations and capital expenditures with proceeds from the issuance of public equity
securities, private placements of securities, government grants, research and development tax credits, interest on investments, royalty
income, product revenue and licensing revenue. The Company has incurred recurring losses since its inception, including net losses of
$ 11.2 million and $ 22.6 million for the years ended December 31, 2024 and 2023, respectively. As of December 31, 2024, the Company had
an accumulated deficit of $ 439.5 million. The Company expects to continue to generate operating losses for the foreseeable future due
to, among other things, costs related to the clinical development of its drug candidate, its preclinical programs and its administrative
organization.
Going
Concern
Pursuant
to the requirements of Accounting Standard Codification (ASC) 205-40, Presentation of Financial Statements-Going Concern , management
is required at each reporting period to evaluate whether there are conditions or 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. 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. When substantial doubt exists under this methodology,
management evaluates whether the mitigating effects of its plans sufficiently alleviate the substantial doubt about the Company’s
ability to continue as a going concern. The mitigating effect of management’s plans, however, is only considered if both (1) it
is probable that the plans will be effectively implemented within one year after the date that the financial statements are issued, and
(2) it is probable that the plans, when implemented, will mitigate the relevant conditions or events that raise substantial doubt about
the entity’s ability to continue as a going concern for one year after the date that these financial statements are issued. In
performing its analysis, management excluded certain elements of its operating plan that cannot be considered probable. Under ASC 205-40,
the future receipts of potential funding from future equity or debt issuances or by entering into partnership agreements cannot be considered
probable at this time because these plans are not entirely within
the Company’s control nor have they been approved by the Board of Directors as of the date of these consolidated financial statements.
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Based
on the Company’s current operating plan, it is anticipated that cash and cash equivalents of $ 3.1 million as of December 31, 2024
will allow it to meet liquidity requirements into the second quarter of 2025. The Company continues to work to raise additional capital
however as of the date of these financial statements there is no guarantee that the Company will be able to raise additional funds to
extend operations beyond the second quarter of 2025. The Company’s history of losses, negative cash flows from operations, liquid
resources currently on hand, and dependence on the ability to obtain additional financing to fund its operations, about which there can
be no certainty, have resulted in the assessment that there is substantial doubt about the Company’s ability to continue as a going
concern for a period of at least twelve months from the issuance date of these financial statements. While the Company has 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 it will
be successful in these mitigation efforts.The accompanying consolidated financial statements have been prepared on a going concern basis,
which contemplates realization of assets and the satisfaction of liabilities in the normal course of business.
Basis
of Presentation
The
accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the
United States of America, or GAAP and include the financial statements of Cyclacel Pharmaceuticals, Inc. and all of the Company’s
wholly owned subsidiaries. All intercompany accounts and transactions have been eliminated.
Reverse
Stock Split
The
Company effected a 15:1 reverse stock split of the Company’s common stock on December 18, 2023 (the “Reverse Stock Split”).
All share and per share information has been adjusted to give effect to the Reverse Stock Split for all periods presented, unless otherwise
indicated.
The
Company held a special meeting of stockholders (the “ Special Meeting ”) on February 6, 2025 at which, among other matters,
the Company’s stockholders approved an amendment to the Company’s Amended and Restated Certificate of Incorporation to effect
a reverse stock split at a ratio not less than 1:4 and not more than 1:16 (the “2025 Reverse Stock Split”) such ratio and
the implementation and timing of such Reverse Stock Split to be determined in the discretion of the Company’s Board of Directors
(the “Board”). The 2025 Reverse Stock Split is expected to be implemented by the Board in or around May 2025.
2. Summary of Significant Accounting Policies
Use
of Estimates
The
preparation of financial statements in accordance with GAAP requires management to make estimates and assumptions that affect the reported
amounts of assets, liabilities and related disclosures of contingent assets and liabilities at the date of the financial statements and
the reported expenses during the reporting period. Critical estimates include inputs used to determine clinical trial accruals and stock-based
compensation expense. Cyclacel reviews its estimates on an ongoing basis. The estimates are based on historical experience and on various
other assumptions that the Company believes to be reasonable under the circumstances. Actual results may differ from these estimates.
Cyclacel believes the judgments and estimates required by the following accounting policies to be significant in the preparation of the
Company’s consolidated financial statements.
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Foreign
Currency and Currency Translation
Transactions
that are denominated in a foreign currency are remeasured into the functional currency at the current exchange rate on the date of the
transaction. Any foreign currency-denominated monetary assets and liabilities are subsequently remeasured at current exchange rates,
with gains or losses recognized as foreign exchange (losses) gains in the statement of operations.
The
assets and liabilities of the Company’s international subsidiary are translated from its functional currency into United States
dollars at exchange rates prevailing at the balance sheet date. Average rates of exchange during the period are used to translate the
statement of operations, while historical rates of exchange are used to translate any equity transactions. Translation adjustments arising
on consolidation due to differences between average rates and balance sheet rates, as well as unrealized foreign exchange gains or losses
arising from translation of intercompany loans for which settlement is not planned or anticipated in the foreseeable future and that
are of a long-term-investment nature, are recorded in other comprehensive loss. As discussed in the subsequent events note, the foreign
subsidiary will be liquidated. Upon loss of control of the foreign subsidiary, the accumulated translation adjustments currently recorded
in other comprehensive income within equity will be reversed and recorded as part of the gain/loss from deconsolidation of the subsidiary.
Cash
and Cash Equivalents
Financial
instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and cash equivalents. The
Company considers all highly liquid investments with an original maturity of three months or less at the time of initial purchase to
be cash equivalents. The objectives of the Company’s cash management policy are to safeguard and preserve funds, to maintain sufficient
liquidity to meet Cyclacel’s cash flow requirements and to attain a market rate of return. The Company deposits its cash in financial
institutions that it believes have high credit quality and has not experienced any losses on such accounts and does not believe it is
exposed to any significant credit risk on cash and cash equivalents.
The
Company’s cash and cash equivalents balance at December 31, 2024 was $ 3.1 million and it maintains its cash accounts in several
entities both within the United States and the United Kingdom. The cash balances for amounts held in the United States are insured by
the Federal Deposit Insurance Corporation, or FDIC up to $ 250,000 per account. The Company has cash balances exceeding the balance insured
by the FDIC that totaled approximately $ 2.8 million at December 31, 2024. The cash balances for amounts held in the United Kingdom are
insured by the UK Government Financial Services Compensation Scheme, or FSCS up to £ 85,000 per account. The Company does not have
cash balances exceeding the balance insured by the FSCS at December 31, 2024.
Property
and Equipment
The
components of property and equipment are stated at cost and depreciated on a straight-line basis over the estimated useful lives of
the related assets, which are generally 3 three to five
years . Amortization of leasehold improvements is performed using the straight-line method over the shorter of the remaining
lease term or the estimated useful life of the related assets. Upon sale or retirement of assets, the costs and related accumulated
depreciation and amortization are removed from the balance sheet and the resulting gain or loss on sale is reflected as a component
of operating income or loss. Expenditures for maintenance and repairs are charged to operating expenses as incurred.
Impairment
of Long-lived Assets
The
Company reviews property and equipment for impairment whenever events or changes in business circumstances indicate that the carrying
amount of the assets may not be fully recoverable. The Company assesses the recoverability of the potentially affected long-lived assets
by determining whether the carrying value of such assets can be recovered through undiscounted future operating cash flows.
Impairment,
if any, is measured as the amount by which the carrying amount of a long-lived asset or asset group exceeds its fair value.
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Fair
Value of Financial Instruments
Fair
value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal
or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date.
Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs.
Assets and liabilities measured at fair value are classified and disclosed in one of the following three levels of the fair value hierarchy,
of which the first two are considered observable and the last is considered unobservable:
● Level
1 — Quoted prices in active markets for identical assets or liabilities.
● Level
2 — Observable inputs (other than Level 1 quoted prices), such as quoted
prices in active markets for similar assets or liabilities, quoted prices in markets that
are not active for identical or similar assets or liabilities, or other inputs that are observable
or can be corroborated by observable market data.
● Level
3 — Unobservable inputs that are supported by little or no market activity
that are significant to determining the fair value of the assets or liabilities, including
pricing models, discounted cash flow methodologies and similar techniques.
The
carrying values of cash and cash equivalents, other receivables, accounts payable and accrued expenses approximate their fair values
due to the short-term nature of these assets and liabilities.
