Q4 2025 Rani Therapeutics Holdings Inc Earnings Call
Speaker #1: Welcome to the Rani Fourth Quarter and Full Year 2025 Financial Results. I'm Corporate Update Conference Call. At this time, all participants are in listen-only mode.
Operator: Welcome to Rani's Q4 and full year 2025 financial results and corporate update conference call. At this time, all participants are on a listen-only mode. Following management's prepared remarks, Rani will hold a Q&A session. To ensure that you have ample time to address everyone's questioning during the Q&A session, we will ask you to limit yourself to one question and one follow-up. To ask a question at that time, please press star one one on your touch-tone telephone. As a reminder, this call is being recorded today, 26 March 2026. I would now like to turn the conference over to your speaker for today. Stephen Jasper of Gilmartin Group, please go ahead.
Operator: Welcome to Rani's Q4 and full year 2025 financial results and corporate update conference call. At this time, all participants are on a listen-only mode. Following management's prepared remarks, Rani will hold a Q&A session. To ensure that you have ample time to address everyone's questioning during the Q&A session, we will ask you to limit yourself to one question and one follow-up. To ask a question at that time, please press star one one on your touch-tone telephone. As a reminder, this call is being recorded today, 26 March 2026. I would now like to turn the conference over to your speaker for today. Stephen Jasper of Gilmartin Group, please go ahead.
Speaker #1: Following the manager's prepared remarks, Rani will hold a Q&A session. To ensure that you have ample time to address everyone's questions during the Q&A session, we will ask you to limit yourself to one question and one follow-up.
Speaker #1: To ask a question, at that time, please press star 11 on your touch tone telephone. As a reminder, this call is being recorded. Today, March 26th, 2026.
Speaker #1: I would now like to turn the conference over to your speaker for today, Steven Jasper of Gilmartin Group. Please go ahead.
Speaker #2: 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.
Stephen Jasper: Thank you, operator. Joining us on the call today from Rani Therapeutics, our 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 identifies the specific factors that may cause actual results or events to differ materially from those described in these forward-looking statements.
Stephen Jasper: Thank you, operator. Joining us on the call today from Rani Therapeutics, our 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 identifies the specific factors that may cause actual results or events to differ materially from those described in these forward-looking statements.
Speaker #2: 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 identified the specific factors that may cause actual results or events to differ materially from those described in these forward-looking statements.
Speaker #2: These statements may include, without limitation, statements regarding product development and clinical trials, product potential, market sizes, platform progress, platform potential, certain business strategies, the strategic partnership with Shugai, including potential milestone payments under the Shugai license and collaboration agreement, capital resources, projected cash runway, financing plans, or operating performance.
Stephen Jasper: 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.
Stephen Jasper: 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.
Speaker #2: 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.
Speaker #2: Talat?
Speaker #3: Thank you, Steven. 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.
Talat Imran: Thank you, Stephen. Good afternoon, everyone, and thank you for joining our earnings call for the Q4 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.
Talat Imran: Thank you, Stephen. Good afternoon, everyone, and thank you for joining our earnings call for the Q4 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.
Speaker #3: During 2025, we made significant progress, advancing and validating the Rani Pill Platform across multiple therapeutic modalities, while also strengthening our financial position and expanding our strategic partnerships.
Speaker #3: 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.
Speaker #3: Our proprietary Rani Pill 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 Rani Pill technology.
Speaker #3: 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.
Talat Imran: 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 Q4 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 Pharmaceutical 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.
Talat Imran: 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 Q4 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 Pharmaceutical 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.
Speaker #3: 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.
Speaker #3: Let me start with our strategic partnerships and financing progress, which we believe further validate both the Rani Pill Platform and our broader business model.
Speaker #3: In October 2025, we entered into a collaboration and licensing agreement with Shugai Pharmaceuticals for a potential total value of up to approximately $1.1 billion.
Speaker #3: The agreement focused on the development of an oral therapy combining our Rani Pill Platform with Shugai's rare disease antibody. Importantly, the agreement also included an option for Shugai to expand the collaboration to up to five additional drug targets under similar terms.
Talat Imran: Importantly, the agreement also included an option for Chugai to expand the collaboration to up to five 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 Q4 2027, enabling us to continue advancing both our pipeline and platform development.
Talat Imran: Importantly, the agreement also included an option for Chugai to expand the collaboration to up to five 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 Q4 2027, enabling us to continue advancing both our pipeline and platform development.
