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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 19

Key Takeaway: Rani Therapeutics has announced a collaboration with ProGen Co., Ltd. to advance their development of oral biologics, specifically targeting the obesity market. Their strategic vision includes optimizing drug delivery and enhancing patient compliance. The partnership is focused on developing RaniPill technology for improved therapeutic efficacy, but the project faces inherent risks associated with clinical trials and regulatory approval processes. Both companies highlight the potential of their collaboration to innovate treatments for chronic diseases.

Market Sentiment Analysis

POSITIVE FACTORS

  • Rani Therapeutics is collaborating with ProGen Co., Ltd.
  • Potential to improve drug delivery and patient compliance with oral biologics.
  • The partnership aims to target the promising obesity market.

CONCERNS & RISKS

  • Risks associated with the preclinical and clinical development processes.
  • Uncertainty surrounding regulatory approval for the new product candidates.
  • The challenges of gaining market acceptance for their therapeutics.

Full Press Release Details

Rani Therapeutics and ProGen
Collaboration June 24, 2024 Exhibit 99.1
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, including
statements regarding collaboration between Rani Therapeutics Holdings, Inc. ("Rani," "we," "us," or "our") and ProGen Co., Ltd., estimated obesity market size, product development and clinical trials,
product potential of oral biologics, including RT-114, the regulatory environment, certain business strategies, capital resources, or operating performance. 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. These risks and uncertainties include our future financial performance, including 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 including RT-114, 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, including our collaboration with ProGen Co., Ltd., competition from other products or procedures, our reliance on third-parties to conduct our clinical and non-clinical trials, non-clinical and any future commercial
supplies of our product candidates, 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,"
"could," "estimate," "expect," "may," "potential," "should," "primed," "opportunity," or "target," 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. 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. Rani Forward-Looking Statements
This presentation and the accompanying
oral statements contain forward-looking statements that are based on the current expectations and beliefs of ProGen Co., Ltd. ("ProGen"). This presentation and the accompanying oral statements regarding matters that are not historical
facts, including, but not limited to, statements relating to the potential for clinical efficacy, potency, and tolerability of ProGen's products; the potential for conducting and successfully completing clinical trials, translation of
preclinical and non-human data to the clinical and human contexts, obtaining favorable trial results, conducting later-phase trials, obtaining regulatory approval of product candidates for sale, successfully commercializing product candidates, and
improving the treatment for more patients; the types of diseases that might be treated by ProGen products; the successful prediction of patient responses and efficacious doses; and the preferability of ProGen products to others available are
forward-looking statements. These forward-looking statements are based on management's expectations and assumptions as of the date of such statements and are subject to numerous risks and uncertainties, which could cause actual results to
differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, the uncertainty of success in research and development activities; risks related to clinical trials, including potential
delays, safety issues, or negative results; competition from alternative therapies; the risk that ProGen may not be able to maintain and enforce its intellectual property; the risk that product candidates may not be successfully commercialized or
adopted; the availability of financing; and risks related to the recruitment and retention of key employees, fluctuating markets and economic conditions, health care reform, prices, and reimbursement rates. The forward-looking statements in this
presentation and the accompanying oral statements speak only as of the date of such statements, and ProGen undertakes no obligation to update or revise any of the statements. ProGen cautions investors not to place considerable reliance on the
forward-looking statements contained in this presentation and the accompanying oral statements. Rani - Confidential ProGen Disclaimer
Today's Agenda 01 Rani
Therapeutics and Progen Introduction & Deal Overview 02 Obesity Strategy 03 Overview of Rani's Technology Platform 04 Overview of PG-102 05 RT-114 / RPG-102 (Obesity) 06 Q&A
Presenters Talat Imran Chief Executive
Officer, Rani Therapeutics >15 years experience in Healthcare Venture capitalist for several Silicon Valley healthcare funds Jong Gyun Kim, PhD Chief Executive Officer, ProGen >30 years of extensive experience in pharmaceutical industry
R&D and strategic planning for drug development across multiple therapeutic areas
