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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, 2024

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 001-38787

CYCLERION THERAPEUTICS, INC.

(Exact Name of Registrant as Specified in its Charter)

 

Massachusetts
(State or other jurisdiction of
incorporation or organization)

83-1895370
(I.R.S. Employer
Identification No.)

245 First Street, 18th Floor, Cambridge, Massachusetts
(Address of principal executive offices)

02142
(Zip Code)

 

(857) 327-8778

Registrant’s Telephone Number, Including Area Code

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, no par value

CYCN

The Nasdaq Capital 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, smaller reporting company, or an emerging growth company. See the 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 company

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 8, 2024, the registrant had 2,710,096 shares of common stock, no par value, outstanding.

 


 

CYCLERION PHARMACEUTICALS, INC.

QUARTERLY REPORT ON FORM 10-Q

FOR THE QUARTER ENDED SEPTEMBER 30, 2024

TABLE OF CONTENTS

 

Page

PART I — FINANCIAL INFORMATION

Item 1.

Financial Statements (unaudited)

5

Condensed Consolidated Balance Sheets as of September 30, 2024 and December 31, 2023

5

Condensed Consolidated Statements of Operations and Comprehensive Loss for Three and Nine Months Ended September 30, 2024 and 2023

6

Condensed Consolidated Statements of Stockholders’ Equity for Three and Nine Months Ended September 30, 2024 and 2023

7

Condensed Consolidated Statements of Cash Flows for Nine Months Ended September 30, 2024 and 2023

9

Notes to the Condensed Consolidated Financial Statements

10

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

22

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

29

Item 4.

Controls and Procedures

29

 

PART II — OTHER INFORMATION

 

Item 1.

Legal Proceedings

31

Item 1A.

Risk Factors

31

Item 5.

Other Information

31

Item 6.

Exhibits

31

Signatures

33

 

 

 

 


 

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of the federal securities laws, which statements involve substantial risks and uncertainties. All statements in this report, other than statements of historical facts, including statements about future events, financing plans, financial position, business strategy, budgets, projected costs, plans and objectives of management for future operations, are forward-looking statements that involve certain risks and uncertainties. Use of the words “may,” “might,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “potential,” “expects,” “plans,” “seeks,” “intends,” “aimed,” “evaluates,” “pursues,” “anticipates,” “continues,” “designs,” “impacts,” “affects,” “forecasts,” “target,” “outlook,” “initiative,” “objective,” “designed,” “priorities,” “goal” or the negative of those words or other similar expressions may identify forward-looking statements that represent our current judgment about possible future events, but the absence of these words does not necessarily mean that a statement is not forward-looking.

Forward-looking statements are based on our current expectations and assumptions regarding our business, the economy and other future conditions. Because forward-looking statements relate to the future, by their nature, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. As a result, our actual results may differ materially from those contemplated by the forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include regional, national, or global political, economic, business, competitive, market and regulatory conditions and the following:

our plans with respect to the development and licensing of our current product candidates and potential future product candidates we may acquire or license and associated timing thereof, including the design and results of pre-clinical and clinical studies;
there is substantial doubt regarding our ability to continue as a going concern;
our ability to enter into collaboration or license agreements of our current product candidates and potential future product candidates;
the timing, investment and associated activities involved in developing, obtaining regulatory approval for, launching and commercializing our current and potential future product candidates;
the risks in our investment in Tisento tied to Tisento developing, obtaining regulatory approval for, launching and commercializing its product candidates;
the uncertainty as to any liquidity or monetizable value of our equity interest in Tisento, which faces all the risks of an early-stage pharmaceutical development company;
our relationships with third parties, collaborators and our employees; our ability to execute our strategic priorities;
our ability to finance our operations and business initiatives;
maintaining our Nasdaq listing;
our ability to access capital, capabilities, and transactions necessary to advance the development of our current product candidates and potential future product candidates;
whether any development, regulatory, and commercialization milestones or royalty payments provided for in the agreement with Akebia will be achieved;
the impact on our business of workforce and expense reduction initiatives;
the safety profile and related adverse events of our current and potential future product candidates;
the efficacy and perceived therapeutic benefits of any potential future product candidates we may acquire or license, their potential indications and their market potential;
U.S. and non-U.S. regulatory requirements, including any post-approval development and regulatory requirements, and the ability of our potential future product candidates to meet such requirements;