Segments
The
Company is managed and operated as one business which is focused on using cell cycle, transcriptional regulation and mitosis control
biology to develop innovative, targeted medicines for cancer and other proliferative diseases. The entire business is managed by a single
management team that reports to the Chief Executive Officer. Historically, the Company has not operated separate lines of business with
respect to any of its products or product candidates and the Company did not prepare discrete financial information with respect to separate
products or product candidates or by location through December 31, 2024. Accordingly, the Company has viewed its business historically
as one reportable operating segment with development operations in two geographic areas, namely the United States and the United Kingdom.
With the commencement of the liquidation of the Subsidiary, the Company will no longer be considered to have control over the Subsidiary
and the financial results of the Subsidiary will be deconsolidated from those of the Company commencing with its first quarter 2025.
Revenue
Recognition
The
Company recognizes revenue in accordance with Accounting Standards Codification (ASC) 606, Revenue from Contracts with Customers .
The
Company has not generated any revenues from product sales to date. However, the Company recognized $ 43,000 of revenue for the year ended
December 31, 2024. This revenue relates to recovery of clinical manufacturing costs associated with an investigator sponsored study managed
by Cedars-Sinai Medical Center (“CSMC”). There were $ 420,000 of revenues recognized for the comparative period in 2023. All
revenues from this customer are recognized at the point in time that the related clinical supply are transferred to CSMC and CSMC obtains
control over the goods. The arrangements with CSMC comprise a single performance obligation.
The
Company has not recognized any other sources of revenue during the years ended December 31 2024 and 2023.
The
Company invoices CSMC following the transfer of the clinical supply and provides CSMC with typical payment terms. The Company has collected
all amounts due from CSMC. As of December 31, 2024, December 31, 2023, and January, 1, 2023, the Company has not recognized any accounts
receivable from CSMC, credit loss allowances, contract assets, contract liabilities, or warranty provisions. There were no remaining
performance obligations outstanding as of December 31, 2024; however, CSMC may place additional orders for clinical supply in 2025 and
beyond.
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Other
Income
Other
income is primarily related to royalty income received under a historical Asset Purchase Agreement for activities which are not part
of the Company’s ongoing operations and activities.
Research
and Development Costs
Research
and development expenses consist primarily of costs associated with the development of the Company’s product candidates, including
upfront fees, milestones, compensation and other expenses for research and development personnel, supplies and development materials,
costs for consultants and related contract research, facility costs and depreciation. Expenditures relating to research and development
are expensed as incurred.
Clinical
Trial Accounting
Data
management and monitoring of the Company’s clinical trials are performed with the assistance of contract research organizations,
or CROs or clinical research associates, or CRAs in accordance with the Company’s standard operating procedures. Typically, CROs
and CRAs bill monthly for services performed, and others bill based upon milestones achieved. The Company accrues unbilled clinical trial
expenses based on estimates of the level of services performed each period. Clinical trial costs related to patient enrollment are accrued
as patients are entered into and progress through the trial.
Patent
Costs
Patent
prosecution costs are charged to general and administrative expenses as incurred as recoverability of such expenditure is uncertain.
Leases
The
Company accounts for lease contracts in accordance with ASC 842. As of December 31, 2024 and 2023, all of the Company’s leases
are classified as operating leases.
The
Company recognizes an asset for the right to use an underlying leased asset for the lease term and records lease liabilities based on
the present value of the Company’s obligation to make lease payments under the lease. As the Company’s leases do not indicate
an implicit rate, the Company uses a best estimate of its incremental borrowing rate to discount the future lease payments. The Company
estimates its incremental borrowing rate based on observable information about risk-free interest rates that are the same tenure as the
lease term, adjusted for various factors, including the effects of assumed collateral, the nature of how a loan would be repaid (e.g.,
amortizing versus bullet), and the Company’s credit risk.
The
Company evaluates options included in its lease agreements to extend or terminate the lease. The Company will reflect the effects of
exercising those options in the lease term when it is reasonably certain that the Company will exercise that option. In assessing whether
it is reasonably certain that the Company will exercise an option, the Company considers factors such as:
● The
lease payments due in any optional period;
● Penalties
for failure to exercise (or not exercise) the option;
● Market
factors, such as the availability of similar assets and current rental rates for such assets;
● The
nature of the underlying leased asset and its importance to the Company’s operations;
and
● The
remaining useful lives of any related leasehold improvements.
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Lease
expense for the Company’s operating leases is recognized on a straight-line basis over the lease term and is reported as a component
of general and administrative expense. Variable lease payments, if any, are recognized in the period when the obligation to make those
payments is incurred. Lease incentives received prior to lease commencement are recorded as a reduction in the right-of-use asset. Fixed
lease incentives received after lease commencement reduce both the lease liability and the right-of-use asset.
The
Company has elected an accounting policy to account for the lease and non-lease components as a single lease component.
Stock-based
Compensation
The
Company measures all stock options and other stock-based awards granted to employees and directors based on the fair value on the
date of the grant and recognizes compensation expense of those awards over the requisite service period, which for the Company is
the period between the grant date and the date the award vests or becomes exercisable. Many awards granted by the Company vest
ratably over 3 three
or four
years . However, certain awards granted to members of the Company’s Board of Directors vest in their entirety on the 1
one-year anniversary following the date of grant. Generally, the Company issues stock options and restricted stock awards to
employees with only service-based vesting conditions and records the expense for these awards using the straight-line method.
However, in certain years, the Company will grant share-based payment awards to employees that are dependent upon the fulfillment of
certain clinical and financial conditions. In such instances where the performance condition must be met for the award to vest, the
company only recognizes compensation expense when the award is probable of vesting (See Note 12 — Stock-Based
Compensation).
The
Company classifies stock-based compensation expenses in its statement of operations in the same manner in which the award recipient’s
payroll costs are classified. The Company accounts for forfeitures as they occur.
The
fair value of restricted stock and restricted stock units is determined based on the number of shares granted and the quoted price of
the Company’s common stock on the date of grant. The determination of grant-date fair value for stock option awards is estimated
using the Black-Scholes model, which includes variables such as the expected volatility of the Company’s share price, expected
term of the award, interest rates, and dividend yields.
The
Company relies on its historical volatility as an input to the option pricing model as management believes that this rate will be representative
of future volatility over the expected term of the options.
The
expected term assumption is estimated using past history of early exercise behavior and expectations about future behaviors.
The
weighted average risk-free interest rate represents the interest rate for treasury constant maturities published by the Federal Reserve
Board. If the term of available treasury constant maturity instruments is not equal to the expected term of an employee option, Cyclacel
interpolates a discount rate based on the two Federal Reserve securities closest to the expected term of the employee option.
The
expected dividend yield is zero, as the Company has never paid cash dividends on common stock and does not expect to pay any cash dividends
on common stock in the foreseeable future.
Income
Taxes
The
Company accounts for income taxes using the liability method. Under this method, deferred tax assets and liabilities are determined based
on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year
in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred
tax assets to the amounts expected to be realized.
The
Company accounts for uncertainty in income taxes recognized in the financial statements by applying a two-step process to determine the
amount of tax benefit to be recognized. First, the tax position must be evaluated to determine the likelihood that it will be sustained
upon external examination by the taxing authorities. If the tax position is deemed more-likely-than-not-to be sustained, the tax position
is then assessed to determine the amount of benefit to recognize in the financial statements. The amount of the benefit that may be recognized
is the largest amount that has a greater than 50% likelihood of being realized upon ultimate settlement. The provision for income taxes
includes the effects of any resulting tax reserves for unrecognized tax benefits that are considered appropriate as well as the related
net interest and penalties.
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The
Company records research and development tax credits within income taxes. Credit is taken in the accounting period for research and development
tax credits, when claimed from H.M. Revenue & Customs, or HMRC, the United Kingdom’s taxation and customs authority, in respect
of qualifying research and development costs incurred in the same accounting period.
Net
Loss Per Common Share
The
Company calculates net loss per common share in accordance with ASC 260 “Earnings Per Share”. Basic and diluted net loss
per common share was determined by dividing the net loss applicable to common stockholders by the weighted average number of common shares
outstanding during the period.
In
periods in which the Company reports a net loss attributable to common stockholders, diluted net loss per share attributable to common
stockholders is the same as basic net loss per share attributable to common stockholders since potentially dilutive common shares are
not assumed to have been issued if their effect is anti-dilutive. The Company reported a net loss attributable to common stockholders
for the years ended December 31, 2024 and 2023.
Comprehensive
Income (Loss)
All
components of comprehensive income (loss), including net income (loss), are reported in the financial statements in the period in which
they are recognized. Comprehensive income (loss) is defined as the change in equity during a period from transactions and other events
and circumstances from non-owner sources. Net income (loss) and other comprehensive income (loss), including foreign currency translation
adjustments, are reported to arrive at comprehensive income (loss). There were no reclassifications out of other comprehensive income
(loss) during the years ended December 31, 2024 and 2023.
