10-Q

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2022

OR

☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
	For the transition period from __________________ to __________________

Commission file number 000-50626

CYCLACEL PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

Delaware	91-1707622
(State or Other Jurisdiction of Incorporation or Organization)	(I.R.S. Employer Identification No.)
200 Connell Drive, Suite 1500 Berkeley Heights, New Jersey	07922
(Address of principal executive offices)	(Zip Code)

Registrant’s telephone number, including area code: (908) 517-7330

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, par value $0.001 per share	CYCC	The Nasdaq Stock Market LLC
Preferred Stock, $0.001 par value	CYCCP	The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See definitions of “large accelerated filer,” “accelerated filer”, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer ☐	Accelerated filer ☐
Non-accelerated filer ☒	Smaller reporting filer ☒
	Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ◻

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of November 7, 2022 there were 12,539,189 shares of the registrant’s common stock outstanding.

CYCLACEL PHARMACEUTICALS, INC.

INDEX

		Page
Part I.       Financial Information
Item 1.	Financial Statements (Unaudited)	3
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	20
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	28
Item 4.	Controls and Procedures	28
Part II.      Other Information
Item 1.	Legal Proceedings	29
Item 1A.	Risk Factors	29
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	29
Item 3.	Defaults Upon Senior Securities	30
Item 4.	Mine Safety Disclosures	30
Item 5.	Other Information	30
Item 6.	Exhibits	30
SIGNATURE PAGE		31

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PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

CYCLACEL PHARMACEUTICALS, INC.

CONSOLIDATED BALANCE SHEETS

(In $000s, except share, per share, and liquidation preference amounts)

(Unaudited)

	September 30,		December 31,
	2022		2021
ASSETS
Current assets:
Cash and cash equivalents	$	23,706	$	36,559
Prepaid expenses and other current assets		4,209		4,383
Total current assets		27,915		40,942
Property and equipment, net		37		64
Right-of-use lease asset		153		30
Non-current deposits		2,916		1,551
Total assets	$	31,021	$	42,587
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	983	$	2,117
Accrued and other current liabilities		3,370		3,177
Total current liabilities		4,353		5,294
Lease liability		107		30
Total liabilities		4,460		5,324
Redeemable common stock, $0.001 par value;
0 and 3,117,100 shares issued and outstanding at December 31, 2021 and September 30, 2022 (Note 10)		4,494		—
Stockholders’ equity:
Preferred stock, $0.001 par value; 5,000,000 shares authorized at December 31, 2021 and September 30, 2022;
6% Convertible Exchangeable preferred stock; 335,273 shares issued and outstanding at December 31, 2021 and September 30, 2022. Aggregate preference in liquidation of  $4,006,512 as of December 31, 2021 and September 30, 2022.		—		—
Series A convertible preferred stock, $0.001 par value; 264 shares issued and outstanding at December 31, 2021 and September 30, 2022.		—		—
Series B convertible preferred stock, $0.001 par value; 237,745 shares issued and outstanding at December 31, 2021 and September 30, 2022.		—		—
Common stock, $0.001 par value; 100,000,000 shares authorized at December 31, 2021 and September 30, 2022; 9,993,135 and 12,539,189 shares issued and outstanding at December 31, 2021 and September 30, 2022 respectively.		9		10
Additional paid-in capital		422,542		422,960
Accumulated other comprehensive loss		(1,746)		(748)
Accumulated deficit		(398,738)		(384,959)
Total stockholders’ equity		22,067		37,263
Total liabilities and stockholders’ equity	$	31,021	$	42,587

The accompanying notes are an integral part of these consolidated financial statements.

3

CYCLACEL PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(In $000s, except share and per share amounts)

(Unaudited)

	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2022		2021		2022		2021
Revenues	$	—	$	—		—		—
Operating expenses:
Research and development		4,413		4,217		13,572		10,884
General and administrative		2,054		1,781		5,239		5,520
Total operating expenses		6,467		5,998		18,811		16,404
Operating loss		(6,467)		(5,998)		(18,811)		(16,404)
Other income (expense):
Foreign exchange gains (losses)		276		9		514		5
Interest income		67		4		88		12
Other income, net		14		—		1,294		144
Total other income, net		357		13		1,896		161
Loss before taxes		(6,110)		(5,985)		(16,915)		(16,243)
Income tax benefit		1,014		998		3,136		2,650
Net loss		(5,096)		(4,987)		(13,779)		(13,593)
Dividend on convertible exchangeable preferred shares		(50)		(50)		(151)		(151)
Net loss applicable to common shareholders	$	(5,146)	$	(5,037)	$	(13,930)	$	(13,744)
Basic and diluted earnings per common share:
Net loss per share – basic and diluted	$	(0.42)	$	(0.54)	$	(1.29)	$	(1.60)
Weighted average common shares outstanding		12,314,679		9,368,056		10,823,138		8,575,379

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 $000s)

(Unaudited)

	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2022		2021		2022		2021
Net loss	$	(5,096)	$	(4,987)	$	(13,779)	$	(13,593)
Translation adjustment		17,874		5,348		39,392		2,896
Unrealized foreign exchange gain (loss) on intercompany loans		(18,344)		(5,443)		(40,390)		(2,903)
Comprehensive loss	$	(5,566)	$	(5,082)	$	(14,777)	$	(13,600)

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 $000s, except share amounts)

(Unaudited)

									Accumulated
							Additional		Other				Total
	Preferred Stock			Common Stock			Paid-in		Comprehensive		Accumulated		Stockholders’
	Shares	Amount		Shares	Amount		Capital		Loss		Deficit		Equity
Balances at December 31, 2020	573,282	$	—	6,246,896	$	6	$	400,071	$	(746)	$	(366,072)	$	33,259
Issue of common stock and associated warrants on underwritten offering, net of expenses	—		—	2,078,214		2		13,499		—		—		13,501
Warrant Exercises	—		—	909,000		1		4,544		—		—		4,545
Stock-based compensation	—		—	—		—		255		—		—		255
Preferred stock dividends	—		—	—		—		(50)		—		—		(50)
Unrealized foreign exchange on intercompany loans	—		—	—		—		—		1,599		—		1,599
Translation adjustment	—		—	—		—		—		(1,583)		—		(1,583)
Loss for the period	—		—	—		—		—		—		(3,478)		(3,478)
Balances at March 31, 2021	573,282	$	—	9,234,110	$	9	$	418,319	$	(730)	$	(369,550)	$	48,048
Stock-based compensation	—		—	—		—		279		—		—		279
Preferred stock dividends	—		—	—		—		(50)		—		—		(50)
Unrealized foreign exchange on intercompany loans	—		—	—		—		—		941		—		941
Translation adjustment	—		—	—		—		—		(869)		—		(869)
Loss for the period	—		—	—		—		—		—		(5,127)		(5,127)
Balances at June 30, 2021	573,282	$	—	9,234,110	$	9	$	418,548	$	(658)	$	(374,677)	$	43,222
Issue of common stock on At Market Issuance sales agreement, net of expenses	—		—	563,625		1		2,954.00		—		—		2,955
Stock-based compensation	—		—	—		—		319		—		—		319
Preferred stock dividends	—		—	—		—		(50)		—		—		(50)
Unrealized foreign exchange on intercompany loans	—		—	—		—		—		(5,443)		—		(5,443)
Translation adjustment	—		—	—		—		—		5,348		—		5,348
Loss for the period	—		—	—		—		—		—		(4,987)		(4,987)
Balances at September 30, 2021	573,282	$	—	9,797,735	$	10	$	421,771	$	(753)	$	(379,664)	$	41,364
Balances at December 31, 2021	573,282	$	—	9,993,135	$	10	$	422,960	$	(748)	$	(384,959)	$	37,263
Stock-based compensation	—		—	—		—		380		—		—		380
Preferred stock dividends	—		—	—		—		(50)		—		—		(50)
Unrealized foreign exchange on intercompany loans	—		—	—		—		—		(5,878)		—		(5,878)
Translation adjustment	—		—	—		—		—		5,803		—		5,803
Loss for the period	—		—	—		—		—		—		(4,108)		(4,108)
Balances at March 31, 2022	573,282	$	—	9,993,135	$	10	$	423,290	$	(823)	$	(389,067)	$	33,410
Issue of common stock on At Market issuance sales agreement, net of expenses	—		—	1,339,742		1		1,524		—		—		1,525
Stock-based compensation	—		—	—		—		350		—		—		350
Stock-based awards	—		—	17,412		—		—		—		—		—
Preferred stock dividends	—		—	—		—		(50)		—		—		(50)
Unrealized foreign exchange on intercompany loans	—		—	—		—		—		(16,168)		—		(16,168)
Translation adjustment	—		—	—		—		—		15,715		—		15,715
Loss for the period	—		—	—		—		—		—		(4,575)		(4,575)
Balances at June 30, 2022	573,282	$	—	11,350,289	$	11	$	425,114	$	(1,276)	$	(393,642)	$	30,207
Issue of common stock on At Market issuance sales agreement, net of expenses	—		—	1,188,900		1		1,581		—		—		1,582
Reclassification of redeemable common stock	—		—	(3,117,100)		(3)		(4,491)		—		—		(4,494)
Stock-based compensation	—		—	—		—		388		—		—		388
Preferred stock dividends	—		—	—		—		(50)		—		—		(50)
Unrealized foreign exchange on intercompany loans	—		—	—		—		—		(18,344)		—		(18,344)
Translation adjustment	—		—	—		—		—		17,874		—		17,874
Loss for the period	—		—	—		—		—		—		(5,096)		(5,096)
Balances at September 30, 2022	573,282	$	—	9,422,089	$	9	$	422,542	$	(1,746)	$	(398,738)	$	22,067

The accompanying notes are an integral part of these consolidated financial statements.

6

CYCLACEL PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(In $000s)

(Unaudited)

	Nine Months Ended
	September 30,
	2022		2021
Operating activities:
Net loss	$	(13,779)	$	(13,593)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation		24		36
Stock-based compensation		1,119		853
Changes in lease liability		29		173
Changes in operating assets and liabilities:
Prepaid expenses and other assets		(2,816)		(2,655)
Accounts payable, accrued and other current liabilities		(235)		1,195
Net cash used in operating activities		(15,658)		(13,991)
Investing activities:
Purchase of property, plant and equipment		(7)		(25)
Net cash used in investing activities		(7)		(25)
Financing activities:
Proceeds, net of issuance costs, from issuing common stock and warrants		3,107		21,001
Payment of preferred stock dividend		(151)		(151)
Net cash provided by financing activities		2,956		20,850
Effect of exchange rate changes on cash and cash equivalents		(144)		(21)
Net (decrease) increase in cash and cash equivalents		(12,853)		6,813
Cash and cash equivalents, beginning of period		36,559		33,406
Cash and cash equivalents, end of period	$	23,706	$	40,219
Supplemental cash flow information:
Cash received during the period for:
Interest		89		13
Research & Development Tax Credits		3,050		1,352
Non cash financing activities:
Accrual of preferred stock dividends		50		50

The accompanying notes are an integral part of these consolidated financial statements.

7

CYCLACEL PHARMACEUTICALS, INC.

NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS

1.           Company Overview

Nature of Operations

Cyclacel Pharmaceuticals, Inc. (“Cyclacel” or the “Company”) is a clinical-stage biopharmaceutical company developing innovative cancer medicines based on cell cycle, transcriptional regulation and mitosis control biology. Cyclacel is a pioneer in the field of cancer cell cycle biology with a vision to improve patient healthcare by translating insights in cancer biology into medicines that can overcome resistance and ultimately increase a patient’s overall survival rate.

Through September 30, 2022, 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.

2.            Summary of Significant Accounting Policies

Basis of Presentation

The consolidated balance sheet as of September 30, 2022, the consolidated statements of operations, comprehensive loss, and stockholders’ equity for the three and nine months ended September 30, 2022 and 2021 and the consolidated statements of cash flows for the nine months ended September 30, 2022 and 2021, and all related disclosures contained in the accompanying notes, are unaudited. The consolidated balance sheet as of December 31, 2021 is derived from the audited consolidated financial statements included in the Annual Report on Form 10-K for the fiscal year ended December 31, 2021 filed with the Securities and Exchange Commission (the “SEC”) on March 30, 2022. The consolidated financial statements are presented on the basis of accounting principles that are generally accepted in the United States (“GAAP”) for interim financial information and in accordance with the rules and regulations of the SEC. Accordingly, they do not include all the information and footnotes required by GAAP for a complete set of financial statements. In the opinion of management, all adjustments, which include only normal recurring adjustments necessary to present fairly the consolidated balance sheet as of September 30, 2022, and the results of operations and, comprehensive loss for the three and nine months ended September 30, 2022, and cash flows for the nine months ended September 30, 2022, have been made. The interim results for the three and nine months ended September 30, 2022 are not necessarily indicative of the results to be expected for the year ending December 31, 2022 or for any other reporting period. The consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the accompanying notes for the year ended December 31, 2021 that are included in the Company’s Annual Report on Form 10-K filed with the SEC on March 30, 2022.

Going Concern

Management considers that there are no conditions or events, in the aggregate, that raise substantial doubt about the entity’s ability to continue as a going concern for a period of at least one year from the date the financial statements are issued. The Company expects that its cash of approximately $23.7 million as of September 30, 2022 will be sufficient to fund its operating expenses and capital expenditure requirements to the end of 2023.

This evaluation is based on relevant conditions and events that are known and reasonably knowable at the date that the financial statements are issued, including:

a. The Company’s current financial condition, including its sources of liquidity;

b. The Company’s conditional and unconditional obligations due or anticipated within one year;

c. The funds necessary to maintain the Company’s operations considering its current financial condition, obligations, and other expected cash flows; and

8

d. Other conditions and events, when considered in conjunction with the above, that may adversely affect the Company’s ability to meet its obligations.

The future viability of the Company beyond 2023 is dependent on its ability to raise additional capital to finance its operations. The Company does not currently have sufficient funds to complete development and commercialization of any of its drug candidates. Additional funding may not be available to the Company on favorable terms, or at all. If the Company is not able to secure additional funding when needed, it may have to delay, reduce the scope of or eliminate one or more of its clinical trials or research and development programs or make changes to its operating plan. In addition, it may have to partner one or more of its product candidate programs at an earlier stage of development, which would lower the economic value of those programs to the Company. The Company’s inability to raise capital as and when needed could have a negative impact on its financial condition and ability to pursue its business strategies.

Accounting Standards Adopted in the Period

In November 2021, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2021-10, Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance. This ASU requires business entities to make annual disclosures about transactions with a government they account for by analogizing to a grant or contribution accounting model under ASC 958-605 or based on International Accounting Standard No. 20. ASU 2021-10 which became effective for us on January 1, 2022. The Company has evaluated the effect that this guidance has on its Consolidated Financial Statements and has determined it does not have a material impact.

In May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt-Modifications and Extinguishments (Subtopic 470-50), Compensation-Stock Compensation (Topic 718), and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40). The new ASU addresses issuer’s accounting for certain modifications or exchanges of freestanding equity-classified written call options. This amendment became effective for us on January 1, 2022. This new guidance does not have a material impact on our financial statements for any past transactions, but it could change the way that the Company accounts for subsequent amendments to its outstanding warrants, if any.

Recently Issued Accounting Pronouncements

The FASB has issued ASU 2020-04, “Reference Rate Reform (Topic 848)”. This standard provides optional expedients and exceptions for applying GAAP to contracts, hedging relationships, and other transactions affected by reference rate reform initiatives that would replace interbank offered rates, including the London Interbank Offered Rate (“LIBOR”). For example, modifications of lease contracts within the scope of ASC 842 solely for changes in reference rates would be accounted for as a continuation of the existing contracts with no reassessments of the lease classification and the discount rate. The amendments in this ASU are effective for all entities as of March 12, 2020 through December 31, 2022. The Company does not currently have any contracts affected by this guidance.