Speaker #3: We believe this highlights the scalability of the Rani Pill Platform and the potential to apply it across a broad range of biologic molecules over time.
Speaker #3: More broadly, this partnership highlights the broad applicability of the Rani Pill 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.
Speaker #3: Concurrently with the Shionogi 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.
Speaker #3: 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.
Speaker #3: 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 RT114, our bispecific GLP-1, GLP-2 receptor agonists, PG102, delivered orally via the Rani Pill Capsule.
Talat Imran: 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.
Talat Imran: 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.
Speaker #3: As a reminder, PG102 is an FC fusion GLP-1, GLP-2 molecule in development by Progen. In March 2025, we reported preclinical data demonstrating that RT114 achieved 111% relative bioavailability compared to subcutaneous PG102, with comparable pharmacokinetic profiles.
Speaker #3: Importantly, we also observed comparable weight loss between oral RT114 and injected PG102, with less variability in the RT114 group. These findings are particularly meaningful in the context of the rapidly evolving obesity treatment landscape.
Speaker #3: While current therapies demonstrate strong efficacy, they are often associated with tolerability challenges that can contribute to high discontinuation rates. We believe the Rani Pill Platform may offer a differentiated approach by enabling oral delivery of these same biologics, while maintaining comparable exposure and absorption.
Talat Imran: 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 via 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 1 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.
Talat Imran: 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 via 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 1 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.
Speaker #3: Across our studies to date, therapies delivered by the Rani Pill Capsule have demonstrated high tolerability, supporting our belief that oral biologics could meaningfully improve the patient experience without compromising efficacy.
Speaker #3: These results also build on encouraging clinical data generated by Progen in its Phase One program with subcutaneous PG102, where obese patients experienced average weight loss of 4.8%, with reductions of up to 8.7% after five weeks of dosing.
Speaker #3: We were also pleased to present additional RT114 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.
Talat Imran: 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 1 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.
Talat Imran: 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 1 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.
Speaker #3: Building on this momentum, in December 2025, we initiated a Phase 1 clinical trial of RT114. The study is designed to evaluate safety, tolerability, bioavailability, pharmacokinetics, and pharmacodynamics across single and multiple doses.
Speaker #3: With RT114 now in the clinic, we are entering an important new phase for the Rani Pill Platform and advancing what we believe could be a meaningful opportunity in oral obesity therapies.
Speaker #3: Moving to our additional programs, in February 2025, we reported preclinical data for RT116, our oral semaglutide delivered via Rani Pill. Demonstrating comparable bioavailability, pharmacokinetics, and weight loss relative to subcutaneous semaglutide.
Speaker #3: RT116 was well tolerated, with no serious adverse events observed. Taken together, the data from RT114 and RT116 continue to reinforce our confidence in the Rani Pill Platform as a versatile oral delivery solution for incretin-based therapies.
Talat Imran: 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.
Talat Imran: 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.
Speaker #3: Overall, we believe the progress we made this past year reflects our continued commitment to advancing the Rani Pill Platform and realizing our vision of making oral biologics a reality across a broad range of therapeutic areas.
Speaker #3: With RT114 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.
Speaker #3: 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.
Speaker #4: Thank you, Talat, and good afternoon, everyone. Thank you for joining us today. As Talat has mentioned, earlier today, we issue a press release and file our Form 10-K with the SEC containing our financial results for the fourth quarter.
Svai Sanford: 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 Q4 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 equivalents, and marketable securities total $49.7 million as of 31 December 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.
Svai Sanford: 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 Q4 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 equivalents, and marketable securities total $49.7 million as of 31 December 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.
Speaker #4: In 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.
Speaker #4: 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.
Speaker #4: 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.
Speaker #4: 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.
Svai Sanford: During Q4 2025, we also repaid all of the outstanding debt due to Avenue Capital and no longer have any outstanding debt obligations as of 31 December 2025. Based on our current operating plan, we believe our existing cash equivalents, and marketable securities, including expected technology transfer milestone payment under the Chugai agreement, will fund our operations into Q4 2027 without the need for additional financing. Turning to our operating results. Contract revenue for Q4 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.
Svai Sanford: During Q4 2025, we also repaid all of the outstanding debt due to Avenue Capital and no longer have any outstanding debt obligations as of 31 December 2025. Based on our current operating plan, we believe our existing cash equivalents, and marketable securities, including expected technology transfer milestone payment under the Chugai agreement, will fund our operations into Q4 2027 without the need for additional financing. Turning to our operating results. Contract revenue for Q4 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.
