Tvardi Therapeutics, Inc 10-Q for FY2020 Q2

Tvardi Therapeutics, Inc. (TVRD)

10-Q 2020-08-10 For: 2020-06-30

Added on April 09, 2026

About this 10-Q

Tvardi Therapeutics, Inc filed this 10-Q on August 10, 2020, covering the quarter ended June 30, 2020 (FY2020 Q2).

Headline figures

Quarter ended June 30, 2020, as reported in this filing, compared with the same period a year earlier where the filing states it.

Revenue: $5.63M; up 8.2% from $5.21M a year earlier
Net loss: $25.07M; compared with a net loss of $22.96M 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 June 30, 2020 and December 31, 2019	1

	Condensed Statements of Comprehensive Loss for the Three and Six Months Ended June 30, 2020 and 2019	2

	Condensed Statements of Stockholders’ Equity for the Three and Six Months Ended June 30, 2020 and 2019	3

	Condensed Statements of Cash Flows for the Six Months Ended June 30, 2020 and 2019	4

	Notes to Condensed Financial Statements	5

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	33

Item 3.	Quantitative and Qualitative Disclosures About Market Risk	52

Item 4.	Controls and Procedures	53

	PART II – OTHER INFORMATION

Item 1.	Legal Proceedings	54

Item 1A	Risk Factors	54

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	97

Item 3.	Defaults Upon Senior Securities	97

Item 4.	Mine Safety Disclosures	97

Item 5.	Other Information	97

Item 6.	Exhibits	98

	SIGNATURES	100



	June 30, 2020		December 31, 2019
Assets
Current assets:
Cash and cash equivalents	$	56,967	$	18,305
Marketable securities		73,218		136,701
Income tax receivable		1,120		816
Other receivables		486		971
Prepaid expenses		10,124		8,863
Total current assets		141,915		165,656
Operating lease right-of-use asset		2,825		3,036
Marketable securities, non-current		22,861		63,159
Property and equipment, net		604		700
Restricted cash		408		408
Total assets	$	168,613	$	232,959
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable and accrued expenses	$	13,952	$	19,665
Operating lease liability, current		1,006		967
Current portion of deferred revenue		9,768		22,262
Total current liabilities		24,726		42,894

Operating lease liability, non-current		2,959		3,352
Commitments and contingencies (Note 15)		—		—
Stockholders’ equity:
Preferred stock; $0.001 par value; 5,000,000 shares authorized at June 30, 2020 and December 31, 2019, zero shares issued and outstanding at June 30, 2020 and December 31, 2019		—		—
Common stock; $0.001 par value; 100,000,000 shares authorized at June 30, 2020 and December 31, 2019, 46,864,405 shares and 46,720,225 shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively		47		47
Additional paid-in capital		594,963		587,223
Accumulated deficit		(454,717)		(400,727)
Accumulated other comprehensive income		635		170
Total stockholders’ equity		140,928		186,713
Total liabilities and stockholders’ equity	$	168,613	$	232,959


	Three Months Ended				Six Months Ended
	June 30, 2020		June 30, 2019		June 30, 2020		June 30, 2019
Revenue:
License and milestone fees	$	5,099	$	5,208	$	13,120	$	9,450
Clinical compound revenue		535		—		607		140
Total revenue		5,634		5,208		13,727		9,590
Operating expenses:
Research and development		26,108		24,356		59,644		47,964
General and administrative		5,410		4,994		9,968		8,902
Total operating expenses		31,518		29,350		69,612		56,866
Operating loss		(25,884)		(24,142)		(55,885)		(47,276)
Other income, net		634		947		1,591		2,036
Loss before benefit from income taxes		(25,250)		(23,195)		(54,294)		(45,240)
Benefit from income taxes		182		235		304		320
Net loss	$	(25,068)	$	(22,960)	$	(53,990)	$	(44,920)
Net loss per share:
Basic and Diluted	$	(0.54)	$	(0.58)	$	(1.15)	$	(1.13)
Weighted average shares:
Basic and Diluted		46,799,703		39,818,162		46,762,327		39,685,954
Other comprehensive income, net of tax of $0:
Change in unrealized gains (losses) on available-for-sale marketable securities		703		92		465		279
Total comprehensive loss	$	(24,365)	$	(22,868)	$	(53,525)	$	(44,641)


