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Rani Therapeutics Holdings, Inc.

For the period ended Mar 31, 2025. Filed May 13, 2025.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Mar 31, 2025 · Filed May 13, 2025

RANI$0.55+5.9%Stored close · as of Nov 6, 2026
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Special Note Regarding Forward-Looking Statements

This Quarterly Report on Form 10-Q, including the section titled "Management's Discussion and Analysis of Financial Condition and Results of Operations," contains forward-looking statements. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q, including statements regarding our future results of operations and consolidated financial position, business strategy, product candidates, planned preclinical studies and clinical trials, results of clinical trials, research and development costs, manufacturing costs, regulatory approvals, development and advancement of our oral delivery technology, timing and likelihood of success, potential partnering activities as well as plans and objectives of management for future operations, are forward-looking statements. These statements involve known and unknown risks, uncertainties, and other important factors that are in some cases beyond our control and may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements.

In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “would,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “believe,” “estimate,” “predict,” “potential,” “seek,” “aim,” or “continue” or the negative of these terms or other similar expressions. Forward-looking statements contained in this Quarterly Report on Form 10-Q include, but are not limited to, statements about:

our ability to raise additional capital to fund our existing operations and continue as a going concern;

our plans to improve our liquidity and financial position in response to the substantial doubt about our ability to continue as a going concern;

the progress and focus of our current and future clinical trials in the United States and abroad, and the reporting of data from those trials;

our potential and ability to successfully manufacture and supply our product candidates for clinical trials and for commercial use, if approved;

our ability to complete development of the RaniPill HC or any redesign and conduct additional preclinical and clinical studies of the RaniPill HC or any future design of the RaniPill capsule to accommodate target payloads that are larger than the payload capacity of the RaniPill GO capsule used to date for clinical studies of our product candidates;

our ability to further develop and expand our platform technology;

our ability to utilize our technology platform to generate and advance additional product candidates;

our financial performance;

our plans relating to commercializing our product candidates, if approved;

our ability to selectively enter into strategic partnership and the expected potential benefits thereof;

the implementation of our strategic plans for our business and product candidates;

our ability to continue to scale and optimize our manufacturing processes, including by expanding our use of automation;

our estimates of the number of patients in the United States who suffer from the indications we target and the number of patients that will enroll in our clinical trials;

the size of the market opportunity for our product candidates in each of the indications we target;

our ability to continue to innovate and expand our intellectual property by developing new applications of the RaniPill capsule;

the scope of protection we are able to establish and maintain for intellectual property rights, including our technology platform and product candidates;

the sufficiency of our existing cash and cash equivalents to fund our future operating expenses and capital expenditure requirements;

our ability to realize savings from any restructuring plans or cost-containment measures we propose to implement;

our realization of any benefit from our organizational structure, taking into account our obligations under the Tax Receivable Agreement (defined herein) and the impact of any payments required to be made thereunder on our liquidity and financial condition; and

our expectations regarding the period during which we will qualify as an emerging growth company under the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”).

These forward-looking statements are subject to a number of risks, uncertainties, and assumptions described in the section titled “Risk Factors” and elsewhere in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 31, 2025. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, or otherwise.

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The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.