Slowing the Progression of Chronic Kidney Disease
Tricida Investor Presentation January 2022
Forward Looking Statements
Any statements contained in this presentation or made during the accompanying oral presentation that are not statements of historical facts are forward-looking statements as defined under the Federal securities laws. Examples of such statements include our plans, beliefs, intentions, expectations and projections regarding, among other things: the Company's plans and expectations for the VALOR-CKD trial, including early termination of the trial and event accrual rates for the trial, our plans for interactions and communications with the FDA, our plans and expectations as to the pathway to approval of veverimer by the FDA, if at all, our plans for future clinical development pathways for veverimer, our assessment of the future market potential for veverimer, and our expectations regarding financial runway. Any such forward-looking statements are based on our current expectations and assumptions, but are subject to a number of risks and uncertainties that could cause our actual future results to differ materially from our current expectations or those implied by the forward-looking statements. In addition, this presentation contains industry and market data prepared by third parties or by us. We have not independently verified this third-party data, and our data is based on our estimates and assumptions, which are subject to uncertainty and risk. As a result, you should not place undue reliance on this industry and market data. The risks and uncertainties that could adversely affect our forward-looking statements and the industry and market data include, but are not limited to: the timing of the FDA's approval of veverimer, if at all; the potential availability of the Accelerated Approval Program and the approvability of veverimer under that program; the Company's plans and expectations with regard to its interactions with the FDA, including the potential resubmission of an NDA for veverimer; the Company's plans and expectations for the VALOR-CKD trial and future clinical and product development milestones; the Company's contractual and financial obligations to its key suppliers and vendors; the Company's financial projections and cost estimates; risks associated with the COVID-19 pandemic; risks associated with the Company's business prospects, financial results and business operations; risks related to the Company's ability to retain its key employees and executives; and risks related to the Company's capital requirements and ability to raise sufficient funds for its operations. These and other factors that may affect our future results and operations are identified and described in more detail in our filings with the Securities and Exchange Commission (the "SEC"), including the Company's most recent Annual Report filed on Form 10-K and our subsequently filed Quarterly Report(s) on Form
10-Q. You should not place undue reliance on these forward-looking statements, which speak only as of the date of this presentation. Except as required by applicable law, the Company does not intend to update any of the forward-looking statements to conform these statements to actual results, later events or circumstances or to reflect the occurrence of unanticipated events.
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Tricida Highlights
- The Unmet Need - Acid-base balance and retained acid fundamentally impact kidney disease
- The In-House Discovered Compound - Veverimer could be the first and only therapy to slow CKD progression through binding and removing retained acid
- The Outcomes Trial - VALOR-CKD is a large, randomized, multicenter, double blind, placebo-controlled trial
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The Unmet Need
There are no FDA-approved therapies to slow CKD progression through the treatment of metabolic acidosis in patients with CKD
Kidney Disease Impacts Acid-Base Balance Which Is Critical to Maintain Normal Physiologic Function
Diseased Kidneys Lose Capacity to Excrete Acid
Acid is generated from | Diseased kidneys lose capacity |
dietary sources | to excrete excess acid |
and daily metabolism |
Daily
Metabolism
Acid-Base Balance Is Impaired When Kidneys
Are Unable to Fully Excrete Acid Load
Additional mechanisms are recruited, but may be unable to remove excess acid
Acid Mitigation Mechanisms: | |||||
• | Upregulation of | retention | |||
hormones by the kidney | |||||
• | Muscle protein | ||||
catabolism to release | |||||
glutamine | Acid | ||||
• | Bone dissolution to | ||||
release carbonate and | |||||
phosphate | |||||
X | |||||
Acid excreted | Acid excreted as | Excess acid | |||
NH + and | is NOT | ||||
as CO2 gas | |||||
4 | |||||
titratable acid | excreted | ||||
Kraut. Nat Rev Nephrol. 2010;6(5):274; KDIGO Clinical Practice Guidelines 2012. | 5 |
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Tricida Inc. published this content on 07 January 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 10 January 2022 11:57:04 UTC.