Q4 2024 Rani Therapeutics Holdings Inc Earnings Call
Okay.
Welcome to the fourth quarter and full year 2024 financial results and corporate update conference call.
Operator: Welcome to the Rani fourth quarter and full year 2024 financial results and corporate update conference call. At this time, all participants are in a listen-only mode.
At this time all participants are in a listen only mode.
Following management's prepared remarks, we'll hold a Q&A session.
Operator: Following management's prepared remarks, Rani will hold a Q&A session. Ensure that we have ample time to address everyone's questions during the Q&A session. We would ask for a limit of one question and one follow-up question per person.
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As a reminder, this call is being recorded today.
Operator: Hall is being recorded today. March 31st, 2025.
March 31st 2025.
Kiki Patel: I would now like to turn the conference over to Kiki Patel at Gilmour. Please go ahead.
Speaker Change: I would now like to turn the conference over to <unk> Patel at Gilmartin group.
Please go ahead.
Speaker Change: Thank you operator, please turn to slide two.
Kiki Patel: Thank you, operator. Please turn to slide two.
Kiki Patel: Joining us on the call today from Rani Therapeutics are Chief Executive Officer Talat Imran and Chief Financial Officer Svai Sanford. 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 reports on Form 10-K and quarterly reports on Form 10-Q, which identify specific risk 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, capital resources, financing plans, or operating performance.
Lot Enron: Joining us on the call today from Ronny Therapeutics, our Chief Executive Officer to lot Enron and Chief Financial Officer Fly Sanford. 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.
Lot Enron: With the Securities and Exchange Commission, including its annual report on Form 10-K, and quarterly reports on Form 10-Q, which identify specific risk 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 <unk>.
Lot Enron: Trials product's potential market sizes platform progress platform potential certain business strategies capital resources financing plans are operating performance actual results and the timing of events could differ materially from those projected in such forward looking statements.
Kiki Patel: Actual results and the timing of events could differ materially from those projected in such forward-looking statements.
Lot Enron: With that I turn the call over to slide three and introduce to you to lot Enron Chief Executive officer of Ronnie Therapeutics to lot.
Kiki Patel: With that, I turn the call over to slide three and introduce to you Talat Imran, Chief Executive Officer of Rani Therapeutics. Thank you, Kiki.
Speaker Change: Thank you <unk> good.
Talat Imran: Good afternoon, everyone, and thank you for joining our earnings call for the fourth quarter and full year of 2020. Rani Therapeutics is a clinical stage biotech company that has developed a platform technology for the oral administration of biologics with proven bioavailability comparable to a subcutaneous injection. Rani Pill Technology is currently being evaluated across several high value indications.
Speaker Change: Good afternoon, everyone and thank you for joining our earnings call for the fourth quarter and full year of 2024.
Speaker Change: Ronnie Therapeutics is a clinical stage biotech company that has developed a platform technology for the oral administration of biologics with proven bioavailability comparable to subcutaneous injection.
Speaker Change: <unk> technology is currently being evaluated across several high value indications, including the obesity and immunology spaces.
Talat Imran: including the Obesity and Immunology. I will start the call by providing a brief overview of our RaniPro capsule technology platform and highlight the important advancements that Rani has achieved in its pipeline over the past Then I will share how we are leveraging the RaniPill technology to develop the next generation of obesity therapies. Including our RT-114 and semiglutide program.
Speaker Change: I will start the call by providing a brief overview of our Ronnie per capsule technology platform and highlight the important advancements that Rodney has achieved and its pipeline over the past year.
Speaker Change: Then I will share how we are leveraging the <unk> technology to develop the next generation of obesity therapies, including our <unk> and <unk> type programs.
Savai Sanford: And then finally, Savai Sanford, our CFO, will provide an update on our financial results for the fourth quarter and full year 2025.
Speaker Change: And then finally <unk> Sanford our CFO will provide an update on our financial results for the fourth quarter and full year 2024.
Talat Imran: So, let's begin please turn to slide five. At Rani Therapeutics, our mission is to end painful injections for the millions of patients living with chronic conditions. With this mission in mind, we have made significant strides since Rani's inception more than 10 years ago. The RaniPill capsule, which has been extensively tested and clinically validated, represents a breakthrough in oral biologics with its ability to match injectable bioavailability across multiple indicators. The RaniPill technology consists of an innovative robotic pill with a proprietary enteric coating that makes it easy to swallow and allows it to pass through the acidic environment of RaniTherapeutic.com Previous attempts at delivering biologics orally have struggled to pass through the stomach and, as a result, have been unsuccessful.
