TVRD 8-K
Tvardi Therapeutics, Inc. (TVRD)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) February 27, 2020
CARA THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-36279 | 75-3175693 |
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
| 4 Stamford Plaza 107 Elm Street, 9th Floor Stamford, Connecticut |
06902 | |
| (Address of principal executive offices) | (Zip Code) |
| Registrant's telephone number, including area code (203) 406-3700 |
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2.):
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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 is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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. ¨.
| Item 2.02. | Results of Operations and Financial Condition. |
On February 27, 2020, Cara Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the fourth quarter and year ended December 31, 2019. A copy of the press release is being furnished to the Securities and Exchange Commission as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference to this Item 2.02.
The information furnished pursuant to this Item 2.02, including Exhibit 99.1, shall not be deemed to be "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference into any of the Company’s filings with the Securities and Exchange Commission under the Exchange Act or the Securities Act of 1933, as amended, whether made before or after the date hereof, regardless of any general incorporation language in such a filing.
| Item 9.01. | Financial Statements and Exhibits. |
| (d) | Exhibits |
| Exhibit No. | Description | |
| 99.1 | Press Release dated February 27, 2020 |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| CARA THERAPEUTICS, INC. | ||
| By: | /s/ RICHARD MAKARA | |
| Richard Makara | ||
| Vice President, Head of Accounting & Controller | ||
| (Principal Financial and Accounting Officer) | ||
Date: February 27, 2020
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Exhibit 99.1
Cara Therapeutics Reports Fourth Quarter and Full Year 2019 Financial Results
– Conference call today at 4:30 p.m. ET –
STAMFORD, Conn., February 27, 2020 – Cara Therapeutics, Inc. (Nasdaq: CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors, or KORs, today announced financial results and operational highlights for the fourth quarter and full year ended December 31, 2019.
“During 2019, we reported significant advancements in both our KORSUVA™ Injection and Oral KORSUVA late-stage clinical pruritus programs, including positive results from our first pivotal Phase 3 efficacy trial (KALM™ -1) of KORSUVA Injection for the treatment of chronic kidney disease-associated pruritus in patients undergoing hemodialysis and our Phase 2 trial of Oral KORSUVA in pre-dialysis patients. Additionally, we broadened our clinical pruritus program for Oral KORSUVA with the initiation of Phase 2 trials in both atopic dermatitis and liver disease patients,” said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. “We expect 2020 to be an exciting year as our KALM-2 pivotal Phase 3 trial advances to top-line data in the second quarter and we aim to file our first NDA for KORSUVA Injection in the second half of the year.”
Fourth Quarter and Recent Developments:
KORSUVA Injection: Chronic Kidney Disease-Associated Pruritus (CKD-aP): Hemodialysis
The Company expects top-line data for its pivotal KALM-2 Phase 3 global trial of KORSUVA Injection in the second quarter of 2020 and remains on track to file a New Drug Application, or NDA, to the U.S. Food and Drug Administration, or FDA, for KORSUVA Injection in the second half of 2020.
In October 2019, the Company announced the completion of an interim statistical assessment for its pivotal KALM-2 Phase 3 global trial of KORSUVA Injection. Based on the recommendation of the Independent Data Monitoring Committee, the size of the trial was increased from an original enrollment target of 350 patients to 430 patients.
Currently, more than 1,500 total patient exposures have been achieved, including all ongoing safety trials, with more than 600 patients completing at least six months of treatment and more than 300 patients completing one year of treatment.
In November 2019, the Company announced a publication in the New England Journal of Medicine of full results from the KALM-1 Phase 3 trial of KORSUVA Injection in patients undergoing hemodialysis with moderate-to-severe CKD-aP.
Oral KORSUVA: CKD-aP: Non-Hemodialysis
In December 2019, the Company announced positive top-line results from its Phase 2 dose-ranging trial of Oral KORSUVA for the treatment of pruritus in patients with stage III-V (moderate-to-severe) CKD. Oral KORSUVA met the primary endpoint with a statistically significant reduction in the weekly mean of the daily 24-hour worst itching intensity Numeric Rating Scale with the 1.0 mg tablet strength versus placebo after the 12-week treatment period (p=0.018). Oral KORSUVA was generally well-tolerated with a safety profile consistent with that seen in previous KORSUVA clinical trials. The Company aims to complete an End of Phase 2 Meeting with the FDA to enable initiation of a Phase 3 program of Oral KORSUVA in non-hemodialysis CKD-aP patients in the second half of 2020.
