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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, 2023

OR

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

COMMISSION FILE NUMBER 001-36279

CARA THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

Delaware

75-3175693

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification No.)

4 Stamford Plaza

107 Elm Street, 9th Floor

Stamford, Connecticut

06902

(Address of registrant’s principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (203) 406-3700

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

Title of each class

Trading Symbol

Name of each exchange on which registered

Common Stock, par value $0.001 per share

CARA

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 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.

The number of outstanding shares of the registrant’s common stock, par value $0.001 per share, as of November 9, 2023 was: 54,480,704.

CARA THERAPEUTICS, INC.

INDEX TO FORM 10-Q

FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2023

PART I –FINANCIAL INFORMATION

PAGE

NUMBER

Item 1.

Financial Statements (Unaudited):

Condensed Balance Sheets as of September 30, 2023 and December 31, 2022

1

Condensed Statements of Comprehensive Loss for the Three and Nine Months Ended September 30, 2023 and 2022

2

Condensed Statements of Stockholders’ Equity for the Three and Nine Months Ended September 30, 2023 and 2022

3

Condensed Statements of Cash Flows for the Nine Months Ended September 30, 2023 and 2022

5

Notes to Condensed Financial Statements

6

Item 2.

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

35

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

63

Item 4.

Controls and Procedures

64

PART II – OTHER INFORMATION

Item 1.

Legal Proceedings

66

Item 1A.

Risk Factors

66

Item 2.

Unregistered Sales of Equity Securities, Use of Proceeds and Issuer Purchases of Equity Securities

68

Item 3.

Defaults Upon Senior Securities

68

Item 4.

Mine Safety Disclosures

68

Item 5.

Other Information

68

Item 6.

Exhibits

69

SIGNATURES

70

PART I

FINANCIAL INFORMATION

Item 1.Financial Statements.

CARA THERAPEUTICS, INC.

CONDENSED BALANCE SHEETS

(amounts in thousands, excluding share and per share data)

(unaudited)

    

September 30, 2023

    

December 31, 2022

Assets

 

 

  

Current assets:

 

  

 

  

Cash and cash equivalents

$

62,875

$

63,741

Marketable securities

 

15,666

 

81,658

Accounts receivable, net - related party

3,351

3,260

Inventory, net

3,266

2,383

Income tax receivable

 

697

 

697

Other receivables

 

1,682

 

496

Prepaid expenses

 

12,658

 

16,267

Restricted cash

 

408

 

408

Total current assets

 

100,603

 

168,910

Operating lease right-of-use assets

7,108

1,551

Marketable securities, non-current

 

4,747

 

11,350

Property and equipment, net

 

1,380

 

426

Restricted cash, non-current

 

1,500

 

Total assets

$

115,338

$

182,237

Liabilities and stockholders’ equity

 

 

  

Current liabilities:

 

 

  

Accounts payable and accrued expenses

$

22,384

$

21,540

Operating lease liabilities, current

 

497

 

1,918

Total current liabilities

 

22,881

 

23,458

Operating lease liabilities, non-current

6,815

Commitments and contingencies (Note 16)

 

 

Stockholders’ equity:

 

 

  

Preferred stock; $0.001 par value; 5,000,000 shares authorized at September 30, 2023 and December 31, 2022, zero shares issued and outstanding at September 30, 2023 and December 31, 2022

 

 

Common stock; $0.001 par value; 100,000,000 shares authorized at September 30, 2023 and December 31, 2022, 54,471,829 shares and 53,797,341 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively

 

54

 

53

Additional paid-in capital

 

738,435

 

726,630

Accumulated deficit

 

(652,408)

 

(566,232)

Accumulated other comprehensive loss

 

(439)

 

(1,672)

Total stockholders’ equity

 

85,642

 

158,779

Total liabilities and stockholders’ equity

$

115,338

$

182,237

See Notes to Condensed Financial Statements.

1

CARA THERAPEUTICS, INC.

