Rani Therapeutics : RT-111 Phase 1 Data Presentation

Our mission at Rani is to end painful injections for the millions of patients suffering from chronic diseases.

Rani Therapeutics

Corporate Presentation

RT-111 Phase 1 Data

NASDAQ: RANI

Disclaimer

This presentation and the accompanying oral statements contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 as contained in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act. Forward-looking statements are based on information available at the time those statements are made or on management's good faith beliefs and assumptions as of that time with respect to future events, and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in, or suggested by, the forward-looking statements. In light of these risks and uncertainties, the forward-looking events and circumstances discussed in this presentation and the accompanying oral statements may not occur and actual results could differ materially from those anticipated or implied in the forward-looking statements. These risks and uncertainties include Rani Therapeutics Holdings, Inc.'s ("Rani," "we," "us," or "our") future financial performance, including our expectations regarding our revenues, cost of revenues, operating expenses, and our ability to achieve and maintain future profitability, those risks inherent in the preclinical and clinical development process and the regulatory approval process, the risks and uncertainties in commercialization and gaining market acceptance, the commercial potential of oral biologics, 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 to accommodate higher target payloads, the risks associated with protecting and defending our patents or other proprietary rights, the risk that our proprietary rights may be insufficient to protect our product candidates, the risk that we will be unable to obtain necessary capital when needed on acceptable terms or at all, our ability to enter into strategic partnerships and to achieve the potential benefits of such partnerships, competition from other products or procedures, our reliance on third-parties to conduct our clinical and non- clinical trials, the ability of our restructuring announced in November 2023 to deliver the expected results, our reliance on single-sourcethird-party suppliers to manufacture clinical, non-clinical and any future commercial supplies of our product candidates, our ability to continue to scale and optimize our manufacturing processes by expanding our use of automation, our expectations regarding the period during which we qualify as an emerging growth company under the JOBS Act, our expectations regarding customer demand for our product candidates, increased regulatory requirements and other factors that are set forth in our filings with the Securities and Exchange Commission ("SEC"), including under the caption "Risk Factors" in our Annual Report on Form 10-K and our Quarterly Reports on Form 10-Q, and our other public filings made with the SEC and available at www.sec.gov.

Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. In some cases, you can identify forward-looking statements by terminology such as "anticipate," "believe," "contemplate," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will" or "would," or the negative of these terms or other comparable terminology. You should not put undue reliance on any forward-looking statements. Forward-looking statements should not be read as a guarantee of future performance or results, and will not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved, if at all. Except as required by law, Rani does not undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.

This presentation and the accompanying oral statements contain statistical data, estimates and forecasts that are based on independent industry publications or other publicly available information, as well as other information based on our internal sources. This information involves many assumptions and limitations, and you are cautioned not to give undue weight to such information. We have not independently verified the accuracy or completeness of the information contained in the industry publications and other publicly available information. Accordingly, we make no representations as to the accuracy or completeness of that information nor do we undertake to update such information after the date of this presentation.

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A registration statement on Form S-3 has been filed and declared effective by the Securities and Exchange Commission (SEC). The offering of securities will only be made by means of a prospectus supplement and base prospectus forming part of the effective registration statement relating to the securities. Copies of the preliminary prospectus supplement and accompanying base prospectus may be obtained, when available, from: Cantor Fitzgerald & Co., Attn: Capital Markets, at 499 Park Avenue, New York, New York, 10022 or by email at [e-mail]; or Canaccord Genuity LLC, Attn: Syndication Department, 99 High Street, Suite 1200, Boston, Massachusetts 02110 or by email at [e-mail].

Trade names, trademarks and service marks of other companies appearing in this presentation are the property of their respective owners. Solely for convenience, the trademarks and trade names referred to in this presentation appear without the ® and symbols, but those references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights, or the right of the applicable licensor to these trademarks and tradenames.