 

3


 

our ability to obtain reimbursement from the U.S. government and third-party payors for potential future product candidates if and when commercialized;
our ability to attract and retain employees needed to execute our business plans and strategies and our ability to manage the impact of any loss of key employees;
our ability to obtain and maintain intellectual property protection for our current and potential future product candidates and the strength thereof;
the risk that third parties may allege we infringe their intellectual property rights;
our future financial performance, revenues, expense levels, payments, cash flows, profitability, tax obligations, capital raising and liquidity sources, and concentration of voting control, as well as the timing and drivers thereof, and internal control over financial reporting;
trends and challenges in the markets for any potential product candidates;
a determination that we constitute an investment company under the Investment Company Act of 1940, as amended, and if we are required to register thereunder, which could have a material adverse effect on us;
our ability to compete with other companies that are or may be developing or selling products that are competitive with any potential future product candidates;
the impact of any pandemic or natural disaster to disrupt our business, including our development activities; and
the impact of government regulation in the life sciences industry, particularly with respect to healthcare reform.

See the “Risk Factors” section in Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, as filed with the Securities and Exchange Commission on March 5, 2024 for a further description of these and other factors. We caution you that the risks, uncertainties, and other factors referenced above may not contain all of the risks, uncertainties and other factors that are important to you. In addition, we cannot assure you that we will realize the results, benefits, or developments that we expect or anticipate or, even if substantially realized, that they will result in the consequences or affect us or our business in the way expected. There can be no assurance that (i) we have correctly measured or identified all of the factors affecting our business or the extent of these factors’ likely impact, (ii) the available information with respect to these factors on which such analysis is based is complete or accurate, (iii) such analysis is correct or (iv) our strategy, which is based in part on this analysis, will be successful. All forward-looking statements in this report apply only as of the date of this report or as of the date they were made and, except as required by applicable law, we undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise.

 

4


 

Cyclerion Therapeutics, Inc.

Condensed Consolidated Balance Sheets

(In thousands except share and per share data)

(Unaudited)

 

 

 

September 30,
2024

 

 

December 31,
2023

 

ASSETS

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

2,872

 

 

$

7,571

 

Account receivable

 

 

44

 

 

 

 

Prepaid expenses

 

 

621

 

 

 

442

 

Other current assets

 

 

11

 

 

 

11

 

Total current assets

 

 

3,548

 

 

 

8,024

 

Other investment

 

 

5,350

 

 

 

5,350

 

Total assets

 

$

8,898

 

 

$

13,374

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

304

 

 

$

1,198

 

Accrued research and development costs

 

 

72

 

 

 

90

 

Accrued expenses and other current liabilities

 

 

324

 

 

 

798

 

Total current liabilities

 

 

700

 

 

 

2,086

 

Commitments and contingencies (Note 8)

 

 

 

 

 

 

Stockholders' equity

 

 

 

 

 

 

 Preferred shares, no par value, 500,000 shares authorized and 351,037 series A convertible preferred stock issued and outstanding at September 30, 2024 and December 31, 2023

 

 

 

 

 

 

Common stock, no par value, 20,000,000 shares authorized at September 30, 2024 and December 31, 2023; 2,710,096 and 2,645,096 shares issued at September 30, 2024 and December 31, 2023, respectively; 2,530,898 and 2,474,159 shares outstanding at September 30, 2024 and December 31, 2023, respectively

 

 

 

 

 

 

Paid-in capital

 

 

276,220

 

 

 

275,717

 

Accumulated deficit

 

 

(268,022

)

 

 

(264,417

)

Accumulated other comprehensive loss

 

 

 

 

 

(12

)

Total stockholders' equity

 

 

8,198

 

 

 

11,288

 

Total liabilities and stockholders' equity

 

$

8,898

 

 

$

13,374

 

 

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

 

5


 

Cyclerion Therapeutics, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(In thousands except per share data)

(Unaudited)

 

 

 

Three Months Ended
September 30,

 

 

Nine Months Ended
September 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

Option to license revenue

 

$

194

 

 

$

 

 

$

194

 

 

$

 

Total revenues

 

 

194

 

 

 

 

 

 

194

 

 

 

 

Cost and expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

81

 

 

 

580

 

 

 

230

 

 

 

1,491

 