Recently
Issued Accounting Pronouncements
The
FASB has issued ASU 2024-03, “ Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures
(Subtopic 220-40): Disaggregation of Income Statement Expenses ”. This standard will require all public entities to disclose
additional information about specific expense categories in the notes to financial statements at interim and annual reporting periods.
The amendments in ASU 2024-03 are effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods
beginning after December 15, 2027. ASU 2024-03 will not change the way in which expenses are recognized or measured. However, the Company
is currently evaluating the effects of ASU 2023-07 on its financial statement presentation and disclosures.
The
FASB has issued ASU 2023-09, “Income Taxes (Topic 740): Improvements to Income Tax Disclosures”. This standard will require
all entities to include specified captions when reconciling the statutory income tax rate to the effective tax rate, on both a percentage
and absolute dollar basis. ASU 2023-09 will also require entities to disclose the amount of income taxes paid (net of refunds received)
disaggregated by federal (national), state, and foreign for each annual reporting period, with separate disclosure of individual jurisdictions
for which tax payments to, or receipts from, exceed a defined threshold. The guidance in ASU 2023-09 becomes effective for annual periods
beginning after December 15, 2024. The Company does not anticipate that ASU 2023-09 will require significant adjustments to the presentation
of that information.
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3.
Significant Contracts
Distribution,
Licensing and Research Agreements
The
Company has entered into licensing and similar agreements with academic and research organizations. Under the terms of these agreements,
the Company has received licenses to technology and patent applications. The Company may be required to pay royalties on future sales
of products employing the technology or falling under claims of patent applications.
Under
a 2003 license agreement, the Company licensed certain patent rights for sapacitabine. The Company will not be pursuing further development
of sapacitabine and the license agreement was terminated effective as of March 23, 2023 for commercial reasons.
The
3 three-year term of the Clinical Collaboration Agreement, or CCA with The University of Texas MD Anderson Cancer Center, or MD
Anderson ended in September 2021, in accordance with its terms. The main objective of the CCA was to clinically evaluate the safety
and efficacy of three Cyclacel medicines in patients with hematological malignancies, including chronic lymphocytic leukemias, acute
myeloid leukemias, myelodysplastic syndromes and other advanced leukemias. Under the terms of the CCA, MD Anderson conducted four
clinical studies and under the risk-sharing agreement MD Anderson assumed the patient costs for all studies and Cyclacel, who is the
sponsor, provided investigational drugs and other limited support. The agreement provided that the Company would make certain
payments to MD Anderson upon first commercial sale in specific indications studied in the alliance. There were no
such payments earned in 2024 or 2023.
4. Cash and Cash Equivalents
The
following is a summary of cash and cash equivalents at December 31, 2024 and 2023 (in thousands):
Summary of Cash and Cash Equivalents
2024
2023
December 31,
2024
2023
Cash
$ 93
$ 3,303
Cash equivalents
3,044
75
Total cash and cash equivalents
$ 3,137
$ 3,378
Cash
equivalents are made up entirely of money market funds.
5. Fair Value of Financial Assets and Liabilities
The
following tables present information about the Company’s financial assets and liabilities measured at fair value on a recurring
basis and indicate the level of the fair value hierarchy utilized to determine such fair values (in thousands):
Schedule of Financial Assets and Liabilities Measured on a Recurring Basis
Level 1
Level 2
Level 3
Total
Fair Value Measurements as of
December 31, 2024 Using:
Level 1
Level 2
Level 3
Total
Assets:
Cash equivalents
$ 3,044
$ —
$ —
$ 3,044
Total Assets
$ 3,044
$ —
$ —
$ 3,044
Level 1
Level 2
Level 3
Total
Fair Value Measurements as of
December 31, 2023 Using:
Level 1
Level 2
Level 3
Total
Assets:
Cash equivalents
$ 75
$ —
$ —
$ 75
Total Assets
$ 75
$ —
$ —
$ 75
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6. Prepaid Expenses and Other Assets
The
following is a summary of prepaid expenses and other current assets at December 31, 2024 and 2023 (in thousands):
Schedule of Prepaid Expenses and Other Assets
December 31,
December 31,
2024
2023
Research and development tax credit receivable
$ —
$ 2,933
Prepayments and VAT receivable
237
792
Other current assets
300
341
Prepaid expense and other
assets
$ 537
$ 4,066
7. Non-Current Assets
As
at December 31, 2024, the Company had non-current assets of $ 0.4 million, which comprised clinical trial deposits held by a contract
research organization in relation to the Company’s Phase 1/2 clinical trials. As at December 31, 2023, the Company had non-current
assets of $ 1.3 million, which was wholly attributable to clinical trial deposits.
8. Property and Equipment
Property
and equipment consisted of the following at December 31, 2024 and 2023 (in thousands):
Schedule of Property and Equipment
Lives in years
2024
2023
December 31,
Lives in years
2024
2023
Leasehold improvements
2 to 5
$ 6
$ 6
Office equipment and furniture
3 to 5
420
423
Property and equipment, gross
427
429
Less: accumulated depreciation and amortization
( 424 )
( 420 )
Property and equipment,
net
$ 3
$ 9
9. Accrued and Other Current Liabilities
Accrued
and other current liabilities consisted of the following at December 31, 2024 and 2023 (in thousands):
Schedule of Accrued and Other Current Liabilities
December 31,
December 31,
2024
2023
Accrued research and development
$ 1,299
$ 3,668
Accrued legal and professional fees
87
570
Other current liabilities
283
380
Accrued and other current
liabilities
$ 1,669
$ 4,618
As
at December 31, 2024, the Company had accounts payables of $ 4.6 million, of which $ 4.1 million related to the UK subsidiary. As at December
31, 2023, the Company had accounts payables of $ 3.5 million, of which $ 3.1 million related to the UK subsidiary.
10. Commitments
and Contingencies
General
Please
refer to Note 3 — Significant Contracts for further discussion of certain of the Company’s commitments
and contingencies.
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Leases
In
April 2022, the Company extended the lease for its corporate headquarters facility in Berkeley Heights, New Jersey for a further three
years , expiring in July 2025. In December 2024, the Company terminated this lease, effective as of January 31, 2025. Effective March
1, 2025, the Company entered into a two year lease agreement for our corporate headquarters at Level 10, Tower 11, Avenue 5, No. 8, Jalan
Kerinchi, 59200 Kuala Lumpur, Malaysia, which we believe will be adequate to accommodate our business needs.
For
the years ended December 31, 2024 and December 31, 2023, the Company recognized operating lease expenses of $ 82,830 and $ 74,218 respectively,
including $ 9,104 and $ 10,851 respectively relating to a short term lease for offices in Dundee, Scotland. The remaining lease term as
of December 31, 2024 is one month for the Berkeley Heights facility and no remaining lease term for Dundee, Scotland. The discount rate
used by the Company in determining the lease liability was 12 %.
The
following is a summary of the Company’s future contractual obligations and commitments relating to its facilities lease as at December
31, 2024 (in thousands):
Schedule of the Company’s Future Contractual Obligations and Commitments Relating to Its Facilities Leases
Operating Lease
Obligation
2025
$ 5
2026
—
Thereafter
—
Total future minimum lease obligation
$ 5
Less imputed interest
—
Total
$ 5
11.
Stockholders’ Equity
The
Company has completed the following equity issuances during the periods presented in the consolidated financial statements.
November
2024 Warrant Exercise and Reload Agreement
On
November 13, 2024, Cyclacel Pharmaceuticals, Inc. (the “Company”) entered into a letter agreement (the “Warrant Exercise
and Reload Agreement”) with the holder (the “Holder”) of its issued and outstanding Series B Warrants (the “Prior
Warrants”) to purchase an aggregate of 20,703 shares of common stock of the Company offering the Holder the opportunity to exercise
all of its Prior Warrants for cash at a reduced exercise price equal to $ 99.60 per share provided the Prior Warrants were exercised in
full for cash on or before 12:30 P.M. Eastern Time on the date of the Warrant Exercise and Reload Agreement. In consideration for the
exercise of the Prior Warrants, the Holder received new unregistered Series C Warrants (the “Series C Warrants”) exercisable
for up to an aggregate of 41,407 shares of common stock (the “Series C Warrant Shares”) and new unregistered Series D Warrants
(the “Series D Warrants” and, together with the Series C Warrants, the “New Warrants”) exercisable for up to
an aggregate of 41,407 shares of common stock (the “Series D Warrant Shares” and, together with the Series C Warrant Shares,
the “New Warrant Shares”). The Series C Warrants are exercisable beginning on the date upon which the Company receives stockholder
approval of the issuance of the New Warrant Shares and the Placement Agent Warrant Shares (as defined below) (the “Stockholder
Approval Date”) for a period of five and one-half ( 5.5 ) years following the Stockholder Approval Date and the Series D Warrants
are exercisable beginning on the Stockholder Approval Date for a period of eighteen ( 18 ) months following the Stockholder Approval Date.
