Rani Therapeutics Holdings Inc - Ordinary Shares Class A Aktie

Welcome to the Rani Fourth Quarter and Full Year 2025 Financial Results and Corporate Update Conference Call. [Operator Instructions] As a reminder, this call is being recorded today, March 26, 2026. I would now like to turn the conference over to your speaker for today, Stephen Jasper of Gilmartin Group. Please go ahead.

Thank you, operator. Joining us on the call today from Rani Therapeutics are Chief Executive Officer, Talat Imran; and Chief Financial Officer, Svai Sanford. Earlier today, Rani released financial results for the quarter and year ended December 31, 2025. A copy of the press release is available on the company's website.

During this conference call, management will make forward-looking statements that are subject to risks, uncertainties and assumptions such as, but not limited to, those discussed in the Risk Factors section of the company's filings with the Securities and Exchange Commission, including its annual report on Form 10-K filed today, which identify the specific factors that may cause actual results or events to differ materially from those described in these forward-looking statements. These statements may include, without limitation, statements regarding product development and clinical trials, product potential, market sizes, platform progress, platform potential, certain business strategies, strategic partnership with Chugai, including potential milestone payments under the Chugai license and collaboration agreement, capital resources, projected cash runway, financing plans or operating performance. Actual results and the timing of events could differ materially from those projected in such forward-looking statements.

With that, I will now turn the call over and introduce you to Talat Imran, Chief Executive Officer of Rani Therapeutics. Talat?

Thank you, Stephen. Good afternoon, everyone, and thank you for joining our earnings call for the fourth quarter and full year of 2025. I'm pleased to share the highlights of what we believe was a transformational year for Rani Therapeutics. During 2025, we made significant progress advancing and validating the RaniPill platform across multiple therapeutic modalities while also strengthening our financial position and expanding our strategic partnerships. For those newer to our story, Rani Therapeutics is a clinical-stage biotherapeutics company developing a platform designed to enable the oral delivery of biologics and other therapies. Our proprietary RaniPill capsule is intended to replace subcutaneous injections or intravenous infusions with an oral capsule while achieving comparable bioavailability.

To date, we have conducted several preclinical and clinical studies evaluating the safety, tolerability and bioavailability of therapies delivered using the RaniPill technology. On today's call, I will begin by reviewing key milestones achieved over the past year across our strategic partnerships and financial activities, followed by progress across our pipeline. Following my remarks, Svai Sanford, our Chief Financial Officer, will review our financial results for the fourth quarter and full year 2025. Also joining us on the call today is Kate McKinley, our Chief Business Officer.

Let me start with our strategic partnerships and financing progress, which we believe further validate both the RaniPill platform and our broader business model. In October 2025, we entered into a collaboration and licensing agreement with Chugai Pharmaceuticals for a potential total value of up to approximately $1.1 billion. The agreement focused on the development of an oral therapy combining our RaniPill platform with Chugai's rare disease antibody. Importantly, the agreement also included an option for Chugai to expand the collaboration to up to 5 additional drug targets under similar terms. We believe this highlights the scalability of the RaniPill platform and the potential to apply it across a broad range of biologic molecules over time.

More broadly, this partnership highlights the broad applicability of the RaniPill platform across multiple high-value therapeutic areas, including rare disease and immunology, where biologics remain the standard of care but are constrained by injectable delivery. Concurrently with the Chugai agreement, we strengthened our balance sheet through an oversubscribed $60.3 million private placement, including $6 million of debt conversion led by leading life science investors. This financing significantly enhanced our capital position and extended our projected cash runway into the fourth quarter of 2027, enabling us to continue advancing both our pipeline and platform development.

Turning now to our pipeline progress, which was driven by strong preclinical and early clinical momentum across our key programs. We continue to be encouraged by the data for RT-114, our bispecific GLP-1/GLP-2 receptor agonist, PG-102, delivered orally via the RaniPill capsule. As a reminder, PG-102 is an Fc fusion GLP-1/GLP-2 molecule in development by ProGen. In March 2025, we reported preclinical data demonstrating that RT-114 achieved 111% relative bioavailability compared to subcutaneous PG-102 with comparable pharmacokinetic profiles. Importantly, we also observed comparable weight loss between oral RT-114 and injected PG-102 with less variability in the RT-114 group.

These findings are particularly meaningful in the context of the rapidly evolving obesity treatment landscape. While current therapies demonstrate strong efficacy, they are often associated with tolerability challenges that can contribute to high discontinuation rates. We believe the RaniPill platform may offer a differentiated approach by enabling oral delivery of these same biologics while maintaining comparable exposure and absorption. Across our studies to date, therapies delivered by the RaniPill capsule have demonstrated high tolerability, supporting our belief that oral biologics could meaningfully improve the patient experience without compromising efficacy.