General and administrative

 

 

1,241

 

 

 

2,131

 

 

 

4,094

 

 

 

6,361

 

Impairment loss

 

 

 

 

 

3,304

 

 

 

 

 

 

3,304

 

Total cost and expenses

 

 

1,322

 

 

 

6,015

 

 

 

4,324

 

 

 

11,156

 

Loss from operations

 

 

(1,128

)

 

 

(6,015

)

 

 

(4,130

)

 

 

(11,156

)

Other income, net

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

42

 

 

 

107

 

 

 

180

 

 

 

257

 

Gain from settlement of account payable

 

 

363

 

 

 

 

 

 

363

 

 

 

 

Total other income, net

 

 

405

 

 

 

107

 

 

 

543

 

 

 

257

 

Net loss from continuing operations

 

 

(723

)

 

 

(5,908

)

 

 

(3,587

)

 

 

(10,899

)

Discontinued operations:

 

 

 

 

 

 

 

 

 

 

 

 

Gain from discontinued operations

 

 

 

 

 

13,474

 

 

 

 

 

 

7,330

 

Net gain (loss)

 

$

(723

)

 

$

7,566

 

 

$

(3,587

)

 

$

(3,569

)

Net gain (loss) per share - basic:

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share from continuing operations - basic

 

$

(0.29

)

 

$

(2.43

)

 

$

(1.43

)

 

$

(4.74

)

Net gain (loss) per share from discontinued operations - basic

 

 

 

 

 

5.53

 

 

 

 

 

 

3.19

 

Basic net gain (loss) per share

 

$

(0.29

)

 

$

3.10

 

 

$

(1.43

)

 

$

(1.55

)

Net gain (loss) per share - basic and diluted

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share from continuing operations

 

$

(0.29

)

 

$

(2.12

)

 

$

(1.43

)

 

$

(4.74

)

Net gain per share from discontinued operations

 

 

 

 

 

4.84

 

 

 

 

 

 

3.19

 

Diluted net gain (loss) per share

 

$

(0.29

)

 

$

2.72

 

 

$

(1.43

)

 

$

(1.55

)

Weighted average shares used in calculating:

 

 

 

 

 

 

 

 

 

 

 

 

Basic shares

 

 

2,526

 

 

 

2,435

 

 

 

2,510

 

 

 

2,299

 

Diluted shares

 

 

2,526

 

 

 

2,786

 

 

 

2,510

 

 

 

2,299

 

 

 

 

 

 

 

 

 

 

 

 

 

Other comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

Net gain (loss)

 

$

(723

)

 

$

7,566

 

 

$

(3,587

)

 

$

(3,569

)

Other comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency translation adjustment gain (loss)

 

 

 

 

 

(2

)

 

 

(6

)

 

 

2

 

Comprehensive loss

 

$

(723

)

 

$

7,564

 

 

$

(3,593

)

 

$

(3,567

)

 

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

 

 

 

6


 

Cyclerion Therapeutics, Inc.

Condensed Consolidated Statements of Stockholders’ Equity

(In thousands except share data)

(Unaudited)

 

 

 

Common Stock

 

 

Preferred Stock

 

 

Paid-in

 

 

Accumulated

 

 

Accumulated
other
comprehensive

 

 

Total
Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

capital

 

 

deficit

 

 

loss

 

 

equity

 

Balance at December 31, 2022

 

 

2,175,936

 

 

$

 

 

 

 

 

$

 

 

$

269,626

 

 

$

(259,154

)

 

$

(20

)

 

$

10,452

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(6,954

)

 

 

 

 

 

(6,954

)

Issuance of common stock upon exercise of stock options, RSUs and employee stock purchase plan

 

 

309

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Share-based compensation expense related to issuance of stock options and RSUs and employee stock purchase plan

 

 

 

 

 

 

 

 

 

 

 

 

 

 

426

 

 

 

 

 

 

 

 

 

426

 

Foreign currency translation adjustment

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1

 

 

 

1

 

Balance at March 31, 2023

 

 

2,176,245

 

 

$

 

 

 

 

 

$

 

 

$

270,052

 

 

$

(266,108

)

 

$

(19

)

 

$

3,925

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(4,181

)

 

 

 

 

 

(4,181

)

Issuance of common stock

 

 

225,000

 

 

 

 

 

