Rani Therapeutics Holdings, Inc. Q4 FY2023 earnings call

• Achieved milestones in 2023, including positive Phase 1 results for RT-111 (orally administered ustekinumab biosimilar) with high bioavailability and no serious adverse events. - Partnered with Celltrion, expanding to include an adalimumab biosimilar for the RT-105 program. - Made progress with the RaniPill HC, including successful preclinical delivery of adalimumab and work with additional antibody and peptide molecules. - Announced preclinical data on obesity showing potential for rapid weight loss with the RaniPill platform. - Financials: Cash, cash equivalents, and marketable securities as of Dec 31, 2023 totaled $48.5M; R&D expenses for Q4 2023 were $7.6M and full year $39.6M; G&A expenses for Q4 2023 were $5.8M and full year $26.5M; net loss for Q4 2023 was $14.1M and full year $67.9M.

Rani Therapeutics is a clinical stage biotech company with a platform technology for oral administration of biologics, but there are no distinct product segments with reported absolute revenue figures and revenue contribution percentages as typically defined for traditional product segments. The company's focus is on its RaniPill platform and pipeline programs.

• Expect current cash to fund operations into 2025 and plan to raise additional capital through equity offerings, debt financing, and potential non-dilutive licensing fees. - Prioritize obesity and other therapeutic areas, aiming for unique dosing schedules for treatments, such as once a month or once every couple of weeks for obesity-related drugs. - Focus on identifying additional opportunities to create better products in terms of efficacy, safety, and dosing schedule compared to originators.

• Management's forward-looking statements are subject to risks, uncertainties, and assumptions discussed in the company's SEC filings, including factors that may cause actual events or results to differ materially from forward-looking statements, such as those regarding product development, clinical trials, market sizes, and operating performance.

Q: Where are you guys with respect to negotiating the terms of the development path forward with Celltrion? And how are you thinking about cost sharing with a partner versus moving forward with the RT-111 program alone?

A: In terms of negotiations, they are ongoing. If going alone, would look to bring in additional capital to support a Phase 2 repeat dose study.

Q: Can you comment on whether or not they've officially opted in?

A: Cannot comment on that.

Q: On obesity, how big of a strategic priority is that program at this point?

A: Obesity is one of the highest priorities, with a focus on creating a unique dosing schedule difficult to replicate with other oral technologies and aiming for once a month or once every couple of weeks dosing.

Q: Now that 102 is going to be entering Phase 2 this year, could you maybe just talk a little bit about the size of that trial and design?

A: Planning to enroll about 25 subjects per arm, 8-week duration, a dose finding, proof-of-concept type study.

Q: How big of a strategic priority is the obesity program?

A: It's a top priority, with focus on creating unique dosing schedules and looking at next-generation technologies for better tolerability.

Q: Assuming that Celltrion signs a deal with you and funds 111, how will your focus shift for the rest of your pipeline if that happens?

A: Focus on obesity assets, RT-105, and potentially TNF-α oral with unique dosing.

Q: As we think about RaniPill and kind of getting to later stages, manufacturing stages, how's that coming along? And will you be using that for a clinical stage product?

A: Have a dedicated automation team making progress, aiming for a pilot line delivering low thousands of pills per day for Phase 3, not needed for Phase 1/2.

Q: What do you think about the environment for more biosimilars to come?

A: More biosimilars likely, but Rani focuses on novel products with unique dosing schedules, not just price competition.