These results also build on encouraging clinical data generated by ProGen in its Phase I program with subcutaneous PG-102, where obese patients experienced average weight loss of 4.8% with reductions of up to 8.7% after 5 weeks of dosing. We were also pleased to present additional RT-114 data at ENDO 2025 in a late-breaking oral presentation where canine data further confirmed bioequivalence and strengthened our confidence in the translational potential of the program. Building on this momentum, in December 2025, we initiated a Phase I clinical trial of RT-114. The study is designed to evaluate safety, tolerability, bioavailability, pharmacokinetics and pharmacodynamics across single and multiple doses.

With RT-114 now in the clinic, we are entering an important new phase for the RaniPill platform and advancing what we believe could be a meaningful opportunity in oral obesity therapies. Moving to our additional programs. In February 2025, we reported preclinical data for RT-116, our oral semaglutide delivered via RaniPill, demonstrating comparable bioavailability, pharmacokinetics and weight loss relative to subcutaneous semaglutide. RT-116 was well tolerated with no serious adverse events observed. Taken together, the data from RT-114 and RT-116 continue to reinforce our confidence in the RaniPill platform as a versatile oral delivery solution for incretin-based therapies.

Overall, we believe the progress we made this past year reflects our continued commitment to advancing the RaniPill platform and realizing our vision of making oral biologics a reality across a broad range of therapeutic areas. With RT-114 now in the clinic and a strengthened balance sheet supporting our development plans, we believe we are entering an exciting new phase for the company. We look forward to building on this momentum in 2026 as we continue advancing our pipeline and expanding our strategic partnerships.

With that, I will now turn the call over to Svai Sanford, our Chief Financial Officer, to review our financial results.

Thank you, Talat, and good afternoon, everyone. Thank you for joining us today. As Talat has mentioned, earlier today, we issued a press release and filed our Form 10-K with the SEC containing our financial results for the fourth quarter and full year 2025. I will briefly highlight a few key financial items on today's call. Additional detail can be found in our press release and in the Form 10-K. Turning to the balance sheet. Cash, cash equivalents and marketable securities totaled $49.7 million as of December 31, 2025, compared to $27.6 million at year-end 2024. The increase reflects the oversubscribed $60.3 million private placement that we closed in October 2025 as well as the upfront license payment from the collaboration agreement with Chugai, which closed concurrently with the private placement.

During the fourth quarter of 2025, we also repaid all of the outstanding debt due to Avenue Capital and no longer have any outstanding debt obligations as of December 31, 2025. Based on our current operating plan, we believe our existing cash, cash equivalents and marketable securities, including expected technology transfer milestone payment under the Chugai agreement will fund our operations into the fourth quarter of 2027 without the need for additional financing.

Turning to our operating results. Contract revenue for the fourth quarter and year-end 2025 was $1.5 million and $1.6 million, respectively. Of this amount, $1.5 million related to the Chugai license and collaboration agreement and $0.1 million related to the evaluation services for our customer. Although the Chugai agreement included a $10 million upfront payment, revenue recognition guidance requires us to recognize that amount over time as we satisfy our performance obligation under the contract. As a result, only $1.5 million of that amount was recognized as revenue in the fourth quarter. For comparison, contract revenue for the same period in 2024 totaled $1.0 million, all of which related to evaluation services.

Research and development expenses for the fourth quarter and full year 2025 were $4.9 million and $20.2 million, respectively, compared to $6.8 million and $26.7 million for the same period in 2024. The $6.5 million year-over-year decrease reflects the cost containment measures that we implemented, including temporary pause and termination of certain R&D programs and reduction in compensation. We do expect R&D expenses to increase going forward as we resume select programs and continue advancing our technology platform. General and administrative expenses for the fourth quarter and full year of 2025 were $5.1 million and $19.7 million, respectively, compared to $5.5 million and $23.9 million for the same period in 2024.

The year-over-year decrease of $4.2 million primarily reflects the cost containment measures, including reduction in employee compensation. Net losses for the fourth quarter and full year 2025 were $9.1 million and $41 million, respectively, compared to $15.7 million and $56.6 million in the same period of 2024. This amount includes noncash stock-based compensation expense of $2.2 million in the fourth quarter and $11.8 million for the full year 2025 compared to $4 million and $16 million for the same period in 2024.

That concludes my comments on the financial section. I will now return the call back over to Talat for closing comments. Talat?

Thank you, Svai. In closing, we believe the progress we made this past year further validates the potential of the RaniPill platform to transform how biologic medicines are delivered. Our collaboration with Chugai represents an important strategic milestone and highlights the broad applicability of our platform across multiple therapeutic areas. Importantly, the agreement also creates the opportunity to expand the partnership to additional molecules over time, which we believe could further unlock the value of the RaniPill platform at scale. We are particularly excited about the near-term opportunity in obesity. The preclinical data we have generated with RT-114 and RT-116 reinforce our belief that the RaniPill platform can deliver meaningful differentiation in this rapidly evolving market.