 

 

 

 

 

 

 

1,953

 

 

 

 

 

 

 

 

 

1,953

 

Issuance of preferred shares

 

 

 

 

 

 

 

 

351,037

 

 

 

 

 

 

3,047

 

 

 

 

 

 

 

 

 

3,047

 

Issuance of common stock upon exercise of stock options, RSUs and employee stock purchase plan

 

 

6,618

 

 

 

 

 

 

 

 

 

 

 

 

24

 

 

 

 

 

 

 

 

 

24

 

Share-based compensation expense related to issuance of stock options and RSUs and employee stock purchase plan

 

 

 

 

 

 

 

 

 

 

 

 

 

 

379

 

 

 

 

 

 

 

 

 

379

 

Foreign currency translation adjustment

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3

 

 

 

3

 

Fractional shares issuance

 

 

(67

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at June 30, 2023

 

 

2,407,796

 

 

$

 

 

 

351,037

 

 

$

 

 

$

275,455

 

 

$

(270,289

)

 

$

(16

)

 

$

5,150

 

Net gain

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

7,566

 

 

 

 

 

 

7,566

 

Issuance of common stock upon vesting of RSUs

 

 

37,300

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Share-based compensation expense related to issuance of stock options and RSUs and employee stock purchase plan

 

 

 

 

 

 

 

 

 

 

 

 

 

 

159

 

 

 

 

 

 

 

 

 

159

 

Foreign currency translation adjustment

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(2

)

 

 

(2

)

Balance at September 30, 2023

 

 

2,445,096

 

 

$

 

 

 

351,037

 

 

$

 

 

$

275,614

 

 

$

(262,723

)

 

$

(18

)

 

$

12,873

 

 

 

7


 

Cyclerion Therapeutics, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(In thousands except per share data)

(Unaudited)

 

 

 

Common Stock

 

 

Preferred Stock

 

 

Paid-in

 

 

Accumulated

 

 

Accumulated
other
comprehensive

 

 

Total
Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

capital

 

 

deficit

 

 

loss

 

 

equity

 

Balance at December 31, 2023

 

 

2,474,159

 

 

$

 

 

 

351,037

 

 

$

 

 

$

275,717

 

 

$

(264,417

)

 

$

(12

)

 

$

11,288

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1,542

)

 

 

 

 

 

(1,542

)

Vesting of restricted stock awards

 

 

25,442

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Share-based compensation expense related to issuance of stock options and restricted stock awards

 

 

 

 

 

 

 

 

 

 

 

 

 

 

181

 

 

 

 

 

 

 

 

 

181

 

Foreign currency translation adjustment

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(4

)

 

 

(4

)

Balance at March 31, 2024

 

 

2,499,601

 

 

$

 

 

 

351,037

 

 

$

 

 

$

275,898

 

 

$

(265,959

)

 

$

(16

)

 

$

9,923

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1,322

)

 

 

 

 

 

(1,322

)

Vesting of restricted stock awards

 

 

16,273

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Share-based compensation expense related to issuance of stock options and restricted stock awards

 

 

 

 

 

 

 

 

 

 

 

 

 

 

184

 

 

 

 

 

 

 

 

 

184

 

Foreign currency translation adjustment

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(2

)

 

 

(2

)

Release of foreign currency translation adjustment upon liquidation of a subsidiary

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(18

)

 

 

18

 

 

 

 

Balance at June 30, 2024

 

 

2,515,874

 

 

$

 

 

 

351,037

 

 

$

 

 

$

276,082

 

 

$

(267,299

)

 

$

 

 

$

8,783

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(723

)

 

 

 

 

 

(723

)

Vesting of restricted stock awards

 

 

15,024

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Share-based compensation expense related to issuance of stock options and restricted stock awards

 

 

 

 

 

 

 

 

 

 

 

 

 

 

138

 

 

 

 

 

 

 

 

 

138

 

Foreign currency translation adjustment

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at September 30, 2024

 

 

2,530,898

 

 

$

 

 

 

351,037

 

 

$

 

 

$

276,220

 

 

$

(268,022

)

 

$

 

 

$

8,198

 

 

 

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

 

 

 

8


 

Cyclerion Therapeutics, Inc.