Speaker #4: Based on our current operating plan, we believe our existing cash, cash equivalents, and marketable securities, including the expected technology transfer milestone payment under the Chugai agreement, will fund our operations into the fourth quarter of 2027.
Speaker #4: Without the need for additional financing. Turning to our
Speaker #1: Operating results: Contract revenue for the fourth quarter and year ended 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.
Speaker #1: 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.
Svai Sanford: 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 Q4. For comparison, contract revenue for the same period in 2024 totaled $1 million, all of which related to evaluation services. Research and development expenses for Q4 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 measure that we implemented, including temporary pause, and termination of certain R&D programs, and reduction in compensation.
Svai Sanford: 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 Q4. For comparison, contract revenue for the same period in 2024 totaled $1 million, all of which related to evaluation services. Research and development expenses for Q4 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 measure that we implemented, including temporary pause, and termination of certain R&D programs, and reduction in compensation.
Speaker #1: 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.
Speaker #1: Total $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.
Speaker #1: Compared to 6.8 million and 26.7 million for the same period in 2020 . For the 6.5 million year over year decrease reflects the cost containment measure that we implemented , including temporary pause and termination of certain R&D programs and reduction in compensation .
Speaker #1: 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 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 .
Svai Sanford: 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 Q4 and full year 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 Q4 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.
Svai Sanford: 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 Q4 and full year 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 Q4 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.
Speaker #1: The year over year decrease of 4.2 million , primarily reflects the cost containment measures , including reductions in employee compensation , net losses for the fourth quarter and full year of 2025 were 9.1 million and 41 million , respectively .
Speaker #1: Compared to 15.7 million and 56.6 million in the same period of 2020 . For these amount includes non-cash stock based compensation expense of 2.2 million in the fourth quarter and 11.8 million for the full year 2025 , compared to 4,000,016 million for the same period in 2020 .
Svai Sanford: This amount includes non-cash stock-based compensation expense of $2.2 million in Q4 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?
Svai Sanford: This amount includes non-cash stock-based compensation expense of $2.2 million in Q4 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?
Speaker #1: That concludes my comments on the financial section. I will now return the call back over to Talat for closing comments.
Speaker #2: Thank you, Suvi. In closing, we believe the progress we made this past year further validates the potential of the pill platform to transform how biologic medicines are delivered.
Talat Imran: 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.
Talat Imran: 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.
Speaker #2: 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 Rani pill platform at scale.
Speaker #2: We are particularly excited about the near-term opportunity in obesity . The preclinical data we have generated with our T 114 and T 116 reinforce our belief that the Ronnie pill platform can deliver meaningful differentiation in this rapidly evolving market .
Speaker #2: While current therapies demonstrate strong efficacy , they are often associated with tolerability challenges and high rates . We believe in oral therapy capable of achieving drug exposures comparable to subcutaneous administration .
Talat Imran: 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?
Talat Imran: 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?
Speaker #2: 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 T 114 now in the clinic , continued progress across our obesity programs and expanding strategic partnerships .
Speaker #2: 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.
Speaker #3: Thank you . As a reminder , if you would like to ask a question , please press star one on your telephone . You will then hear the automated message advising your hand is raised .
Operator: Thank you. As a reminder, if you would like to ask a question, please press star and one on your telephone. You will then hear the automated message advising your hand is raised. If you would like to remove yourself from the queue, please press star and one again. One moment while we compile the Q&A roster. Our first question today will be coming from the line of Brandon Folkes of H.C. Wainwright. Your line is open.
Operator: Thank you. As a reminder, if you would like to ask a question, please press star and one on your telephone. You will then hear the automated message advising your hand is raised. If you would like to remove yourself from the queue, please press star and one again. One moment while we compile the Q&A roster. Our first question today will be coming from the line of Brandon Folkes of H.C. Wainwright. Your line is open.
Speaker #3: If you would like to remove yourself from the queue , please press star one again . One moment while we compile the Q&A roster Our first question today will be coming from the line of Brandon Fowlkes of H.C.
Speaker #3: Wainwright, your line is open.
Speaker #4: Hi . Thanks for taking my questions and congrats on all the progress Maybe just two from me . Firstly , on one . One four .