Oral KORSUVA: Atopic Dermatitis (AD)
In January 2020, the Company expanded its ongoing Phase 2 trial of Oral KORSUVA for the treatment of pruritus in patients with AD from 240 adult patients to approximately 320 adult AD patients with moderate-to-severe pruritus. The Phase 2 trial is evaluating the safety and efficacy of three tablet strengths (0.25 mg, 0.5 mg and 1.0 mg, twice daily) of Oral KORSUVA versus placebo for 12 weeks, followed by a 4-week active extension phase. An interim statistical analysis will be conducted after approximately 50% of the targeted number of patients complete the designated 12-week treatment period, which is expected in the second quarter of 2020. The Company aims to report top-line data from this trial in 2020.
Oral KORSUVA: Chronic Liver Disease-Associated Pruritus (CLD-aP): Primary Biliary Cholangitis (PBC)
The Company continues to enroll patients in the ongoing Phase 2 trial of Oral KORSUVA for the treatment of pruritus in patients with hepatic impairment due to PBC. The trial is evaluating the safety and efficacy of Oral KOSRUVA (1.0 mg tablet, twice daily) versus placebo for 16 weeks. The Company aims to report top-line data from this trial in 2020.
Expected 2020 Milestones
| · | Top-line efficacy and safety data from the KALM-2 Phase 3 trial of KORSUVA Injection in hemodialysis patients with moderate-to-severe CKD-aP in the second quarter of 2020. |
| · | Interim statistical analysis on the Phase 2 trial of Oral KORSUVA in AD in the second quarter of 2020. |
| · | Submission of an NDA to the FDA for KORSUVA Injection in hemodialysis patients with moderate-to-severe CKD-aP in the second half of 2020. |
| · | Top-line data from the Phase 2 trial of Oral KORSUVA in AD in 2020. |
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| · | Top-line data from the Phase 2 trial of Oral KORSUVA in CLD-aP in 2020. |
| · | Completion of End of Phase 2 Meeting with the FDA to enable initiation of a Phase 3 program of Oral KORSUVA in non-hemodialysis CKD-aP patients in the second half of 2020. |
Upcoming Meeting Activities
The Company expects to make presentations at the following upcoming conferences:
| · | American Academy of Dermatology Annual Meeting, March 20-24, 2020 |
| · | Needham & Co. Annual Healthcare Conference, April 14-15, 2020 |
| · | H.C. Wainwright Global Life Sciences Conference, April 19-21, 2020 |
| · | Bank of America Merrill Lynch Health Care Conference, May 12-14, 2020 |
Fourth Quarter and Full Year 2019 Financial Results
Cash, cash equivalents and marketable securities at December 31, 2019 totaled $218.2 million compared to $182.8 million at December 31, 2018. The increase in the balance resulted primarily from $136.5 million of cash raised in a follow-on offering of the Company’s common stock in July 2019 and $6.1 million received from the exercise of stock options, partially offset by $109.2 million of cash used in operating activities.
For the fourth quarter of 2019, net loss was $28.6 million, or $0.61 per basic and diluted share, compared to a net loss of $20.7 million, or $0.52 per basic and diluted share, for the same period in 2018.
| · | Revenues: The Company recognized $4.5 million and $5.5 million of license and milestone fees revenue during the fourth quarter of 2019 and 2018, respectively, related to its collaboration agreement with Vifor Fresenius Medical Care Renal Pharma Ltd., or VFMCRP. |
| · | Research and Development (R&D) Expenses: R&D expenses were $29.9 million in the fourth quarter of 2019 compared to $22.8 million in the same period of 2018. The higher R&D expenses in 2019 were principally due to a net increase in costs associated with clinical trials, as well as increases in payroll and related costs. |
| · | General and Administrative (G&A) Expenses: G&A expenses were relatively consistent at $4.6 million during the fourth quarter of 2019 compared to $4.7 million in the same period of 2018. |
| · | Other Income: Other income was $1.2 million in the fourth quarter of both 2019 and 2018. |
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For the full year ended December 31, 2019, net loss was $106.4 million, or $2.49 per basic and diluted share compared to a net loss of $74.0 million, or $2.06 per basic and diluted share, for the full year ended December 31, 2018.
