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Rani Therapeutics (RANI) - 2024 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - As of December 31, 2024, cash, cash equivalents, and marketable securities totaled 27.6million,downfrom27.6 million, down from 48.5 million as of December 31, 2023, indicating a significant decrease in liquidity [40] - The net loss for Q4 2024 was 15.7million,comparedtoanetlossof15.7 million, compared to a net loss of 14.1 million in Q4 2023. For the full year 2024, the net loss was 56.6million,downfrom56.6 million, down from 67.9 million in 2023, reflecting a reduction in overall losses [45] Business Line Data and Key Metrics Changes - Contract revenue for Q4 2024 was approximately 1million,withnocontractrevenuereportedforthesameperiodin2023,indicatinganewrevenuestream[41]ResearchanddevelopmentexpensesforQ42024were1 million, with no contract revenue reported for the same period in 2023, indicating a new revenue stream [41] - Research and development expenses for Q4 2024 were 6.8 million, down from 7.6 million in Q4 2023. For the full year, R&D expenses decreased to 26.7 million from 39.6millionin2023,attributedtocostcontainmentmeasures[42]MarketDataandKeyMetricsChangesTheobesitymarketisprojectedtoreach39.6 million in 2023, attributed to cost containment measures [42] Market Data and Key Metrics Changes - The obesity market is projected to reach 100 billion by 2030, highlighting significant growth potential for oral alternatives in treatment [19] Company Strategy and Development Direction - The company aims to leverage its Ronnie Pill technology to develop next-generation obesity therapies, focusing on RT-114 and semaglutide programs [10][20] - A strategic partnership was established with Progen Co Limited for the co-development and commercialization of RT-114, combining their GLP-1, GLP-2 dual agonist with the Ronnie Pill [20][21] - The company is open to additional partnerships to advance oral biologics across various indications, including immunology and endocrinology [23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the advancements made in the pipeline, particularly in the obesity space, and plans to bring RT-114 into clinical trials by mid-2025 [48] - The management highlighted the potential of the Ronnie Pill platform to redefine the treatment paradigm for injectable large molecule therapeutics [48] Other Important Information - The company has a robust patent portfolio with over 450 granted patents and pending applications, supporting its innovative delivery technology [15] Q&A Session Summary Question: Development of oral semaglutide and capital constraints - Management confirmed that the primary focus is on RT-114 due to capital constraints, and while RT-116 is a discovery program, it is not currently planned for clinical study [55][56] Question: Variability in weight loss with RT-114 - Management explained that the transenteric route has shown to be more efficient than subcutaneous delivery, leading to less variability in weight loss outcomes [70] Question: Tolerability and dosing flexibility for RT-114 - Management emphasized that tolerability is key and that the oral formulation allows for flexible dosing, which can be adjusted based on patient response [78][80] Question: Comparison of PG-102 with other GLP-1, GLP-2 therapies - Management noted that PG-102 has shown sustained weight loss over time compared to other therapies, and the FC fusion protein nature of PG-102 allows for rapid titration without the need for extensive dose adjustments [100] Question: Future studies for RT-114 - Management confirmed that no additional animal studies are planned before entering clinical trials, expressing confidence based on previous studies [104] Question: Regulatory pathway for PG-102 - Management indicated that Progen is moving forward with Phase 2A studies for PG-102 and plans to file an IND in the near future, which could benefit the RT-114 program [112]