While current therapies demonstrate strong efficacy, they are often associated with tolerability challenges and high discontinuation rates. We believe an oral therapy capable of achieving drug exposures comparable to subcutaneous administration could represent a significant advancement for patients. Finally, following the successful private placement completed in October, we are well capitalized to execute on our development plans and advance our clinical pipeline. Overall, we are excited about the momentum we are carrying into 2026 with RT-114 now in the clinic, continued progress across our obesity programs and expanding strategic partnerships. We believe we are well positioned to continue advancing our vision of making oral biologics a reality across a broad range of therapeutic areas.

With that, I will now open the call up for questions. Operator?

[Operator Instructions] Our first question today will be coming from the line of Brandon Folkes of H.C. Wainwright.

Congrats on all the progress. Maybe just 2 from me. Firstly, on 114, when we do see the data, are you going to present any weight loss data? Or should we just look at the bioavailability data and draw a parallel to PG-102? And then secondly, given the potential tolerability of 114, how should we think about additional doses that you could explore? Are you going to explore an equivalent dose to PG-102? Or could you explore additional doses as well?

Brandon, thank you for the questions. For the first one, your question around our RT-114, GLP-1, GLP-2 program and what data to expect once we've completed the Phase I. We are doing a Phase Ib. As a reminder, this is an 8-week study in obese patients. So weight loss is one of the endpoints. And we will look at that against the historical data for this molecule as it's called by ProGen PG-102 to see if we're running around the same type of weight loss or the same trajectory.

In terms of tolerability, it is something that we have debated that if we're showing similar tolerability and the convenience of an oral, could you pursue higher doses? I think even ProGen is looking at that with their subcu. I think it remains to be seen what we get in terms of data from this Phase Ib study as it pertains to weight loss. The reality, I think, in this space is that there are many options to lose weight with these incretin-based therapies. There are very few, vanishingly few that do so with tolerability profiles that will keep most patients on the therapy for the long term. So our focus is more on the latter than on just maximizing weight loss and driving up any kind of nausea or vomiting or other tolerability issues that might present. So I would say on first blush, we would err towards tolerability because I think that's the primary differentiation factor of this drug. But we will, just as anyone else would look at the data once it's generated and draw our conclusions from that.

And the next question will be coming from the line of Michael Okunewitch of Maxim Group.

Congrats on all the great progress. I guess I'd like to follow up and talk a little bit more about the Phase I study for RT-114 and particularly the importance of that study and what new questions we should be looking for answers to, particularly in the context of PG-102 already having demonstrated some efficacy and safety for the active ingredient. I guess where do you see the additional value to be unlocked in the clinical data for RT-114 specifically?

Michael, thank you for your question. If you look back at the historical clinical data generated by Rani, we've shown -- consistently shown high bioavailability across multiple programs, octreotide, teriparatide and ustekinumab, a monoclonal antibody. This is the first Fc fusion protein to go into the clinic. So there's -- there will be some interesting learnings from that in terms of PK. But primarily, what we are most excited about and what we hope the market sees as well is this is the first PD study, going back to Brandon's question. This is the first PD study with the RaniPill in humans. We've generated PD data, weight loss data, in particular, with several incretins, RT-114 or PG-102 included in canines and showed comparable weight loss to subcu.

If we can recreate that in humans, if we're able to show that in the Phase Ib, we believe that, that has the potential to read on to other incretin programs and really other programs in general, whether they're in immunology or rare disease or some other therapeutic area because ultimately, the RaniPill is a delivery mechanism. It's a swallowable auto-injector. So if we can show similar PK correlates to similar weight loss with RT-114, we think this has -- first, it's a milestone for the company and for that program. But then more broadly, it speaks to the broad applicability and potential of the RaniPill platform in multiple therapeutic areas.

All right. So would it be fair to say this is a key item for your -- for any additional conversations you're having on partnering efforts either with Chugai for their other compounds that they have the 5 additional options for or for additional pharma partners?

It depends on the pharma partner. It goes back to the comment I made about the broad applicability. Some partners may be looking for that. I think it's going to be a derisking event, assuming the data is good for any conversations that we have. Specifically with Chugai, I don't want to comment on what their thinking is for their option programs. They're our partner, and it's within their decision-making on when to exercise if and when to exercise. I'm sure that having PD data -- positive PD data would not hurt for anybody though.

Look forward to seeing that data as it starts to emerge.

We do, too. Thank you, Michael.

This does conclude today's Q&A session. I would like to go ahead and turn the call over to Talat for closing remarks. Please go ahead.

Thank you, Lisa. This concludes our fourth quarter and full year 2025 financial results and corporate update conference call. Thank you again, everyone, for joining us this afternoon.

Thank you, everyone, for dialing in. You may now disconnect.