Speaker Change: So let's begin please turn to slide five.
Speaker Change: And Ronny Therapeutics, our mission is to and painful injections for the millions of patients living with chronic conditions.
Speaker Change: With this mission in mind, we have made significant strides since <unk> inception more than 10 years ago.
Speaker Change: The <unk> capsule, which has been extensively tested and clinically validated represents a breakthrough in oral biologics with its ability to match injectable bioavailability across multiple indications.
Speaker Change: The <unk> technology consists of an innovative robotic pill with a proprietary enteric coating that makes it easier to swallow and allows us to pass through the aesthetic environment of the stomach.
Speaker Change: Previous attempts to delivering biologics orally have struggled to pass through the stomach and as a result have been unsuccessful.
Talat Imran: Once in the small intestines, the higher pH level breaks down the entire coating and outer shell of the Ranipo capsule, which exposes the delivery mechanism to intestine. in the small intestine. Self-inflating balloon creates the pressure needed to inject the dissolvable microneedle and deliver the drug via transenteric painless Once delivered, the drug is quickly absorbed by the vascular. and the device deflates and is safely passed. Our platform technology is intended to enable the oral administration of any biologic with bioavailability comparable to a subcutaneous. Resulting in a potential for broad application across multiple Our Ronnie pill technology is currently being evaluated in several high value indications across the immunology and obesity.
Speaker Change: Once in the small intestine, the hire ph level breaks down the entire coding and outer shell doronicum capsule, which exposes the delivery mechanism to intestinal fluid in.
Speaker Change: In the small intestine.
Speaker Change: Self inflating balloon creates the pressure needed to inject the dissolvable microneedle and deliver the drug via Trans enteric painless injection.
Speaker Change: Once delivered the drug as quickly absorbed by the vascular system and the device deflate and safely pass sale.
Speaker Change: Our platform technology is intended to enable the oral administration of any biologic with bioavailability comparable to subcutaneous injection, resulting in a potential for broad application across multiple indications.
Speaker Change: <unk> technology is currently being evaluated in several high value indications across the immunology and obesity spaces.
Talat Imran: Furthermore, Rani has a robust patent portfolio with over 450 granted patents and pending applications.
Speaker Change: Furthermore, Ronnie has a robust patent portfolio with over 450 granted patents and pending applications.
Speaker Change: Please turn to slide six.
Talat Imran: please turn to slide. Today, our platform technology stands as a proven success, demonstrating consistency across a wide range of preclinical and clinical trials. In preclinical studies, the Rani pill has delivered high bioavailability compared to subcutaneous injection for 19 molecules. Including antibodies, peptides, and large proteins. In addition, we have conducted a 60-day repeat administration GLP study, where the Rani pill was well-tolerated and there were no serious adverse.
Speaker Change: Today, our platform technology stands as a proven success demonstrating consistency across a wide range of preclinical and clinical trials in.
Speaker Change: In preclinical studies that <unk> has delivered high bioavailability compared to subcutaneous injection for 19 molecules, including antibodies peptides and large proteins.
Speaker Change: In addition, we have conducted a 60 day repeat administration <unk> study, where the <unk> was well tolerated and there were no serious adverse events.
Talat Imran: Clinically, we have completed three phase one. and in these studies, the Rani pill has been well tolerated with no serious adverse events reported with more than 200 pills administered to 146. Overall, we believe the Rani Pill addresses the challenges faced by chemistry-based oral delivery by having the potential to deliver drug with high bioavailability and dosing size and frequency similar to a subcutaneous. We believe this represents a distinct advantage that positions Rani Programs for future success.
Speaker Change: Clinically we have completed three phase one studies.
Speaker Change: And in these studies <unk> has been well tolerated with no serious adverse events reported with more than 200 pills administered to a 146 subjects.
Speaker Change: Overall, we believe the riding pillar addresses the challenges faced by chemistry based oral delivery by having the potential to deliver drug with high bioavailability and dosing size and frequency similar to a subcutaneous injection.
Speaker Change: We believe this represents a distinct advantage that positions Ronnie programs for future success.