Condensed Consolidated Statements of Cash Flows

(In thousands)

(Unaudited)

 

 

Nine Months Ended September 30,

 

 

 

2024

 

 

2023

 

CASH FLOWS FROM OPERATING ACTIVITIES:

 

 

 

 

 

 

Net loss

 

$

(3,587

)

 

$

(3,569

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

Gain on disposal of discontinued operations

 

 

 

 

 

(15,752

)

Gain from settlement of account payable

 

 

(363

)

 

 

 

Impairment loss

 

 

 

 

 

3,304

 

Share-based compensation expense

 

 

503

 

 

 

964

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

Account receivable

 

 

(44

)

 

 

96

 

Prepaid expenses

 

 

(179

)

 

 

79

 

Other current assets

 

 

 

 

 

140

 

Operating lease assets

 

 

 

 

 

107

 

Other assets

 

 

 

 

 

213

 

Accounts payable

 

 

(531

)

 

 

(2,157

)

Accrued research and development costs

 

 

(18

)

 

 

(1,912

)

Accrued expenses and other current liabilities

 

 

(474

)

 

 

(1,217

)

Net cash used in operating activities

 

 

(4,693

)

 

 

(19,704

)

CASH FLOWS FROM INVESTING ACTIVITIES:

 

 

 

 

 

 

Net proceeds from disposal of discontinued operations

 

 

 

 

 

10,402

 

Net cash provided by investing activities

 

 

 

 

 

10,402

 

CASH FLOWS FROM FINANCING ACTIVITIES:

 

 

 

 

 

 

Proceeds from stock purchase agreement

 

 

 

 

 

5,000

 

Proceeds from exercises of stock options and ESPP

 

 

 

 

 

24

 

Net cash provided by financing activities

 

 

 

 

 

5,024

 

Effect of exchange rate changes on cash and cash equivalents

 

 

(6

)

 

 

4

 

Net decrease in cash and cash equivalents

 

 

(4,699

)

 

 

(4,274

)

Cash and cash equivalents, beginning of period

 

 

7,571

 

 

 

13,382

 

Cash and cash equivalents, end of period

 

$

2,872

 

 

$

9,108

 

Supplemental cash flow disclosure:

 

 

 

 

 

 

Non-cash gain on disposal of discontinued operations

 

$

 

 

$

5,350

 

 

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

 

9


 

Cyclerion Therapeutics, Inc.

Notes to the Condensed Consolidated Financial Statements

(Unaudited)

1. Nature of Business

Nature of Operations

Cyclerion Therapeutics, Inc. (“Cyclerion”, the “Company” or “we”) became an independent public company on April 1, 2019 after Ironwood Pharmaceuticals, Inc., or Ironwood, completed a tax-free spin-off of its novel soluble guanylate cyclase ("sGC") business, which we refer to herein as the "Separation". Cyclerion has one employee as of September 30, 2024.

At inception, Cyclerion was a biopharmaceutical company focused on the treatment of serious diseases with sGC stimulators in both the central nervous system ("CNS") and the periphery. The nitric oxide ("NO") sGC cyclic guanosine monophosphate ("cGMP") signaling pathway is a fundamental mechanism that precisely controls key aspects of physiology throughout the body. The NO-sGC-cGMP pathway regulates diverse and critical biological functions in both the CNS and the periphery and has been successfully targeted with several drugs.

Praliciguat is an orally administered, once-daily systemic sGC stimulator. On June 3, 2021, Cyclerion entered into a license agreement (as defined below) with Akebia Therapeutics Inc. (“Akebia”) relating to the exclusive worldwide license to Akebia of the Company's rights to the development, manufacture, medical affairs and commercialization of pharmaceutical products containing praliciguat and other related products and forms thereof enumerated in such agreement. Cyclerion is eligible to receive up to $585 million in total potential future development, regulatory, and commercialization milestone payments. Cyclerion is also eligible to receive tiered, sales-based royalties ranging from single-digit to high-teen percentages and subject to reduction upon expiration of patent rights or the launch of a generic product.

Olinciguat is a Phase 2 orally administered, once-daily, vascular sGC stimulator that Cyclerion intends to out-license to an entity with strong cardiovascular and/or cardiopulmonary capabilities.

