UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
(Mark One)
FOR THE QUARTERLY PERIOD ENDED
OR
COMMISSION FILE NUMBER
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) |
(Address of registrant’s principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code: (
Securities registered pursuant to Section 12(b) of the Act:
Title of each class | Trading Symbol | Name of each exchange on which registered |
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. ☒
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). ☒
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.
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).
The number of outstanding shares of the registrant’s common stock, par value $0.001 per share, as of November 3, 2022 was:
CARA THERAPEUTICS, INC.
INDEX TO FORM 10-Q
FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2022
PART I –FINANCIAL INFORMATION
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, 2022 |
| December 31, 2021 | |||
Assets |
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Current assets: |
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Cash and cash equivalents | $ | | $ | | ||
Marketable securities |
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Accounts receivable, net - related party | | — | ||||
Inventory, net | | | ||||
Income tax receivable |
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Other receivables |
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Prepaid expenses |
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Total current assets |
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Operating lease right-of-use assets | | | ||||
Marketable securities, non-current |
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Property and equipment, net |
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Restricted cash |
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Total assets | $ | | $ | | ||
Liabilities and stockholders’ equity |
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Current liabilities: |
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Accounts payable and accrued expenses | $ | | $ | | ||
Operating lease liabilities, current |
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Total current liabilities |
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Operating lease liabilities, non-current | | | ||||
Commitments and contingencies (Note 16) |
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Stockholders’ equity: |
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Preferred stock; $ |
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Common stock; $ |
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Additional paid-in capital |
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Accumulated deficit |
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Accumulated other comprehensive loss |
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity | $ | | $ | | ||
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, 2022 |
| September 30, 2021 |
| September 30, 2022 |
| September 30, 2021 |
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Revenue: | |||||||||||||
Collaborative revenue | $ | | $ | — | $ | | $ | | |||||
License and milestone fees | — | | | | |||||||||
Commercial supply revenue |
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Clinical compound revenue |
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Total revenue |
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Operating expenses: |
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Cost of goods sold | | — | | — | |||||||||
Research and development |
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General and administrative |
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Total operating expenses |
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Operating loss |
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Other income, net |
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Net loss | $ | ( | $ | ( | $ | ( | $ | ( | |||||
Net loss per share: |
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Basic and Diluted | ( | ( | ( | ( | |||||||||
Weighted average shares: |
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Basic and Diluted |
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Other comprehensive income (loss), net of tax of $ |
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Change in unrealized gains (losses) on available-for-sale marketable securities |
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Total comprehensive loss | $ | ( | $ | ( | $ | ( | $ | ( | |||||
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 | |||||||||||||||||||||||||
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 | | $ | | — | $ | — | $ | | $ | — | $ | ( | $ | ( | $ | | |||||||||
Stock-based compensation expense | — | — | — | — | | — | — | — | | ||||||||||||||||
Shares issued upon exercise of stock options | | — | — | — | | — | — | — | | ||||||||||||||||
Shares issued upon vesting of restricted stock units | | — | — | — | | — | — | — | | ||||||||||||||||
Net loss |
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Other comprehensive loss |
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Balance at March 31, 2022 | | $ | | — | $ | — | $ | | $ | — | $ | ( | $ | ( | $ | | |||||||||
Stock-based compensation expense | — |
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Shares issued upon exercise of stock options | |
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Shares issued upon vesting of restricted stock units | |
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Net loss | — |
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Other comprehensive loss | — |
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Balance at June 30, 2022 | | $ | | — | $ | — | $ | | $ | — | $ | ( | $ | ( | $ | | |||||||||
Stock-based compensation expense | — | — | — | — | | — | — | — | | ||||||||||||||||
Shares issued upon exercise of stock options | | — | — | — | | — | — | — | | ||||||||||||||||
Shares issued upon vesting of restricted stock units | | — | — | — | | — | — | — | | ||||||||||||||||
Net loss | — | — | — | — | — | — | ( | — | ( | ||||||||||||||||
Other comprehensive loss | — | — | — | — | — | — | — | ( | ( | ||||||||||||||||
Balance at September 30, 2022 | | $ | | — | $ | — | $ | | $ | — | $ | ( | $ | ( | $ | | |||||||||
3
CARA THERAPEUTICS, INC.