Leadership Team Mir Hashim, PhD Chief
Scientific Officer, Rani Therapeutics Jesper H iland, Strategic Advisor, Rani Therapeutics Kyung-Hwa Son, PhD Chief Development Officer, Progen Sae Won Kim, PhD Chief Scientific Officer, Progen
Our mission at Rani is to end painful
injections for the millions of patients suffering from chronic diseases Rani Therapeutics NASDAQ: RANI Clinical-stage biotech focused on Oral Delivery of Biologic Drugs with Bioavailability Comparable to Parenteral Products TECHNOLOGY: RaniPill 200
L Capacity (20-40mgs*) Liquid Drug Formulation PIPELINE: Programs across a variety of high value indications, including obesity, psoriasis, and osteoporosis DISCOVERY: Broad applicability across Nanobodies, Hemophilia, Bispecific MABs,
Fertility, Genetic Medicine Dependent on drug concentration ** As of May 4, 2024 IP: 472 Granted Patents and Pending Applications, 262 Granted Patents*
Rani's Strategic Vision in the
50 / 50 Partnership with ProGen Deal Rationale: Targeting optimized delivery + optimized therapeutic Differentiated oral, low dose, convenient once-weekly GLP-1 / GLP-2 agonist, with potential to preserve lean mass & improve nutrient absorption
Validating preclinical and clinical data Drug-agnostic oral delivery platform for biologics Differentiated oral delivery mechanism, with bioavailability comparable to SubQ injection Clinically demonstrated equivalent PD to SubQ delivery of GLP-1
through Rani route of administration - at the same dose Versatile delivery platform with broad applicability to address significant opportunities across large market indications in immunology, endocrinology, and beyond Differentiated
anti-obesity mechanism, with preclinical data showing improved body composition compared with Tirzepatide Long-acting Fc fusion platform for multivalent agonists Clinically demonstrated favorable safety and differential PK profiles Versatile
metabolic benefits with broad applicability to address significant opportunities across broad market indications including T2D, MAFLD/MASH and CVD RaniPill PG-102 GLP-1/GLP-2
Rani / ProGen Deal Structure
Rani and ProGen have entered into a collaboration agreement for the development and commercialization of a RaniPill capsule containing PG-102 (GLP-1 / GLP-2 dual agonist) for weight management (including obesity). Deal Structure No upfront
payment Co-Development Deal 50/50 WW revenue and cost share Development initially focused on major markets Commercial Rights Manufacturing ProGen manufactures the drug substance Rani manufactures the drug product Rani holds exclusive rights to
commercialize in the US, Europe, UK, Canada and Australia ProGen holds exclusive rights to commercialize in rest of world Each party has the right to sublicense within its territories
Obesity is a Fast-Growing Market;
Potential for Oral Options to Play an Important Role * Why the anti-obesity drug market could grow to $100 billion by 2030, Goldman Sachs published 30 Oct 2023 ** Data aggregated from two third-party surveys commissioned by Rani of U.S. patients (in
2017 for Humira and basal insulin and 2021 for other products). Patients surveyed (n=1,689) were aged 18 years or older and presently used one of Prolia, Humira, basal insulin, Stelara, Cosentyx, Entyvio, Simponi, or Evenity as an injectable
biologic to treat a condition. 2023 2030 Anti-Obesity Medications Market * $6B, still in early stages Forecasted to reach $100B by 2030 16x increase 64%-88% of patients with injection regimens of daily to every 6 months Across various therapeutic
areas, patients prefer daily pill over current injection regimen **
RaniPill Delivery Technology May
Solve for the Shortcomings of Current Orals in Development Low Bioavailability High API Cost & Supply Chain Issues Restrictive Administration Requirements Inconvenient Dosing Regimen Tolerability Risk Oral chemistry-based formulations
demonstrate bioavailability as low as <1% [1] Extremely high doses to reach therapeutic effectiveness Novo's Oral semaglutide 350mg per week vs Wegovy 2.4 mg injectable dose (145x higher dose) [2] Novo's Oral amycretin and
Viking's oral GLP-1/GIP may require 280-350 mg of API/week to compete [3] RaniPill Potential Advantages Restrictive pre-treatment requirements can impact efficacy and patient adherence Rybelsus (oral semaglutide) patients instructed
to take drug in fasted state as it may increase absorption [4] Rybelsus clinical success rate 67% [5] BID or daily dosing often required to reach therapeutic serum concentrations Twice-daily Danuglipron (small molecule) discontinued due to
tolerability issues and discontinuation rates [6] Significantly better bioavailability than other oral biologic technologies Significantly less API amount and cost needed than current orals in development Can dose infrequently compared to other
orals (weekly or monthly) Can dose more frequently than SC to limit tolerability issues No evidence of food effect so may avoid restrictive administration requirements
Clear Opportunity in Obesity
Landscape for RT-114/RPG-102 [7] Frequency of Administration Max API Dose per Week BID Daily Weekly Monthly 500+mg 200mg 15mg <5mg ORAL INJECTABLE VK2735 (Ph1) Oral Semaglutide (Ph3) Orfoglipron (Ph2) Oral Amycretin (Ph1) Danuglipron Ph2 dose =