Brandon Folkes: Hi. Thanks for taking my questions and congrats on all the progress. Maybe just two from me. Firstly, on RT-114, you know, when we do see the data, are you gonna present any weight loss data? Or should we just look at bioavailability data and draw a parallel to PG-102? Then secondly, you know, given the potential tolerability of RT-114, how should we think about additional doses that you could explore? Are you gonna explore an equivalent dose to PG-102 or could you explore additional doses as well? Thank you.
Brandon Folkes: Hi. Thanks for taking my questions and congrats on all the progress. Maybe just two from me. Firstly, on RT-114, you know, when we do see the data, are you gonna present any weight loss data? Or should we just look at bioavailability data and draw a parallel to PG-102? Then secondly, you know, given the potential tolerability of RT-114, how should we think about additional doses that you could explore? Are you gonna explore an equivalent dose to PG-102 or could you explore additional doses as well? Thank you.
Speaker #4: You know, when we do see the data, are you going to present any weight loss data, or should we just look at bioavailability data and draw a parallel to PG 102?
Speaker #4: And then secondly , you know , 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 ?
Speaker #4: Thank you .
Speaker #2: Hi , Brandon , thank you for the questions For the first one , your question around our HT 114 , GLP one , GLP two program and what data to expect once we've completed the phase one , we are doing a phase one B .
Talat Imran: Hi, Brandon. Thank you for the questions. For the first one on your question around our RT-114 GLP-1, GLP-2 program and what data to expect once we've completed the phase 1. We are doing a phase 1B. As a reminder, this is an 8-week study in obese patients, so weight loss is one of the endpoints. 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 sub-Q.
Talat Imran: Hi, Brandon. Thank you for the questions. For the first one on your question around our RT-114 GLP-1, GLP-2 program and what data to expect once we've completed the phase 1. We are doing a phase 1B. As a reminder, this is an 8-week study in obese patients, so weight loss is one of the endpoints. 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 sub-Q.
Speaker #2: As a reminder , this is an eight 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 project PG 102 to see if we're 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 ?
Speaker #2: I think even pro Gen is looking at that with their sub-q . I think it remains to be seen what we get in terms of data from this phase one B study , as it pertains to weight loss .
Talat Imran: I think it remains to be seen what we get in terms of data from this phase 1b 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'll keep most patients on the therapy for the long term. 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. I would say on first blush we would err towards tolerability, because I think that's the primary differentiation factor of this drug.
Talat Imran: I think it remains to be seen what we get in terms of data from this phase 1b 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'll keep most patients on the therapy for the long term. 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. I would say on first blush we would err towards tolerability, because I think that's the primary differentiation factor of this drug.
Speaker #2: 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 .
Speaker #2: 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 .
Speaker #2: So I would say on first blush , we would towards tolerability , because I think that's the primary differentiation factor of this drug .
Speaker #2: But we will , you know , just as anyone else would look at the data once it's generated and draw our conclusions from that
Talat Imran: We will, you know, just as anyone else would, look at the data once it's generated and draw our conclusions from that.
Talat Imran: We will, you know, just as anyone else would, look at the data once it's generated and draw our conclusions from that.
Speaker #4: Great. Thank you very much, and congrats on all the progress.
Brandon Folkes: Great. Thank you very much and congrats on all the progress.
Brandon Folkes: Great. Thank you very much and congrats on all the progress.
Speaker #2: Yeah . Thank you Brandon
Talat Imran: Yeah. Thank you, Brandon.
Talat Imran: Yeah. Thank you, Brandon.
Speaker #3: One moment for the next question. The next question will be coming from the line of Michael Okulitch of Maximum Group. Your line is open.
Operator: One moment for the next question. The next question will be coming from the line of Michael Okunewitch of Maxim Group. Your line is open.
Operator: One moment for the next question. The next question will be coming from the line of Michael Okunewitch of Maxim Group. Your line is open.
Speaker #5: Hey , guys . Thank you so much for taking my questions today . Congrats on all the great progress I guess I'd like to follow up and talk a little bit more about the the phase one study for our T 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 .
Michael Okunewitch: Hey, guys. Thank you so much for taking my questions today. 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 Okunewitch: Hey, guys. Thank you so much for taking my questions today. 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?
Speaker #5: Where do you see the additional value to be unlocked in the clinical data? For our T-114 specifically.
Speaker #2: Hi Michael , thank you for your question . If you look back at the historical clinical data generated by Ronnie , we've shown consistently shown high bioavailability across multiple programs .