CONDENSED STATEMENTS OF COMPREHENSIVE LOSS

(amounts in thousands, excluding share and per share data)

(unaudited)

Three Months Ended

Nine Months Ended

    

September 30, 2023

    

September 30, 2022

    

September 30, 2023

    

September 30, 2022

    

Revenue:

Collaborative revenue

$

2,471

$

7,443

$

10,631

$

15,446

Commercial supply revenue

1,252

3,370

5,843

8,160

Royalty revenue

167

415

License and milestone fees

910

910

15,000

Clinical compound revenue

 

66

 

 

165

 

Total revenue

 

4,866

 

10,813

 

17,964

 

38,606

Operating expenses:

 

  

 

  

 

 

  

Cost of goods sold

1,558

3,055

5,566

5,136

Research and development

 

25,451

 

24,691

 

80,095

 

65,869

General and administrative

 

6,755

 

6,912

 

21,191

 

23,829

Total operating expenses

 

33,764

 

34,658

 

106,852

 

94,834

Operating loss

 

(28,898)

 

(23,845)

 

(88,888)

 

(56,228)

Other income, net

 

866

 

665

 

2,712

 

1,093

Net loss

$

(28,032)

$

(23,180)

$

(86,176)

$

(55,135)

Net loss per share:

 

 

  

 

  

 

  

Basic and Diluted

$

(0.52)

$

(0.43)

$

(1.59)

$

(1.03)

Weighted average shares:

 

 

 

 

Basic and Diluted

 

54,235,695

 

53,726,123

 

54,038,239

 

53,616,753

Other comprehensive income (loss), net of tax of $0:

 

  

 

 

  

 

  

Change in unrealized gains (losses) on available-for-sale marketable securities

 

291

 

(101)

 

1,233

 

(1,790)

Total comprehensive loss

$

(27,741)

$

(23,281)

$

(84,943)

$

(56,925)

See Notes to Condensed Financial Statements.

2

CARA THERAPEUTICS, INC.

CONDENSED STATEMENTS OF STOCKHOLDERS’ EQUITY

(amounts in thousands except share and per share data)

(unaudited)

Accumulated

Additional

Other

Total

Common Stock

Paid-In

Accumulated

Comprehensive

Stockholders’

    

Shares

    

Amount

    

Capital

    

Deficit

    

Loss

    

Equity

Balance at December 31, 2022

53,797,341

$

53

$

726,630

$

(566,232)

$

(1,672)

$

158,779

Stock-based compensation expense

2,972

2,972

Shares issued upon exercise of stock options

93,218

1

559

560

Shares issued upon vesting of restricted stock units

83,793

381

381

Net loss

 

 

 

 

(26,665)

 

 

(26,665)

Other comprehensive income

 

 

 

 

 

571

 

571

Balance at March 31, 2023

53,974,352

$

54

$

730,542

$

(592,897)

$

(1,101)

$

136,598

Stock-based compensation expense

 

 

3,116

 

 

 

3,116

Shares issued upon vesting of restricted stock units

94,454

 

 

326

 

 

 

326

Net loss

 

 

 

(31,479)

 

 

(31,479)

Other comprehensive income

 

 

 

 

371

 

371

Balance at June 30, 2023

54,068,806

$

54

$

733,984

$

(624,376)

$

(730)

$

108,932

Net proceeds from sales of common stock under open market sales agreement

386,881

1,117

1,117

Stock-based compensation expense

3,171

3,171

Shares issued upon vesting of restricted stock units

16,142

163

163

Net loss

(28,032)

(28,032)

Other comprehensive income

291

291

Balance at September 30, 2023

54,471,829

$

54

$

738,435

$

(652,408)

$

(439)

$

85,642

3

CARA THERAPEUTICS, INC.