The New Warrants each have an exercise price of $ 99.60 per share. The shares of common stock issued upon exercise of the Prior Warrants
are registered pursuant to an effective registration statement on Form S-1 (No. 333-279157).
April
2024 Securities Purchase Agreement
On
April 30, 2024, the Company entered into a securities purchase agreement (the “Purchase Agreement”) with an institutional
investor (the “Purchaser”) for the issuance and sale in a private placement (the “Private Placement”) of (i)
604 shares of the Company’s common stock, (ii) pre-funded warrants to purchase up to 20,099 shares of common stock (the “Pre-Funded
Warrants”), (iii) series A warrants to purchase up to 20,703 shares of common stock (the “Series A Warrants”), and
(iv) series B warrants to purchase up to 20,703 shares of common stock (the “Series B Warrants” and together with the Series
A Warrants, the “Common Warrants”). The purchase price of each share of common stock and associated Common Warrants was $ 386.40
and the purchase price of each Pre-Funded Warrant and associated Common Warrants was $ 386.38 .
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The
Common Warrants are exercisable immediately upon issuance at an exercise price of $ 326.40
per share. The Series A Warrants will expire five and one-half
years 5.5 from
the date of issuance and the Series B Warrants will expire 18
eighteen months from the date of issuance. The Pre-Funded Warrants
are exercisable immediately upon issuance at an exercise price of $ 0.024 per share and may be exercised at any time until the Pre-Funded
Warrants are exercised in full. A holder of Pre-Funded Warrants or Common Warrants (together with its affiliates) may not exercise any
portion of such warrants to the extent that the holder would own more than 4.99 % (or, at the election of the holder 9.99 %) of the Company’s
outstanding common stock immediately after exercise.
In
connection with the Private Placement, the Company entered into a registration rights agreement (the “Registration Rights Agreement”),
dated as of April 30, 2024, with the Purchaser, pursuant to which the Company agreed to prepare and file a registration statement with
the Securities and Exchange Commission (the “SEC”) registering the resale of the securities issued in the Private Placement.
The
Private Placement closed on May 2, 2024. The gross proceeds to the Company from the Private Placement were approximately $ 8.0 million,
before deducting placement agent fees and estimated offering expenses payable by the Company.
H.C.
Wainwright & Co., LLC (“Wainwright”) acted as the Company’s exclusive placement agent in connection with the
Private Placement, pursuant to that certain engagement letter, dated as of April 29, 2024, between the Company and Wainwright (as
amended, the “Engagement Letter”). Pursuant to the Engagement Letter, the Company paid Wainwright (i) a cash fee
equal to 7.0 % of the aggregate gross proceeds of the Private Placement and (ii) a management fee of 1.0 % of the aggregate gross
proceeds of the Private Placement. In addition, the Company agreed to pay Wainwright certain expenses and issued to Wainwright or
its designees warrants (the “Placement Agent Warrants”) to purchase up to an aggregate of 1,242 shares of common stock
at an exercise price equal to $ 483.00 per share. The Placement Agent Warrants are exercisable immediately upon issuance and have a
term of exercise equal to five and a half years 5.5 from the date of issuance.
In
connection with this transaction, the Company was required to compensate Roth Capital Partners, LLC, pursuant to a tail provision contained
in an engagement letter entered into on March 14, 2024, in an amount equal to 7.0 % of the aggregate proceeds of the Private Placement
plus the reimbursement of certain expenses. The Company was also required to compensate Ladenburg Thalmann & Co. Inc, pursuant to
a tail provision contained in an engagement letter entered into on October 30, 2023, in an amount equal to 8.0 % of the aggregate proceeds
of the Private Placement.
Each
of the instruments issued in the Private Placement have been classified and recorded as part of shareholders’ equity (deficit).
The amounts allocated to each issued security were based on their relative fair values, resulting in initial carrying values of the respective
instruments as follows:
Schedule
of Fair Value of Instruments Issued in Offering
Allocated Amount
Common shares
$ 72,108
Prefunded warrants
2,398,831
Common warrants
3,819,274
Net proceeds
$ 6,290,213
The
aggregate fair value of the Placement Agent Warrants was $ 609,179 . These have been accounted for as a direct cost of the Private Placement,
resulting in no net effect to overall shareholders’ equity (deficit).
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In
determining the fair values of the Pre-Funded Warrants, Common Warrants, and Placement Agent Warrants, the Company used a Black-Scholes
Option Pricing model with the following assumptions:
Schedule of Fair value of Warrants Valuation Assumption
Pre-Funded
Warrants
Common
Warrants
Placement
Agent Warrants
Expected
volatility
100 %
103 %
- 121 %
103 %
Contractual
term
1
year
1.5
1½ - 5½ years 5.5
5½
years 5.5
Risk-free
interest rate
5.51 %
4.57 %
- 5.51 %
4.57 %
Expected
dividend yield
0 %
0 %
0 %
The
fair value of the common stock was determined using the closing price of the Company’s common stock as of May 2, 2024, which is
the date that the Private Placement closed.
December
2023 Registered Direct Offering Securities Purchase Agreement
On
December 21, 2023, the Company entered into a securities purchase agreement (the “Securities Purchase Agreement”) with certain
institutional investors (“Purchasers”). Pursuant to the Securities Purchase Agreement, the Company agreed to sell in a registered
direct offering (“Registered Direct Offering”) 702 shares (“Shares”) of the Company’s common stock and
pre-funded warrants (“Pre-Funded Warrants”) to purchase up to 915 shares of common stock. The Pre-Funded Warrants have an
exercise price of $ 0.24 per share and are immediately exercisable and can be exercised at any time after their original issuance until
such Pre-Funded Warrants are exercised in full. Each Share is being sold at an offering price of $ 795.60 and each Pre-Funded Warrant
is being sold at an offering price of $ 795.36 (equal to the purchase price per Share minus the exercise price of the Pre-Funded Warrant).
Pursuant
to the Securities Purchase Agreement, in a concurrent private placement (together with the Registered Direct Offering, the “Offerings”),
the Company also agreed to issue to the Purchasers unregistered warrants (“Common Warrants”) to purchase up to 1,617 shares
of common stock. Each Common Warrant has an exercise price of $ 765.60 per share, is exercisable immediately following their original
issuance and will expire seven years from the original issuance date. The closing of the offering occurred on December 26, 2023, and
the net proceeds to the Company were approximately $ 1.0 million, after deducting placement agent fees and other offering expenses payable
by the Company.
On
December 21, 2023, in a separate concurrent insider private placement (the “Insider Private Placement”), the Company also
entered into a Securities Purchase Agreement with certain of its executive officers (the “Insider Securities Purchase Agreement”)
pursuant to which the Company agreed to sell in a private placement (i) 25 shares of common stock and warrants to purchase 25 shares
of common stock on the same terms as the Common Warrants issued to the Purchasers in the Offerings to Spiro Rombotis, the Company’s
Chief Executive Officer, and (ii) 7 shares of common stock and warrants to purchase 7 shares of common stock on the same terms as the
Common Warrants issued to the Purchasers in the Offerings to Paul McBarron, the Company’s Executive Vice President-Finance, Chief
Financial Officer and Chief Operating Officer. Each such share of common stock and accompanying warrant was sold at a purchase price
of $ 795.60 , which was the same purchase price for the Shares sold in the Registered Direct Offering.
Ladenburg
Thalmann & Co. Inc. (the “Placement Agent”) acted as the exclusive placement agent for the Offerings, pursuant to a placement
agency agreement (the “Placement Agency Agreement”), dated December 21, 2023, by and between the Company and the Placement
Agent.