| · | Revenues: Total revenue was $19.9 million for the full year ended December 31, 2019 as compared to $13.5 million for the full year ended December 31, 2018. Total revenue consisted of: |
(1) License and milestone fees revenue of $19.7 million and $13.4 million for the full year ended December 31, 2019 and 2018, respectively, was recognized by the Company related to its license agreement with VFMCRP.
(2) There was no collaborative revenue recognized for the full year ended December 31, 2019 or 2018.
(3) The Company recognized $140,000 and $33,000 of revenue from the sales of clinical compound during the full year ended December 31, 2019 and 2018, respectively, in connection with the sale of clinical compound to Maruishi Pharmaceuticals Co. Ltd.
| · | Research and Development (R&D) Expenses: R&D expenses were $113.8 million for the full year ended December 31, 2019 compared to $75.5 million for the full year ended December 31, 2018. The higher R&D expenses in 2019 were principally due to a net increase in clinical trial costs, increases in stock compensation expense, payroll and related costs as well as an expense in connection with the license agreement with Enteris Biopharma, Inc. in 2019. |
| · | General and Administrative (G&A) Expenses: G&A expenses were $17.7 million for the full year ended December 31, 2019 compared to $15.3 million for the full year ended December 31, 2018. The increase in 2019 was primarily due to increases in stock compensation expense, payroll and related costs, consultants’ costs, legal and accounting fees, insurance costs and franchise taxes. Those increases were partially offset by decreased rent, utilities and related costs. |
| · | Other Income: Other income was $4.5 million for the full year ended December 31, 2019 compared to $3.0 million for the year ended 2018. The increase in 2019 was primarily due to a higher average balance of the Company’s portfolio of investments in 2019. |
Financial Guidance
Based on timing expectations and projected costs for current clinical development plans, Cara expects that its existing cash and cash equivalents and available-for-sale marketable securities as of December 31, 2019 will be sufficient to fund its currently anticipated operating expenses and capital expenditures into the second half of 2021, without giving effect to any potential milestone payments under existing collaborations.
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Conference Call
Cara management will host a conference call today at 4:30 p.m. ET to discuss fourth quarter and full year 2019 financial results and provide a business update.
To participate in the conference call, please dial (855) 445-2816 (domestic) or (484) 756-4300 (international) and refer to conference ID 9907568. A live webcast of the call can be accessed under "Events and Presentations" in the News & Investors section of the Company's website at www.CaraTherapeutics.com.
An archived webcast recording will be available on the Cara website beginning approximately two hours after the call.
About Cara Therapeutics
Cara Therapeutics is a clinical-stage biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral KORs. Cara is developing a novel and proprietary class of product candidates, led by KORSUVA (CR845/difelikefalin), a first-in-class KOR agonist that targets KORs located in the peripheral nervous system and on immune cells. In the Company’s KALM-1 Phase 3 trial and two Phase 2 trials, KORSUVA (CR845/difelikefalin) Injection has demonstrated statistically significant reductions in itch intensity and concomitant improvement in pruritus-related quality of life measures in hemodialysis patients with moderate-to-severe CKD-aP and is currently being investigated in Phase 3 trials in hemodialysis patients with CKD-aP. Oral KORSUVA is in Phase 2 trials for the treatment of pruritus in patients with CKD, AD and PBC.
The FDA has conditionally accepted KORSUVA as the trade name for difelikefalin injection. CR845/difelikefalin is an investigational drug product and its safety and efficacy have not been fully evaluated by any regulatory authority.
Forward-looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of these forward-looking statements include statements concerning the expected timing of the data readouts from the Company’s ongoing clinical trials, the potential results of ongoing clinical trials, timing of future regulatory and development milestones for the Company’s product candidates, including the Company’s projected timeline for the submission of its first NDA, the potential for the Company’s product candidates to be alternatives in the therapeutic areas investigated, and the Company’s expected cash reach. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in Cara Therapeutics’ filings with the Securities and Exchange Commission, including the “Risk Factors” section of the Company’s most recent Annual Report on Form 10-K and its other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Cara Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Financial tables follow
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CARA THERAPEUTICS, INC.