Fair Value of Financial Instruments

Financial instruments consist of cash equivalents, accounts payable and accrued liabilities. The carrying amounts of cash equivalents, accounts payable and accrued liabilities approximate their respective fair values due to the nature of the accounts, notably their short maturities.

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, net of any related tax effect, to arrive at comprehensive income (loss). No taxes were recorded on items of other comprehensive income

9

(loss). There were no reclassifications out of other comprehensive income (loss) during the nine months ended September 30, 2021 and 2022.

Revenue Recognition

When the Company enters into contracts with customers, the Company recognizes revenue using the five step-model provided in ASC 606, Revenue from Contracts with Customers (“ASC 606”):

(1) Identify the contract with a customer;

(2) Identify the performance obligations in the contract;

(3) Determine the transaction price;

(4) Allocate the transaction price to the performance obligations in the contract; and

(5) Recognize revenue when, or as, the Company satisfies a performance obligation.

The transaction price includes fixed payments and an estimate of variable consideration, including milestone payments. The Company determines the variable consideration to be included in the transaction price by estimating the most likely amount that will be received and then applies a constraint to reduce the consideration to the amount which is probable of being received. When applying the constraint, the Company considers:

● Whether achievement of a development milestone is highly susceptible to factors outside the entity’s influence, such as milestones involving the judgment or actions of third parties, including regulatory bodies;

● Whether the uncertainty about the achievement of the milestone is not expected to be resolved for a long period of time;

● Whether the Company can reasonably predict that a milestone will be achieved based on previous experience; and.

● The complexity and inherent uncertainty underlying the achievement of the milestone.

The transaction price is allocated to each performance obligation based on the relative selling price of each performance obligation. The best estimate of the selling price is determined after considering all reasonably available information, including market data and conditions, entity-specific factors such as the cost structure of the deliverable and internal profit and pricing objectives.

The revenue allocated to each performance obligation is recognized as or when the Company satisfies the performance obligation.

The Company recognizes a contract asset, when the value of satisfied (or part satisfied) performance obligations is in excess of the payment due to the Company, and deferred revenue when the amount of unconditional consideration is in excess of the value of satisfied (or part satisfied) performance obligations. Once a right to receive consideration is unconditional, that amount is presented as a receivable.

Grant revenue received from organizations that are not the Company’s customers, such as charitable foundations or government agencies, is presented as a reduction against the related research and development expenses. Moreover, other inflows that are not a result of the Company’s ongoing and central operations are presented as other income, net.

Leases

The Company accounts for lease contracts in accordance with ASC 842. As of September 30, 2022, the Company’s only outstanding facilities lease is classified as an operating lease.

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

10

Company’s lease does not specify 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 the loan is repaid (e.g., amortizing versus bullet), and the Company’s credit risk.

The Company evaluates options included in its lease agreement 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.

Lease expense for operating leases is recognized on a straight-line basis over the lease term. 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.

3.           Revenue

Revenue recognized in the three and nine months ended September 30, 2021 and 2022 was $0.

4.           Net Loss per Common Share

The Company calculates net loss per common share in accordance with ASC 260 “Earnings Per Share” (“ASC 260”). Basic and diluted net loss per common share was determined by dividing net loss applicable to common stockholders by the weighted average number of shares of common stock outstanding during the period.

The following potentially dilutive securities have not been included in the computation of diluted net loss per share for the three months ended September 30, 2021 and 2022, as the result would be anti-dilutive:

	September 30,	September 30,
	2022	2021
Stock options	1,618,089	720,788
Restricted Stock Units	137,657	—
6% convertible exchangeable preferred stock	85	85
Series A preferred stock	6,600	6,600
Series B preferred stock	1,188,725	1,188,725
Common stock warrants	3,234,379	3,234,379
Total shares excluded from calculation	6,185,535	5,150,577

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5.            Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consisted of the following (in $000s):

	September 30,		December 31,
	2022		2021
Research and development tax credit receivable	$	2,791	$	3,727
Prepayments and VAT receivable		1,248		577
Other current assets		170		79
	$	4,209	$	4,383

6.            Non-Current Assets

As of September 30, 2022, the Company had non-current assets of $2.9 million, which is comprised of clinical trial deposits held by a contract research organization in relation to the Company’s Phase 1/2 clinical trials.

7.            Accrued and Other Liabilities

Accrued and other current liabilities consisted of the following (in $000s):

	September 30,		December 31,
	2022		2021
Accrued research and development	$	2,767	$	2,310
Accrued legal and professional fees		431		233
Other current liabilities		172		634
	$	3,370	$	3,177

Other current liabilities for the year ended December 31, 2021 were largely attributed to accrued payroll costs.

8.            Leases

The Company currently has one lease, relating to its facility in Berkeley Heights, New Jersey. On April 4, 2022 the Company extended this lease by three years, expiring July 31, 2025. On May 4, 2021, the Company assigned an operating lease relating to its U.K. facility to the University of Dundee, Scotland, incurring lease assignment costs of approximately $400,000, of which 50% was paid on assignment and the remaining 50% was paid on May 4, 2022. The Company has no further obligations, liabilities or commitments in relation to this facility.

As of and for the nine months ended September 30, 2022 and 2021:

The Company recognized operating lease expenses of $46,699 and $159,898 in the nine month periods ending September 30, 2022 and 2021 respectively. Cash payments made during the nine months ended September 30, 2022 and 2021 totaled $46,489 and $166,376 respectively and were presented within cash outflows from operating activities. The remaining lease term as of September 30, 2022 is approximately 2.8 years for the Berkeley Heights facility. The discount rate used by the Company in determining the lease liability was 12%.

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Remaining lease payments under the lease are (in $000’s):

2022	$	16
2023		63
2024		65
2025		38
2026		—
Thereafter		—
	$	182

9.            Stock Based Compensation

ASC 718 requires compensation expense associated with share-based awards to be recognized 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. Most of the awards granted by the Company (and still outstanding) vest ratably over one to four years. The Company recognizes all share-based awards under the straight-line attribution method, assuming that all granted awards will vest. Forfeitures are recognized in the periods when they occur.

Stock based compensation has been reported within expense line items on the consolidated statement of operations for the three and nine months ended September 30, 2021 and 2022 as shown in the following table (in $000s):

	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2022		2021		2022		2021
General and administrative	$	255	$	223	$	724	$	587
Research and development		134	$	96	$	396	$	266
Stock-based compensation costs before income taxes	$	389	$	319	$	1,119	$	853

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 replaces 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 14, 2022, the Company’s stockholders approved an amendment to the 2018 Plan to increase the number of shares of common stock available for grant under the 2018 Plan by 500,000 shares. As of September 30, 2022, the Company has reserved 384,896 shares of the Company’s common stock under the 2018 Plan for future issuances, including shares that were available under the 2015 Plan and carried forward to the 2018 Plan. 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.

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 200,000 shares of the Company’s common stock (or the equivalent of such number). As of September 30, 2022, 120,000 shares under the Inducement Plan have been issued, leaving a remaining reserve of 80,000 shares.

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Option Grants and Exercises

There were 522,337 options granted during the nine months ended September 30, 2022. These options had a grant date fair value ranging between $0.83-$2.90 per option. There were 154,653 options granted during the nine months ended September 30, 2021. These options had a grant date fair value ranging between $3.44-$6.14 per option. 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:

	Nine months ended	Nine months ended
	September 30, 2022	September 30, 2021
Expected term (years)	5 – 6	5 – 6
Risk free interest rate	1.370% – 3.605%	0.420%  – 1.000%
Volatility	86% – 93%	96% – 102%
Expected dividend yield over expected term	0.00%	0.00%

There were no stock options exercised during each of the nine months ended September 30, 2021 and 2022, 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.

In the second quarter of 2022, the Company amended the terms of 11,952 options and 2,374 restricted stock units issued to a former director. Specifically, the Company accelerated the vesting of 4,748 options and 2,374 restricted stock units that otherwise would have been forfeited upon the director’s retirement from service. In addition, the Company extended the time by which the director may exercise all vested awards from 90 days to two years. The Company recorded an additional $3,500 of compensation cost in the second quarter of 2022 as a result of these modifications.

Outstanding Options

A summary of the share option activity and related information is as follows:

				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, 2021	1,099,357	$	7.53	8.99	$	189
Granted	522,337	$	2.41	—		—
Cancelled/forfeited	(3,604)	$	28.15
Options outstanding at September 30, 2022	1,618,090	$	5.83	8.60	$	85
Unvested at September 30, 2022	990,399	$	3.16	9.14	$	85
Vested and exercisable at September 30, 2022	627,691	$	10.04	7.75	$	—

Restricted Stock Units

The Company issued 118,665 restricted stock units during the nine months ended September 30, 2022. These restricted stock units will vest over a period of one year for grants to directors and three years for grants to employees. Each restricted stock unit was valued at $1.11 based on their fair value at the date of grant, which is equivalent to the market price of a share of the Company’s common stock.

The Company issued an additional 18,992 restricted stock units to employees during the year ended December 31, 2021. These restricted stock units will vest over a period of one or three years. Each restricted stock unit was valued at $6.69 based on their fair value at the date of grant, which is equivalent to the market price of a share of the Company’s common stock.

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Summarized information for restricted stock units as of September 30, 2022 is as follows:

		Weighted
		Average
	Restricted	Grant Date
	Stock Units	Value Per Share
Restricted Stock Units outstanding at December 31, 2021	18,992	$	6.69
Granted	118,665		1.11
Restricted Stock Units outstanding at September 30, 2022	137,657	$	—
Unvested at September 30, 2022	120,248	$	1.18
Vested and exercisable at September 30, 2022	17,409	$	6.69

10.            Stockholders Equity

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 $10.0 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 3,117,100 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 $4,494,496. There was no sale of shares after August 12, 2022. The sale of these shares may be subject to potential rescission rights by certain shareholders. As of September 30, 2022, there have been no claims or demands to exercise such rights. As a result of these potential rescission rights, the Company reclassified 3,117,100 shares, with an aggregate purchase price of $4,494,496 of its common stock as outside stockholders’ equity. The reclassification of these shares shall remain for a period of one year from the applicable transaction date. These shares have been treated as issued and outstanding for financial reporting purposes.

On August 15, 2022, due to expiry of the Registration Statement, the Sales Agreement was mutually terminated. Since the start of the agreement on August 12, 2021, a total of 3,281,067 shares, for gross proceeds of approximately $7.6 million, had been sold pursuant to the Sales Agreement.

March 2021 Equity Financing

On March 12, 2021, the Company entered into an Underwriting Agreement (the “Underwriting Agreement”) with Oppenheimer & Co. Inc., as representative of the underwriters identified therein (collectively, the “Underwriters”), pursuant to which the Company agreed to issue and sell 1,807,143 shares of common stock, $0.001 par value per share, at a public offering price of $7.00 per share (the “Offering”) along with a 30-day overallotment option to purchase up to an additional 271,071 shares of common stock at the public offering price, less underwriting discounts and commissions.

The closing of the offering occurred on March 16, 2021, and the net proceeds to the Company (including exercise of the over-allotment option) were approximately $13.5 million, after deducting placement agent fees and other offering expenses payable by the Company.

December 2020 Equity Financing

On December 18, 2020, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with Acorn Bioventures, LP (the “Purchaser”), pursuant to which the Company agreed to offer, issue and sell to the Purchaser, (i) in a registered direct offering, (a) an aggregate of 485,912 shares (the “Common Shares”) of

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common stock, par value $0.001 per share (“Common Stock”), and (b) an aggregate of 237,745 shares of Series B Convertible Preferred Stock (the “Preferred Shares,” and collectively with the Common Shares, the “Shares”), par value $0.001 per share (“Series B Preferred Stock”), and (ii) in a concurrent private placement, warrants (the “Warrants”) to purchase up to an aggregate of 669,854 shares (the “Warrant Shares”) of Common Stock.

 The combined purchase price for each Share, together with one Warrant to purchase 0.4 shares of Common Stock, is $4.18. 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 $4.13 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.

Each share of Series B Convertible Preferred Stock will convert into five shares of Common Stock.

The conversion feature within the Series B Convertible Preferred Stock was determined to be beneficial as of the offering date. A beneficial conversion feature is defined as a nondetachable conversion feature that is "in-the-money" at issuance. The Company calculated the value of the beneficial conversion feature based on its intrinsic value, which is the difference between the “effective conversion price” (after allocating the proceeds of the offering between the Series B Convertible Preferred Stock, the Warrants and Common Stock issued) and the market price of the Company's common shares, multiplied by the number of shares into which the Series B Convertible Preferred Stock is convertible. The effective conversion price of $3.18 per share is different from the $4.18 per share contractual conversion price.  

As the series B Preferred Stock contained no stated redemption date and the conversion feature could be exercised at any time, the discount associated with the beneficial conversion feature was immediately charged against additional paid-in-capital and treated as a deemed dividend for both financial reporting and earnings per share purposes.

The common stock, Warrants and Series B Preferred Stock are freestanding financial instruments. The Warrants are classified within equity (as a component of additional paid-in capital) in the consolidated balance sheet and are not remeasured on a recurring basis. The Series B Preferred Stock is classified within permanent equity in the consolidated balance sheet.

The closing of the offering occurred on December 22, 2020 and the net proceeds to the Company were approximately $6.9 million, after deducting offering expenses payable by the Company.

As of September 30, 2022, 237,745 shares of the Series B Preferred Stock remained issued and outstanding.

April 2020 Equity Financing

On April 21, 2020, the Company entered into a co-placement agency agreement with Roth Capital Partners, LLC, Ladenburg Thalmann & Co. Inc., and Brookline Capital Markets, a division of Arcadia Securities, LLC (the “Co-Placement Agents”) and a securities purchase agreement with certain purchasers for the purchase and sale of (i) 1,910,000 shares of common stock, (ii) pre-funded warrants to purchase up to 2,090,000 shares of common stock at an exercise price of $0.001 per share, and (iii) accompanying common stock warrants to purchase up to 4,000,000 shares of common stock at an exercise price of $5.00 per share. The shares of common stock and accompanying common stock warrants were sold at a combined public offering price of $5.00 per share and common stock warrant. Each common stock warrant sold with the shares of common stock represents the right to purchase one share of common stock at an exercise price of $5.00 per share.  The common stock warrants are exercisable immediately and expire five years from the date of issuance.

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The pre-funded warrants and accompanying common stock warrants were sold at a combined public offering price of $4.999 per pre-funded warrant and common stock warrant. The pre-funded warrants were sold to purchasers whose purchase of shares of common stock in the public offering would otherwise result in the purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99% (or, at the election of the purchaser, 9.99%) of the Company’s outstanding common stock immediately following the consummation of the public offering, in lieu of shares of common stock. Each pre-funded warrant represents the right to purchase one share of the Company’s common stock at an exercise price of $0.001 per share. The pre-funded warrants are exercisable immediately and may be exercised at any time until the pre-funded warrants are exercised in full. The shares of common stock and pre-funded warrants, and accompanying common stock warrants, were issued separately and are immediately separable upon issuance.

The closing of the offering occurred on April 24, 2020, and the net proceeds to the Company were approximately $18.3 million, after deducting placement agent fees and other offering expenses payable by the Company.

Subsequent to the closing of the offering, all of the pre-funded warrants issued in connection therewith were converted into 2,090,000 shares of common stock.

Warrants

December 2020 Warrants

As of September 30, 2022, warrants to purchase 669,854 shares of common stock 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 $4.13 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.

There were no exercises of these warrants during the three and nine months ended September 30, 2022 or September 30, 2021.

April 2020 Warrants

As of September 30, 2022, 2,190,000 warrants issued in connection with the April 2020 equity financing remained outstanding, each with an exercise price of $5.00. All such warrants were issued in connection with the April 2020 co-placement agency agreement. 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.

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There were no warrants exercised during the three and nine months ended September 30, 2022, and a total of 909,000 warrants exercised during the three and nine months ended September 30, 2021.