Zagociguat is a clinical-stage CNS-penetrant sGC stimulator that has shown rapid improvement in cerebral blood flow, functional brain connectivity, brain response to visual stimulus, cognitive performance, and biomarkers associated mitochondrial function and inflammation in clinical studies. CY3018 is a CNS-targeted sGC stimulator that preferentially localizes to the brain and has a pharmacology profile that suggests its potential for the treatment of neuropsychiatric diseases and disorders. On July 28, 2023, the Company sold zagociguat and CY3018 to Tisento Therapeutics, Inc. (“Tisento”), a newly formed private company focused on their development, in exchange for $8.0 million in cash consideration, $2.4 million as reimbursement for certain operating expenses related to zagociguat and CY3018 for the period between signing and closing of the transaction, and 10% of all of Tisento’s parent’s outstanding equity securities. See “Asset Purchase Agreement” and “Note 4” below.

Cyclerion is actively evaluating other activities aimed at enhancing shareholder value, which may potentially include collaborations, licenses, mergers, acquisitions and/or other targeted investments.

The Company has shifted its strategy to identify, non-sGC stimulator assets within the CNS therapeutic area to build a new portfolio. If the Company identifies and acquires or licenses suitable new assets, the Company will seek to develop the new assets and retain contract research, development and manufacturing organizations for these specific purposes. Additionally, Cyclerion plans to seek to raise funds for further research and development activities associated with any new assets. The Company’s goal is to find the best combination of capital, capabilities, and transactions that will enable the advancement of current and any future assets the Company may acquire for patients in a way that maximizes shareholder value.

Cyclerion GmbH, a wholly owned subsidiary, was incorporated in Zug, Switzerland on May 3, 2019. The functional currency is the Swiss franc. The liquidation process for Cyclerion GmbH has been concluded and the subsidiary was de-registered in May 2024.

 

10


 

Cyclerion Securities Corporation, a wholly owned subsidiary, was incorporated in Massachusetts on November 15, 2019 and was granted securities corporation status in Massachusetts for the 2019 tax year. Cyclerion Securities Corporation has no employees.

Stock Purchase Agreement

In March 2023, the Company entered into a stock purchase agreement with the Company's former Chief Executive Officer (the “Former CEO”) pursuant to which he invested $5 million in cash for 225,000 shares of common stock and 351,037 shares of Series A Convertible Preferred Stock of the Company at a price of $8.68 per share (after giving effect to the 1-for-20 reverse stock split the Company implemented on May 15, 2023). Such Series A Convertible Preferred Stock is convertible into shares of the Company's common stock on a one-to-one basis. The closing of the equity investment took place on May 19, 2023, and (to comply with Nasdaq listing requirements) the Company's shareholders approved such convertibility on July 19, 2023.

Asset Purchase Agreement

On May 11, 2023, the Company entered into an Asset Purchase Agreement (the “Asset Purchase Agreement”) with an investor group that included the Former CEO, JW Celtics Investment Corp and JW Cycle Inc. which subsequently changed their names to Tisento Therapeutics Holdings Inc. (“Tisento Parent”) and Tisento. Upon the closing on July 28, 2023, of the transactions contemplated by the Asset Purchase Agreement, the Company sold to Tisento specified assets relating to the Company’s zagociguat and CY3018 programs (the "Transferred Assets") and Tisento assumed certain liabilities relating thereto, including, but not limited to (i) liabilities, costs and expenses arising after the date of the Asset Purchase Agreement relating to the employment of certain Cyclerion employees and the conduct of certain preclinical and clinical trial activities prior to the closing of the transactions contemplated by the Asset Purchase Agreement, and (ii) liabilities relating to such assets to the extent relating to the period after the closing of the transaction. In consideration for such sale and assumption, at such closing the Company received proceeds of $8.0 million as cash consideration, $2.4 million as reimbursement for certain operating expenses related to such assets for the period between signing and closing of the Asset Purchase Agreement, and shares of common stock of Tisento Parent comprising 10% of the then issued and outstanding equity securities of Tisento Parent immediately following such closing, subject to certain protections against dilution.

Reverse Stock Split

On May 15, 2023, the Company filed Articles of Amendment to the Company's Restated Articles of Organization with the Secretary of Commonwealth of Massachusetts to effect a 1-for-20 reverse stock split of the Company's issued and outstanding shares of common stock. The reverse stock split was reflected on the Nasdaq Capital Market beginning with the opening of trading on May 16, 2023. All share amounts and per share amounts disclosed in this Quarterly Report on Form 10-Q have been adjusted retroactively to reflect the reverse stock split for all periods presented.

