Tvardi Therapeutics, Inc 10-Q for FY2022 Q3

Tvardi Therapeutics, Inc. (TVRD)

10-Q 2022-11-07 For: 2022-09-30

Added on April 09, 2026

About this 10-Q

Tvardi Therapeutics, Inc filed this 10-Q on November 7, 2022, covering the quarter ended September 30, 2022 (FY2022 Q3).

Headline figures

Quarter ended September 30, 2022, as reported in this filing, compared with the same period a year earlier where the filing states it.

Revenue: $10.81M; down 46.7% from $20.27M a year earlier
Net loss: $23.18M; compared with a net loss of $1.01M a year earlier
Diluted EPS: -$0.43; compared with -$0.02 a year earlier

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Delaware	75-3175693
(State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification No.)

4 Stamford Plaza 107 Elm Street, 9^th Floor Stamford, Connecticut	06902
(Address of registrant’s principal executive offices)	(Zip Code)

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


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

		PAGE NUMBER

Item 1.	Financial Statements (Unaudited):

	Condensed Balance Sheets as of September 30, 2022 and December 31, 2021	1

	Condensed Statements of Comprehensive Loss for the Three and Nine Months Ended September 30, 2022 and 2021	2

	Condensed Statements of Stockholders’ Equity for the Three and Nine Months Ended September 30, 2022 and 2021	3

	Condensed Statements of Cash Flows for the Nine Months Ended September 30, 2022 and 2021	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	62

Item 4.	Controls and Procedures	63

	PART II – OTHER INFORMATION

Item 1.	Legal Proceedings	64

Item 1A.	Risk Factors	64

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	66

Item 3.	Defaults Upon Senior Securities	66

Item 4.	Mine Safety Disclosures	66

Item 5.	Other Information	66

Item 6.	Exhibits	67

	SIGNATURES	68



	September 30, 2022		December 31, 2021
Assets
Current assets:
Cash and cash equivalents	$	42,806	$	13,453
Marketable securities		112,806		153,582
Accounts receivable, net - related party		9,623		—
Inventory, net		1,835		2,584
Income tax receivable		697		697
Other receivables		451		455
Prepaid expenses		18,562		2,519
Total current assets		186,780		173,290
Operating lease right-of-use assets		1,918		2,973
Marketable securities, non-current		23,916		69,754
Property and equipment, net		487		631
Restricted cash		408		408
Total assets	$	213,509	$	247,056
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable and accrued expenses	$	26,316	$	15,861
Operating lease liabilities, current		1,876		1,755
Total current liabilities		28,192		17,616

Operating lease liabilities, non-current		497		1,918
Commitments and contingencies (Note 16)		—		—
Stockholders’ equity:
Preferred stock; $0.001 par value; 5,000,000 shares authorized at September 30, 2022 and December 31, 2021, zero shares issued and outstanding at September 30, 2022 and December 31, 2021		—		—
Common stock; $0.001 par value; 100,000,000 shares authorized at September 30, 2022 and December 31, 2021, 53,733,607 shares and 53,480,812 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively		53		53
Additional paid-in capital		722,808		708,585
Accumulated deficit		(535,893)		(480,758)
Accumulated other comprehensive loss		(2,148)		(358)
Total stockholders’ equity		184,820		227,522
Total liabilities and stockholders’ equity	$	213,509	$	247,056


	Three Months Ended				Nine Months Ended
	September 30, 2022		September 30, 2021		September 30, 2022		September 30, 2021
Revenue:
Collaborative revenue	$	7,443	$	—	$	15,446	$	706
License and milestone fees		—		20,031		15,000		21,223
Commercial supply revenue		3,370		—		8,160		—
Clinical compound revenue		—		241		—		278
Total revenue		10,813		20,272		38,606		22,207
Operating expenses:
Cost of goods sold		3,055		—		5,136		—
Research and development		24,691		15,514		65,869		59,870
General and administrative		6,912		5,882		23,829		17,898
Total operating expenses		34,658		21,396		94,834		77,768
Operating loss		(23,845)		(1,124)		(56,228)		(55,561)
Other income, net		665		111		1,093		502
Net loss	$	(23,180)	$	(1,013)	$	(55,135)	$	(55,059)
Net loss per share:
Basic and Diluted	$	(0.43)	$	(0.02)	$	(1.03)	$	(1.10)
Weighted average shares:
Basic and Diluted		53,726,123		50,114,710		53,616,753		50,031,615
Other comprehensive income (loss), net of tax of $0:
Change in unrealized gains (losses) on available-for-sale marketable securities		(101)		6		(1,790)		(72)
Total comprehensive loss	$	(23,281)	$	(1,007)	$	(56,925)	$	(55,131)


													Accumulated
				Common Stock			Additional		Stock				Other		Total
	Common Stock			Subscribed in Private Offering			Paid-In		Subscription		Accumulated		Comprehensive		Stockholders’
	Shares	Amount		Shares	Amount		Capital		Receivable		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