CONDENSED STATEMENTS OF STOCKHOLDERS’ EQUITY

(amounts in thousands except share and per share data)

(unaudited)

Accumulated

Additional

Other

Total

Common Stock

Paid-In

Accumulated

Comprehensive

Stockholders’

    

Shares

    

Amount

    

Capital

    

Deficit

    

Loss

    

Equity

Balance at December 31, 2021

53,480,812

$

53

$

708,585

$

(480,758)

$

(358)

$

227,522

Stock-based compensation expense

 

 

 

4,266

 

 

 

4,266

Shares issued upon exercise of stock options

 

470

 

 

3

 

 

 

3

Shares issued upon vesting of restricted stock units

109,943

1,438

1,438

Net loss

 

 

 

 

(27,749)

 

 

(27,749)

Other comprehensive loss

 

 

 

 

 

(1,365)

 

(1,365)

Balance at March 31, 2022

53,591,225

$

53

$

714,292

$

(508,507)

$

(1,723)

$

204,115

Stock-based compensation expense

 

 

4,232

 

 

 

4,232

Shares issued upon exercise of stock options

30,000

 

 

182

 

 

 

182

Shares issued upon vesting of restricted stock units

89,075

423

423

Net loss

 

 

 

(4,206)

 

 

(4,206)

Other comprehensive loss

 

 

 

 

(324)

 

(324)

Balance at June 30, 2022

53,710,300

$

53

$

719,129

$

(512,713)

$

(2,047)

$

204,422

Stock-based compensation expense

3,520

3,520

Shares issued upon exercise of stock options

15,807

104

104

Shares issued upon vesting of restricted stock units

7,500

55

55

Net loss

(23,180)

(23,180)

Other comprehensive loss

(101)

(101)

Balance at September 30, 2022

53,733,607

$

53

$

722,808

$

(535,893)

$

(2,148)

$

184,820

See Notes to Condensed Financial Statements.

4

CARA THERAPEUTICS, INC.

CONDENSED STATEMENTS OF CASH FLOWS

(amounts in thousands)

(unaudited)

Nine Months Ended

    

September 30, 2023

    

September 30, 2022

    

Operating activities

 

  

 

  

Net loss

$

(86,176)

$

(55,135)

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

 

  

 

Stock-based compensation expense

 

10,129

 

13,933

Depreciation and amortization

 

177

 

187

Noncash lease expense

 

1,221

 

1,055

(Accretion)/amortization of available-for-sale marketable securities, net

(159)

498

Changes in operating assets and liabilities:

 

 

Accounts receivable, net - related party

(91)

(9,623)

Inventory, net

(883)

749

Other receivables

 

(1,186)

 

4

Prepaid expenses

 

3,609

 

(16,043)

Accounts payable and accrued expenses

 

37

 

10,455

Operating lease liabilities

(1,278)

(1,300)

Other

(108)

Net cash used in operating activities

 

(74,708)

 

(55,220)

Investing activities

 

  

 

  

Proceeds from maturities of available-for-sale marketable securities

 

118,590

 

162,185

Proceeds from redemptions of available-for-sale marketable securities, at par

4,000

Purchases of available-for-sale marketable securities

 

(48,601)

 

(77,858)

Purchases of property and equipment

(323)

(43)

Net cash provided by investing activities

 

73,666

 

84,284

Financing activities

 

 

  

Net proceeds from sales of common stock under open market sales agreement

1,117

Proceeds from the exercise of stock options

 

559

 

289

Net cash provided by financing activities

 

1,676

 

289

Net increase in cash, cash equivalents and restricted cash

 

634

 

29,353

Cash, cash equivalents and restricted cash at beginning of period

 

64,149

 

13,861

Cash, cash equivalents and restricted cash at end of period

$

64,783

$

43,214

Noncash investing and financing activities

Accrual for leasehold improvements

$

807

$

See Notes to Condensed Financial Statements.

5

Table of Contents

CARA THERAPEUTICS, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(amounts in thousands, except share and per share data)

(unaudited)

1. Business

Cara Therapeutics, Inc., or the Company, is a commercial-stage biopharmaceutical corporation formed on July 2, 2004. The Company is leading a new treatment paradigm to improve the lives of patients suffering from pruritus. The Company’s primary activities to date have been organizing and staffing the Company, developing its lead product and product candidates, including conducting preclinical studies and clinical trials of difelikefalin-based product candidates, and raising capital.