								Accumulated
				Additional				Other		Total
	Common Stock			Paid-In		Accumulated		Comprehensive		Stockholders’
	Shares	Amount		Capital		Deficit		Income (Loss)		Equity
Balance at December 31, 2018	39,547,558	$	39	$	428,059	$	(294,354)	$	(114)	$	133,630
Stock-based compensation expense	—		—		2,234		—		—		2,234
Shares issued upon exercise of stock options	17,291		—		234		—		—		234
Shares issued for consulting services	10,195		—		197		—		—		197
Net loss	—		—		—		(21,960)		—		(21,960)
Other comprehensive income	—		—		—		—		187		187
Balance at March 31, 2019	39,575,044	$	39	$	430,724	$	(316,314)	$	73	$	114,522
Stock-based compensation expense	—		—		2,681		—		—		2,681
Shares issued upon exercise of stock options	378,706		1		3,974		—		—		3,975
Shares issued upon vesting of restricted stock units	74,166		—		1,235		—		—		1,235
Net loss	—		—		—		(22,960)		—		(22,960)
Other comprehensive income	—		—		—		—		92		92
Balance at June 30, 2019	40,027,916	$	40	$	438,614	$	(339,274)	$	165	$	99,545


			Gross Unrealized				Estimated Fair
Type of Security	Amortized Cost		Gains		Losses		Value
U.S. Treasury securities	$	13,070	$	180	$	—	$	13,250
U.S. government agency obligations		3,499		18		—		3,517
Corporate bonds		62,077		416		(3)		62,490
Commercial paper		13,298		24		—		13,322
Municipal bonds		3,500		—		—		3,500
Total available-for-sale marketable securities	$	95,444	$	638	$	(3)	$	96,079


	Less than 12 Months				12 Months or Greater				Total
			Gross				Gross				Gross
	Fair		Unrealized		Fair		Unrealized		Fair		Unrealized
	Value		Losses		Value		Losses		Value		Losses
Corporate bonds	$	5,507	$	(3)	$	—	$	—	$	5,507	$	(3)
Total	$	5,507	$	(3)	$	—	$	—	$	5,507	$	(3)


	As of June 30, 2020				As of December 31, 2019
Contractual maturity	Amortized Cost		Fair Value		Amortized Cost		Fair Value
Less than one year	$	72,845	$	73,218	$	136,565	$	136,701
One year to two years		22,599		22,861		63,125		63,159
Total	$	95,444	$	96,079	$	199,690	$	199,860


	Total Accumulated
	Other Comprehensive
	Income (Loss)
Balance, December 31, 2019	$	170
Other comprehensive income before reclassifications		525
Amount reclassified from accumulated other comprehensive income		(60)
Net current period other comprehensive income		465
Balance, June 30, 2020	$	635

Balance, December 31, 2018	$	(114)
Other comprehensive income before reclassifications		279
Amount reclassified from accumulated other comprehensive income		—
Net current period other comprehensive income		279
Balance, June 30, 2019	$	165


	Three Months Ended				Six Months Ended				Affected Line Item in the
	June 30,				June 30,				Statements of
Component of AOCI	2020		2019		2020		2019		Operations
Unrealized gains (losses) on available-for- sale marketable securities
Realized gains on sale of securities	$	60	$	—	$	60	$	—	Other income, net
		—		—		—		—	Benefit from income taxes
	$	60	$	—	$	60	$	—