At-the-Market Offering

On July 24, 2020, the Company filed a Registration Statement on Form S-3 (the “Shelf”). On September 3, 2020, the Company entered into a Sales Agreement (the “Sales Agreement”) with Jefferies LLC (“Jefferies”) with respect to an at-the-market offering (the “ATM Offering”) under the Shelf. Under the ATM Offering, the Company could offer and sell, from time to time at its sole discretion, shares of its common stock, having an aggregate offering price of up to $50.0 million through Jefferies as its sales agent. The Company agreed to pay Jefferies cash commissions of 3.0 percent of the gross proceeds of sales of common stock which could be sold under the Sales Agreement. Prior to January 1, 2022, the Company sold 3,353,059 shares of its common stock for net proceeds of $12.5 million under the ATM Offering, since entering into the Sales Agreement. No shares of common stock have been issued or sold under the ATM Offering from January 1, 2022 to July 31, 2023. The Shelf expired in July 31, 2023. Due to the current market value of the Company's publicly traded common stock held by non-affiliates, the Company's ability to raise future funding though a shelf offering will be limited.

 

11


 

Basis of Presentation

The condensed consolidated financial statements and the related disclosures are unaudited and have been prepared in accordance with accounting principles generally accepted in the U.S. Additionally, certain information and footnote disclosures normally included in the Company’s annual financial statements have been condensed or omitted. Accordingly, these interim condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, which was filed with the Securities and Exchange Commission on March 5, 2024.

In the opinion of management, the unaudited interim condensed consolidated financial statements reflect all normal recurring adjustments considered necessary for a fair presentation of the Company’s financial position and the results of its operations for the interim periods presented. The results of operations for the three and nine months ended September 30, 2024 and 2023 are not necessarily indicative of the results that may be expected for the full year or any other subsequent interim period.

The condensed consolidated financial statements include the financial statements of the Company and its wholly owned subsidiaries, Cyclerion GmbH (prior to its deregistration), and Cyclerion Securities Corporation. All significant intercompany accounts and transactions have been eliminated in the preparation of the accompanying condensed consolidated financial statements.

Going Concern

At each reporting period, in accordance with Accounting Standards Codification ("ASC") 205-40, Going Concern, the Company evaluates whether there are conditions or events that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued. The Company’s evaluation entails analyzing prospective operating budgets and forecasts for expectations of the Company’s cash needs and comparing those needs to the current cash and cash equivalent balances. The Company is required to make certain additional disclosures if it concludes substantial doubt exists and it is not alleviated by the Company’s plans or when its plans alleviate substantial doubt about the Company’s ability to continue as a going concern.

This evaluation initially does not take into consideration the potential mitigating effect of management’s plans that have not been fully implemented as of the date the financial statements are issued. When substantial doubt exists under this methodology, management evaluates whether the mitigating effect of its plans sufficiently alleviates substantial doubt about the Company’s ability to continue as a going concern. The mitigating effect of management’s plans, however, is only considered if both (1) it is probable that the plans will be effectively implemented within one year after the date that the financial statements are issued, and (2) it is probable that the plans, when implemented, will mitigate the relevant conditions or events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date that these condensed consolidated financial statements are issued. In performing its analysis, management excluded certain elements of its operating plan that cannot be considered probable. Under ASC 205-40, the future receipt of potential funding from future partnerships, license payments, equity or debt issuances, certain cost reduction measures and the achievement of potential milestone payments from Akebia cannot be considered probable at this time because these plans are not entirely within the Company’s control and/or have not been approved by the Board of Directors as of the date of these condensed consolidated financial statements.

The Company expects that its cash and cash equivalents as of September 30, 2024, will be sufficient to fund operations through mid-2025, however the Company will need to obtain additional funding to sustain operations as it expects to continue to generate operating losses for the foreseeable future. The Company's expectation to generate negative operating cash flows in the future and the need for additional funding to support its planned operations, raise substantial doubt regarding the Company’s ability to continue as a going concern. Management's plans to alleviate the conditions that raise substantial doubt include reduced spending, and the pursuit of additional capital. Management has concluded the likelihood that its plan to successfully obtain sufficient funding, or adequately reduce expenditures, while reasonably possible, is less than probable. Accordingly, the Company has concluded that substantial doubt exists about the Company’s ability to continue as a going concern. The accompanying financial statements have been prepared on a going concern basis, which contemplates the

 

12


 

realization of assets and satisfaction of liabilities in the ordinary course of business. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described above.

