Rani Therapeutics Holdings, Inc. Q4 FY2021 earnings call

• 2021 was transformative: completed IPO raising ~$84M, expanded executive leadership and board, progressed development pipeline, and optimized RaniPill oral delivery platform.
• Key milestones: successful IPO in August 2021, expanded executive team, progressed drug development plans, completed GLP 7-day repeat dose oral administration study for RT-102, initiated Phase I study of RT-102 for osteoporosis, and made progress on RaniPill HC with preclinical success in canine model.
• Market research showed strong patient preference for oral over injectable drugs, with high percentages indicating preference for switching from injections to pills for various drugs.
• Mock RaniPill capsule study showed easy swallowing by participants.

No detailed product segment financial performance with absolute terms and revenue contribution % provided in the transcript.

• Look forward to sharing top line results from RT-102 Phase I clinical trial in the second half of 2022.
• Intend to initiate Phase I study of RT-109, our oral human growth hormone program, in the second half of 2021.
• Plan to make further progress with the RaniPill HC and explore opportunities with the higher payload system.

• Forward-looking statements are subject to risks and uncertainties related to future events and financial performance, including those in the company's SEC filings such as product development, clinical trials, regulatory environment, business strategies, capital resources, etc., which may cause actual results to differ materially from forward-looking statements.

Q: When you look at the high capacity pill, are there any additional modifications beyond just the ability to scale up those? Is it fair to say that the HC strategically could be the preferred product going forward?

A: The RaniPill HC shares commonalities with the current platform but has modifications to increase dose. There may be safety/tolerability work needed. The HC opens new opportunities for higher dose drugs, but the current RaniPill is suited for lower dose drugs.

Q: For the RaniPill HC, are there any programs of current programs better suited to it? Do you have to start a new master file for the high capacity?

A: Pediatric applications could benefit from smaller size (but further development needed). No new programs announced yet. There'll be one master file with chapters for different embodiments.

Q: For RT-102 Phase I study, can you walk through the trial design? What about the RaniPill HC's next steps?

A: RT-102 Phase I is single dose in healthy volunteers with doses up to 80 micrograms. For RaniPill HC, next steps include laparotomy placement, oral administration in canines, and candidate selection for pipeline and partnerships.

Q: How are you thinking about partnerships for the portfolio including HC and regular RaniPill?

A: There may be small additions to the regular RaniPill platform and additional programs for HC. Partnerships are possible for lifecycle management and novel compounds, with strategic consideration of clinical trial burden, cost, revenue potential, and patient access.