July 2017 Warrants

As of September 30, 2021, 374,525 warrants issued in connection with the July 2017 underwritten public offering remained outstanding, each with an exercise price of $40.00. All such warrants were issued in connection with the July 2017 underwritten public offering and are immediately exercisable. The warrants expire in 2024. Subject to limited exceptions, a holder of warrants will not have the right to exercise any portion of its warrants if the holder (together with such holder’s affiliates, and any persons acting as a group together with such holder or any of such holder’s affiliates) would beneficially own a number of shares of common stock in excess of 4.99% (or, at the election of the purchaser, 9.99%) of the shares of our Common Stock then outstanding after giving effect to such exercise.

The exercise price and the number of shares issuable upon exercise of the warrants is subject to appropriate adjustment in the event of recapitalization events, stock dividends, stock splits, stock combinations, reclassifications, reorganizations or similar events affecting the Company’s common stock. The warrant holders must pay the exercise price in cash upon exercise of the warrants unless such warrant holders are utilizing the cashless exercise provision of the warrants. On the expiration date, unexercised warrants will automatically be exercised via the “cashless” exercise provision.

Prior to the exercise of any warrants to purchase common stock, holders of the warrants will not have any of the rights of holders of the common stock purchasable upon exercise, including the right to vote, except as set forth therein.

There were no exercises of these warrants during the three and nine months ended September 30, 2022 or September 30, 2021.

Series A Preferred Stock

8,872 shares of the Company’s Series A Preferred Stock were issued in the July 2017 underwritten public offering. During the year ended December 31, 2017, 8,608 shares of the Series A Preferred Stock were converted into 215,200 shares of common stock. As of September 30, 2022, 264 shares of the Series A Preferred Stock remained issued and outstanding.

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 $40.00 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. The 264 shares of Series A Preferred Stock issued and outstanding at September 30, 2022 are convertible into 6,600 shares of common stock.

In the event of a liquidation, the holders of shares of the Series A Preferred Stock shall be permitted to 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 the 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 (the “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

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information which was provided by the Company. 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 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 September 30, 2022, there were 335,273 shares of the Company’s 6% Convertible Exchangeable Preferred Stock (the “6% Preferred Stock”) issued and outstanding at an issue price of $10.00 per share. Dividends on the 6% Preferred Stock are cumulative from the date of original issuance at the annual rate of 6% of the liquidation preference of the 6% Preferred Stock, 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 6% Preferred Stock has a liquidation preference of $10.00 per share, plus accrued and unpaid dividends. As of September 30, 2022, accrued and unpaid dividends amounted to $50,291.

The Company may automatically convert the 6% Preferred Stock into common stock if the per share closing price of the Company’s common stock has exceeded $59,220, which is 150% of the conversion price of the 6% Preferred Stock, for at least 20 trading days during any 30 day trading period, ending within five trading days prior to notice of automatic conversion.

The 6% 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 6% Preferred Stock in whole or in part, out of funds legally available at the redemption price of $10.00 per share.

The 6% 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 (the “Exchange Date”) for the Company’s 6% Convertible Subordinated Debentures (the “Debentures”) at the rate of $10.00 principal amount of Debentures for each share of 6% Preferred Stock. The Debentures, if issued, will mature 25 years after the Exchange Date and have substantially similar terms to those of the 6% Preferred Stock. No such exchanges have taken place to date.

11.          Subsequent Events

Dividends on 6% Preferred Stock

On September 7, 2022, the board of directors declared a quarterly cash dividend in the amount of $0.15 per share on the Company’s Preferred Stock. The cash dividend was paid on November 1, 2022 to the holders of record of the 6% Preferred Stock as of the close of business on October 14, 2022.

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q, including, without limitation, Management’s Discussion and Analysis of Financial Condition and Results of Operations, contains “forward-looking statements” within the meaning of Section 27A of the Securities Exchange Act of 1933 as amended and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). We intend that the forward-looking statements be covered by the safe harbor for forward-looking statements in the Exchange Act. The forward-looking information is based on various factors and was derived using numerous assumptions. All statements, other than statements of historical fact, that address activities, events or developments that we intend, expect, project, believe or anticipate will or may occur in the future are forward-looking statements. Such statements are based upon certain assumptions and assessments made by our management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These forward-looking statements are usually accompanied by words such as “believe,” “anticipate,” “plan,” “seek,” “expect,” “intend” and similar expressions.

Forward-looking statements necessarily involve risks and uncertainties, and our actual results could differ materially from those anticipated in the forward-looking statements due to a number of factors, including those set forth in Part I, Item 1A, entitled “Risk Factors,” of our Annual Report on Form 10-K for the year ended December 31, 2021, as updated and supplemented by Part II, Item 1A, entitled “Risk Factors,” of our Quarterly Reports on Form 10-Q, and elsewhere in this report. In addition, while we expect the coronavirus pandemic to have an ongoing impact on our business operations and financial results, the extent of the impact on our clinical development and regulatory efforts, our corporate development objectives, our financial position and the value of and market for our common stock will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time, such as the ultimate duration of the pandemic, the emergence of new geographic hotspots, the re-emergence of subsequent outbreaks, travel restrictions, quarantines, social distancing and business closure requirements in the United States and in other countries, and the effectiveness of actions taken globally to contain and treat the disease. These factors as well as other cautionary statements made in this Quarterly Report on Form 10-Q, should be read and understood as being applicable to all related forward-looking statements wherever they appear herein. The forward-looking statements contained in this Quarterly Report on Form 10-Q represent our judgment as of the date hereof. We encourage you to read those descriptions carefully. We caution you not to place undue reliance on the forward-looking statements contained in this report. These statements, like all statements in this report, speak only as of the date of this report (unless an earlier date is indicated) and we undertake no obligation to update or revise the statements except as required by law. Such forward-looking statements are not guarantees of future performance and actual results will likely differ, perhaps materially, from those suggested by such forward-looking statements. In this report, “Cyclacel,” the “Company,” “we,” “us,” and “our” refer to Cyclacel Pharmaceuticals, Inc.

Overview

We are a clinical-stage biopharmaceutical company developing innovative cancer medicines based on cell cycle, transcriptional regulation and mitosis control biology. We are a pioneer in the field of cancer cell cycle biology with a vision to improve patient healthcare by translating insights in cancer biology into medicines that can overcome resistance and ultimately increase a patient’s overall survival rate. Our primary focus has been on our transcriptional regulation program, which is evaluating fadraciclib, a CDK2/9 inhibitor, in solid tumors and hematological malignancies. In addition, the anti-mitotic program is evaluating CYC140, a PLK1 inhibitor, in advanced cancers.

We are evaluating oral fadraciclib and CYC140 in Phase 1/2 streamlined studies the aim of which is to assess safety and identify signals of clinical activity which may lead to registration-enabling outcomes.

Fadraciclib Phase 1/2 Study in Advanced Solid Tumors and Lymphomas (065-101; NCT#04983810)

In this ongoing study, eighteen patients have been treated in the first five dose escalation levels. Following a protocol amendment, we are enrolling dose level six. The proof-of-concept stage includes seven histologically defined cohorts thought to be sensitive to the drug’s mechanism: breast, colorectal (including KRAS mutant), endometrial/

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

Fadraciclib Phase 1/2 Study in Hematological Malignancies (065-102; NCT#05168904)

Based on good tolerability in the 065-101 study and following FDA clearance of a protocol amendment we have has accelerated dose progression by omitting dose levels two and three and enrolling patients at dose level four. The proof-of-concept stage, where fadraciclib will be administered both as a single agent and in combination, includes seven histologically defined cohorts which will include patients with acute myeloid leukemia (or AML) or myelodysplastic syndromes (or MDS) who have an inadequate response or have progressed on venetoclax combinations with hypomethylating agent (or HMA) or low dose Ara C. The trial will also include patients with chronic lymphocytic leukemia or CLL who have progressed after at least two lines of therapy including a BTK inhibitor and/or venetoclax.

CYC140 Phase 1/2 Study in Advanced Solid Tumors and Lymphomas (140-101; NCT#05358379)

The first patient was dosed in this study in April 2022 and treated at the second dose escalation level. Similar to fadraciclib this Phase 1/2 registration-directed trial uses a streamlined design and will first determine in a dose escalation stage the recommended Phase 2 dose (or RP2D) for single-agent CYC140. Once RP2D has been established, the trial will immediately enter into proof-of-concept, cohort stage, using a Simon 2-stage design. In this stage CYC140 will be administered to patients in up to seven mechanistically relevant cohorts including patients with bladder, breast, colorectal (including KRAS mutant), hepatocellular and biliary tract, and lung cancers (both small cell and non-small cell), as well as lymphomas. An additional basket cohort will enroll patients with biomarkers relevant to the drug’s mechanism, including MYC amplified tumors. The protocol allows for expansion of individual cohorts based on response which may allow acceleration of the clinical development and registration plan for CYC140.

We currently retain virtually all marketing rights worldwide to the compounds associated with our drug programs.

Results of Operations

Three and Nine Months Ended September 30, 2021 and 2022

Revenues

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

The future

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

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Research and Development Expenses

From our inception, we have focused on drug discovery and development programs, with a particular emphasis on orally available anticancer agents, and our research and development expenses have represented costs incurred to discover and develop novel small molecule therapeutics, including clinical trial costs for fadraciclib and CYC140, as well as other compounds such as sapacitabine and seliciclib. We will not be pursuing further development of sapacitabine and have notified Daiichi Sankyo Co., Ltd., the licensor, that we wishe to terminate the sapacitabine license agreement for commercial reasons. The termination is expected to be effective as of March 23, 2023.

We have also incurred costs in the advancement of product candidates toward clinical and preclinical trials and the development of in-house research to advance our biomarker program and technology platforms. We expense all research and development costs as they are incurred. Research and development expenses primarily include:

● Clinical trial and regulatory-related costs;

● Payroll and personnel-related expenses, including consultants and contract research organizations;

● Preclinical studies, supplies and materials;

● Technology license costs;

● Stock-based compensation; and

● Rent and facility expenses for our offices.

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

	Three Months Ended							Nine Months Ended
	September 30,				Difference			September 30,				Difference
	2022		2021		$		%	2022		2021		$		%
Transcriptional Regulation (fadraciclib)	$	2,512	$	3,331	$	(819)	(25)	$	8,740	$	7,748	$	992	13
Anti-mitotic (CYC140)		1,707		664		1,043	157		4,289		2,480		1,809	73
DNA Damage Response (sapacitabine)		20		96		(76)	(79)		72		269		(197)	(73)
Other research and development expenses		174		126		48	38		471		387		84	22
Total research and development expenses	$	4,413	$	4,217	$	196	5	$	13,572	$	10,884	$	2,688	25

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

Research and development expenses increased by $2.7 million from $10.9 million for the nine months ended September 30, 2021 to $13.6 million for the nine months ended September 30, 2022. Expenditure for the transcriptional regulation program increased by $1.0 million for the nine months ended September 30, 2022, relative to the respective comparative period. This was due to an increase in clinical trial costs of $1.2 million associated with the progression of clinical trials for the evaluation of fadraciclib in Phase 1/2 studies, offset by a decrease in non-clinical expenditure of $0.2 million. Research and development expenses relating to CYC140 increased by $1.8 million for the nine months ended September 30, 2022, relative to the respective comparative period. This was due to an increase in clinical trial costs of $2.4 million associated with the progression of clinical trials for the evaluation of CYC140 in Phase 1/2 studies, offset by a decrease in non-clinical expenditure of $0.6 million.

22

The future

We continue to anticipate that overall research and development expenses for the year ended December 31, 2022 will increase compared to the year ended December 31, 2021 as we progress our clinical development programs.

General and administrative expenses

General and administrative expenses include costs for administrative personnel, legal and other professional expenses and general corporate expenses. The following table summarizes the general and administrative expenses for the three and nine months ended September 30, 2021 and 2022 (in $000s except percentages):

	Three Months Ended							Nine Months Ended
	September 30,				Difference			September 30,				Difference
	2022		2021		$		%	2022		2021		$		%
Total general and administrative expenses	$	2,054	$	1,781	$	273	15	$	5,239	$	5,520	$	(281)	(5)

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

During the three months ended September 30, 2022, the increase in general and administrative expenses was primarily due to a $0.4 million cost associated with the Controlled Equity Offering Sales Agreement with Cantor Fitzgerald & Co. (the “Sales Agreement”). The decrease in general and administrative expenses during the nine months ended September 30, 2022 relative to the corresponding prior year period was due to reductions in legal and professional expenses and recruitment costs relating to expansion of the clinical team that were incurred in the first half of 2021 along with a one-time $0.4 million reverse premium charge in relation to assignation of the lease facility in Dundee, Scotland which was recognized during the second quarter of 2021.

The future

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

Other income (expense), net

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

	Three Months Ended							Nine Months Ended
	September 30,				Difference			September 30,				Difference
	2022		2021		$		%	2022		2021		$		%
Foreign exchange gains	$	276	$	9	$	267	2,967	$	514	$	5	$	509	10,180
Interest income		67		4		63	1,575		88		12		76	633
Other income, net		14		—		14	—		1,294		144		1,150	799
Total other income	$	357		13	$	344	2,646	$	1,896		161	$	1,735	1,078

Total other income increased by $1.7 million from $0.2 million for the nine months ended September 30, 2021 to $1.9 million for the nine months ended September 30, 2022. Other income primarily relates to royalties receivable under a December 2005 Asset Purchase Agreement, or APA, whereby Xcyte Therapies, Inc., or Xcyte (a business acquired by us in March 2006) sold through the APA and other related agreements certain assets and intellectual property which are not related to our product development plans to ThermoFisher Scientific Company, or TSC. Accordingly, we presented $1.3 million and $144,000 as other income received from TSC during the nine months ended September 30, 2022 and 2021 respectively.

23

Foreign exchange gains (losses)

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

The future

Other income (expense), net for the year ended December 31, 2022, will continue to be impacted by changes in foreign exchange rates and the receipt of income under the APA. As we are not in control of sales made by TSC, we are unable to estimate the level and timing of income under the APA, if any.

Because the nature of funding advanced through intercompany loans is that of a long-term investment, unrealized foreign exchange gains and losses on such funding will be recognized in other comprehensive income until repayment of any intercompany loan becomes foreseeable.

Income Tax Benefit

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

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

	Three Months Ended							Nine Months Ended
	September 30,				Difference			September 30,				Difference
	2022		2021		$		%	2022		2021		$		%
Total income tax benefit	$	1,014	$	998	$	16	2%	$	3,136	$	2,650	$	486	18%

The total income tax benefit, which comprised of research and development tax credits recoverable, increased by approximately $0.5 million from $2.6 million for the nine months ended September 30, 2021 to $3.1 million for the nine months ended September 30, 2022. The level of tax credits recoverable is linked directly to qualifying research and development expenditure incurred in any one year and the availability of trading losses.

The future

We expect to continue to be eligible to receive United Kingdom research and development tax credits for the foreseeable future and will continue to elect to receive payment of the tax credit. The amount of tax credits we will receive is entirely dependent on the amount of eligible expenses we incur and could be restricted by any future cap introduced by HMRC. As we expect our eligible expenses to be higher in the fiscal year ended December 31, 2022, the level of tax credits recoverable is anticipated to be higher in 2022 compared to the prior year.

Liquidity and Capital Resources

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

	September 30,
	2022		2021
Cash and cash equivalents	$	23,706	$	40,219
Working capital:
Current assets	$	27,915	$	43,375
Current liabilities		(4,353)		(3,591)
Total working capital	$	23,562	$	39,784

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Since our inception, we have relied primarily on the proceeds from sales of common and preferred equity securities to finance our operations and internal growth. Additional funding has come through research and development tax credits, government grants, the sale of product rights, interest on investments and licensing revenue. We have incurred significant losses since our inception. As of September 30, 2022, we had an accumulated deficit of $398.7 million.