 

2. Summary of Significant Accounting Policies

The accounting policies of the Company are set forth in Note 2. Summary of Significant Accounting Policies to the consolidated financial statements contained in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023.

New Accounting Pronouncements

From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that are adopted by the Company as of the specified effective date. Except as discussed elsewhere in the notes to the consolidated financial statements, the Company did not adopt any new accounting pronouncements during the nine months ended September 30, 2024 that had a material effect on its condensed consolidated financial statements.

In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which requires public entities to disclose information about their reportable segments’ significant expenses and other segment items on an interim and annual basis. Public entities with a single reportable segment are required to apply the disclosure requirements in ASU 2023-07, as well as all existing segment disclosures and reconciliation requirements in ASC 280 on an interim and annual basis. ASU 2023-07 is effective for annual reporting periods beginning after December 15, 2023, and for interim reporting periods beginning January 1, 2025, with early adoption permitted. The Company is currently evaluating the impact that adoption of ASU 2023-07 will have on the Company's consolidated financial statement disclosures.

In June 2016, the FASB issued ASU 2016-13, Financial Instruments-Credit Losses. This standard requires entities to measure all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions, and reasonable and supportable forecasts. As a smaller reporting company, ASU 2016-13 will become effective for the Company for fiscal years beginning after December 15, 2022, and early adoption is permitted. The Company adopted ASU 2016-13 in the first quarter of 2023, and the adoption of this standard did not have any impact on the Company's financial position or results of operations.

No other accounting standards known by the Company to be applicable to it that have been issued by the FASB or other standard-setting bodies and that do not require adoption until a future date are expected to have a material impact on the Company’s condensed consolidated financial statements upon adoption.

3. Fair Value of Financial Instruments

The Company’s cash equivalents are generally classified within Level 1 of the fair value hierarchy. The following tables present information about the Company’s financial assets measured at fair value on a recurring basis and indicate the level of the fair value hierarchy used to determine such fair values as of September 30, 2024 and December 31, 2023 (in thousands):

 

 

 

Fair Value Measurements as of September 30, 2024:

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

2,793

 

 

$

 

 

$

 

 

$

2,793

 

Cash equivalents

 

$

2,793

 

 

$

 

 

$

 

 

$

2,793

 

 

 

 

Fair Value Measurements as of December 31, 2023:

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

7,244

 

 

$

 

 

$

 

 

$

7,244

 

Cash equivalents

 

$

7,244

 

 

$

 

 

$

 

 

$

7,244

 

 

 

13


 

 

During the nine months ended September 30, 2024 and 2023, there were no transfers between levels. The fair value of the Company’s cash equivalents, consisting of money market funds, is based on quoted market prices in active markets with no valuation adjustment.

The Company believes the carrying amounts of its prepaid expenses and other current assets, accounts payable, and accrued expenses approximate their fair value due to the short-term nature of these amounts.

4. Discontinued Operations

 

On May 11, 2023, the Company entered into the Asset Purchase Agreement for Tisento’s acquisition of substantially all of the assets comprising the Company’s zagociguat and CY3018 programs, in exchange for consideration at closing of $8.0 million, the reimbursement of employee expenses and R&D expenses of $2.4 million that Tisento reimbursed the Company for upon closing, and 10% of the issued and outstanding shares of Tisento Parent (Note 5). Upon closing of the transaction, the Company transferred certain fully depreciated software included within property and equipment to Tisento.

 

The operations of the Transferred Assets are presented as discontinued for all periods presented. The transaction closed on July 28, 2023.

 

The following table presents the results of the discontinued operations for the three and nine months ended September 30, 2024 and 2023 (in thousands):

 

 

 

Three Months Ended
September 30,

 

 

Nine Months Ended September 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

Revenue from grants

 

$

 

 

$

50

 

 

$

 

 

$

50

 

Total revenues

 

 

 

 

 

50

 

 

 

 

 

 

50

 

Cost and expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

 

 

 

691

 

 

 

 

 

 

4,439

 

General and administrative