In August 2021, the Company received U.S. Food and Drug Administration, or FDA, approval for KORSUVA® (difelikefalin) injection, or KORSUVA injection, for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis. Commercial launch of KORSUVA injection began in the United States in April 2022 and the Company began recording the associated profit-sharing revenues in the second quarter of 2022.

In April 2022, the European Commission granted marketing authorization to difelikefalin injection under the brand name Kapruvia® (difelikefalin), or Kapruvia, for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult hemodialysis patients. The marketing authorization approved Kapruvia for use in all member states of the European Union, or EU, as well as Iceland, Liechtenstein, and Norway. Kapruvia was also approved in the United Kingdom in April 2022. Commercial launches in Austria, Germany, Sweden, France, the Netherlands, and Finland have commenced. In August 2022, as part of the Access Consortium, difelikefalin injection was approved in Switzerland under the brand name Kapruvia, as well as Singapore and Canada under the brand name KORSUVA. Commercial launch in Switzerland has also commenced. In November 2022, difelikefalin injection was approved in the last Access Consortium country, Australia, under the brand name KORSUVA. Difelikefalin injection was also approved in the United Arab Emirates, Kuwait, Israel, and Japan under the brand name KORSUVA in January 2023, May 2023, June 2023, and September 2023, respectively. The Company expects additional approvals and commercial launches over the next 12-18 months. On November 1, 2023, the Company entered into a Purchase and Sale Agreement, or the HCR Agreement, with HCRX Investments Holdco, L.P. and Healthcare Royalty Partners IV, L.P., or collectively HCR, where HCR will receive future royalty payments for Kapruvia and KORSUVA (ex U.S. only) up to certain capped amounts in exchange for certain payments to the Company (see Note 18, Subsequent Event).

In 2018, the Company entered into a license and collaboration agreement with a joint venture between Vifor Pharma Group and Fresenius Medical Care Renal Pharmaceutical Ltd., or Vifor Fresenius Medical Care Renal Pharma Ltd., that provides full commercialization rights of Kapruvia, and where applicable KORSUVA, to Vifor Fresenius Medical Care Renal Pharma Ltd. worldwide (excluding the United States, Japan and South Korea). In markets outside of the United States, the Company is eligible to receive tiered double-digit royalty payments based on annual net sales, as defined in the agreement with Vifor Fresenius Medical Care Renal Pharma Ltd., of difelikefalin injection in the licensed territories. In the U.S. market, the agreement with Vifor Fresenius Medical Care Renal Pharma Ltd. provides that Vifor Fresenius Medical Care Renal Pharma Ltd. will promote difelikefalin injection in the dialysis clinics of Fresenius Medical Care North America, or FMCNA, under a profit-sharing arrangement, whereby the Company is generally entitled to 50% of the annual net profits (as defined in the agreement with Vifor Fresenius Medical Care Renal Pharma Ltd.) based on net FMCNA clinic sales (as defined in the agreement with Vifor Fresenius Medical Care Renal Pharma Ltd.) and Vifor Fresenius Medical Care Renal Pharma Ltd. is entitled to 50% of such net profits, subject to potential adjustments in a calendar year based on certain conditions (see Note 11, Collaboration and Licensing Agreements).

In 2020, the Company entered into a second licensing and collaboration agreement, along with stock purchase agreements, with Vifor (International) Ltd., or Vifor International, that provides full commercialization rights of KORSUVA injection to Vifor International in dialysis clinics in the United States under a profit-sharing arrangement, whereby total net sales of KORSUVA injection in the United States, as recorded by Vifor International, are reduced by

6

Table of Contents

CARA THERAPEUTICS, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(amounts in thousands, except share and per share data)

(unaudited)

Vifor International’s cost of goods sold, or COGS, as well as a marketing and distribution fee owed by the Company based on the level of annual net sales, and the resulting amount is shared according to a 60% (Company)/40% (Vifor International) profit split (excluding sales to Fresenius Medical Center dialysis clinics, compensation for which is governed by the agreement with Vifor Fresenius Medical Care Renal Pharma Ltd.), subject to potential temporary adjustment in future years based on certain conditions (see Note 11, Collaboration and Licensing Agreements).