			Gross Unrealized				Estimated Fair
Type of Security	Amortized Cost		Gains		Losses		Value
U.S. Treasury securities	$	4,004	$	—	$	(7)	$	3,997
U.S. government agency obligations		9,500		—		(646)		8,854
Corporate bonds		39,955		—		(838)		39,117
Commercial paper		62,884		—		(64)		62,820
Municipal bonds		22,527		—		(593)		21,934
Total available-for-sale marketable securities	$	138,870	$	—	$	(2,148)	$	136,722


	Less than 12 Months				12 Months or Greater				Total
			Gross				Gross				Gross
	Fair		Unrealized		Fair		Unrealized		Fair		Unrealized
	Value		Losses		Value		Losses		Value		Losses
U.S. Treasury securities	$	3,997	$	(7)	$	—	$	—	$	3,997	$	(7)
U.S. government agency obligations		4,646		(354)		4,208		(292)		8,854		(646)
Corporate bonds		23,606		(606)		15,511		(232)		39,117		(838)
Commercial paper		62,820		(64)		—		—		62,820		(64)
Municipal bonds		7,912		(204)		14,022		(389)		21,934		(593)
Total	$	102,981	$	(1,235)	$	33,741	$	(913)	$	136,722	$	(2,148)


	As of September 30, 2022				As of December 31, 2021
Contractual maturity	Amortized Cost		Fair Value		Amortized Cost		Fair Value
Less than one year	$	113,967	$	112,806	$	153,631	$	153,582
One year to three years		24,903		23,916		70,063		69,754
Total	$	138,870	$	136,722	$	223,694	$	223,336


	Total Accumulated
	Other Comprehensive
	(Loss) Income
Balance, December 31, 2021	$	(358)
Other comprehensive loss before reclassifications		(1,790)
Amount reclassified from accumulated other comprehensive loss		—
Net current period other comprehensive loss		(1,790)
Balance, September 30, 2022	$	(2,148)

Balance, December 31, 2020	$	73
Other comprehensive loss before reclassifications		(33)
Amount reclassified from accumulated other comprehensive income		(39)
Net current period other comprehensive loss		(72)
Balance, September 30, 2021	$	1


	Three Months Ended				Nine Months Ended				Affected Line Item in the
Component of Accumulated Other	September 30,				September 30,				Condensed Statements of
Comprehensive (Loss) Income	2022		2021		2022		2021		Comprehensive Loss
Unrealized gains (losses) on available-for-sale marketable securities:
Realized gains on sales of securities	$	—	$	—	$	—	$	39	Other income, net
Income tax effect		—		—		—		—	Benefit from income taxes
Realized gains on sales of securities, net of tax	$	—	$	—	$	—	$	39


			Quoted prices in		Significant other		Significant
Financial assets			active markets for		observable		unobservable
			identical assets		inputs		inputs
Type of Instrument	Total		(Level 1)		(Level 2)		(Level 3)
Cash and cash equivalents:
Money market funds and checking accounts	$	42,806	$	42,806	$	—	$	—
Available-for-sale marketable securities:
U.S. Treasury securities		3,997		—		3,997		—
U.S. government agency obligations		8,854		—		8,854		—
Corporate bonds		39,117		—		39,117		—
Commercial paper		62,820		—		62,820		—
Municipal bonds		21,934		—		21,934		—
Restricted cash:
Commercial money market account		408		408		—		—
Total financial assets	$	179,936	$	43,214	$	136,722	$	—


	September 30, 2022		December 31, 2021
Raw materials	$	1,833	$	927
Work-in-process		2		1,657
Total	$	1,835	$	2,584


	September 30, 2022		December 31, 2021
Accounts payable	$	15,218	$	5,625
Accrued research projects		5,149		4,648
Accrued compensation and benefits		4,228		4,959
Accrued professional fees and other		1,721		629
Total	$	26,316	$	15,861


		Weighted
	Number of	Average Grant
	Units	Date Fair Value
Outstanding, December 31, 2021	576,544	$	17.50
Awarded	466,926		10.11
Vested and released	(206,518)		16.74
Forfeited	(196,002)		17.06
Outstanding, September 30, 2022	640,950	$	12.50
Restricted stock units exercisable (vested and deferred), September 30, 2022	—


	Three Months Ended		Nine Months Ended
	September 30,		September 30,
	2022	2021	2022	2021
Risk-free interest rate	2.65% - 4.09%	0.92% - 1.01%	1.70% - 4.09%	0.66% - 1.23%
Expected volatility	77.7% - 78.2%	83.0% - 83.4%	77.7% - 81.9%	71.6% - 83.5%
Expected dividend yield	0%	0%	0%	0%
Expected life of employee and Board options (in years)	6.25	6.25	6.25	6.25


		Weighted
	Number of	Average Exercise
	Shares	Price
Outstanding, December 31, 2021	6,512,280	$	15.58
Granted	1,739,919		10.28
Exercised	(46,277)		6.26
Forfeited	(356,819)		14.50
Expired	(194,580)		16.21
Outstanding, September 30, 2022	7,654,523	$	14.47
Options exercisable, September 30, 2022	4,764,271


