8-K

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): June 25, 2019

TRICIDA, INC.

(Exact name of Registrant as specified in its charter)

Delaware	001-38558	46-3372526
(State or other jurisdiction of incorporation)	(Commission File Number)	(I.R.S. Employer Identification Number)

7000 Shoreline Court

Suite 201

South San Francisco, CA 94080

(Address of principal executive offices)

(415) 429-7800

(Registrant’s telephone number, including area code)

N/A

(Former name or former address, if changed since last report)

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:

¨ 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))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

ý Emerging growth company

ý 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 7.01 Regulation FD Disclosure.

On June 25, 2019, Tricida, Inc. (the “Company”), published a press release which is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

The information contained in this Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1 hereto, is furnished pursuant to Item 7.01 of Form 8-K and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except as shall be expressly stated by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.

(d)     Exhibits.

Exhibit No.	Description
99.1	Press Release

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	TRICIDA, INC.
Dated: June 25, 2019	By:	/s/ Geoffrey M. Parker
	Name:	Geoffrey M. Parker
	Title:	Chief Financial Officer and Senior Vice President

EX-99.1

Exhibit 99.1

FOR IMMEDIATE RELEASE

Tricida Announces Publication of Positive Long-Term Phase 3 Clinical Trial Results of Veverimer (TRC101) in The Lancet

TRCA-301E trial is the first, long-term, randomized, multicenter, blinded, placebo-controlled trial to evaluate the treatment of metabolic acidosis in patients with CKD

SOUTH SAN FRANCISCO, Calif., June 25, 2019 (Business Wire)--Tricida, Inc. (Nasdaq: TCDA), a pharmaceutical company focused on the development and commercialization of its drug candidate, veverimer (TRC101), a non-absorbed, orally-administered polymer designed to treat metabolic acidosis in patients with chronic kidney disease (CKD),announced that The Lancetpublished online detailed results from its long-term, Phase 3, multicenter, parallel, randomized, blinded, placebo-controlled trial, TRCA-301E, in 196 patients with CKD and metabolic acidosis. Full results of the trial are available in The Lancet:

A multicentre, randomised, blinded, placebo-controlled, 40-week extension study to assess the long-term safety and efficacy of veverimer for the treatment of metabolic acidosis in chronic kidney disease

“This new data highlights the value of treating metabolic acidosis in patients with CKD,” saidDonald E. Wesson, M.D., M.B.A., Professor of Medicine at Texas A&M Health Science Center College of Medicine in Dallas, TX, lead investigator of the study and primary author of The Lancet paper. “As patients advance to later stages of CKD, metabolic acidosis may further complicate their disease, resulting in muscle wasting, bone loss and further progression of CKD. The importance of metabolic acidosis as both a serious complication of CKD and an underlying cause of CKD progression has been under-recognized, and it has been markedly under-treated.”

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“The publication of our veverimer clinical trial data from both our 12-week TRCA-301 trial and now our TRCA-301E 40-week extension trial in two separate publications in The Lancet, one of the most prestigious general medical journals in the world, clearly advances the understanding of metabolic acidosis and speaks to the importance of these results,”said Gerrit Klaerner, Ph.D., CEO and President of Tricida, and a coauthor of The Lancet paper. “I would like to personally thank the authors, our clinical trial investigators, and the patients who participated in the study for their contributions to this important work.”

Tricida provided a summary of the topline trial data from the TRCA-301E clinical trial in a March 28, 2019 press release.

In addition to Dr. Wesson, study authors included: Vandana Mathur, M.D. (MathurConsulting); Navdeep Tangri, M.D., Ph.D. (University of Manitoba), Yuri Stasiv, Ph.D.(Tricida), Dawn Parsell, Ph.D.(Tricida); Elizabeth Li, M.S.(PharmaStat LLC); Gerrit Klaerner, Ph.D.(Tricida) and David A. Bushinsky, M.D.(University of Rochester School of Medicine).

About Tricida

Tricida, Inc. is a pharmaceutical company focused on the development and commercialization of its drug candidate, veverimer (TRC101), a non-absorbed, orally-administered polymer designed to treat metabolic acidosis in patients with chronic kidney disease (CKD). Metabolic acidosis is a condition commonly caused by CKD that is believed to accelerate the progression of kidney deterioration. It is estimated to pose a health risk to approximately three million patients with CKD in the United States. Tricida has successfully completed all of the clinical trials that it planned to complete prior to submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA). Tricida plans to submit an NDA in the second half of 2019, seeking approval of veverimer through the FDA’s Accelerated Approval Program.

For more information about Tricida, please visit www.Tricida.com.

Cautionary Note on Forward-Looking Statements

This press release includes forward-looking statements, including for example, statements about our ability to submit an NDA for veverimer under the FDA’s Accelerated Approval Program. Forward‐looking statements involve known and unknown risks, uncertainties, assumptions and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or

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implied by the forward‐looking statements. These risks and uncertainties include, among others, timing and results of clinical trials and other studies; that many drug candidates that have completed Phase 3 trials do not become approved drugs on a timely or cost effective basis or at all; there can be no assurance that the FDA would approve an NDA under the Accelerated Approval Program, or at all, and even if approval for a drug is obtained, there can be no assurance that it will be adopted in the market or accepted as a benefit to patients and healthcare providers; possible safety and efficacy concerns; and that we completely rely on third-party suppliers to manufacture our clinical drug supply. The forward-looking statements contained in this press release reflect Tricida’s current views with respect to future events, and Tricida does not undertake and specifically disclaims any obligation to update any forward-looking statements.

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Contact:

Jackie Cossmon, IRC

Tricida, Inc.

Vice President of Investor Relations and Communications

IR@Tricida.com

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