Rani Therapeutics and ProGen Collaboration
June 24, 2024
Rani Forward-Looking Statements
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.
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ProGen Disclaimer
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.
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Today's Agenda
Rani Therapeutics and Progen Introduction & Deal Overview
Obesity Strategy
Overview of Rani'sTechnology Platform
Overview of PG-102
RT-114 /RPG-102 (Obesity)
Q&A
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Presenters
Talat Imran | Jong Gyun Kim, PhD |
• Chief Executive Officer, Rani Therapeutics | • Chief Executive Officer, ProGen |
• >15 years experience in Healthcare | • >30 years of extensive experience in |
• Venture capitalist for several Silicon Valley | pharmaceutical industry |
healthcare funds | • R&D and strategic planning for drug development |
across multiple therapeutic areas |
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Leadership Team
Mir Hashim, PhD | Jesper Høiland, | Kyung-Hwa Son, PhD | Sae Won Kim, PhD |
• Chief Scientific Officer, | • Strategic Advisor, | • Chief Development | • Chief Scientific Officer, |
Rani Therapeutics | Rani Therapeutics | Officer, Progen | Progen |
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Our mission at Rani is to end painful injections for the millions of patients suffering from chronic diseases
Rani Therapeutics Clinical-stage biotech focused on Oral Delivery of Biologic Drugs
NASDAQ: RANI | with Bioavailability Comparable to Parenteral Products | ||
TECHNOLOGY: | RaniPill | • | 200 µL 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 | |||
IP: | 472 Granted Patents and Pending Applications, 262 Granted Patents** |
*Dependent on drug concentration | |
** As of May 4, 2024 | 7 |
Rani's Strategic Vision in the 50 / 50 Partnership with ProGen
RaniPill
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
PG-102
GLP-1/GLP-2
Long-acting Fc fusion platform for multivalent
agonists
Differentiated anti-obesity mechanism, with preclinical data showing improved body composition compared with Tirzepatide
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
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
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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).
➢ Rani holds exclusive rights to | ||||||
➢ | No upfront payment | |||||
commercialize in the US, Europe, | ||||||
➢ | Co-Development Deal | UK, Canada and Australia | ||||
Deal | Commercial | |||||
➢ | 50/50 WW revenue and cost share | ➢ | ProGen holds exclusive rights to | |||
Structure | Rights | |||||
➢ | Development initially focused on | commercialize in rest of world | ||||
major markets | ➢ Each party has the right to | |||||
sublicense within its territories | ||||||
➢ ProGen manufactures the drug substance
Manufacturing
➢ Rani manufactures the drug product
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Obesity Strategy
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Disclaimer
Rani Therapeutics Holdings Inc. published this content on 24 June 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 24 June 2024 12:08:21 UTC.