CONDENSED STATEMENTS OF STOCKHOLDERS’ EQUITY (continued)
(amounts in thousands except share and per share data)
(unaudited)
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 |
| Income (Loss) |
| Equity | ||||||||
Balance at December 31, 2020 | | $ | | — | $ | — | $ | | $ | — | $ | ( | $ | | $ | | |||||||||
Stock-based compensation expense |
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Shares issued upon exercise of stock options |
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Shares issued upon vesting of restricted stock units | | — | — | — | | — | — | — | | ||||||||||||||||
Net loss |
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Other comprehensive loss |
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Balance at March 31, 2021 | | $ | | — | $ | — | $ | | $ | — | $ | ( | $ | | $ | | |||||||||
Stock-based compensation expense | — |
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Shares issued upon exercise of stock options | |
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Shares issued upon vesting of restricted stock units | | — | — | — | | — | — | — | | ||||||||||||||||
Net loss | — |
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Other comprehensive loss | — |
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Balance at June 30, 2021 | | $ | | — | $ | — | $ | | $ | — | $ | ( | $ | ( | $ | | |||||||||
Subscription of common stock in Vifor stock purchase ($ | — | — | | | | ( | — | — | — | ||||||||||||||||
Stock-based compensation expense | — | — | — | — | | — | — | — | | ||||||||||||||||
Shares issued upon exercise of stock options | | — | — | — | | — | — | — | | ||||||||||||||||
Shares issued upon vesting of restricted stock units | | — | — | — | | — | — | — | | ||||||||||||||||
Net loss | — | — | — | — | — | — | ( | — | ( | ||||||||||||||||
Other comprehensive income | — | — | — | — | — | — | — | | | ||||||||||||||||
Balance at September 30, 2021 | | $ | | | $ | | $ | | $ | ( | $ | ( | $ | | $ | | |||||||||
See Notes to Condensed Financial Statements.
4
CARA THERAPEUTICS, INC.
CONDENSED STATEMENTS OF CASH FLOWS
(amounts in thousands)
(unaudited)
Nine Months Ended | |||||||
| September 30, 2022 |
| September 30, 2021 |
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Operating activities |
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Net loss | $ | ( | $ | ( | |||
Adjustments to reconcile net loss to net cash used in operating activities: |
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Stock-based compensation expense |
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Depreciation and amortization |
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Amortization expense component of lease expense |
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Amortization of available-for-sale marketable securities, net | | | |||||
Realized gain on sale of available-for-sale marketable securities |
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Realized gain on sale of property and equipment |
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Changes in operating assets and liabilities: |
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Accounts receivable, net - related party | ( | — | |||||
Inventory, net | | — | |||||
Income tax receivable | — | | |||||
Other receivables |
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Prepaid expenses |
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Accounts payable and accrued expenses |
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Operating lease liabilities | ( | ( | |||||
Net cash used in operating activities |
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Investing activities |
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Proceeds from maturities of available-for-sale marketable securities |
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Proceeds from redemptions of available-for-sale marketable securities, at par | — | | |||||
Proceeds from sale of available-for-sale marketable securities |
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Purchases of available-for-sale marketable securities |
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Purchases of property and equipment |
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Proceeds from sale of property and equipment | — | | |||||
Net cash provided by investing activities |
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Financing activities |
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Proceeds from the exercise of stock options |
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Net cash provided by financing activities |
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Net increase (decrease) in cash, cash equivalents and restricted cash |
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Cash, cash equivalents and restricted cash at beginning of period |
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Cash, cash equivalents and restricted cash at end of period | $ | | $ | | |||
Noncash investing and financing activities | |||||||
Stock subscription receivable from Vifor International | $ | — | $ | | |||
See Notes to Condensed Financial Statements.
5
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
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. The Company has a license agreement with Vifor (International) Ltd., or Vifor International, that provides full commercialization rights of KORSUVA injection to Vifor in dialysis clinics in the U.S. under a profit-sharing arrangement, whereby total net sales of KORSUVA injection in the U.S., as recorded by Vifor International, are reduced by 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
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 approves 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 UK in April 2022. In addition, as part of the Access Consortium, the product was approved in August 2022 in Switzerland as Kapruvia, as well as Singapore and Canada as KORSUVA. In 2018, the Company entered into a license agreement with Vifor that provides full commercialization rights of Kapruvia, and where applicable KORSUVA, to Vifor worldwide (excluding the U.S., Japan and South Korea). In markets outside of the U.S., the Company is eligible to receive tiered double-digit royalty payme