40-200mg BID (discontinued) Liraglutide (Approved) Semaglutide (approved) Tirzepatide (approved) VK2735 (Ph2) Pemvidutide (Ph2) Mazdutide (Ph2) RaniPill + PG-102 MariTide (Ph2) Survodutide (Ph2) Only Convenient, Oral, Low Dose Option Dapiglutide
(Ph2) GSBR1290 (Ph1) Small Molecules Oral Peptides
Overview of Rani's Technology
RaniPill Development Progress and
Safety 15 Molecules Assessed antibodies, peptides, and large proteins delivered with high bioavailability 60-Day GLP Study completed with no clinical findings 3 Phase 1 Studies* completed 233 RaniPill Capsules administered to 146 humans >7000
Capsules tested in vitro & in vivo Preclinical Clinical Well-Tolerated with No Serious Adverse Events Observed in Clinical Studies Completed to Date 7-Day Repeat Dose Study completed * As of 3/1/24; clinical studies with solid-dosage
Demonstrated Equivalent PD to SC
through Rani Route of Administration - At Same Dose Objective To evaluate the PK-PD profiles of Triagonist (a unimolecular incretin agonist for GLP-1, GIP and Glucagon receptors) in Beagle dogs delivered SC or via endoscopically guided
transenteric injection (to mimic the Rani route of administration) Subjects Beagles, adult male, 11 - 13 kg, Total N=10 Test Groups Group 1 Transenteric (N=5): Triagonist, 0.12mg/kg (0.05ml/kg) injected via endoscopic access Group 2 SC (N=5):
Triagonist, 0.12mg/kg (0.04ml/kg) injected subcutaneously Protocol All animals were dosed after an overnight fast Over 2 weeks, fasted body weights were taken, and blood samples were serially collected for tracking serum drug concentrations and
various PD & safety biomarkers D Body Weight (%) Group 1: Endoscopic Group 2: SC D Serum Cholesterol (%) D Serum Triglycerides (%) All data are Means SE Data from preclinical study conducted by Rani using third party triagonist
Rani Has Demonstrated
Bioavailability Comparable to Subcutaneous Injection in Preclinical and Clinical Studies Biotherapeutic Mean RaniPill Relative Bioavailability Compared to SC* Ustekinumab Biosimilar 91-159% Dupilumab 89-102% Adalimumab Biosimilar 93-103% FSH
alpha/Gonal-F 110-146% Exenatide 80% * Data from preclinical head-to-head studies conducted by Rani. PK Profiles of Single Doses of RT-111 (Oral Ustekinumab Biosimilar) vs SC Stelara Injection Data shown are Mean SE, SC = Subcutaneous
Our Mission at Progen is to Improve
Patients' Quality of Life with Longer-acting Protein Therapeutics Progen KONEX: 296160 PIPELINE: PG-102 for Obesity & T2D (Phase 1) Bispecific ADCs for Autoimmune diseases & cancer TECHNOLOGY: Multi-specific Fc fusion protein
Long-acting injectables NTIG (Neo Tri-ImmunoGlobulin) ProGen Clinical-stage Biotech Company Developing Next Generation Long-acting, Multi-specific Fusion Protein Therapeutics
Rani - Confidential PG-102: Long
Acting, Bispecific GLP-1/GLP-2 Dual Agonist for the Treatment of Obesity Bispecific GLP-1/GLP-2, with optimized ratio biased toward GLP-1 Heterodimeric Fc Fusion Protein Prolonged Half-Life
Experimentally-optimized, Biased Agonist Biased agonism provided better weight management & glycemic control Normal mouse model (Q2D, SC)
Phase 1a SAD Results Show Good
Tolerability TEAEs PG-102 Placebo 5 mg 15 mg 30 mg 60mg Decreased appetite 0 0 1 (12.5%) 2 (25%) 2 (25%) Nausea 0 0 0 0 3 (37.5%) Diarrhea 1 (12.5%) 0 0 0 0 Vomiting 0 0 0 0 1 (12.5%) Dyspepsia 0 1 (12.5%) 0 2 (25%) 2 (25%) Constipation 1 (12.5%) 0
0 1 (12.5%) 0 Summary of treatment-emergent adverse events (during 28-day period, Phase 1 SAD) Target Population Healthy Subject Administration Single Dosing Regimen PG-102 vs Placebo Primary Endpoint Safety / Tolerability / PK N= 8 Subjects per
Group Safety and Tolerability are a main concern with metabolic therapies due to high discontinuation rates Potentially No Need to Titrate to High Dose
RT-114 / RPG-102 (Obesity)
Differentiation, Dosing and Development
PG-102 Reduces Body Weight &
Improves Body Composition (DIO mice) **p<0.01. Data are shown in SEM. DIO=diet-induced obesity; HFD=high fat diet; SEM=standard error of the mean; VAT=visceral adipose tissue; SAT=subcutaneous adipose tissue Source: Timothy Oh et al., The
Effect of Bispecific GLP-1R/GLP-2R Agonist Compared with Dual GLP-1R/GLP-2R Agonist and Dual GLP-1R/GIPR Agonist in Diet-Induced Obesity Mouse Model. Presentation at the 83rd ADA Annual Meeting.; Jastreboff AM et al., N Engl J Med. 2022
Jul 21;387(3):205-216. Improvement of body composition (fat vs. lean mass loss), under similar weight loss condition (vs. Tirzepatide) Change in body composition (%)

Frequently Asked Questions

What is the collaboration between Rani Therapeutics and ProGen?

Rani Therapeutics and ProGen Co., Ltd. have partnered to advance product development and clinical trials, focusing on oral biologics.

What is Rani Therapeutics' mission?

Rani Therapeutics aims to eliminate painful injections for patients with chronic diseases.

What is RT-114?

RT-114 is part of Rani's pipeline targeting obesity, focusing on oral delivery of biologics.

What are the risks involved in Rani's forward-looking statements?

Forward-looking statements involve risks related to financial performance, clinical development, and regulatory approval.

Who leads the Rani Therapeutics team?

Talat Imran serves as CEO, supported by a team with extensive experience in biotech and pharmaceuticals.

Last updated: Jun 24, 2024