Pursuant
to the Placement Agency Agreement, the Company paid the Placement Agent a cash placement fee equal to 8.0 % of the aggregate gross proceeds
raised in the Offerings from sales arranged for by the Placement Agent. Subject to certain conditions, the Company also agreed to reimburse
all reasonable travel and other out-of-pocket expenses of the Placement Agent in connection with the Offerings, including but not limited
to legal fees, up to a maximum of $ 85,000 . In addition, the Placement Agent also received warrants that have substantially the same terms
as the Warrants issued in the concurrent private placement to the Purchasers in the Offerings to purchase that number of shares of common
stock equal to 6.0 % of the aggregate number of shares of common stock and Prefunded Warrants sold in the Offerings, or an aggregate of
99 shares of common stock, at an exercise price of $ 994.50 per share (the “Placement Agent Warrants”). The Placement Agent
Warrants will be exercisable immediately following the date of issuance and will expire five years from issuance. The Placement Agency
Agreement contains customary representations, warranties and agreements by the Company and customary conditions to closing. The Company
has agreed to indemnify the Placement Agent against certain liabilities, including liabilities under the Securities Act, and liabilities
arising from breaches of representations and warranties contained in the Placement Agency Agreement, or to contribute to payments that
the Placement Agent may be required to make in respect of those liabilities.
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Each
of the instruments issued in the Offerings and the Insider Private Placement have been classified and recorded as part of shareholders’
equity. The amounts allocated to each issued security were based on their relative fair values, resulting in initial carrying values
of the respective instruments as follows:
Schedule
of Fair Value of Instruments Issued in Offering
Allocated Amount
Common Shares
$ 258,000
Pre-Funded Warrants
$ 321,000
Regular Warrants
$ 470,000
Net Proceeds
$ 1,049,000
The
aggregate fair value of the Placement Agent Warrants was $ 47,000 . These have been accounted for as a direct cost of the Offerings and
Inside Private Placement, resulting in no net effect to overall shareholders’ equity.
In
determining the fair values of the Pre-Funded Warrants, Regular Warrants, and Placement Agent Warrants, the Company used a Black-Scholes
Option Pricing model with the following assumptions:
Schedule
of Fair value of Warrants Valuation Assumption
Pre-Funded Warrants
Regular Warrants
Placement Agent Warrants
Expected volatility
134 %
96 %
99 %
Contractual/expected term
1 month
7 years
5 years
Risk-free interest rate
5.53 %
3.91 %
3.89 %
Expected dividend yield
0 %
0 %
0 %
The
fair value of the common shares was determined using the closing price of the Company’s common stock as of December 26, 2023, which
is the date that the Offerings and the Insider Private Placement closed.
August
2021 Controlled Equity Offering Sales Agreement
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 $ 50.0 million through Cantor as the sales agent. Cantor could sell the Company’s
common stock by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) of the
Securities Act.
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 551 shares of its common stock at the market price, following the expiration of the Registration Statement and through
August 12, 2022, for aggregate proceeds of approximately $ 2,721,187 . There was no sale of shares post August 12, 2022. The sale of these
shares were subject to potential rescission rights by certain shareholders. As a result of these potential rescission rights, the Company
reclassified 865 shares (including 313 shares sold for which the Company did not receive any proceeds), with an aggregate purchase price
of $ 4,494,496 of its common stock outside stockholders’ equity as of December 31, 2022. These shares have been treated as issued
and outstanding for financial reporting purposes. The rescission rights for these shares lapsed and the shares were reclassified back
to permanent equity as of December 31, 2023. As of December 31, 2024, there have been no claims or demands to exercise such rights.
On
August 15, 2022, the Sales Agreement was mutually terminated. A total of 911 shares, for gross proceeds of approximately $ 7.6 million,
had been sold pursuant to the Sales Agreement.
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Warrants
November
2024 Warrants
As
of December 31, 2024, warrants to purchase a total of 82,814
shares of common stock issued pursuant to a securities purchase
agreement in a November 2024 financing transaction (the “November 2024 Warrant Exercise and Reload Agreement”) remained outstanding.
A total of 82,814
warrants were issued in pursuant to the November 2024 Warrant
Exercise and Reload Agreement. This consisted of i) series C warrants to purchase up to 41,407
shares of common stock, exercisable immediately from the date
of issuance for a period of 5.5
five and a half years after the date of issuance, at an exercise
price of $ 99.60
per warrant share, ii) series D warrants to purchase up to
41,407
shares of common stock, exercisable immediately from the date
of issuance for a period of eighteen months 18
after the date of issuance, at an exercise price of $ 99.60
per warrant share.
There
were no exercises of these warrants during the years ended December 31, 2024 or December 31, 2023.
April
2024 Warrants
As
of December 31, 2024, warrants to purchase a total of 31,933
shares of common stock issued pursuant to a securities purchase
agreement in an April 2024 financing transaction (the “April 2024 Securities Purchase Agreement”) remained outstanding. A
total of 62,749
warrants were issued in pursuant to the April 2024 Securities
Purchase Agreement. This consisted of i) pre-funded warrants to purchase 20,099
of common stock, exercisable immediately from the date of issuance,
and with no expiry date, at an exercise price of $ 0.024
per warrant share, ii) series A warrants to purchase up to
20,703
shares of common stock, exercisable immediately from the date
of issuance for a period of 5.5
five and a half years after the date of issuance, at an exercise
price of $ 326.40
per warrant share, iii) series B warrants to purchase up to
20,099
shares of common stock, exercisable immediately from the date
of issuance for a period of eighteen months 18
after the date of issuance, at an exercise price of $ 326.40
per warrant share. A further 1,242
warrants issued in a concurrent placement agency agreement,
are exercisable immediately from the date of issuance for a period of five and a half years 5.5
after the date of issuance, at an exercise price of $ 483.00
per warrant share.
A
total of 20,099 pre-funded warrants and 10,716 Series B warrants were exercised during the year ended December 31, 2024.
December
2023 Warrants
As
of December 31, 2024, warrants to purchase a total of 1,749 shares of common stock issued pursuant to a securities purchase agreement
in a December 2023 financing transaction remained outstanding. A total of 1,650 warrants, including 32 warrants issued in a concurrent
private placement, are exercisable immediately from the date of issuance for a period of seven years after the date of issuance, at an
exercise price of $ 765.60 per warrant share. A further 99 warrants issued in a concurrent placement agency agreement, are exercisable
immediately from the date of issuance for a period of five years after the date of issuance, at an exercise price of $ 994.50 per warrant
share.
There
were no exercises of these warrants during the years ended December 31, 2024 or December 31, 2023.
December
2020 Warrants
As
of December 31, 2024, warrants to purchase 186 shares of common stock issued pursuant to a securities purchase agreement in a December
2020 financing transaction remained outstanding. Each warrant shall be exercisable beginning on the 12-month anniversary of the date
of issuance for a period of five years after the date of issuance, at an exercise price of $ 14,868.00 per warrant share. The exercise
price of the warrants will be subject to adjustment in the event of any stock dividends and splits, reverse stock split, recapitalization,
reorganization or similar transaction, as described in the warrants. The warrants may be exercised on a “cashless” basis.
During
the year ended December 31, 2024, 65 warrants lapsed upon conversion of the associated Series B Preferred Stock. There were no exercises
of these warrants during the year ended December 31, 2023.
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April
2020 Warrants
As
of December 31, 2024, 497 warrants issued in connection with an April 2020 equity financing remained outstanding, each with an exercise
price of $ 18,000.00 . The common warrants are immediately exercisable and will expire on the fifth anniversary of the original issuance
date. The exercise price and number of shares of common stock issuable upon exercise is subject to appropriate adjustment in the event
of stock dividends, stock splits, reorganizations or similar events affecting the Company’s common stock. The common warrants were
issued separately from the common stock and were eligible for transfer immediately after issuance. A common warrant to purchase one share
of common stock was issued for every share of common stock purchased in this offering.
The
common warrants are exercisable, at the option of each holder, in whole or in part, by delivering to the Company a duly executed exercise
notice accompanied by payment in full for the number of shares of the Company’s common stock purchased upon such exercise (except
in the case of a cashless exercise). A holder (together with its affiliates) may not exercise any portion of the common warrant to the
extent that the holder would own more than 4.99 % of the outstanding common stock immediately after exercise, except that upon at least
61 days prior notice from the holder to the Company, the holder may increase the amount of ownership of outstanding stock after exercising
the holder’s common warrants up to 9.99 % of the number of shares of the Company’s common stock outstanding immediately after
giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the common warrants. No fractional
shares of common stock will be issued in connection with the exercise of a common warrant. In lieu of fractional shares, the Company
will round down to the next whole share.
A
total of 111 warrants were exercised during the year ended December 31, 2024. No warrants were exercised during the year ended December
31, 2023.
Series
B Preferred Stock
A
total of 237,745 shares of the Company’s Series B Preferred Stock were issued in a December 2020 Securities Purchase Agreement.