Year Ending December 31,
2022 (Excluding the nine months ended September 30, 2022)	$	494
2023		1,992
Total future minimum lease payments, undiscounted		2,486
Less imputed interest		(113)
Total	$	2,373

Operating lease liabilities reported as of September 30, 2022:
Operating lease liabilities - current	$	1,876
Operating lease liabilities - non-current		497
Total	$	2,373


Program	Product Candidate	Primary Indication	Status	Commercialization Rights
Pruritus	KORSUVA (difelikefalin) injection	Pruritus CKD - Hemodialysis	• FDA approved in August 2021 • TDAPA application granted in December 2021 by CMS, effective April 2022 • EMA MAA granted in April 2022 (Kapruvia) • UK MAA granted in April 2022 (Kapruvia) • Switzerland (Kapruvia), Canada (KORSUVA) and Singapore (KORSUVA) MAAs granted in August 2022 • Japan New Drug Application filed in September 2022 • U.S. commercial launch commenced in April 2022	Vifor (Worldwide, other than Japan and South Korea)*; Maruishi (Japan); CKDP (South Korea)
	Oral difelikefalin	Pruritus Atopic Dermatitis (AD-aP)	• Phase 2 trial completed; data reported • Phase 3 trial ongoing	Cara (Worldwide, other than South Korea); CKDP (South Korea)
	Oral difelikefalin	Pruritus advanced NDD-CKD	• Phase 2 trial completed; data reported • Phase 3 trial ongoing	Cara (Worldwide, other than Japan and South Korea); Maruishi (Japan); CKDP (South Korea)
	Oral difelikefalin	Notalgia Paresthetica (NP)	• Phase 2 trial completed; data reported	Cara (Worldwide, other than South Korea); CKDP (South Korea)
	Oral difelikefalin	Pruritus Primary Biliary Cholangitis (PBC)	• Phase 2 trial discontinued based on slow enrollment due primarily to COVID-19	Cara (Worldwide, other than South Korea); CKDP (South Korea)


	Material Cash Requirements
	Total		Less than 1 Year		1-2 Years

	Dollar amounts in thousands
Operating lease obligations⁽¹⁾	$	2,486	$	1,983	$	503
Manufacturing purchase obligations⁽²⁾		14,154		14,154		—
Other obligations⁽³⁾		408		—		408
Total	$	17,048	$	16,137	$	911


	Nine Months Ended September 30,
	2022		2021

	Dollar amounts in thousands
Net cash used in operating activities	$	(55,220)	$	(58,842)
Net cash provided by investing activities		84,284		48,830
Net cash provided by financing activities		289		1,320
Net increase (decrease) in cash, cash equivalents and restricted cash	$	29,353	$	(8,692)


				Incorporated by Reference
Exhibit No.	Description of Exhibit	Form	File No.		Exhibit No.	Date Filed

3.1	Amended and Restated Certificate of Incorporation.	8-K	001-36279		3.1	February 7, 2014

3.2	Amended and Restated Bylaws.	8-K	001-36279		3.2	February 7, 2014

31.1†	Certification of Chief Executive Officer of Cara Therapeutics, Inc. pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934.

31.2†	Certification of Chief Financial Officer of Cara Therapeutics, Inc. pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934.

32.1†*	Certifications of Chief Executive Officer and Chief Financial Officer of Cara Therapeutics, Inc. pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

101.CAL†	Inline XBRL Taxonomy Extension Calculation Linkbase.

101.INS†	Inline XBRL Instance Document.

101.LAB†	Inline XBRL Taxonomy Extension Label Linkbase.

101.PRE†	Inline XBRL Taxonomy Extension Presentation Linkbase.

101.SCH†	Inline XBRL Taxonomy Extension Schema Linkbase.

101.DEF†	Inline XBRL Taxonomy Extension Definition Linkbase Document.

104†	Cover page interactive data file (formatted as Inline XBRL and contained in Exhibit 101).

	CARA THERAPEUTICS, INC.

Date: November 7, 2022	By	/s/ CHRISTOPHER POSNER
		Christopher Posner
		President, Chief Executive Officer, and Director
		(Principal Executive Officer)

Date: November 7, 2022	By	/s/ RYAN MAYNARD
		Ryan Maynard
		Chief Financial Officer
		(Principal Financial and Accounting Officer)


Date: November 7, 2022	By:	/s/ Christopher Posner
		CHRISTOPHER POSNER
		CHIEF EXECUTIVE OFFICER


Date: November 7, 2022	By:	/s/ Ryan Maynard
		RYAN MAYNARD CHIEF FINANCIAL OFFICER
		(PRINCIPAL FINANCIAL OFFICER)


/s/ CHRISTOPHER POSNER
Name: Christopher Posner
Title: Chief Executive Officer
Date: November 7, 2022


/s/ RYAN MAYNARD
Name: Ryan Maynard
Title: Chief Financial Officer (Principal Financial Officer)
Date: November 7, 2022