On August 12, 2021, the Company entered into a Controlled Equity Offering Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co. ("Cantor"), pursuant to which the Company could issue and sell, from time to time, shares of its common stock having an aggregate offering price of up to $10.0 million through Cantor as the sales agent. On August 12, 2022, the Company became aware that the shelf registration statement on Form S-3 (file number 333-231923) (the “Registration Statement”) associated with this Sales Agreement had expired on June 21, 2022. Prior to becoming aware of the expiration, the Company sold an aggregate of 3,117,100 shares of its common stock following the expiration of the Registration Statement and through August 12, 2022, for an aggregate of approximately $4,494,496 under the Registration Statement pursuant to the Sales Agreement. The sale of these shares may be subject to potential rescission rights by the shareholders, as described in more detail under “Risk Factors”. As of September 30, 2022, there have been no claims or demands to exercise such rights.

Cash Flows

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

	Nine Months Ended September 30,
	2022		2021
Net cash used in operating activities	$	(15,658)	$	(13,991)
Net cash used in investing activities		(7)		(25)
Net cash provided by financing activities		2,956		20,850

Operating activities

Net cash used in operating activities increased by $1.7 million, from $14.0 million for the nine months ended September 30, 2021 to $15.7 million for the nine months ended September 30, 2022. The increase in cash used by operating activities was primarily the result of a change in working capital of $1.6 million, a change in lease liability of $0.2 million, and an increase in net loss of $0.2 million, offset by an increase of stock compensation expense of $0.3 million.

Investing activities

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

Financing activities

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

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

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

● $4.5 million from warrant exercises associated with a co-placement agency agreement with Roth Capital Partners, LLC, Ladenburg Thalmann & Co. Inc., and Brookline Capital Markets, a division of Arcadia Securities, LLC, and

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

25

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

Operating Capital and Capital Expenditure Requirements

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

We believe that existing funds together with cash generated from operations, such as recent financing activities and the R&D tax credit, are sufficient to satisfy our planned working capital, capital expenditures and other financial commitments to the end of 2023. However, we do not currently have sufficient funds to complete development and commercialization of any of our drug candidates. Current business and capital market risks could have a detrimental effect on the availability of sources of funding and our ability to access them in the future, which may delay or impede our progress of advancing our drugs currently in the clinical pipeline to approval by the FDA or EMA for commercialization. Additionally, we plan to continue to evaluate in-licensing and acquisition opportunities to gain access to new drugs or drug targets that would fit with our strategy. Any such transaction would likely increase our funding needs in the future.

Our future funding requirements will depend on many factors, including but not limited to:

● the rate of progress and cost of our clinical trials, preclinical studies and other discovery and research and development activities;

● the costs associated with establishing manufacturing and commercialization capabilities;

● the costs of acquiring or investing in businesses, product candidates and technologies;

● the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights;

● the costs and timing of seeking and obtaining FDA and EMA approvals;

● the effect of competing technological and market developments;

● the economic and other terms and timing of any collaboration, licensing or other arrangements into which we may enter; and

● the extent to which the coronavirus impacts our financial condition and operations, which will depend on future developments that are highly uncertain and cannot be predicted with confidence, including the ultimate duration of the pandemic, the emergence of new geographic hotspots, the re-emergence of subsequent outbreaks, travel restrictions, quarantines, social distancing and business closure requirements in the United States and in other countries, and the effectiveness of actions taken globally to contain and treat the disease.

Until we can generate a sufficient amount of product revenue to finance our cash requirements, which we may never do, we expect to finance future cash needs primarily through public or private equity offerings, debt financings or strategic collaborations. Although we are not reliant on institutional credit finance and therefore not subject to debt covenant compliance requirements or potential withdrawal of credit by banks, we are reliant on the availability of funds and activity in equity markets. We do not know whether additional funding will be available on acceptable terms, or at all. If we are not able to secure additional funding when needed, we may have to delay, reduce the scope of or eliminate

26

one or more of our clinical trials or research and development programs or make changes to our operating plan. In addition, we may have to partner one or more of our product candidates at an earlier stage of development, which would lower the economic value of those programs to us.

Impact of COVID-19

The COVID-19 pandemic has led to global supply chain challenges, which have negatively impacted the availability and cost of materials. The global outbreak of COVID-19 has also adversely affected our clinical trials with regards to the pace of patient enrollment as a result of restrictions on travel and/or transport of clinical materials, as well as diversion of hospital staff and resources to COVID-19 infected patients. The extent to which COVID-19 will continue to impact our business will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the duration of the pandemic, the severity of COVID-19 or new variants or the effectiveness of actions to contain and treat COVID-19 and its variants, particularly in the geographies where we or our third-party suppliers, contract manufacturers, or contract research organizations operate. At this time, we are unable to fully estimate the impact of the pandemic or current geopolitical turmoil on our financial condition or operations, but either or both could materially affect our ability to raise future capital or to conduct clinical studies on a timely basis.

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Critical Accounting Policies and Estimates

Our critical accounting policies are those policies which require the most significant judgments and estimates in the preparation of our consolidated financial statements. We evaluate our estimates, judgments, and assumptions on an ongoing basis. Actual results may differ from these estimates under different assumptions or conditions. A summary of our critical accounting policies is presented in Part II, Item 7, of our Annual Report on Form 10-K for the year ended December 31, 2021 and Note 2 to our unaudited consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q. There have been no material changes to our critical accounting policies during the three months ended September 30, 2022.

Item 3. Quantitative and Qualitative Disclosures about Market Risk

As a smaller reporting company, we are not required to provide information in response to this item.

Item 4. Controls and Procedures

Under the supervision and with the participation of our management, including our chief executive officer and principal financial and accounting officer, we conducted an evaluation of the effectiveness, as of September 30, 2022, of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act. Based upon such evaluation, our chief executive officer and principal financial and accounting officer have concluded that, as of September 30, 2022, our disclosure controls and procedures were effective to provide reasonable assurance that the information we are required to disclose in our filings with the Securities and Exchange Commission, or SEC, under the Exchange Act (i) is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and (ii) accumulated and communicated to our management, including our chief executive officer and principal financial and accounting officer, as appropriate to allow timely decisions regarding required disclosure.

Changes in Internal Control over Financial Reporting

There were no significant changes made in our internal controls over financial reporting.

Inherent Limitation on the Effectiveness of Internal Controls

The effectiveness of any system of internal control over financial reporting, including ours, is subject to inherent limitations, including the exercise of judgment in designing, implementing, operating, and evaluating the controls and procedures, and the inability to eliminate misconduct completely. Accordingly, any system of internal control over financial reporting, including ours, no matter how well designed and operated, can only provide reasonable, not absolute, assurances. In addition, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. We intend to continue to monitor and upgrade our internal controls as necessary or appropriate for our business but cannot ensure that such improvements will be sufficient to provide us with effective internal control over financial reporting.

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PART II. Other Information

Item 1. Legal Proceedings

None.

Item 1A. Risk Factors

Except as set forth below, there have been no material changes to our risk factors contained in our Annual Report on Form 10-K for the year ended December 31, 2021. For a further discussion of our Risk Factors, refer to Part I, Item 1A, “Risk Factors,” of our Annual Report on Form 10-K for the year ended December 31, 2021.

Shares sold under our ATM Sales Agreement may be subject to rescission rights and other penalties, requiring us to repurchase shares sold thereunder.

In connection with our August 2021 Controlled Equity Offering Sales Agreement (the “Sales Agreement”), on August 12, 2022, we became aware that our shelf registration statement on Form S-3 (file number 333-231923) (the “Registration Statement”) expired on June 21, 2022. Prior to becoming aware of the expiration, we sold an aggregate of 3,117,100 shares of our common stock following the expiration of the Registration Statement and through August 12, 2022 at an average price of approximately $1.44 per share for an aggregate of approximately $4,494,496 (the “Sales”) under the Registration Statement pursuant to the Sales Agreement. Because the Registration Statement had already expired, the Sales could be determined to be unregistered sales of securities, which could subject us to enforcement actions or penalties and fines by federal and/or state regulatory authorities. In accordance with Section 5 of the Securities Act, direct purchasers in the Sales may have rescission rights pursuant to which they may be entitled to recover the amount paid for such shares, plus statutory interest, upon returning the shares to us within one year from the transaction date. If all purchasers in the Sales demanded rescission and it was determined that every such purchaser were entitled to such rights, we may be obligated to repay an aggregate of approximately $4,494,496 for the Sales, excluding statutory interest. If purchasers successfully seek rescission and/or damages, and/or the SEC and/or state securities agencies impose financial penalties on us which are not covered by insurance, we may not have sufficient resources to make the necessary payments, and any such claims, damages or penalties could have a material adverse effect on our stock price, business prospects, results of operations, and financial condition. We cannot predict the likelihood of any claims or actions being brought against us or the amount of any penalties or fines in connection with the Sales.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

In connection with the Sales Agreement, on August 12, 2022, we became aware that the Registration Statement expired on June 21, 2022. Prior to becoming aware of the expiration, we sold an aggregate of 3,177,100 shares of our common stock following the expiration of the Registration Statement and through August 12, 2022 at an average price of approximately $1.44 per share for an aggregate of approximately $4,494,496 under the Registration Statement pursuant to the Sales Agreement. Because the Registration Statement had already expired, the Sales could be determined to be unregistered sales of securities, which could subject us to enforcement actions or penalties and fines by federal or state regulatory authorities. In accordance with Section 5 of the Securities Act, direct purchasers in the Sales may have rescission rights pursuant to which they may be entitled to recover the amount paid for such shares, plus statutory interest, upon returning the shares to us within one year from the transaction date. If all purchasers in the Sales demanded rescission and it was determined that every such purchaser were entitled to such rights, we may be obligated to repay an aggregate of approximately $4,494,496 for the Sales, excluding statutory interest. If purchasers successfully seek rescission and/or damages, and/or the SEC and/or state securities agencies impose financial penalties on us which are not covered by insurance, we may not have sufficient resources to make the necessary payments, and any such claims, damages or penalties could have a material adverse effect on our stock price, business prospects, results of operations, and financial condition. We cannot predict the likelihood of any claims or actions being brought against us or the amount of any penalties or fines in connection with the Sales. Since becoming aware of the expiration of the Registration Statement, we have not offered any securities under the Registration Statement and will not do so until a

29

new shelf registration statement becomes effective. As of September 30, 2022, there have been no claims or demands to exercise such rescission rights.

Item 3. Defaults upon Senior Securities

None.

Item 4. Mine Safety Disclosures

Not applicable.

Item 5. Other Information

None.

Item 6. Exhibits

Exhibit Number		Description
31.1*		Certification of Principal Executive Officer Pursuant to Securities Exchange Act Rule 13a-14(a) As Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2*		Certification of Principal Financial Officer Pursuant to Securities Exchange Act Rule 13a-14(a) As Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1*		Certification of Principal Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2*		Certification of Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101		The following materials from Cyclacel Pharmaceuticals, Inc.’s Quarterly Report on Form 10-Q for the period ended September 30, 2022, formatted in iXBRL (Inline eXtensible Business Reporting Language): (i) the Consolidated Statements of Income, (ii) the Consolidated Balance Sheets, (iii) the Consolidated Statements of Cash Flows, and (iv) Notes to Consolidated Financial Statements.
104		The cover page from the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, formatted in Inline eXtensible Business Reporting Language (included with Exhibit 101).
	*	Filed herewith.

30

SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned.

	CYCLACEL PHARMACEUTICALS, INC.
Date: November 10, 2022	By:	/s/ Paul McBarron
		Paul McBarron
		Chief Operating Officer, Chief Financial Officer and Executive Vice President, Finance

31

EX-31.1

EXHIBIT 31.1

Certification of Principal Executive Officer

Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

I, Spiro Rombotis, certify that:

1. I have reviewed this Quarterly Report on Form 10-Q for the three months ended September 30, 2022 of Cyclacel Pharmaceuticals, Inc.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c) evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d) disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting: and

5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: November 10, 2022

/s/ Spiro Rombotis

Spiro Rombotis

President & Chief Executive Officer

(Principal Executive Officer)

EX-31.2

EXHIBIT 31.2

Certification of Principal Financial Officer

Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

I, Paul McBarron, certify that:

1. I have reviewed this Quarterly Report on Form 10-Q for the three months ended September 30, 2022 of Cyclacel Pharmaceuticals, Inc.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c) evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d) disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: November 10, 2022

/s/ Paul McBarron

Paul McBarron

Chief Operating Officer, Chief Financial Officer

and Executive Vice President, Finance

(Principal Financial Officer)

EX-32.1

EXHIBIT 32.1

Certification of Principal Executive Officer

Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

Pursuant to 18 U.S.C. s 1350, as created by Section 906 of the Sarbanes-Oxley Act of 2002, the undersigned officer of Cyclacel Pharmaceuticals, Inc. ( the “Company”) hereby certifies, to such officer’s knowledge, that:

(i) the Quarterly Report on Form10-Q of the Company for the three months ended September 30, 2022 (the “Report”) fully complies with the requirements of Section 13(a) or Section 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and

(ii) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Date: November 10, 2022	/s/ Spiro Rombotis
	Spiro Rombotis
	President & Chief Executive Officer

EX-32.2

EXHIBIT 32.2

Certification of Principal Financial Officer

Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

Pursuant to 18 U.S.C. s 1350, as created by Section 906 of the Sarbanes-Oxley Act of 2002, the undersigned officer of Cyclacel Pharmaceuticals, Inc. ( the “Company”) hereby certifies, to such officer’s knowledge, that:

(i) the Quarterly Report on Form10-Q of the Company for the three months ended September 30, 2022 (the “Report”) fully complies with the requirements of Section 13(a) or Section 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and

(ii) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Date: November 10, 2022	/s/ Paul McBarron
	Paul McBarron
	Chief Operating Officer, Chief Financial Officer
	and Executive Vice President, Finance

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	Sep. 30, 2022	Nov. 07, 2022
Document Type	10-Q
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Entity Registrant Name	Cyclacel Pharmaceuticals, Inc.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	91-1707622
Entity Address, Address Line One	200 Connell Drive
Entity Address, Address Line Two	Suite 1500
Entity Address, City or Town	Berkeley Heights
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Entity Emerging Growth Company	false
Entity Shell Company	false
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2022
Document Fiscal Period Focus	Q3
Entity Central Index Key	0001130166
Amendment Flag	false
Entity Common Stock, Shares Outstanding		12,539,189
Common Stock
Title of 12(b) Security	Common Stock, par value $0.001 per share
Trading Symbol	CYCC
Security Exchange Name	NASDAQ
Preferred Stock
Title of 12(b) Security	Preferred Stock, $0.001 par value
Trading Symbol	CYCCP
Security Exchange Name	NASDAQ

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CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Current assets:
Cash and cash equivalents	$ 23,706	$ 36,559
Prepaid expenses and other current assets	4,209	4,383
Total current assets	27,915	40,942
Property and equipment, net	37	64
Right-of-use lease asset	153	30
Non-current deposits	2,916	1,551
Total assets	31,021	42,587
Current liabilities:
Accounts payable	983	2,117
Accrued and other current liabilities	3,370	3,177
Total current liabilities	4,353	5,294
Lease liability	107	30
Total liabilities	4,460	5,324
Redeemable common stock, $0.001 par value, 0 and 3,117,100 shares issued and outstanding at December 31, 2021 and September 30, 2022 (Note 10)	4,494	0
Stockholders' equity:
Common stock, $0.001 par value; 100,000,000 shares authorized at December 31, 2021 and September 30, 2022; 9,993,135 shares and 12,539,189 shares issued and outstanding at December 31, 2021 and September 30, 2022, respectively.	9	10
Additional paid-in capital	422,542	422,960
Accumulated other comprehensive loss	(1,746)	(748)
Accumulated deficit	(398,738)	(384,959)
Total stockholders' equity	22,067	37,263
Total liabilities and stockholders' equity	31,021	42,587
6% convertible exchangeable preferred stock
Stockholders' equity:
Preferred stock, $0.001 par value; 5,000,000 shares authorized at December 31, 2021 and September 30, 2022;	0	0
Series A Convertible Preferred Stock
Stockholders' equity:
Preferred stock, $0.001 par value; 5,000,000 shares authorized at December 31, 2021 and September 30, 2022;	0	0
Series B Convertible Preferred Stock
Stockholders' equity:
Preferred stock, $0.001 par value; 5,000,000 shares authorized at December 31, 2021 and September 30, 2022;	$ 0	$ 0