Talat Imran: Hi, Michael. Thank you for your question. If you look back at the historical clinical data generated by Rani, we've consistently shown high bioavailability across multiple programs, octreotide, teriparatide, and the secukinumab monoclonal antibody. This is the first Fc fusion protein to go into the clinic, so there will be some interesting learnings from that in terms of PK. Primarily, what we are most excited about and what we hope the market sees as well, is this the first PD study. Going back to Brandon's question, this is the first PD study with a RaniPill in humans.
Talat Imran: Hi, Michael. Thank you for your question. If you look back at the historical clinical data generated by Rani, we've consistently shown high bioavailability across multiple programs, octreotide, teriparatide, and the secukinumab monoclonal antibody. This is the first Fc fusion protein to go into the clinic, so there will be some interesting learnings from that in terms of PK. Primarily, what we are most excited about and what we hope the market sees as well, is this the first PD study. Going back to Brandon's question, this is the first PD study with a RaniPill in humans.
Speaker #2: 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 .
Speaker #2: But primarily, what we are most excited about—and what we hope the market sees as well—is that this is the first PD study, going back to Brandon's question.
Speaker #2: This is the first PD study with a Ronnie pill in humans . We've generated PD , PD data , weight loss data in particular with several and RT1 14 or PG 102 included in canines and showed comparable weight loss to Sub-q .
Talat Imran: 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 sub-Q. If we can recreate that in humans, if we're able to show that in the phase 1b, we believe that that has the potential to read onto 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. More broadly, it speaks to the broad applicability and potential of the RaniPill platform in multiple therapeutic areas.
Talat Imran: 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 sub-Q. If we can recreate that in humans, if we're able to show that in the phase 1b, we believe that that has the potential to read onto 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. More broadly, it speaks to the broad applicability and potential of the RaniPill platform in multiple therapeutic areas.
Speaker #2: If we can recreate that in humans , if we're able to show that in the phase one B , 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 Ronnie pill is a delivery mechanism .
Speaker #2: It's a swallowable autoinjector . So if we can show similar PK correlates to similar weight loss with T 114 , we think this has first , it's a milestone for the company and for that program .
Speaker #2: But then, more broadly, it speaks to the broad applicability and potential of the Rani pill platform in multiple therapeutic areas.
Speaker #5: All right. So would it be fair to say this is a key item for you for any additional conversations you're having on partnering efforts, either with Chugai for their other compounds that they have the five additional options for, or for additional foreign partners?
Michael Okunewitch: All right. Would it be fair to say this is a key item for any additional conversations you're having on partnering efforts, either with Chugai for their other compounds that they have the five additional options for or for additional pharma partners?
Michael Okunewitch: All right. Would it be fair to say this is a key item for any additional conversations you're having on partnering efforts, either with Chugai for their other compounds that they have the five additional options for or for additional pharma partners?
Talat Imran: 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 gonna be a de-risking 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, you know, 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.
Speaker #2: 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.
Talat Imran: 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 gonna be a de-risking 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, you know, 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.
Speaker #2: I think it's going to be a de-risking event , assuming the data is good for for any conversations that we have and specifically with Chugai , I don't want to to comment on what their thinking is for their option programs .
Speaker #2: They're our partner and it's , you know , 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
Speaker #5: Right. Well, thank you for the additional clarity, and I look forward to seeing that data as it starts to emerge.
Michael Okunewitch: Right. Well, thank you for the additional clarity, and look forward to seeing that data as it starts to emerge.
Michael Okunewitch: Right. Well, thank you for the additional clarity, and look forward to seeing that data as it starts to emerge.
Speaker #2: We do too. Thank you. Michael
Talat Imran: We do too. Thank you, Michael.
Talat Imran: We do too. Thank you, Michael.
Speaker #3: Thank you . This does conclude today's Q&A session . I would like to go ahead and turn the call over to Talat for closing remarks .
Operator: Thank you. 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.
Operator: Thank you. 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.
Speaker #3: Please go ahead .
Speaker #2: 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
Talat Imran: Thank you, Lisa. This concludes our Q4 and full year 2025 financial results and corporate update conference call. Thank you again, everyone, for joining us this afternoon.
Talat Imran: Thank you, Lisa. This concludes our Q4 and full year 2025 financial results and corporate update conference call. Thank you again, everyone, for joining us this afternoon.
Operator: Thank you, everyone, for dialing in. You may now disconnect.
Operator: Thank you, everyone, for dialing in. You may now disconnect.