			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	$	56,967	$	56,967	$	—	$	—
Available-for-sale marketable securities:
U.S. Treasury securities		13,250		—		13,250		—
U.S. government agency obligations		3,517		—		3,517		—
Corporate bonds		62,490		—		62,490		—
Commercial paper		13,322		—		13,322		—
Municipal bonds		3,500		—		3,500		—
Restricted cash:
Commercial money market account		408		408		—		—
Total financial assets	$	153,454	$	57,375	$	96,079	$	—


	June 30, 2020		December 31, 2019
Accounts payable	$	4,828	$	9,100
Accrued research projects		5,864		6,637
Accrued professional fees		706		635
Accrued compensation and benefits		2,554		3,293
Total	$	13,952	$	19,665



		January 1, 2019
Risk-free interest rate		2.59% - 2.62%
Expected volatility		58.9% - 84.6%
Expected dividend yield		0%
Expected life of non-employee options (in years)		0.81 - 8.19


		Weighted
	Number of	Average Exercise
	Shares	Price
Outstanding, December 31, 2019	4,450,517	$	14.73
Granted	820,350		16.04
Exercised	(24,346)		11.34
Expired	(167,964)		13.85
Forfeited	(113,791)		16.21
Outstanding, June 30, 2020	4,964,766	$	14.96
Options exercisable, June 30, 2020	2,756,734


Year Ending December 31,
2020 (Excluding the six months ended June 30, 2020)	$	625
2021		1,264
2022		1,288
2023		1,311
2024		—
Total future minimum lease payments, undiscounted		4,488
Less imputed interest		(523)
Total	$	3,965

Operating lease liability reported as of June 30, 2020:
Operating lease liability - current	$	1,006
Operating lease liability - non-current		2,959
Total	$	3,965


Program	Product Candidate	Primary Indication	Status	Commercialization Rights
Pruritus	KORSUVA (CR845/difelikefalin) Injection	Pruritus CKD - Hemodialysis	• KALM-2 (Global) Phase 3 pivotal trial completed; top-line data reported • KALM-1 pivotal trial completed; top-line data reported	Cara (United States); Maruishi (Japan); CKDP (South Korea); VFMCRP (Worldwide, other than United States, Japan and South Korea)
			• Phase 3 safety trials complete
			• Breakthrough Therapy Designation granted by FDA in June 2017
	Oral KORSUVA (CR845/difelikefalin)	Pruritus CKD (Stage III - V)	• Phase 2 trial completed; top-line data reported	Cara (Worldwide, other than Japan and South Korea); Maruishi (Japan); CKDP (South Korea)
	Oral KORSUVA (CR845/difelikefalin)	Pruritus CLD -PBC	• Phase 2 efficacy trial ongoing	Cara (Worldwide, other than South Korea); CKDP (South Korea)
	Oral KORSUVA (CR845/difelikefalin)	Pruritus Atopic Dermatitis	• KARE Phase 2 efficacy trial ongoing; interim assessment complete – target enrollment increased to 410 patients	Cara (Worldwide, other than South Korea); CKDP (South Korea)
Post-Op Setting	CR845/difelikefalin Injection	Acute Post-Operative Pain/PONV	• Adaptive Phase 2/3 trial completed; top-line data reported	Cara (Worldwide, other than Japan and South Korea); Maruishi (Japan); CKDP (South Korea)


				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

10.1+	Amended and Restated Non-Employee Director Compensation Policy.	10-Q	001-36279		10.1	May 11, 2020

10.2†	Amendment to Lease Agreement between the Registrant and Four Stamford Plaza Owner L.L.C. Stamford Lease, dated June 23, 2020.

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 Principal 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 Principal 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: August 10, 2020	By	/s/ DEREK CHALMERS
		Derek Chalmers, Ph.D., D.Sc.
		President, Chief Executive Officer and Director
		(Principal Executive Officer)

Date: August 10, 2020	By	/s/ RICHARD MAKARA
		Richard Makara
		VP, Head of Accounting & Controller
		(Principal Financial and Accounting Officer)