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CONSOLIDATED BALANCE SHEETS (Parentheticals) - USD ($)	9 Months Ended	12 Months Ended
	Sep. 30, 2022	Dec. 31, 2021
Redeemable common stock, par value (in dollars per share)	$ 0.001
Redeemable common stock, shares issued	3,117,100	0
Redeemable common stock, shares outstanding	3,117,100	0
Preferred stock, par value (in dollars per share)	$ 0.001	$ 0.001
Preferred stock, shares authorized	5,000,000	5,000,000
Common stock, par value (in dollars per share)	$ 0.001	$ 0.001
Common stock, shares authorized	100,000,000	100,000,000
Common stock, shares issued	12,539,189	9,993,135
Common stock, shares outstanding	12,539,189	9,993,135
6% convertible exchangeable preferred stock
Preferred stock, shares issued	335,273	335,273
Preferred stock, shares outstanding	335,273	335,273
Dividend rate on convertible exchangeable preferred stock (in percent)	6.00%	6.00%
Preferred stock, liquidation preference value (in dollars)	$ 4,006,512	$ 4,006,512
Series A Convertible Preferred Stock
Preferred stock, par value (in dollars per share)	$ 0.001	$ 0.001
Preferred stock, shares issued	264	264
Preferred stock, shares outstanding	264	264
Series B Convertible Preferred Stock
Preferred stock, par value (in dollars per share)	$ 0.001	$ 0.001
Preferred stock, shares issued	237,745	237,745
Preferred stock, shares outstanding	237,745	237,745

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CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Revenues:
Revenues	$ 0	$ 0	$ 0	$ 0
Operating expenses:
Research and development	4,413	4,217	13,572	10,884
General and administrative	2,054	1,781	5,239	5,520
Total operating expenses	6,467	5,998	18,811	16,404
Operating loss	(6,467)	(5,998)	(18,811)	(16,404)
Other income (expense):
Foreign exchange gains (losses)	276	9	514	5
Interest income	67	4	88	12
Other income, net	14		1,294	144
Total other income, net	357	13	1,896	161
Loss before taxes	(6,110)	(5,985)	(16,915)	(16,243)
Income tax benefit	1,014	998	3,136	2,650
Net loss	(5,096)	(4,987)	(13,779)	(13,593)
Dividend on convertible exchangeable preferred shares	(50)	(50)	(151)	(151)
Net loss applicable to common shareholders	$ (5,146)	$ (5,037)	$ (13,930)	$ (13,744)
Basic and diluted earnings per common share:
Net loss per share - basic	$ (0.42)	$ (0.54)	$ (1.29)	$ (1.60)
Net loss per share - diluted	$ (0.42)	$ (0.54)	$ (1.29)	$ (1.60)
Weighted average common shares outstanding basic	12,314,679	9,368,056	10,823,138	8,575,379
Weighted average common shares outstanding diluted	12,314,679	9,368,056	10,823,138	8,575,379

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CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
Net loss	$ (5,096)	$ (4,987)	$ (13,779)	$ (13,593)
Translation adjustment	17,874	5,348	39,392	2,896
Unrealized foreign exchange gain (loss) on intercompany loans	(18,344)	(5,443)	(40,390)	(2,903)
Comprehensive loss	$ (5,566)	$ (5,082)	$ (14,777)	$ (13,600)

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CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands	Preferred Stock	Common Stock	Additional Paid-in Capital	Accumulated Other Comprehensive Loss	Accumulated Deficit	Total
Balance at Dec. 31, 2020		$ 6	$ 400,071	$ (746)	$ (366,072)	$ 33,259
Balance (in shares) at Dec. 31, 2020	573,282	6,246,896
Issue of common stock and associated warrants on underwritten offering, net of expenses		$ 2	13,499			13,501
Issue of common stock and associated warrants on underwritten offering, net of expenses (in shares)		2,078,214
Warrant Exercises		$ 1	4,544			4,545
Warrant Exercises (in shares)		909,000
Stock-based compensation			255			255
Preferred stock dividends			(50)			(50)
Unrealized foreign exchange on intercompany loans				1,599		1,599
Translation adjustment				(1,583)		(1,583)
Loss for the period					(3,478)	(3,478)
Balance at Mar. 31, 2021		$ 9	418,319	(730)	(369,550)	48,048
Balance (in shares) at Mar. 31, 2021	573,282	9,234,110
Balance at Dec. 31, 2020		$ 6	400,071	(746)	(366,072)	33,259
Balance (in shares) at Dec. 31, 2020	573,282	6,246,896
Unrealized foreign exchange on intercompany loans						(2,903)
Translation adjustment						2,896
Loss for the period						(13,593)
Balance at Sep. 30, 2021		$ 10	421,771	(753)	(379,664)	41,364
Balance (in shares) at Sep. 30, 2021	573,282	9,797,735
Balance at Mar. 31, 2021		$ 9	418,319	(730)	(369,550)	48,048
Balance (in shares) at Mar. 31, 2021	573,282	9,234,110
Stock-based compensation			279			279
Preferred stock dividends			(50)			(50)
Unrealized foreign exchange on intercompany loans				941		941
Translation adjustment				(869)		(869)
Loss for the period					(5,127)	(5,127)
Balance at Jun. 30, 2021		$ 9	418,548	(658)	(374,677)	43,222
Balance (in shares) at Jun. 30, 2021	573,282	9,234,110
Issue of common stock on At Market Issuance sales agreement, net of expenses		$ 1	2,954			2,955
Issue of common stock on At Market Issuance sales agreement, net of expenses (in shares)		563,625
Expenses paid in connection with an At Market issuance sales agreement		$ 1	2,954			2,955
Expenses paid in connection with an At Market issuance sales agreement (in shares)		563,625
Stock-based compensation			319			319
Preferred stock dividends			(50)			(50)
Unrealized foreign exchange on intercompany loans				(5,443)		(5,443)
Translation adjustment				5,348		5,348
Loss for the period					(4,987)	(4,987)
Balance at Sep. 30, 2021		$ 10	421,771	(753)	(379,664)	41,364
Balance (in shares) at Sep. 30, 2021	573,282	9,797,735
Balance at Dec. 31, 2021		$ 10	422,960	(748)	(384,959)	37,263
Balance (in shares) at Dec. 31, 2021	573,282	9,993,135
Stock-based compensation			380			380
Preferred stock dividends			(50)			(50)
Unrealized foreign exchange on intercompany loans				(5,878)		(5,878)
Translation adjustment				5,803		5,803
Loss for the period					(4,108)	(4,108)
Balance at Mar. 31, 2022		$ 10	423,290	(823)	(389,067)	33,410
Balance (in shares) at Mar. 31, 2022	573,282	9,993,135
Balance at Dec. 31, 2021		$ 10	422,960	(748)	(384,959)	37,263
Balance (in shares) at Dec. 31, 2021	573,282	9,993,135
Unrealized foreign exchange on intercompany loans						(40,390)
Translation adjustment						39,392
Loss for the period						(13,779)
Balance at Sep. 30, 2022		$ 9	422,542	(1,746)	(398,738)	22,067
Balance (in shares) at Sep. 30, 2022	573,282	9,422,089
Balance at Mar. 31, 2022		$ 10	423,290	(823)	(389,067)	33,410
Balance (in shares) at Mar. 31, 2022	573,282	9,993,135
Issue of common stock on At Market Issuance sales agreement, net of expenses		$ 1	1,524			1,525
Issue of common stock on At Market Issuance sales agreement, net of expenses (in shares)		1,339,742
Expenses paid in connection with an At Market issuance sales agreement		$ 1	1,524			1,525
Expenses paid in connection with an At Market issuance sales agreement (in shares)		1,339,742
Stock-based compensation			350			350
Stock-based awards (in shares)		17,412
Preferred stock dividends			(50)			(50)
Unrealized foreign exchange on intercompany loans				(16,168)		(16,168)
Translation adjustment				15,715		15,715
Loss for the period					(4,575)	(4,575)
Balance at Jun. 30, 2022		$ 11	425,114	(1,276)	(393,642)	30,207
Balance (in shares) at Jun. 30, 2022	573,282	11,350,289
Issue of common stock on At Market Issuance sales agreement, net of expenses		$ 1	1,581			1,582
Issue of common stock on At Market Issuance sales agreement, net of expenses (in shares)		1,188,900
Reclassification of redeemable common stock		$ (3)	(4,491)			(4,494)
Reclassification of redeemable common stock (in shares)		(3,117,100)
Expenses paid in connection with an At Market issuance sales agreement		$ 1	1,581			1,582
Expenses paid in connection with an At Market issuance sales agreement (in shares)		1,188,900
Stock-based compensation			388			388
Preferred stock dividends			(50)			(50)
Unrealized foreign exchange on intercompany loans				(18,344)		(18,344)
Translation adjustment				17,874		17,874
Loss for the period					(5,096)	(5,096)
Balance at Sep. 30, 2022		$ 9	$ 422,542	$ (1,746)	$ (398,738)	$ 22,067
Balance (in shares) at Sep. 30, 2022	573,282	9,422,089

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CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021
Operating activities:
Net loss	$ (13,779)	$ (13,593)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation	24	36
Stock-based compensation	1,119	853
Changes in lease liability	29	173
Changes in operating assets and liabilities:
Prepaid expenses and other assets	(2,816)	(2,655)
Accounts payable, accrued and other current liabilities	(235)	1,195
Net cash used in operating activities	(15,658)	(13,991)
Investing activities:
Purchase of property, plant and equipment	(7)	(25)
Net cash used in investing activities	(7)	(25)
Financing activities:
Proceeds, net of issuance costs, from issuing common stock and warrants	3,107	21,001
Payment of preferred stock dividend	(151)	(151)
Net cash (used in) provided by financing activities	2,956	20,850
Effect of exchange rate changes on cash and cash equivalents	(144)	(21)
Net (decrease) increase in cash and cash equivalents	(12,853)	6,813
Cash and cash equivalents, beginning of period	36,559	33,406
Cash and cash equivalents, end of period	23,706	40,219
Supplemental cash flow information:
Interest	89	13
Research & Development Tax Credits	3,050	1,352
Non cash financing activities:
Accrual of preferred stock dividends	$ 50	$ 50

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Company Overview

9 Months Ended

Sep. 30, 2022

Company Overview

Company Overview

1.           Company Overview

Nature of Operations

Cyclacel Pharmaceuticals, Inc. (“Cyclacel” or the “Company”) is a clinical-stage biopharmaceutical company developing innovative cancer medicines based on cell cycle, transcriptional regulation and mitosis control biology. Cyclacel is a pioneer in the field of cancer cell cycle biology with a vision to improve patient healthcare by translating insights in cancer biology into medicines that can overcome resistance and ultimately increase a patient’s overall survival rate.

Through September 30, 2022, 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.

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Summary of Significant Accounting Policies

9 Months Ended

Sep. 30, 2022

Summary of Significant Accounting Policies [Abstract]

Summary of Significant Accounting Policies

2.            Summary of Significant Accounting Policies

Basis of Presentation

The consolidated balance sheet as of September 30, 2022, the consolidated statements of operations, comprehensive loss, and stockholders’ equity for the three and nine months ended September 30, 2022 and 2021 and the consolidated statements of cash flows for the nine months ended September 30, 2022 and 2021, and all related disclosures contained in the accompanying notes, are unaudited. The consolidated balance sheet as of December 31, 2021 is derived from the audited consolidated financial statements included in the Annual Report on Form 10-K for the fiscal year ended December 31, 2021 filed with the Securities and Exchange Commission (the “SEC”) on March 30, 2022. The consolidated financial statements are presented on the basis of accounting principles that are generally accepted in the United States (“GAAP”) for interim financial information and in accordance with the rules and regulations of the SEC. Accordingly, they do not include all the information and footnotes required by GAAP for a complete set of financial statements. In the opinion of management, all adjustments, which include only normal recurring adjustments necessary to present fairly the consolidated balance sheet as of September 30, 2022, and the results of operations and, comprehensive loss for the three and nine months ended September 30, 2022, and cash flows for the nine months ended September 30, 2022, have been made. The interim results for the three and nine months ended September 30, 2022 are not necessarily indicative of the results to be expected for the year ending December 31, 2022 or for any other reporting period. The consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the accompanying notes for the year ended December 31, 2021 that are included in the Company’s Annual Report on Form 10-K filed with the SEC on March 30, 2022.

Going Concern

Management considers that there are no conditions or events, in the aggregate, that raise substantial doubt about the entity’s ability to continue as a going concern for a period of at least one year from the date the financial statements are issued. The Company expects that its cash of approximately $23.7 million as of September 30, 2022 will be sufficient to fund its operating expenses and capital expenditure requirements to the end of 2023.

This evaluation is based on relevant conditions and events that are known and reasonably knowable at the date that the financial statements are issued, including:

a. The Company’s current financial condition, including its sources of liquidity;

b. The Company’s conditional and unconditional obligations due or anticipated within one year;

c. The funds necessary to maintain the Company’s operations considering its current financial condition, obligations, and other expected cash flows; and

d. Other conditions and events, when considered in conjunction with the above, that may adversely affect the Company’s ability to meet its obligations.

The future viability of the Company beyond 2023 is dependent on its ability to raise additional capital to finance its operations. The Company does not currently have sufficient funds to complete development and commercialization of any of its drug candidates. Additional funding may not be available to the Company on favorable terms, or at all. If the Company is not able to secure additional funding when needed, it may have to delay, reduce the scope of or eliminate one or more of its clinical trials or research and development programs or make changes to its operating plan. In addition, it may have to partner one or more of its product candidate programs at an earlier stage of development, which would lower the economic value of those programs to the Company. The Company’s inability to raise capital as and when needed could have a negative impact on its financial condition and ability to pursue its business strategies.

Accounting Standards Adopted in the Period

In November 2021, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2021-10, Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance. This ASU requires business entities to make annual disclosures about transactions with a government they account for by analogizing to a grant or contribution accounting model under ASC 958-605 or based on International Accounting Standard No. 20. ASU 2021-10 which became effective for us on January 1, 2022. The Company has evaluated the effect that this guidance has on its Consolidated Financial Statements and has determined it does not have a material impact.

In May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt-Modifications and Extinguishments (Subtopic 470-50), Compensation-Stock Compensation (Topic 718), and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40). The new ASU addresses issuer’s accounting for certain modifications or exchanges of freestanding equity-classified written call options. This amendment became effective for us on January 1, 2022. This new guidance does not have a material impact on our financial statements for any past transactions, but it could change the way that the Company accounts for subsequent amendments to its outstanding warrants, if any.

Recently Issued Accounting Pronouncements

The FASB has issued ASU 2020-04, “Reference Rate Reform (Topic 848)”. This standard provides optional expedients and exceptions for applying GAAP to contracts, hedging relationships, and other transactions affected by reference rate reform initiatives that would replace interbank offered rates, including the London Interbank Offered Rate (“LIBOR”). For example, modifications of lease contracts within the scope of ASC 842 solely for changes in reference rates would be accounted for as a continuation of the existing contracts with no reassessments of the lease classification and the discount rate. The amendments in this ASU are effective for all entities as of March 12, 2020 through December 31, 2022. The Company does not currently have any contracts affected by this guidance.