Each share of Series B Preferred Stock shall initially be convertible into one third (1/3) share of common stock (the “Conversion
Shares”), subject to adjustment in accordance with the Certificate of Designation.
Holders
of Series B Preferred Stock are entitled to receive dividends on shares of Series B Preferred Stock equal, on an as-if-converted-to-Common-Stock
basis, and in the same form as dividends actually paid on shares of the common stock. Except as otherwise required by law, the Series
B Preferred Stock does not have voting rights. However, as long as any shares of Series B Preferred Stock are outstanding, the Company
will not, without the affirmative vote of the holders of a majority of the then outstanding shares of the Series B Preferred Stock, (a)
alter or change adversely the powers, preferences or rights given to the Series B Preferred Stock, (b) alter or amend the Certificate
of Designation, (c) amend its certificate of incorporation or other charter documents in any manner that adversely affects any rights
of the holders of Series B Preferred Stock, (d) increase the number of authorized shares of Series B Preferred Stock, (e) pay certain
dividends or (f) enter into any agreement with respect to any of the foregoing. The Series B Preferred Stock does not have a preference
upon any liquidation, dissolution or winding-up of the Company. The Purchaser may convert shares of Series B Preferred Stock through
a conversion into shares of common stock if and solely to the extent that such conversion would not result in the Purchaser beneficially
owning in excess of 9.99 % of then-outstanding common stock or aggregate voting power of the Company (such limitation, the “Ownership
Limitation”) and any portion in excess of such limitation will remain outstanding as Series B Preferred Stock.
During
the year ended December 31, 2024, 119,000 shares of Series B Preferred Stock was converted, at the option of the holder, into 165 shares
of common stock. As of December 31, 2024, there were no remaining shares of the Series B Preferred Stock.
Series
A Preferred Stock
A
total of 8,872 shares of the Company’s Series A Preferred Stock were issued in a July 2017 Underwritten Public Offering. Each share
of Series A Preferred Stock is convertible at any time at the option of the holder thereof, into a number of shares of common stock determined
by dividing $ 1,000 by the initial conversion price of $ 600.00 per share, subject to a 4.99 % blocker provision, or, upon election by a
holder prior to the issuance of shares of Series A Preferred Stock, 9.99 %, and is subject to adjustment for stock splits, stock dividends,
distributions, subdivisions and combinations.
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As
of December 31, 2024 and 2023, 264 shares of the Series A Preferred Stock remain issued and outstanding. The 264 shares of Series A Preferred
Stock issued and outstanding at December 31, 2024, are convertible into 1 share of common stock.
In
the event of a liquidation, the holders of shares of the Series A Preferred Stock may participate on an as-converted-to-common-stock
basis in any distribution of assets of the Company. The Company shall not pay any dividends on shares of common stock (other than dividends
in the form of common stock) unless and until such time as dividends on each share of Series A Preferred Stock are paid on an as-converted
basis. There is no restriction on the Company’s ability to repurchase shares of Series A Preferred Stock while there is any arrearage
in the payment of dividends on such shares, and there are no sinking fund provisions applicable to Series A Preferred Stock.
Subject
to certain conditions, at any time following the issuance of the Series A Preferred Stock, the Company has the right to cause each holder
of the Series A Preferred Stock to convert all or part of such holder’s Series A Preferred Stock in the event that (i) the volume
weighted average price of our common stock for 30 consecutive trading days, or Measurement Period exceeds 300 % of the initial conversion
price of the Series A Preferred Stock (subject to adjustment for forward and reverse stock splits, recapitalizations, stock dividends
and similar transactions), (ii) the daily trading volume on each Trading Day during such Measurement Period exceeds $ 500,000 per trading
day and (iii) the holder is not in possession of any information that constitutes or might constitute, material non-public information
which was provided by the Company. The right to cause each holder of Series A Preferred Stock to convert all or part of such holder’s
Series A Preferred Stock shall be exercised ratably among the holders of the then outstanding preferred stock.
The
Series A Preferred Stock has no maturity date, will carry the same dividend rights as the common stock, and with certain exceptions contains
no voting rights. In the event of any liquidation or dissolution of the Company, the Series A Preferred Stock ranks senior to the common
stock in the distribution of assets, to the extent legally available for distribution.
6%
Convertible Exchangeable Preferred Stock
As
of December 31, 2024, there were 135,273 shares of the Company’s 6 % Convertible Exchangeable, or Preferred Stock issued and outstanding
at an issue price of $ 10.00 per share. Dividends on the Preferred Stock are cumulative from the date of original issuance at the annual
rate of 6 % of the liquidation preference of the Preferred Stock, and if declared, payable quarterly on the first day of February, May,
August and November, commencing February 1, 2005. Any dividends must be declared by the Company’s Board of Directors and must come
from funds that are legally available for dividend payments. The Preferred Stock has a liquidation preference of $ 10.00 per share, plus
accrued and unpaid dividends.
The
Company’s Board of Directors considers numerous factors in determining whether to declare the quarterly dividend pursuant to the
Certificate of Designations governing the terms of the Company’s Preferred Stock, including the requisite financial analysis and
determination of a surplus. Accumulated but unpaid dividends in arrears on preferred stock were $ 0.3 million, or $ 2.55 per share, of
preferred stock, as of December 31, 2024.
The
Preferred Stock is convertible at the option of the holder at any time into the Company’s shares of common stock at a conversion
rate of approximately 0.000000069 shares of common stock for each share of Preferred Stock based on a price of $ 142,128,000 per share.
The Company has reserved 6 shares of common stock for issuance upon conversion of the remaining shares of Preferred Stock outstanding
at December 31, 2024. The shares of previously converted Preferred Stock have been retired, cancelled and restored to the status of authorized
but unissued shares of preferred stock, subject to reissuance by the Board of Directors as shares of Preferred Stock of one or more series.
The
Company may automatically convert the Preferred Stock into common stock if the closing price of the Company’s common stock has
exceeded $ 213,192,000 ,
which is 150 %
of the conversion price of the Preferred Stock, for at least 20
trading days during any 30 -day
trading period, ending within five
5
trading days prior to notice of automatic conversion.
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The
Certificate of Designations governing the Preferred Stock provides that if the Company fails to pay dividends on its Preferred Stock
for six quarterly periods, holders of Preferred Stock are entitled to nominate and elect two directors to the Company’s Board of
Directors. This right accrued to the holders of Preferred Stock as of August 2, 2010 and two directors were nominated and elected at
the annual meeting held on May 24, 2011.
The
Preferred Stock has no maturity date and no voting rights prior to conversion into common stock, except under limited circumstances.
The
Company may, at its option, redeem the Preferred Stock in whole or in part, out of funds legally available at the redemption price of
$ 10.00 per share.
The
Preferred Stock is exchangeable, in whole but not in part, at the option of the Company on any dividend payment date beginning on November
1, 2005, or Exchange Date for the Company’s 6 % Convertible Subordinated Debentures, or Debentures at the rate of $ 10.00 principal
amount of Debentures for each share of Preferred Stock. The Debentures, if issued, will mature 25 years after the Exchange Date and have
terms substantially similar to those of the Preferred Stock. No such exchanges have taken place as of December 31, 2024.
For
the year ended December 31, 2023, the company declared dividends of $ 0.15 per share quarterly on its 6 % Convertible Exchangeable Preferred
Stock. These dividends were paid on February 1, 2024. No further dividends were declared or paid subsequent to this.
12.
Stock-Based Compensation
Stock
based compensation has been reported within expense line items on the consolidated statement of operations for the years ended 2024 and
2023 as shown in the following table (in thousands):
Schedule of Stock Based Compensation Expense
2024
2023
Year
Ended
December
31,
2024
2023
General
and administrative
$ 498
$ 1,039
Research
and development
94
434
Stock-based
compensation costs
$ 592
$ 1,473
2018
Plan
In
May 2018, the Company’s stockholders approved the 2018 Equity Incentive Plan (the “2018 Plan”), under which Cyclacel
may make equity incentive grants to its officers, employees, directors and consultants. The 2018 Plan replaced the 2015 Equity Incentive
Plan (the “2015 Plan”).
The
2018 Plan allows for various types of award grants, including stock options and restricted stock units.
On
June 21, 2024, the Company’s stockholders approved an additional 160,000 shares of common stock that may be issued under the 2018
Plan. On June 13, 2023, the Company’s stockholders approved an additional 60,000 shares of common stock that may be issued under
the 2018 Plan. As of December 31, 2024, the Company has reserved approximately 196,000 shares of the Company’s common stock under
the 2018 Plan for future issuances. Stock option awards granted under the Company’s equity incentive plans have a maximum life
of 10 years and generally vest over a one to four-year period from the date of grant.