STATEMENTS OF OPERATIONS
(amounts in thousands, except share and per share data)
(unaudited)
| Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||
| Revenue: | ||||||||||||||||
| License and milestone fees | $ | 4,511 | $ | 5,533 | $ | 19,746 | $ | 13,436 | ||||||||
| Clinical compound revenue | — | — | 140 | 33 | ||||||||||||
| Total revenue | 4,511 | 5,533 | 19,886 | 13,469 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 29,864 | 22,799 | 113,820 | 75,531 | ||||||||||||
| General and administrative | 4,617 | 4,711 | 17,745 | 15,320 | ||||||||||||
| Total operating expenses | 34,481 | 27,510 | 131,565 | 90,851 | ||||||||||||
| Operating loss | (29,970 | ) | (21,977 | ) | (111,679 | ) | (77,382 | ) | ||||||||
| Other income | 1,193 | 1,200 | 4,490 | 2,980 | ||||||||||||
| Loss before benefit from income taxes | (28,777 | ) | (20,777 | ) | (107,189 | ) | (74,402 | ) | ||||||||
| Benefit from income taxes | 166 | 125 | 816 | 389 | ||||||||||||
| Net loss | $ | (28,611 | ) | $ | (20,652 | ) | $ | (106,373 | ) | $ | (74,013 | ) | ||||
| Net loss per share: | ||||||||||||||||
| Basic and Diluted | $ | (0.61 | ) | $ | (0.52 | ) | $ | (2.49 | ) | $ | (2.06 | ) | ||||
| Weighted average shares: | ||||||||||||||||
| Basic and Diluted | 46,691,009 | 39,441,640 | 42,669,333 | 35,892,786 | ||||||||||||
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| CARA THERAPEUTICS, INC. | ||||||||
| BALANCE SHEETS | ||||||||
| (in thousands) | ||||||||
| (unaudited) | ||||||||
| December 31, | ||||||||
| 2019 | 2018 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 18,305 | $ | 15,081 | ||||
| Marketable securities | 136,701 | 146,302 | ||||||
| Income tax receivable | 816 | 664 | ||||||
| Other receivables | 971 | 926 | ||||||
| Prepaid expenses | 8,863 | 4,805 | ||||||
| Restricted cash, current | — | 361 | ||||||
| Total current assets | 165,656 | 168,139 | ||||||
| Operating lease right-of-use asset | 3,036 | — | ||||||
| Marketable securities, noncurrent | 63,159 | 21,396 | ||||||
| Property and equipment, net | 700 | 880 | ||||||
| Restricted cash | 408 | 408 | ||||||
| Total assets | $ | 232,959 | $ | 190,823 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued expenses | $ | 19,665 | $ | 13,622 | ||||
| Operating lease liability, current | 967 | — | ||||||
| Current portion of deferred revenue | 22,262 | 26,825 | ||||||
| Total current liabilities | 42,894 | 40,447 | ||||||
| Operating lease liability, non-current | 3,352 | — | ||||||
| Deferred revenue, non-current | — | 15,184 | ||||||
| Deferred lease obligation | — | 1,562 | ||||||
| Commitments and contingencies | — | — | ||||||
| Stockholders’ equity: | ||||||||
| Preferred stock | — | — | ||||||
| Common stock | 47 | 39 | ||||||
| Additional paid-in capital | 587,223 | 428,059 | ||||||
| Accumulated deficit | (400,727 | ) | (294,354 | ) | ||||
| Accumulated other comprehensive income (loss) | 170 | (114 | ) | |||||
| Total stockholders’ equity | 186,713 | 133,630 | ||||||
| Total liabilities and stockholders’ equity | $ | 232,959 | $ | 190,823 | ||||
INVESTOR CONTACT:
Jane Urheim
Stern Investor Relations,
Inc.
212-362-1200
[email protected]
MEDIA CONTACT:
Annie Starr
6 Degrees
973-415-8838
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