Fair Value of Financial Instruments

Financial instruments consist of cash equivalents, accounts payable and accrued liabilities. The carrying amounts of cash equivalents, accounts payable and accrued liabilities approximate their respective fair values due to the nature of the accounts, notably their short maturities.

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, net of any related tax effect, to arrive at comprehensive income (loss). No taxes were recorded on items of other comprehensive income

(loss). There were no reclassifications out of other comprehensive income (loss) during the nine months ended September 30, 2021 and 2022.

Revenue Recognition

When the Company enters into contracts with customers, the Company recognizes revenue using the five step-model provided in ASC 606, Revenue from Contracts with Customers (“ASC 606”):

(1) Identify the contract with a customer;

(2) Identify the performance obligations in the contract;

(3) Determine the transaction price;

(4) Allocate the transaction price to the performance obligations in the contract; and

(5) Recognize revenue when, or as, the Company satisfies a performance obligation.

The transaction price includes fixed payments and an estimate of variable consideration, including milestone payments. The Company determines the variable consideration to be included in the transaction price by estimating the most likely amount that will be received and then applies a constraint to reduce the consideration to the amount which is probable of being received. When applying the constraint, the Company considers:

● Whether achievement of a development milestone is highly susceptible to factors outside the entity’s influence, such as milestones involving the judgment or actions of third parties, including regulatory bodies;

● Whether the uncertainty about the achievement of the milestone is not expected to be resolved for a long period of time;

● Whether the Company can reasonably predict that a milestone will be achieved based on previous experience; and.

● The complexity and inherent uncertainty underlying the achievement of the milestone.

The transaction price is allocated to each performance obligation based on the relative selling price of each performance obligation. The best estimate of the selling price is determined after considering all reasonably available information, including market data and conditions, entity-specific factors such as the cost structure of the deliverable and internal profit and pricing objectives.

The revenue allocated to each performance obligation is recognized as or when the Company satisfies the performance obligation.

The Company recognizes a contract asset, when the value of satisfied (or part satisfied) performance obligations is in excess of the payment due to the Company, and deferred revenue when the amount of unconditional consideration is in excess of the value of satisfied (or part satisfied) performance obligations. Once a right to receive consideration is unconditional, that amount is presented as a receivable.

Grant revenue received from organizations that are not the Company’s customers, such as charitable foundations or government agencies, is presented as a reduction against the related research and development expenses. Moreover, other inflows that are not a result of the Company’s ongoing and central operations are presented as other income, net.

Leases

The Company accounts for lease contracts in accordance with ASC 842. As of September 30, 2022, the Company’s only outstanding facilities lease is classified as an operating lease.

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 lease does not specify 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 the loan is repaid (e.g., amortizing versus bullet), and the Company’s credit risk.

The Company evaluates options included in its lease agreement 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.

Lease expense for operating leases is recognized on a straight-line basis over the lease term. 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.

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Revenue

9 Months Ended

Sep. 30, 2022

Revenue [Abstract]

Revenue

3.           Revenue

Revenue recognized in the three and nine months ended September 30, 2021 and 2022 was $0.

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Net Loss per Common Share

9 Months Ended

Sep. 30, 2022

Net Loss per Common Share

Net Loss per Common Share

4.           Net Loss per Common Share

The Company calculates net loss per common share in accordance with ASC 260 “Earnings Per Share” (“ASC 260”). Basic and diluted net loss per common share was determined by dividing net loss applicable to common stockholders by the weighted average number of shares of common stock outstanding during the period.

The following potentially dilutive securities have not been included in the computation of diluted net loss per share for the three months ended September 30, 2021 and 2022, as the result would be anti-dilutive:

	September 30,	September 30,
	2022	2021
Stock options	1,618,089	720,788
Restricted Stock Units	137,657	—
6% convertible exchangeable preferred stock	85	85
Series A preferred stock	6,600	6,600
Series B preferred stock	1,188,725	1,188,725
Common stock warrants	3,234,379	3,234,379
Total shares excluded from calculation	6,185,535	5,150,577

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Prepaid Expenses and Other Current Assets

9 Months Ended

Sep. 30, 2022

Prepaid Expenses And Other Current Assets [Abstract]

Prepaid Expenses and Other Current Assets

5.            Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consisted of the following (in $000s):

	September 30,		December 31,
	2022		2021
Research and development tax credit receivable	$	2,791	$	3,727
Prepayments and VAT receivable		1,248		577
Other current assets		170		79
	$	4,209	$	4,383

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Non-Current Assets

9 Months Ended

Sep. 30, 2022

Non-Current Assets [Abstract]

Non-Current Assets

6.            Non-Current Assets

As of September 30, 2022, the Company had non-current assets of $2.9 million, which is comprised of clinical trial deposits held by a contract research organization in relation to the Company’s Phase 1/2 clinical trials.

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Accrued and Other Current Liabilities

9 Months Ended

Sep. 30, 2022

Accrued and Other Current Liabilities [Abstract]

Accrued and Other Current Liabilities

7.            Accrued and Other Liabilities

Accrued and other current liabilities consisted of the following (in $000s):

	September 30,		December 31,
	2022		2021
Accrued research and development	$	2,767	$	2,310
Accrued legal and professional fees		431		233
Other current liabilities		172		634
	$	3,370	$	3,177

Other current liabilities for the year ended December 31, 2021 were largely attributed to accrued payroll costs.

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Leases

9 Months Ended

Sep. 30, 2022

Leases [Abstract]

Leases

8.            Leases

The Company currently has one lease, relating to its facility in Berkeley Heights, New Jersey. On April 4, 2022 the Company extended this lease by three years, expiring July 31, 2025. On May 4, 2021, the Company assigned an operating lease relating to its U.K. facility to the University of Dundee, Scotland, incurring lease assignment costs of approximately $400,000, of which 50% was paid on assignment and the remaining 50% was paid on May 4, 2022. The Company has no further obligations, liabilities or commitments in relation to this facility.

As of and for the nine months ended September 30, 2022 and 2021:

The Company recognized operating lease expenses of $46,699 and $159,898 in the nine month periods ending September 30, 2022 and 2021 respectively. Cash payments made during the nine months ended September 30, 2022 and 2021 totaled $46,489 and $166,376 respectively and were presented within cash outflows from operating activities. The remaining lease term as of September 30, 2022 is approximately 2.8 years for the Berkeley Heights facility. The discount rate used by the Company in determining the lease liability was 12%.

Remaining lease payments under the lease are (in $000’s):

2022	$	16
2023		63
2024		65
2025		38
2026		—
Thereafter		—
	$	182

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Stock Based Compensation

9 Months Ended

Sep. 30, 2022

Stock Based Compensation [Abstract]

Stock Based Compensation

9.            Stock Based Compensation

ASC 718 requires compensation expense associated with share-based awards to be recognized 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. Most of the awards granted by the Company (and still outstanding) vest ratably over one to four years. The Company recognizes all share-based awards under the straight-line attribution method, assuming that all granted awards will vest. Forfeitures are recognized in the periods when they occur.

Stock based compensation has been reported within expense line items on the consolidated statement of operations for the three and nine months ended September 30, 2021 and 2022 as shown in the following table (in $000s):

	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2022		2021		2022		2021
General and administrative	$	255	$	223	$	724	$	587
Research and development		134	$	96	$	396	$	266
Stock-based compensation costs before income taxes	$	389	$	319	$	1,119	$	853

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 replaces 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 14, 2022, the Company’s stockholders approved an amendment to the 2018 Plan to increase the number of shares of common stock available for grant under the 2018 Plan by 500,000 shares. As of September 30, 2022, the Company has reserved 384,896 shares of the Company’s common stock under the 2018 Plan for future issuances, including shares that were available under the 2015 Plan and carried forward to the 2018 Plan. 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.

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 200,000 shares of the Company’s common stock (or the equivalent of such number). As of September 30, 2022, 120,000 shares under the Inducement Plan have been issued, leaving a remaining reserve of 80,000 shares.

Option Grants and Exercises

There were 522,337 options granted during the nine months ended September 30, 2022. These options had a grant date fair value ranging between $0.83-$2.90 per option. There were 154,653 options granted during the nine months ended September 30, 2021. These options had a grant date fair value ranging between $3.44-$6.14 per option. 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:

	Nine months ended	Nine months ended
	September 30, 2022	September 30, 2021
Expected term (years)	5 – 6	5 – 6
Risk free interest rate	1.370% – 3.605%	0.420%  – 1.000%
Volatility	86% – 93%	96% – 102%
Expected dividend yield over expected term	0.00%	0.00%

There were no stock options exercised during each of the nine months ended September 30, 2021 and 2022, 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.

In the second quarter of 2022, the Company amended the terms of 11,952 options and 2,374 restricted stock units issued to a former director. Specifically, the Company accelerated the vesting of 4,748 options and 2,374 restricted stock units that otherwise would have been forfeited upon the director’s retirement from service. In addition, the Company extended the time by which the director may exercise all vested awards from 90 days to two years. The Company recorded an additional $3,500 of compensation cost in the second quarter of 2022 as a result of these modifications.

Outstanding Options

A summary of the share option activity and related information is as follows:

				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, 2021	1,099,357	$	7.53	8.99	$	189
Granted	522,337	$	2.41	—		—
Cancelled/forfeited	(3,604)	$	28.15
Options outstanding at September 30, 2022	1,618,090	$	5.83	8.60	$	85
Unvested at September 30, 2022	990,399	$	3.16	9.14	$	85
Vested and exercisable at September 30, 2022	627,691	$	10.04	7.75	$	—

Restricted Stock Units

The Company issued 118,665 restricted stock units during the nine months ended September 30, 2022. These restricted stock units will vest over a period of one year for grants to directors and three years for grants to employees. Each restricted stock unit was valued at $1.11 based on their fair value at the date of grant, which is equivalent to the market price of a share of the Company’s common stock.

The Company issued an additional 18,992 restricted stock units to employees during the year ended December 31, 2021. These restricted stock units will vest over a period of one or three years. Each restricted stock unit was valued at $6.69 based on their fair value at the date of grant, which is equivalent to the market price of a share of the Company’s common stock.

Summarized information for restricted stock units as of September 30, 2022 is as follows:

		Weighted
		Average
	Restricted	Grant Date
	Stock Units	Value Per Share
Restricted Stock Units outstanding at December 31, 2021	18,992	$	6.69
Granted	118,665		1.11
Restricted Stock Units outstanding at September 30, 2022	137,657	$	—
Unvested at September 30, 2022	120,248	$	1.18
Vested and exercisable at September 30, 2022	17,409	$	6.69

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Stockholders Equity

9 Months Ended

Sep. 30, 2022

Stockholders' Equity [Abstract]

Stockholders Equity

10.            Stockholders Equity

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 $10.0 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 3,117,100 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 $4,494,496. There was no sale of shares after August 12, 2022. The sale of these shares may be subject to potential rescission rights by certain shareholders. As of September 30, 2022, there have been no claims or demands to exercise such rights. As a result of these potential rescission rights, the Company reclassified 3,117,100 shares, with an aggregate purchase price of $4,494,496 of its common stock as outside stockholders’ equity. The reclassification of these shares shall remain for a period of one year from the applicable transaction date. These shares have been treated as issued and outstanding for financial reporting purposes.

On August 15, 2022, due to expiry of the Registration Statement, the Sales Agreement was mutually terminated. Since the start of the agreement on August 12, 2021, a total of 3,281,067 shares, for gross proceeds of approximately $7.6 million, had been sold pursuant to the Sales Agreement.

March 2021 Equity Financing

On March 12, 2021, the Company entered into an Underwriting Agreement (the “Underwriting Agreement”) with Oppenheimer & Co. Inc., as representative of the underwriters identified therein (collectively, the “Underwriters”), pursuant to which the Company agreed to issue and sell 1,807,143 shares of common stock, $0.001 par value per share, at a public offering price of $7.00 per share (the “Offering”) along with a 30-day overallotment option to purchase up to an additional 271,071 shares of common stock at the public offering price, less underwriting discounts and commissions.

The closing of the offering occurred on March 16, 2021, and the net proceeds to the Company (including exercise of the over-allotment option) were approximately $13.5 million, after deducting placement agent fees and other offering expenses payable by the Company.

December 2020 Equity Financing

On December 18, 2020, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with Acorn Bioventures, LP (the “Purchaser”), pursuant to which the Company agreed to offer, issue and sell to the Purchaser, (i) in a registered direct offering, (a) an aggregate of 485,912 shares (the “Common Shares”) of

common stock, par value $0.001 per share (“Common Stock”), and (b) an aggregate of 237,745 shares of Series B Convertible Preferred Stock (the “Preferred Shares,” and collectively with the Common Shares, the “Shares”), par value $0.001 per share (“Series B Preferred Stock”), and (ii) in a concurrent private placement, warrants (the “Warrants”) to purchase up to an aggregate of 669,854 shares (the “Warrant Shares”) of Common Stock.

 The combined purchase price for each Share, together with one Warrant to purchase 0.4 shares of Common Stock, is $4.18. 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 $4.13 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.

Each share of Series B Convertible Preferred Stock will convert into five shares of Common Stock.

The conversion feature within the Series B Convertible Preferred Stock was determined to be beneficial as of the offering date. A beneficial conversion feature is defined as a nondetachable conversion feature that is "in-the-money" at issuance. The Company calculated the value of the beneficial conversion feature based on its intrinsic value, which is the difference between the “effective conversion price” (after allocating the proceeds of the offering between the Series B Convertible Preferred Stock, the Warrants and Common Stock issued) and the market price of the Company's common shares, multiplied by the number of shares into which the Series B Convertible Preferred Stock is convertible. The effective conversion price of $3.18 per share is different from the $4.18 per share contractual conversion price.  

As the series B Preferred Stock contained no stated redemption date and the conversion feature could be exercised at any time, the discount associated with the beneficial conversion feature was immediately charged against additional paid-in-capital and treated as a deemed dividend for both financial reporting and earnings per share purposes.

The common stock, Warrants and Series B Preferred Stock are freestanding financial instruments. The Warrants are classified within equity (as a component of additional paid-in capital) in the consolidated balance sheet and are not remeasured on a recurring basis. The Series B Preferred Stock is classified within permanent equity in the consolidated balance sheet.

The closing of the offering occurred on December 22, 2020 and the net proceeds to the Company were approximately $6.9 million, after deducting offering expenses payable by the Company.

As of September 30, 2022, 237,745 shares of the Series B Preferred Stock remained issued and outstanding.

April 2020 Equity Financing

On April 21, 2020, the Company entered into a co-placement agency agreement with Roth Capital Partners, LLC, Ladenburg Thalmann & Co. Inc., and Brookline Capital Markets, a division of Arcadia Securities, LLC (the “Co-Placement Agents”) and a securities purchase agreement with certain purchasers for the purchase and sale of (i) 1,910,000 shares of common stock, (ii) pre-funded warrants to purchase up to 2,090,000 shares of common stock at an exercise price of $0.001 per share, and (iii) accompanying common stock warrants to purchase up to 4,000,000 shares of common stock at an exercise price of $5.00 per share. The shares of common stock and accompanying common stock warrants were sold at a combined public offering price of $5.00 per share and common stock warrant. Each common stock warrant sold with the shares of common stock represents the right to purchase one share of common stock at an exercise price of $5.00 per share.  The common stock warrants are exercisable immediately and expire five years from the date of issuance.

The pre-funded warrants and accompanying common stock warrants were sold at a combined public offering price of $4.999 per pre-funded warrant and common stock warrant. The pre-funded warrants were sold to purchasers whose purchase of shares of common stock in the public offering would otherwise result in the purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99% (or, at the election of the purchaser, 9.99%) of the Company’s outstanding common stock immediately following the consummation of the public offering, in lieu of shares of common stock. Each pre-funded warrant represents the right to purchase one share of the Company’s common stock at an exercise price of $0.001 per share. The pre-funded warrants are exercisable immediately and may be exercised at any time until the pre-funded warrants are exercised in full. The shares of common stock and pre-funded warrants, and accompanying common stock warrants, were issued separately and are immediately separable upon issuance.