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2020
Inducement Equity Incentive Plan
In
October 2020, the Inducement Equity Incentive Plan (the “Inducement Plan”), became effective. Under the Inducement Plan,
Cyclacel may make equity incentive grants to new senior level Employees (persons to whom the Company may issue securities without stockholder
approval). The Inducement Plan allows for the issuance of up to 55 shares of the Company’s common stock (or the equivalent of such
number). As of December 31, 2024, the reserve remains at 55 shares.
Option
Grants and Exercises
There
were 52 options granted during the year ended December 31, 2024, all issued under the 2018 Plan. These options had a grant date fair
value of $ 424.80 per option. There were 180 options granted during the year ended December 31, 2023. These options had a grant date fair
value ranging between $ 1,516.80 -$ 2,635.20 per option.
Of
the options granted during the year ended December 31, 2024, all vested six months from their date of grant. Of the options granted during
the year ended December 31, 2023, 71 awards shall vest on the third anniversary of their date of grant, or earlier if either of the certain
performance conditions are met relating to enrollment goals for various clinical studies. A further 35 options granted during the year
ended December 31, 2023 were forfeited during 2024 due to the holders’ termination of employment with the Company. The Company
had assumed that these awards will vest after three years as satisfaction of the performance conditions is not probable at this time.
As
of December 31, 2024, the total remaining unrecognized compensation cost related to the non-vested stock options with service conditions
amounted to approximately $ 0.1 million, which will be amortized over the weighted-average remaining requisite service period of 1.30
years.
Outstanding
Options
A
summary of the share option activity and related information is as follows:
Schedule of Share Option Activity
Weighted
Weighted
Average
Number
of
Average
Remaining
Aggregate
Options
Exercise
Contractual
Intrinsic
Outstanding
Price
Per Share
Term
(Years)
Value
($000)
Options
outstanding at December 31, 2022
447
$ 21,049.14
8.34
$ —
Granted
181
$ 2,117.94
—
$ —
Exercised
—
$ —
—
$ —
Cancelled/forfeited
( 33 )
$ 79,737.60
—
$ —
Options
outstanding at December 31, 2023
595
$ 12,048.00
7.96
$ —
Granted
52
$ 547.20
—
$ —
Cancelled/forfeited
( 153 )
$ 12,327.88
—
$ —
Options
outstanding at December 31, 2024
494
$ 10,658.14
7.20
$ —
Unvested
at December 31, 2024
74
$ 2,250.91
8.45
$ —
Vested
and exercisable at December 31, 2024
420
$ 12,141.75
6.99
$ —
The
fair value of the stock options granted is calculated using the Black-Scholes option-pricing model as prescribed by ASC 718 using the
following assumptions:
Schedule of Assumptions Used for Fair Value of Stock Options Granted Using Black-Scholes Option Pricing Model
Year
ended
Year
ended
December
31, 2024
December
31, 2023
Expected
term (years)
6
5
- 6
Risk
free interest rate
3.995 %
3.660 %
– 4.160 %
Volatility
93 %
89 % – 92 %
Expected
dividend yield over expected term
0.00 %
0.00 %
Resulting
weighted average grant date fair value
$ 1.77
$ 6.63
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There
were no stock options exercised during each of the years ended December 31, 2024 and 2023, respectively. The Company does not expect
to be able to benefit from the deduction for stock option exercises that may occur because the company has tax loss carryforwards from
prior periods that would be expected to offset any potential taxable income.
Restricted
Stock Units
The
Company issued 52
restricted stock units during the year ended December 31, 2024.
These restricted stock units vest monthly over a six-month 6
service period. These restricted stock units were valued at
$ 547.20 at the date of grant, which was equivalent to the market price of a share of the Company’s common stock on that date.
A
total of 71
restricted stock units were issued in January 2023 vest on
the third anniversary of their date of grant, or earlier if certain defined clinical trial related performance targets are met. A three-year
3
vesting assumption was applied to these restricted stock units
as satisfaction of the performance conditions is not probable at this time. Each of these restricted stock units was valued at $ 3,240
at the date of grant, which was equivalent to the market price of a share of the Company’s common stock on that date. During 2023,
1 of these restricted stock units were forfeited as the recipient voluntarily terminated employment with the Company. A further 35 restricted
stock units issued in June 2023 vest on the first anniversary of the date of grant. Each of these restricted stock units were valued
at $ 2,121.60 at the date of grant, which was equivalent to the market price of a share of the Company’s common stock on that date.
During
the year ended December 31, 2024, an additional 31.60 of these restricted stock units have been forfeited due to the holders’ termination
of employment with the Company.
Summarized
information for restricted stock units as of December 31, 2024 and 2023 is as follows:
Schedule of Restricted Stock Units Activity
Weighted
Average
Restricted
Remaining
Stock
Units
Term
Restricted
Stock Units outstanding at December 31, 2022
38
$ 6,768.00
Granted
106
$ 2,870.40
Cancelled/forfeited
( 1 )
$ 3,240.00
Restricted
Stock Units outstanding at December 31, 2023
143
$ 3,902.40
8.96
years
Granted
52
$ 547.20
9.03
years
Cancelled/forfeited
( 32 )
$ 3,675.17
Restricted
Stock Units outstanding at December 31, 2024
164
$ 2,881.62
8.30
years
Unvested
at December 31, 2024
41
$ 3,280.09
8.06
years
Vested
at December 31, 2024
123
$ 2,747.14
8.39
years
13.
Employee Benefit Plans
Pension
Plan
The
Company operates a defined contribution group personal pension plan for all of its UK based employees. Company contributions to the plan
totaled approximately $ 51,000 and $ 52,000 for the years ended December 31, 2024 and 2023, respectively.
401(k)
Plan
The
401(k) Plan provides for matching contributions by the Company in an amount equal to the lesser of 100 % of the employee’s deferral
or 6 % of the U.S. employee’s qualifying compensation. The 401(k) Plan is intended to qualify under Section 401(k) of the Internal
Revenue Code, so that contributions to the 401(k) Plan by employees or by the Company, and the investment earnings thereon, are not taxable
to the employees until withdrawn. Company matching contributions are tax deductible by the Company when made. In 2024, Company employees
could elect to reduce their current compensation by up to the statutorily prescribed annual limit of $ 23,000 if under 50 years old and
$ 30,500 if over 50 years old and to have those funds contributed to the 401(k) Plan. The Company made contributions of approximately
$ 40,000 and $ 103,000 to the 401(k) Plan for the years ended December 31, 2024 and 2023, respectively.
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14.
Taxes
(Loss)
income from continuing operations before taxes is comprised of the following components for the years ended December 31, 2024 and 2023
(in thousands):
Schedule of Components of (Loss) Income Before Taxes from Continuing Operations
2024
2023
Year
Ended December 31,
2024
2023
Domestic
$ 36
$ ( 806 )
Foreign
( 12,030 )
( 24,745 )
Loss
from continuing operations before taxes
$ ( 11,994 )
$ ( 25,551 )
The
benefit (provision) for income taxes from continuing operations consists of the following (in thousands):
Schedule of Benefit (Provision) for Income Taxes from Continuing Operations
2024
2023
Year
Ended December 31,
2024
2023
Current – domestic
$ ( 21 )
$ ( 2 )
Current – foreign
803
2,998
Current – total
782
2,996
Deferred – domestic
—
—
Income
tax benefit
$ 782
$ 2,996
The
Company has incurred a taxable loss in each of the operating periods since incorporation. The income tax credits of $ 0.8 million and
$ 3.0 million for the years ended December 31, 2024 and 2023, respectively, represent UK research and development (“R&D”)
tax credits for expenditures in the United Kingdom.