In May 2022, Vifor International assigned its rights and obligations under the license agreement and a supply agreement, as permitted under the agreements, to Vifor Fresenius Medical Care Renal Pharma Ltd. The Company’s rights and obligations under these agreements were unaffected by this assignment and the assignment did not affect the Company’s economic rights under the agreements with Vifor International.

In August 2022, Vifor Pharma Group (which includes Vifor International) was acquired by CSL Limited and subsequently renamed CSL Vifor as part of the acquisition. The acquisition of Vifor Pharma Group did not affect any of the Company’s rights and obligations pursuant to these agreements.

The Company also has a license agreement with Maruishi Pharmaceutical Co. Ltd., or Maruishi, under which the Company granted Maruishi an exclusive license to develop, manufacture, and commercialize drug products containing difelikefalin for acute pain and/or uremic pruritus in Japan. In September 2023, Maruishi received manufacturing and marketing approval from Japan’s Ministry of Health, Labour and Welfare for KORSUVA IV Injection Syringe for the treatment of pruritus in hemodialysis patients. In conjunction with the approval, the Company earned a $1,449 milestone payment per the terms of the licensing agreement (see Note 11, Collaboration and Licensing Agreements and Note 12, Revenue Recognition).

As of September 30, 2023, the Company had raised aggregate net proceeds of approximately $520,700 from several rounds of equity financing, including its initial public offering, or IPO, which closed in February 2014, four follow-on public offerings of common stock, which closed in July 2019, July 2018, April 2017 and August 2015, respectively, the issuance of common stock pursuant to its open market sales agreement with Jefferies LLC as sales agent, or the Sales Agreement, in 2023, and the issuance of convertible preferred stock and debt prior to the IPO. Including profit share revenue and royalties, the Company has also earned approximately $284,800 under its license and supply agreements for difelikefalin, primarily with CSL Vifor, Maruishi, and Chong Kun Dang Pharmaceutical Corp., or CKDP, and an earlier product candidate for which development efforts ceased in 2007. The Company has also received aggregate net proceeds of approximately $98,000 from the issuance and sale of the Company’s common stock to Vifor International in connection with the Company’s licensing agreement with CSL Vifor (see Note 11, Collaboration and Licensing Agreements).

As of September 30, 2023, the Company had unrestricted cash and cash equivalents and marketable securities of $83,288 and an accumulated deficit of $652,408. The Company has incurred substantial net losses and negative cash flows from operating activities in nearly every fiscal period since inception and expects this trend to continue for the foreseeable future. The Company recognized net losses of $28,032 and $23,180 for the three months ended September 30, 2023 and 2022, respectively, and $86,176 and $55,135 for the nine months ended September 30, 2023 and 2022, respectively, and had net cash used in operating activities of $74,708 and $55,220 for the nine months ended September 30, 2023 and 2022, respectively.

The Company is subject to risks common to other life science companies including, but not limited to, uncertainty of product development and commercialization, lack of marketing and sales history, development by its competitors of new technological innovations, dependence on key personnel, market acceptance of products, product liability, protection of proprietary technology, ability to raise additional financing, and compliance with FDA and other

7

Table of Contents

CARA THERAPEUTICS, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(amounts in thousands, except share and per share data)

(unaudited)

government regulations. If the Company does not successfully commercialize KORSUVA injection, Kapruvia or any of its other product candidates, it will be unable to generate additional recurring product revenue or achieve profitability.