The closing of the offering occurred on April 24, 2020, and the net proceeds to the Company were approximately $18.3 million, after deducting placement agent fees and other offering expenses payable by the Company.

Subsequent to the closing of the offering, all of the pre-funded warrants issued in connection therewith were converted into 2,090,000 shares of common stock.

Warrants

December 2020 Warrants

As of September 30, 2022, warrants to purchase 669,854 shares of common stock 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 $4.13 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.

There were no exercises of these warrants during the three and nine months ended September 30, 2022 or September 30, 2021.

April 2020 Warrants

As of September 30, 2022, 2,190,000 warrants issued in connection with the April 2020 equity financing remained outstanding, each with an exercise price of $5.00. All such warrants were issued in connection with the April 2020 co-placement agency agreement. 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.

There were no warrants exercised during the three and nine months ended September 30, 2022, and a total of 909,000 warrants exercised during the three and nine months ended September 30, 2021.

July 2017 Warrants

As of September 30, 2021, 374,525 warrants issued in connection with the July 2017 underwritten public offering remained outstanding, each with an exercise price of $40.00. All such warrants were issued in connection with the July 2017 underwritten public offering and are immediately exercisable. The warrants expire in 2024. Subject to limited exceptions, a holder of warrants will not have the right to exercise any portion of its warrants if the holder (together with such holder’s affiliates, and any persons acting as a group together with such holder or any of such holder’s affiliates) would beneficially own a number of shares of common stock in excess of 4.99% (or, at the election of the purchaser, 9.99%) of the shares of our Common Stock then outstanding after giving effect to such exercise.

The exercise price and the number of shares issuable upon exercise of the warrants is subject to appropriate adjustment in the event of recapitalization events, stock dividends, stock splits, stock combinations, reclassifications, reorganizations or similar events affecting the Company’s common stock. The warrant holders must pay the exercise price in cash upon exercise of the warrants unless such warrant holders are utilizing the cashless exercise provision of the warrants. On the expiration date, unexercised warrants will automatically be exercised via the “cashless” exercise provision.

Prior to the exercise of any warrants to purchase common stock, holders of the warrants will not have any of the rights of holders of the common stock purchasable upon exercise, including the right to vote, except as set forth therein.

There were no exercises of these warrants during the three and nine months ended September 30, 2022 or September 30, 2021.

Series A Preferred Stock

8,872 shares of the Company’s Series A Preferred Stock were issued in the July 2017 underwritten public offering. During the year ended December 31, 2017, 8,608 shares of the Series A Preferred Stock were converted into 215,200 shares of common stock. As of September 30, 2022, 264 shares of the Series A Preferred Stock remained issued and outstanding.

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 $40.00 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. The 264 shares of Series A Preferred Stock issued and outstanding at September 30, 2022 are convertible into 6,600 shares of common stock.

In the event of a liquidation, the holders of shares of the Series A Preferred Stock shall be permitted to 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 the 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 (the “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 the 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 September 30, 2022, there were 335,273 shares of the Company’s 6% Convertible Exchangeable Preferred Stock (the “6% Preferred Stock”) issued and outstanding at an issue price of $10.00 per share. Dividends on the 6% Preferred Stock are cumulative from the date of original issuance at the annual rate of 6% of the liquidation preference of the 6% Preferred Stock, 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 6% Preferred Stock has a liquidation preference of $10.00 per share, plus accrued and unpaid dividends. As of September 30, 2022, accrued and unpaid dividends amounted to $50,291.

The Company may automatically convert the 6% Preferred Stock into common stock if the per share closing price of the Company’s common stock has exceeded $59,220, which is 150% of the conversion price of the 6% Preferred Stock, for at least 20 trading days during any 30 day trading period, ending within five trading days prior to notice of automatic conversion.

The 6% 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 6% Preferred Stock in whole or in part, out of funds legally available at the redemption price of $10.00 per share.

The 6% 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 (the “Exchange Date”) for the Company’s 6% Convertible Subordinated Debentures (the “Debentures”) at the rate of $10.00 principal amount of Debentures for each share of 6% Preferred Stock. The Debentures, if issued, will mature 25 years after the Exchange Date and have substantially similar terms to those of the 6% Preferred Stock. No such exchanges have taken place to date.

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Subsequent Events

9 Months Ended

Sep. 30, 2022

Subsequent Events [Abstract]

Subsequent Events

11.          Subsequent Events

Dividends on 6% Preferred Stock

On September 7, 2022, the board of directors declared a quarterly cash dividend in the amount of $0.15 per share on the Company’s Preferred Stock. The cash dividend was paid on November 1, 2022 to the holders of record of the 6% Preferred Stock as of the close of business on October 14, 2022.

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Summary of Significant Accounting Policies (Policies)

9 Months Ended

Sep. 30, 2022

Summary of Significant Accounting Policies [Abstract]

Basis of Presentation

Basis of Presentation

The consolidated balance sheet as of September 30, 2022, the consolidated statements of operations, comprehensive loss, and stockholders’ equity for the three and nine months ended September 30, 2022 and 2021 and the consolidated statements of cash flows for the nine months ended September 30, 2022 and 2021, and all related disclosures contained in the accompanying notes, are unaudited. The consolidated balance sheet as of December 31, 2021 is derived from the audited consolidated financial statements included in the Annual Report on Form 10-K for the fiscal year ended December 31, 2021 filed with the Securities and Exchange Commission (the “SEC”) on March 30, 2022. The consolidated financial statements are presented on the basis of accounting principles that are generally accepted in the United States (“GAAP”) for interim financial information and in accordance with the rules and regulations of the SEC. Accordingly, they do not include all the information and footnotes required by GAAP for a complete set of financial statements. In the opinion of management, all adjustments, which include only normal recurring adjustments necessary to present fairly the consolidated balance sheet as of September 30, 2022, and the results of operations and, comprehensive loss for the three and nine months ended September 30, 2022, and cash flows for the nine months ended September 30, 2022, have been made. The interim results for the three and nine months ended September 30, 2022 are not necessarily indicative of the results to be expected for the year ending December 31, 2022 or for any other reporting period. The consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the accompanying notes for the year ended December 31, 2021 that are included in the Company’s Annual Report on Form 10-K filed with the SEC on March 30, 2022.

Going Concern

Going Concern

Management considers that there are no conditions or events, in the aggregate, that raise substantial doubt about the entity’s ability to continue as a going concern for a period of at least one year from the date the financial statements are issued. The Company expects that its cash of approximately $23.7 million as of September 30, 2022 will be sufficient to fund its operating expenses and capital expenditure requirements to the end of 2023.

This evaluation is based on relevant conditions and events that are known and reasonably knowable at the date that the financial statements are issued, including:

a. The Company’s current financial condition, including its sources of liquidity;

b. The Company’s conditional and unconditional obligations due or anticipated within one year;

c. The funds necessary to maintain the Company’s operations considering its current financial condition, obligations, and other expected cash flows; and

d. Other conditions and events, when considered in conjunction with the above, that may adversely affect the Company’s ability to meet its obligations.

The future viability of the Company beyond 2023 is dependent on its ability to raise additional capital to finance its operations. The Company does not currently have sufficient funds to complete development and commercialization of any of its drug candidates. Additional funding may not be available to the Company on favorable terms, or at all. If the Company is not able to secure additional funding when needed, it may have to delay, reduce the scope of or eliminate one or more of its clinical trials or research and development programs or make changes to its operating plan. In addition, it may have to partner one or more of its product candidate programs at an earlier stage of development, which would lower the economic value of those programs to the Company. The Company’s inability to raise capital as and when needed could have a negative impact on its financial condition and ability to pursue its business strategies.

Accounting standards adopted in the period

Accounting Standards Adopted in the Period

In November 2021, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2021-10, Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance. This ASU requires business entities to make annual disclosures about transactions with a government they account for by analogizing to a grant or contribution accounting model under ASC 958-605 or based on International Accounting Standard No. 20. ASU 2021-10 which became effective for us on January 1, 2022. The Company has evaluated the effect that this guidance has on its Consolidated Financial Statements and has determined it does not have a material impact.

In May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt-Modifications and Extinguishments (Subtopic 470-50), Compensation-Stock Compensation (Topic 718), and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40). The new ASU addresses issuer’s accounting for certain modifications or exchanges of freestanding equity-classified written call options. This amendment became effective for us on January 1, 2022. This new guidance does not have a material impact on our financial statements for any past transactions, but it could change the way that the Company accounts for subsequent amendments to its outstanding warrants, if any.

Recently Issued Accounting Pronouncements

Recently Issued Accounting Pronouncements

The FASB has issued ASU 2020-04, “Reference Rate Reform (Topic 848)”. This standard provides optional expedients and exceptions for applying GAAP to contracts, hedging relationships, and other transactions affected by reference rate reform initiatives that would replace interbank offered rates, including the London Interbank Offered Rate (“LIBOR”). For example, modifications of lease contracts within the scope of ASC 842 solely for changes in reference rates would be accounted for as a continuation of the existing contracts with no reassessments of the lease classification and the discount rate. The amendments in this ASU are effective for all entities as of March 12, 2020 through December 31, 2022. The Company does not currently have any contracts affected by this guidance.

Fair Value of Financial Instruments

Fair Value of Financial Instruments

Financial instruments consist of cash equivalents, accounts payable and accrued liabilities. The carrying amounts of cash equivalents, accounts payable and accrued liabilities approximate their respective fair values due to the nature of the accounts, notably their short maturities.

Comprehensive Income (Loss)

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, net of any related tax effect, to arrive at comprehensive income (loss). No taxes were recorded on items of other comprehensive income

(loss). There were no reclassifications out of other comprehensive income (loss) during the nine months ended September 30, 2021 and 2022.

Revenue recognition

Revenue Recognition

When the Company enters into contracts with customers, the Company recognizes revenue using the five step-model provided in ASC 606, Revenue from Contracts with Customers (“ASC 606”):

(1) Identify the contract with a customer;

(2) Identify the performance obligations in the contract;

(3) Determine the transaction price;

(4) Allocate the transaction price to the performance obligations in the contract; and

(5) Recognize revenue when, or as, the Company satisfies a performance obligation.

The transaction price includes fixed payments and an estimate of variable consideration, including milestone payments. The Company determines the variable consideration to be included in the transaction price by estimating the most likely amount that will be received and then applies a constraint to reduce the consideration to the amount which is probable of being received. When applying the constraint, the Company considers:

● Whether achievement of a development milestone is highly susceptible to factors outside the entity’s influence, such as milestones involving the judgment or actions of third parties, including regulatory bodies;

● Whether the uncertainty about the achievement of the milestone is not expected to be resolved for a long period of time;

● Whether the Company can reasonably predict that a milestone will be achieved based on previous experience; and.

● The complexity and inherent uncertainty underlying the achievement of the milestone.

The transaction price is allocated to each performance obligation based on the relative selling price of each performance obligation. The best estimate of the selling price is determined after considering all reasonably available information, including market data and conditions, entity-specific factors such as the cost structure of the deliverable and internal profit and pricing objectives.

The revenue allocated to each performance obligation is recognized as or when the Company satisfies the performance obligation.

The Company recognizes a contract asset, when the value of satisfied (or part satisfied) performance obligations is in excess of the payment due to the Company, and deferred revenue when the amount of unconditional consideration is in excess of the value of satisfied (or part satisfied) performance obligations. Once a right to receive consideration is unconditional, that amount is presented as a receivable.

Grant revenue received from organizations that are not the Company’s customers, such as charitable foundations or government agencies, is presented as a reduction against the related research and development expenses. Moreover, other inflows that are not a result of the Company’s ongoing and central operations are presented as other income, net.

Leases

Leases

The Company accounts for lease contracts in accordance with ASC 842. As of September 30, 2022, the Company’s only outstanding facilities lease is classified as an operating lease.

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 lease does not specify 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 the loan is repaid (e.g., amortizing versus bullet), and the Company’s credit risk.

The Company evaluates options included in its lease agreement 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.

Lease expense for operating leases is recognized on a straight-line basis over the lease term. 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.

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Net Loss per Common Share (Tables)

9 Months Ended

Sep. 30, 2022

Net Loss per Common Share

Schedule of Basic and Diluted Net Loss Per Share

The following potentially dilutive securities have not been included in the computation of diluted net loss per share for the three months ended September 30, 2021 and 2022, as the result would be anti-dilutive:

	September 30,	September 30,
	2022	2021
Stock options	1,618,089	720,788
Restricted Stock Units	137,657	—
6% convertible exchangeable preferred stock	85	85
Series A preferred stock	6,600	6,600
Series B preferred stock	1,188,725	1,188,725
Common stock warrants	3,234,379	3,234,379
Total shares excluded from calculation	6,185,535	5,150,577

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Prepaid Expenses and Other Current Assets (Tables)

9 Months Ended

Sep. 30, 2022

Prepaid Expenses And Other Current Assets [Abstract]

Schedule of prepaid expenses and other current assets

Prepaid expenses and other current assets consisted of the following (in $000s):

	September 30,		December 31,
	2022		2021
Research and development tax credit receivable	$	2,791	$	3,727
Prepayments and VAT receivable		1,248		577
Other current assets		170		79
	$	4,209	$	4,383

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Accrued and Other Liabilities (Tables)

9 Months Ended

Sep. 30, 2022

Accrued and Other Current Liabilities [Abstract]

Schedule of Accrued and Other Current Liabilities

Accrued and other current liabilities consisted of the following (in $000s):

	September 30,		December 31,
	2022		2021
Accrued research and development	$	2,767	$	2,310
Accrued legal and professional fees		431		233
Other current liabilities		172		634
	$	3,370	$	3,177

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Leases (Tables)

9 Months Ended

Sep. 30, 2022

Leases [Abstract]

Schedule of the Company's Contractual Obligations and Commitments Relating to its Facilities Leases

Remaining lease payments under the lease are (in $000’s):

2022	$	16
2023		63
2024		65
2025		38
2026		—
Thereafter		—
	$	182

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Stock Based Compensation (Tables)

9 Months Ended

Sep. 30, 2022

Stock Based Compensation [Abstract]

Schedule of Stock Based Compensation Expense

	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2022		2021		2022		2021
General and administrative	$	255	$	223	$	724	$	587
Research and development		134	$	96	$	396	$	266
Stock-based compensation costs before income taxes	$	389	$	319	$	1,119	$	853

Schedule of Fair Value of the Stock Options Granted

	Nine months ended	Nine months ended
	September 30, 2022	September 30, 2021
Expected term (years)	5 – 6	5 – 6
Risk free interest rate	1.370% – 3.605%	0.420%  – 1.000%
Volatility	86% – 93%	96% – 102%
Expected dividend yield over expected term	0.00%	0.00%

Schedule of Share Option Activity

A summary of the share option activity and related information is as follows:

				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, 2021	1,099,357	$	7.53	8.99	$	189
Granted	522,337	$	2.41	—		—
Cancelled/forfeited	(3,604)	$	28.15
Options outstanding at September 30, 2022	1,618,090	$	5.83	8.60	$	85
Unvested at September 30, 2022	990,399	$	3.16	9.14	$	85
Vested and exercisable at September 30, 2022	627,691	$	10.04	7.75	$	—

Schedule of Restricted Stock Units Activity

		Weighted
		Average
	Restricted	Grant Date
	Stock Units	Value Per Share
Restricted Stock Units outstanding at December 31, 2021	18,992	$	6.69
Granted	118,665		1.11
Restricted Stock Units outstanding at September 30, 2022	137,657	$	—
Unvested at September 30, 2022	120,248	$	1.18
Vested and exercisable at September 30, 2022	17,409	$	6.69