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Talat Imran	Svai Sanford	Mir Hashim, Ph.D.	Kate McKinley
Chief Executive	Chief Financial	Chief Scientific	Chief Business Officer
Officer	Officer	Officer

Eric Groen	Arvinder Dhalla, Ph.D.	Betsy Gutierrez	Jacques Van Dam, M.D.
General Counsel	Vice President, Clinical	Vice President,	Vice President, Medical
	Development	Quality	Affairs

Rani Therapeutics is a public, clinical-stage biotech company developing a platform technology for the oral delivery of biologic drugs.

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Our mission at Rani is to end painful injections for the millions of patients suffering from chronic diseases

FOCUS: Oral Delivery of Biologic Drugs with Bioavailability Comparable to Parenteral Products

TECHNOLOGY: GO

•	3mg Capacity	HC	•	200 µL Capacity
•	Solid Drug Formulation	•	Liquid Drug Formulation
(High Capacity)

PIPELINE:

Immunology & Endocrinology

DISCOVERY:

Obesity, Nanobodies, Hemophilia, Bispecific MABs, Fertility

425+ Patent Applications, 225+ Granted Patents

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Development Pipeline

INDICATION(S)

CORE PROGRAMS

RT-111	Psoriasis
RT-102	Osteoporosis
RT-105	Psoriatic Arthritis
RT-110	Hypo-
parathyroidism

FORMULATION

Ustekinumab**

PTH-OP

Adalimumab**

PTH-Hypo

PRE-CLINICAL

PHASE 1

PHASE 2

PHASE 3

KEY MILESTONE*

Phase 1 Study

Completed

Initiate Phase 2 in 2024

Initiate Phase 1

Initiate Phase 1

RT-XXX refers to the RaniPill capsule containing a biologic in a proprietary Rani formulation

• Clinical timelines are subject to potential regulatory agency review delays
• Partnered with Celltrion, Inc. Celltrion grants Rani a license and drug supply for the drug and has a right of first negotiation following a Phase 1 study

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Development Pipeline

INDICATION(S)

CORE PROGRAMS

RT-111	Psoriasis
RT-102	Osteoporosis
RT-105	Psoriatic Arthritis
RT-110	Hypo-
parathyroidism

FORMULATION

Ustekinumab**

PTH-OP

Adalimumab**

PTH-Hypo

PRE-CLINICAL

PHASE 1

PHASE 2

PHASE 3

KEY MILESTONE*

Phase 1 Study

Completed

Initiate Phase 2 in 2024

Initiate Phase 1

Initiate Phase 1

RT-XXX refers to the RaniPill capsule containing a biologic in a proprietary Rani formulation

• Clinical timelines are subject to potential regulatory agency review delays
• Partnered with Celltrion, Inc. Celltrion grants Rani a license and drug supply for the drug and has a right of first negotiation following a Phase 1 study

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RT-111 Phase 1 Study Data

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Study Overview

A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of RT-111 - RaniPill Capsule

Containing Ustekinumab (CT-P43) - Administered Orally to Healthy Volunteers

Objective	To assess safety, tolerability and PK of Ustekinumab delivered via Oral RaniPill
Study Population	Healthy men and women volunteers recruited from the general population
Study Site	Single site in Australia
End Points	PK parameters, safety and tolerability

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Study Design: Single Ascending Doses

• Study Groups
• • Control Group: 0.50 mg Stelara SC (N=15)
  • RT-111Group: 0.50 mg CT-P43 in RaniPill (N=20)
  • RT-111Group: 0.75 mg CT-P43 in RaniPill (N=20)
• Protocol
• • Participants were given a single dose of the study drug (SC or Oral) after an overnight fast
  • Blood samples were collected at various time points over 60 days and analyzed for ustekinumab concentrations
  • Blood samples were analyzed for anti-drug antibodies at 3 timepoints
  • Excretion of device remnants confirmed with imaging

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Pharmacokinetics