A
reconciliation of the (benefit) provision for income taxes from continuing operations with the amount computed by applying the statutory
federal tax rate to loss from continuing operations before income taxes is as follows (in thousands):
Schedule of Effective Income Tax Rate Reconciliation
2024
2023
Year
Ended December 31,
2024
2023
Loss
from continuing operations before taxes
$ ( 11,994 )
$ ( 25,551 )
Income
tax expense computed at statutory federal tax rate
( 2,527 )
( 5,366 )
Additional
research and development tax relief
—
( 5,409 )
Loss
surrendered to generate R&D credit
—
4,865
Change
in valuation allowance
2,798
1,261
Other
foreign items
( 1,158 )
809
Disallowed
expenses and non-taxable income
35
782
Stock
Compensation
30
62
Foreign
items, including change in tax rates, and other
—
—
Other
items
40
—
Income tax benefit
$ ( 782 )
$ ( 2,996 )
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Significant
components of the Company’s deferred tax assets are shown below (in thousands):
Schedule of Deferred Tax Assets
2024
2023
Year
Ended December 31,
2024
2023
Net
operating loss and tax credit carryforwards
$ 59,417
$ 57,074
Depreciation,
amortization and impairment of property and equipment
39
39
Stock
options
250
210
Research
and development credits
—
—
Right
of use asset
( 1 )
( 26 )
Lease
liability
1
26
Other
114
-
Total
deferred tax assets
59,820
57,323
Valuation
allowance for deferred tax assets
( 59,820 )
( 57,323 )
Net
deferred tax assets
$ —
$ —
A
valuation allowance has been established, as realization of such assets is uncertain. The Company’s management evaluated the positive
and negative evidence bearing upon the realizability of its deferred assets, and has determined that, at present, the Company may not
be able to recognize the benefits of the deferred tax assets under the more likely than not criteria. Accordingly, a valuation allowance
of approximately $ 59.8 million has been established at December 31, 2024. The valuation allowance has increased by approximately $ 2.5
million in 2024.
As
specified in the Tax Reform Act of 1986, due to ownership changes, the Company’s ability to utilize its net operating loss (“NOL”)
carryforwards may be limited. Utilization of the NOLs may be subject to a substantial annual limitation under Section 382 of the Internal
Revenue Code of 1986 due to ownership change limitations that have occurred previously or that could occur in the future. These ownership
changes may limit the amount of NOL and R&D credit carryforwards that can be utilized annually to offset future taxable income and
tax, respectively. The Company completed a Section 382 study and has concluded that an ownership change occurred on March 4, 2015 and
July 21, 2017. As a result of the ownership changes, the NOLs are limited.
As
of December 31, 2024 and 2023, the Company has federal NOLs of $ 3.5 million and $ 3.8 million, respectively. The federal NOLs have an
indefinite life. As of December 31, 2024 and 2023, the Company has state NOLs of $ 16.8 million and $ 17.3 million, respectively,
which will begin to expire in 2028. As of December 31, 2024 and 2023, the Company had foreign NOLs of $ 230.0 million and $ 220.1 million,
respectively. The Company’s foreign NOL’s do not expire under UK tax law however the use of these NOLs is restricted to an
annual £ 5.0 million allowance in each standalone company or group and above this allowance, there will be a 50 % restriction in
the profits that can be covered by losses brought forward.
Management
has evaluated all significant tax positions at December 31, 2024 and 2023 and concluded that there are no material uncertain tax positions.
The Company would recognize both interest and penalties related to unrecognized benefits in income tax expense. The Company has not recorded
any interest and penalties on any unrecognized tax benefits since its inception.
Tax
years 2020 - 2023 remain open to examination by major taxing jurisdictions to which the Company is subject, which are primarily in the
United Kingdom and the United States, as carryforward attributes generated in years past may still be adjusted upon examination by the
United Kingdom’s H.M. Revenue & Customs, the Internal Revenue Service (“IRS”) or state tax authorities. The Company
is currently not under examination by the IRS or any other jurisdictions for any tax years.
We
have not provided a deferred tax liability on the cumulative amount of unremitted foreign earnings of international subsidiaries because
it is our intent to permanently reinvest such earnings outside of the United States.
The
Company has an aggregate deficit in foreign earnings and therefore has not provided any deferred tax liability on its outside book-tax
basis difference in its foreign subsidiaries and because it is also our intent to permanently reinvest any earnings outside of the United
States. We would recognize this deferred tax liability if we were to experience a change in circumstances producing a change in that
intention. As a result of the repeal of Section 902 foreign tax credit under the Tax Act, future distributions would not be offset by
a foreign tax credit.
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Effective
for tax years beginning after December 31, 2021, taxpayers are required to capitalize any expenses incurred that are considered incidental
to research and experimentation (R&E) activities under IRC Section 174. While taxpayers historically had the option of deducting
these expenses under IRC Section 174, the December 2017 Tax Cuts and Jobs Act mandates capitalization and amortization of R&E expenses
for tax years tax years beginning after December 31, 2021. Expenses incurred in connection with R&E activities in the US must be
amortized over a 5-year period if incurred, and R&E expenses incurred outside the US must be amortized over a 15-year period. R&E
activities are broader in scope than qualified research activities that are considered under IRC Section 41 (relating to the research
tax credit). For the year ended December 31, 2024, the Company performed an analysis based on available guidance and determined that
the company does not have any R&E expenses in the US. The company will continue to monitor this issue for future developments, but
it does not expect R&E capitalization and amortization to require it to pay cash taxes now or in the near future.
15.
Net Loss Per Share
Basic
and diluted net loss per share attributable to common stockholders was calculated as follows:
Schedule of Basic and Diluted Net Loss Per Share
2024
2023
Years
ended December 31,
2024
2023
Numerator:
Net
loss
$ ( 11,212 )
$ ( 22,555 )
Dividend
on convertible exchangeable preferred shares
—
( 201 )
Net
loss attributable to common shareholders
$ ( 11,212 )
$ ( 22,756 )
Denominator:
Weighted-average
number of common shares used in loss per share – basic and diluted
22,314
3,545
Loss
per share - basic and diluted
$ ( 504.30 )
$ ( 6,419.18 )
Potential
dilutive securities have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss
per share. Therefore, the weighted average number of common shares outstanding used to calculate both basic and diluted net loss per
share attributable to common stockholders is the same. The Company excluded the following potential common shares, presented based on
amounts outstanding at each period end, from the computation of diluted net loss per share attributable to common stockholders for the
periods indicated because including them would have had an anti-dilutive effect:
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share
2024
2023
December
31,
December
31,
2024
2023
Stock
options
493
594
Restricted
Stock Units
164
143
6 %
convertible exchangeable preferred stock
—
—
Series
A preferred stock
1
1
Series
B preferred stock
—
165
Common
stock warrants
117,182
2,648
Total
shares excluded from calculation
117,840
3,551
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16.
Geographic and Segment Information
Geographic
information for the years ended December 31, 2024 and 2023 is as follows (in thousands):
Schedule of Geographic Information
2024
2023
Year
Ended December 31,
2024
2023
Revenue
United
Kingdom
$ 43
$ 420
Total
Revenue
$ 43
$ 420
Net
loss
United
States
$ ( 37 )
$ ( 808 )
United
Kingdom
( 11,175 )
( 21,747 )
Total
Net Loss
$ ( 11,212 )
$ ( 22,555 )
2024
2023
December
31,
2024
2023
Total
Assets
United
States
$ 3,285
$ 2,938
United
Kingdom
809
5,867
Total
Assets
$ 4,094
$ 8,805
Long
Lived Assets, net
United
States
$ 1
$ —
United
Kingdom
2
9
Total
Long Lived Assets, net
$ 3
$ 9
The
Company operates as a single
1 segment engaged in the development of innovative cancer medicines based on cell cycle, transcriptional regulation and
mitosis control biology. Consistent with our operational structure, our Chief Executive Officer (CEO), as the chief operating
decision maker, makes resource allocation and business process decisions globally across our consolidated business. Managing and
allocating resources at the consolidated level enables our CEO to assess the overall level of resources available and how to best
deploy these resources across functions, and research and development projects in line with our overarching long-term corporate-wide
strategic goals, rather than on a geographic or some other basis. Consistent with this decision-making process, our CEO considers
consolidated net loss, which is our single segment’s principal measure of segment profit and loss, when evaluating performance
and allocating company-wide resources.
Significant
expenses are amounts that are regularly provided to our CEO and included in consolidated net loss, our primary measure of our single
segment’s profit or loss. Our CEO regularly reviews reported consolidated revenues, significant expenses and consolidated net loss,
in addition to forecasted revenues, significant expenses and net loss amounts for future periods.
A
summary of our consolidated net loss for the years ended December 31, 2024 and 2023 is as follows, including the significant expenses
provided to and regularly reviewed by our CEO:
Schedule of Summary of Consolidated Net Loss
2024
2023
December
31,
2024
2023
Revenues
$ 43
$ 420
Operating
expenses:
Research
and development
6,655
19,155
General
and administrative
5,392
6,718
Total
operating expenses
12,047
25,873
Operating
loss
( 12,004 )
( 25,453 )
Total
other income (expense), net
10
( 98 )
Loss
before taxes
( 11,994 )
( 25,551 )
Income
tax benefit
782
2,996
Net
loss
$ ( 11,212 )
$ ( 22,555 )
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Item
9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
None.