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Summary of Significant Accounting Policies - Narrative (Details) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Dec. 31, 2021
Summary of Significant Accounting Policies [Abstract]
Cash and cash equivalents	$ 23,706		$ 36,559
Tax on other comprehensive income (loss)	0
Reclassifications out of other comprehensive income (loss)	$ 0	$ 0

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Revenue (Narrative) (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Revenue [Abstract]
Revenue	$ 0	$ 0	$ 0	$ 0

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Net Loss per Common Share - Schedule of Company's Potential Anti Dilutive Securities (Details) - shares	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total shares excluded from calculation	6,185,535	5,150,577
Stock options
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total shares excluded from calculation	1,618,089	720,788
Restricted Stock Units (RSUs)
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total shares excluded from calculation	137,657
6% convertible exchangeable preferred stock
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total shares excluded from calculation	85	85
Preferred stock, dividend rate (in percent)	6.00%
Series A Convertible Preferred Stock
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total shares excluded from calculation	6,600	6,600
Series B Convertible Preferred Stock
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total shares excluded from calculation	1,188,725	1,188,725
Common Stock Warrants
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total shares excluded from calculation	3,234,379	3,234,379

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Prepaid Expenses and Other Current Assets - Schedule of Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Prepaid Expense and Other Assets, Current [Abstract]
Research and development tax credit receivable	$ 2,791	$ 3,727
Prepayments and VAT receivable	1,248	577
Other current assets	170	79
Prepaid expenses and other current assets	$ 4,209	$ 4,383

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Non-Current Assets (Details) $ in Millions	Sep. 30, 2022 USD ($)
Non-Current Assets [Abstract]
Clinical trial deposits held by a contract research organization	$ 2.9

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Accrued and Other Liabilities - Schedule of accrued and other current liabilities (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Accrued and Other Current Liabilities [Abstract]
Accrued research and development	$ 2,767	$ 2,310
Accrued legal and professional fees	431	233
Other current liabilities	172	634
Accrued and other current liabilities	$ 3,370	$ 3,177

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Leases - Narrative (Details)		9 Months Ended
	Apr. 04, 2022	Sep. 30, 2022 USD ($) lease	Sep. 30, 2021 USD ($)	May 04, 2021 USD ($)
Operating lease expense		$ 46,699	$ 159,898
Operating lease, payments		$ 46,489	$ 166,376
Berkeley Heights Facility [Member]
Number of leases | lease		1
Lease extension term	3 years
Remaining lease term		2 years 9 months 18 days
Discount rate lease liability		12.00%
Assignation of Lease Relating to Facility in Dundee, Scotland [Member]
Reverse premium				$ 400,000
Percentage of reverse premium payable on assignment				50.00%
Percentage of reverse premium payable on next year				50.00%
Obligations, liabilities or commitments		$ 0

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Leases - Future Minimum Lease Payments (Details) $ in Thousands	Sep. 30, 2022 USD ($)
Operating Lease Obligation
2022	$ 16
2023	63
2024	65
2025	38
2026	0
Thereafter	0
Lease payments, Total	$ 182

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Stock Based Compensation - Narrative (Details) - USD ($)		3 Months Ended				9 Months Ended		12 Months Ended
	Jun. 14, 2022	Sep. 30, 2022	Jun. 30, 2022	Mar. 31, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021	Dec. 31, 2021
Stock-based compensation
Common stock, shares issued		12,539,189				12,539,189		9,993,135
Options granted (in shares)						522,337	154,653
Options exercised (in shares)						0	0
Stock-based compensation costs before income taxes		$ 389,000			$ 319,000	$ 1,119,000	$ 853,000
Minimum
Stock-based compensation
Stock awards vesting period						1 year
Options granted, grant date fair value						$ 0.83	$ 3.44
Maximum
Stock-based compensation
Stock awards vesting period						4 years
Options granted, grant date fair value						$ 2.90	$ 6.14
Stock options
Stock-based compensation
Options granted (in shares)						522,337
Number of awards amended			11,952
Number of awards with accelerated vesting			4,748
Restricted Stock Units (RSUs)
Stock-based compensation
Restricted Stock Units, Granted						118,665		18,992
Restricted Stock Units outstanding/unvested		137,657				137,657		18,992
Restricted stock units, grant date fair value		$ 1.18				$ 1.18		$ 6.69
Number of awards amended			2,374
Number of awards with accelerated vesting			2,374
Modified Stock Options And Restricted Stock Units [Member]
Stock-based compensation
Stock awards vesting period			2 years	90 days
Stock-based compensation costs before income taxes			$ 3,500
2018 Equity Incentive Plan (the "2018 Plan") [Member]
Stock-based compensation
Number of shares reserved for issuance		384,896				384,896
Life of stock option awards granted						10 years
Number of authorized additional shares to be issued	500,000
2018 Equity Incentive Plan (the "2018 Plan") [Member] | Minimum
Stock-based compensation
Stock awards vesting period						1 year
2018 Equity Incentive Plan (the "2018 Plan") [Member] | Maximum
Stock-based compensation
Stock awards vesting period						4 years
Inducement Equity Incentive Plan 2020 [Member]
Stock-based compensation
Number of shares reserved for issuance		80,000				80,000
Number of authorized shares		200,000				200,000
Common stock, shares issued		120,000				120,000

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Stock Based Compensation - Schedule of Stock Based Compensation Expense (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]
Stock-based compensation costs before income taxes	$ 389	$ 319	$ 1,119	$ 853
General and administrative
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]
Stock-based compensation costs before income taxes	255	223	724	587
Research and development
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]
Stock-based compensation costs before income taxes	$ 134	$ 96	$ 396	$ 266

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Stock Based Compensation - Schedule of Fair Value of the Stock Options Granted (Details) - Stock options	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions and Methodology [Abstract]
Expected dividend yield over expected term	0.00%	0.00%
Minimum
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions and Methodology [Abstract]
Expected term (years)	5 years	5 years
Risk free interest rate	1.37%	0.42%
Volatility	86.00%	96.00%
Maximum
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions and Methodology [Abstract]
Expected term (years)	6 years	6 years
Risk free interest rate	3.605%	1.00%
Volatility	93.00%	102.00%

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Stock Based Compensation - Schedule of Share Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands	9 Months Ended		12 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Dec. 31, 2021
Number of Options Outstanding
Granted	522,337	154,653
Exercised (in shares)	0	0
Stock options
Number of Options Outstanding
Options outstanding	1,099,357
Granted	522,337
Cancelled/forfeited	(3,604)
Options outstanding	1,618,090		1,099,357
Unvested	990,399
Vested and exercisable	627,691
Weighted Average Exercise Price Per Share
Options outstanding	$ 7.53
Granted	2.41
Cancelled/forfeited (in dollars per share)	28.15
Options outstanding	5.83		$ 7.53
Unvested	3.16
Vested and exercisable	$ 10.04
Weighted Average Remaining Contractual Term (Years)
Options outstanding	8 years 7 months 6 days		8 years 11 months 26 days
Unvested	9 years 1 month 20 days
Vested and exercisable	7 years 9 months
Aggregate Intrinsic Value
Options Outstanding	$ 85		$ 189
Options Outstanding	189
Unvested	$ 85

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Stock Based Compensation - Schedule of Restricted Stock Units Activity (Details) - Restricted Stock Units (RSUs) - $ / shares	9 Months Ended	12 Months Ended
	Sep. 30, 2022	Dec. 31, 2021
Number of Options Outstanding
Restricted Stock Units outstanding/unvested	18,992
Granted	118,665	18,992
Restricted Stock Units outstanding/unvested	137,657	18,992
Unvested	137,657	18,992
Vested and exercisable	17,409
Weighted Average Grant Date Value Per Share
Restricted stock units, grant date fair value	$ 1.18	$ 6.69
Granted	1.11	6.69
Unvested, Weighted Average Grant Date Value Per Share	1.18	$ 6.69
Vested and exercisable	$ 6.69
Board Director [Member]
Weighted Average Grant Date Value Per Share
Stock awards vesting period	1 year	1 year
Employees
Weighted Average Grant Date Value Per Share
Stock awards vesting period	3 years	3 years

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Stockholders Equity - Narrative (Details) - USD ($)							1 Months Ended	3 Months Ended			9 Months Ended		12 Months Ended
	Aug. 12, 2021	Mar. 12, 2021	Dec. 22, 2020	Dec. 18, 2020	Apr. 24, 2020	Apr. 21, 2020	Jul. 31, 2017	Sep. 30, 2022	Sep. 30, 2021	Mar. 31, 2021	Sep. 30, 2022	Sep. 30, 2021	Dec. 31, 2021	Dec. 31, 2017
Class of Stock [Line Items]
Aggregate offering price										$ 13,501,000
Common stock, par value (in dollars per share)								$ 0.001			$ 0.001		$ 0.001
Preferred stock, par value (in dollars per share)								$ 0.001			$ 0.001		$ 0.001
Common stock, shares issued								12,539,189			12,539,189		9,993,135
March 2021 Equity Financing [Member]
Class of Stock [Line Items]
Proceeds from issuance of common stock, net of issuance costs		$ 13,500,000
July 2017 - Underwritten Public Offering [Member]
Class of Stock [Line Items]
Warrants, exercise price per share									$ 40.00			$ 40.00
Percentage Of Outstanding Common Stock												4.99%
Outstanding common stock at election of purchaser												9.99%
Warrants outstanding									374,525			374,525
Warrants exercised								0	0		0	0
Cantor Fitzgerald & Co. [Member]
Class of Stock [Line Items]
Aggregate offering price	$ 10,000,000.0
Number of share sold under the sales agreement											3,281,067
Proceeds from issuance of common stock, net of issuance costs											$ 7,600,000
Oppenheimer & Co. Inc. [Member] | March 2021 Equity Financing [Member]
Class of Stock [Line Items]
Number of share sold under the sales agreement		1,807,143
Share issue price per share		$ 7.00
Sale of stock, number of additional shares issued in transaction		271,071
Acorn Bioventures, LP [Member]
Class of Stock [Line Items]
Warrants to purchase shares									669,854			669,854
Warrant outstanding Term									5 years			5 years
Warrants, exercise price per share									$ 4.13			$ 4.13
Warrants exercised								0	0		0	0
Acorn Bioventures, LP [Member] | Common Stock Warrants
Class of Stock [Line Items]
Number of share sold under the sales agreement				669,854
Co-Placement Agents [Member]
Class of Stock [Line Items]
Sale of stock, price per share						$ 5.00
Warrants, exercise price per share								$ 5.00			$ 5.00
Proceeds from issuance of stocks/warrants					$ 18,300,000
Number of common shares called by each warrant								1			1
Warrant Exercises (in shares)								0	909,000		0	909,000
Warrants outstanding								2,190,000			2,190,000
Fractional shares issued											0
Co-Placement Agents [Member] | Pre Funded Warrants [Member]
Class of Stock [Line Items]
Number of share sold under the sales agreement						2,090,000
Sale of stock, price per share						$ 4.999
Warrants, exercise price per share						$ 0.001
Number of common shares issued upon conversion						1
Percentage Of Outstanding Common Stock						4.99%
Outstanding common stock at election of purchaser						9.99%
Shares issued on conversion of prefunded warrants					2,090,000
Co-Placement Agents [Member] | Common Stock Warrants
Class of Stock [Line Items]
Warrants to purchase shares						4,000,000
Warrant outstanding Term						5 years
Warrants, exercise price per share						$ 5.00
Number of common shares issued upon conversion						1
Percentage Of Outstanding Common Stock											4.99%
Outstanding common stock at election of purchaser											9.99%
Notice period from the holder to increase the percentage of ownership of outstanding common stock after exercise of warrants											61 days
Series B Convertible Preferred Stock
Class of Stock [Line Items]
Preferred stock, par value (in dollars per share)								$ 0.001			$ 0.001		$ 0.001
Sale of stock, price per share								$ 4.18			$ 4.18
Number of common shares issued upon conversion								5			5
Effective Conversion price per share											$ 3.18
Preferred stock, shares issued								237,745			237,745		237,745
Preferred stock, shares outstanding								237,745			237,745		237,745
Series B Convertible Preferred Stock | Acorn Bioventures, LP [Member]
Class of Stock [Line Items]
Number of share sold under the sales agreement				237,745
Preferred stock, par value (in dollars per share)				$ 0.001
Sale of stock, price per share				$ 4.18
Warrant outstanding Term				5 years
Warrants, exercise price per share				$ 4.13
Proceeds from issuance of stocks/warrants			$ 6,900,000
Number of common shares called by each warrant				0.4
Common Stock | Acorn Bioventures, LP [Member]
Class of Stock [Line Items]
Number of share sold under the sales agreement				485,912
Common stock, par value (in dollars per share)				$ 0.001
Common Stock | Co-Placement Agents [Member]
Class of Stock [Line Items]
Number of share sold under the sales agreement						1,910,000
Series A Convertible Preferred Stock
Class of Stock [Line Items]
Measurement period of consecutive trading days used in determining whether specified triggers are met which would allow the entity to require the conversion of all or part of outstanding preferred stock											30 days
Preferred stock, par value (in dollars per share)								$ 0.001			$ 0.001		$ 0.001
Number of common shares issued upon conversion							215,200
Effective Conversion price per share							$ 40.00
Preferred stock, shares issued							8,872	264			264		264
Preferred stock, shares outstanding								264			264		264
Number of shares converted											6,600			8,608
Price per share used to determine number of shares of common stock							$ 1,000
Percentage of blocker provision							4.99%
Conversion percentage							9.99%
Series A Convertible Preferred Stock | Minimum
Class of Stock [Line Items]
Percentage by which the weighted average price of common stock during the measurement period exceeds the initial conversion price which triggers the right of the entity to cause all or part of the outstanding preferred stock to be converted											300.00%
Threshold amount of daily trading volume on each trading day during the measurement period which triggers the right of the entity to cause all or part of the outstanding preferred stock to be converted											$ 500,000
6% convertible exchangeable preferred stock
Class of Stock [Line Items]
Share issue price per share								$ 10.00			$ 10.00
Preferred stock, shares issued								335,273			335,273		335,273
Preferred stock, shares outstanding								335,273			335,273		335,273
Dividend rate on convertible exchangeable preferred stock (in percent)											6.00%		6.00%
Accrued and unpaid dividends								$ 50,291			$ 50,291
Convertible Preferred Stock, Terms of Conversion											The Company may automatically convert the 6% Preferred Stock into common stock if the per share closing price of the Company’s common stock has exceeded $59,220, which is 150% of the conversion price of the 6% Preferred Stock, for at least 20 trading days during any 30 day trading period, ending within five trading days prior to notice of automatic conversion.
Redemption price per share (in dollars per share)								$ 10.00			$ 10.00
Debt principal amount per share, basis for exchange (in dollars per share)											$ 10.00
Debt Instrument, Term											25 years
Liquidation preference (in dollars per share)								$ 10.00			$ 10.00
Interest rate of Convertible Subordinated Debentures (as a percent)								6.00%			6.00%

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Subsequent Events - Narrative (Details) - USD ($) $ / shares in Units, $ in Millions				9 Months Ended	12 Months Ended
	Nov. 01, 2022	Oct. 14, 2022	Sep. 07, 2022	Sep. 30, 2022	Dec. 31, 2021
Cantor Fitzgerald & Co. [Member]
Subsequent Event [Line Items]
Number of share sold under the sales agreement				3,281,067
Proceeds from issuance of common stock, net of issuance costs				$ 7.6
6% convertible exchangeable preferred stock
Subsequent Event [Line Items]
Dividend declared, date			Sep. 07, 2022
Preferred stock dividend declared, amount per share			$ 0.15
Preferred stock, dividend rate (in percent)				6.00%	6.00%
6% convertible exchangeable preferred stock | Subsequent event
Subsequent Event [Line Items]
Dividends payable, date to be paid	Nov. 01, 2022
Dividend, record date		Oct. 14, 2022
Preferred stock, dividends per share, cash paid	$ 0.15