2. Basis of Presentation

The unaudited interim condensed financial statements included herein have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission, or SEC. Accordingly, they do not include all information and disclosures necessary for a presentation of the Company’s financial position, results of operations and cash flows in conformity with generally accepted accounting principles in the United States of America, or GAAP. In the opinion of management, these unaudited interim financial statements reflect all adjustments, consisting primarily of normal recurring accruals, necessary for a fair presentation of results for the periods presented. The results of operations for interim periods are not necessarily indicative of the results for the full year. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted from this report, as is permitted by SEC rules and regulations; however, the Company believes that the disclosures are adequate to make the information presented not misleading. The condensed balance sheet data as of December 31, 2022 were derived from audited financial statements, but do not include all disclosures required by GAAP. These unaudited interim condensed financial statements should be read in conjunction with the audited financial statements and accompanying notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022.

Use of Estimates

The preparation of financial statements in conformity with GAAP requires the Company to make estimates and assumptions that affect the reported amounts of assets and liabilities, and disclosure of contingent assets and liabilities, as of the date of the financial statements as well as the reported amounts of revenues and expenses during the reporting period. The more significant estimates include the fair value of marketable securities that are classified as level 2 of the fair value hierarchy, the amount and periods over which certain revenues will be recognized, including licensing and collaborative revenue recognized from non-refundable up-front and milestone payments, related party accounts receivable reserve, as applicable, inventory valuation and related reserves, research and development, or R&D, clinical costs and accrued research projects included in prepaid expenses and accounts payable and accrued expenses, the amount of non-cash compensation costs related to share-based payments to employees and non-employees, the amount of lease incentives, as applicable, and the incremental borrowing rate used in lease calculations, and the likelihood of realization of deferred tax assets.

The impact from global economic conditions and potential and continuing disruptions to and volatility in the credit and equity markets in the United States and worldwide are highly uncertain and cannot be predicted, including impacts from the COVID-19 pandemic or future public health crises, geopolitical tensions, such as the ongoing military conflict between Russia and Ukraine, the conflict between Israel and Hamas, and government actions implemented as a result of either of the foregoing, high rates of inflation, rising interest rates, uncertainty and liquidity concerns in the broader financial services industry, such as those caused by certain recent banking failures, and a potential recession in the United States. Estimates and assumptions about future events and their effects cannot be determined with certainty and therefore require the exercise of judgment. As of the date of issuance of these condensed financial statements, the Company is not aware of any specific event or circumstance that would require the Company to update its estimates, assumptions and judgments or revise the reported amounts of assets and liabilities or the disclosure of contingent assets and liabilities. These estimates, however, may change as new events occur and additional information is obtained, and are recognized in the condensed financial statements as soon as they become known.

Actual results could differ materially from the Company’s estimates and assumptions.

8

Table of Contents

CARA THERAPEUTICS, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(amounts in thousands, except share and per share data)

(unaudited)

Significant Accounting Policies

There have been no material changes to the significant accounting policies previously disclosed in Note 2 to the Financial Statements in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022.

3. Available-for-Sale Marketable Securities

As of September 30, 2023 and December 31, 2022, the Company’s available-for-sale marketable securities consisted of debt securities issued by U.S. government-sponsored entities and investment grade institutions as well as municipal bonds.

The following tables summarize the Company’s available-for-sale marketable securities by major type of security as of September 30, 2023 and December 31, 2022:

As of September 30, 2023

Gross Unrealized

Estimated Fair

Type of Security

    

Amortized Cost

    

Gains

    

Losses

    

Value

U.S. government agency obligations

$

9,500

$

$

(397)

$

9,103

Corporate bonds

 

9,327

 

 

(42)

 

9,285

Municipal bonds

 

2,025

 

 

 

2,025

Total available-for-sale marketable securities

$

20,852

$

$

(439)

$

20,413

As of December 31, 2022

Gross Unrealized

Estimated Fair

Type of Security

    

Amortized Cost

    

Gains

    

Losses

    

Value

U.S. government agency obligations

$

9,500

$

$

(623)

$

8,877

Corporate bonds

 

35,828

 

 

(643)

 

35,185

Commercial paper

 

26,879

 

2

 

(6)

 

26,875

Municipal bonds

22,473

(402)