Talat Imran: Now on to slides.
Speaker Change: Now onto slide seven.
Speaker Change: Moving on to our pipeline we are proud of all that we've accomplished in 2024 and thus far in 2025, especially the advancements we have made in our pipeline focus in the obesity space a market projected to reach $100 billion by 2030, we're all alternatives could redefine the treatment paradigm.
Talat Imran: Moving on to our pipeline, we are proud of all that we have accomplished in 2024 and thus far in 2025, especially the advancements we have made in our pipeline focused in the obesity. A market projected to reach $100 billion by 2030, where oral alternatives could redefine the treatment paradigm. To date, Rani has successfully evaluated four and cretin-based molecules in preclinical. These studies underscore the potential of the RaniPill platform to enable the oral delivery of a diverse range of obesity treatments, including both single and triagonal syncretin therapies, as well as semaglutide and RT-141. We are confident that the significant advancements made in our pipeline over the past year position us to further expand our obesity portfolio and realize the transformative potential of Rani Pilten.
Speaker Change: To date, Ronnie has successfully evaluated four base molecules in preclinical studies.
Speaker Change: These studies underscore the potential of the <unk> platform to enable the oral delivery of a diverse range of obesity treatments, including both single and Tri agonist therapies as well as 700 tied in our Q1 2014.
Speaker Change: We are confident that the significant advancements made in our pipeline over the past year position us to further expand our obesity portfolio and realized the transformative potential of <unk> technology.
Talat Imran: As a reminder, in June of 2024, Rani announced that it entered into a definitive agreement for the co-development and commercialization of RT-114 with ProGen Co Ltd. and South Korean clinical stage biotech company developing next-generation, long-acting, multi-specific fusion protein therapy. RT-114 combines Progen's FC-Fusion Protein Conjugated GLP-1 GLP-2 Dual Agonist PG-102 with the Rani. The rationale behind this strategic partnership is to combine a potential best-in-class GLP-1, GLP-2 asset with the convenience and dosing flexibility of the Rani to create a strongly differentiated, singular product in the obesity.
Speaker Change: As a reminder, in June of 2020 for Ronnie announced that it entered into a definitive agreement for the co development and commercialization of our tier one 2014 with project Co Ltd.
Speaker Change: Our South Korean clinical stage biotech company developing next generation long acting multi specific fusion protein therapeutics.
Speaker Change: <unk> hundred 14 combines <unk> FC fusion protein conjugated <unk> <unk> dual agonist PG, one or two with the right zone.
Speaker Change: The rationale behind this strategic partnership is to combine our potential best in class <unk> asset with the convenience and dosing flexibility of the Ronnie pill to create a strongly differentiated singular product in the obesity market.
Speaker Change: Ronnie shared a preclinical update on our tier $1 14 last week and project presented data on PD, one or two at the agent Association for the study of diabetes conference.
Talat Imran: Rani shared a preclinical update on RT-114 last week and ProGen presented data on PG-102 at the Asian Association for the Study of Diabetes. I will review the results and next steps for our RT-114 program later on in the webinar.
Speaker Change: I will review the results and next steps for our tier 114 program later on in the call.
Talat Imran: Beyond RT-114, one of the most significant advancements in our pipeline over the past year is the introduction of RT-169.
Speaker Change: Beyond our Q1 2014, one of the most significant advancements in our pipeline over the past year is the introduction of <unk> 16, an orally administered version of seminal type setting.
Talat Imran: and Orally Administered Version of Seminar. Cenozotide selectively binds to and activates the GLP-1 receptor, mimicking its natural activation. GLP-1 is an incretin hormone and enterogastrone that plays a crucial role in regulating appetite and food intake by stimulating insulin secretion, inhibiting glucagon secretion, and delaying gastric.
Speaker Change: <unk> selectively binds to and activates the <unk> one receptor mimicking its natural activity.
Speaker Change: <unk> is an incredible hormone and antero gas thrown that plays a crucial role in regulating appetite and food intake by stimulating an insulin secretion inhibiting glucagon to accretion and delaying gastric emptying last month.
Talat Imran: Last month, we shared encouraging preclinical data demonstrating the successful delivery of semaglutide by the Rani Therapeutic.
Speaker Change: We shared encouraging preclinical data demonstrating the successful delivery of semi tied by the Rodney pill and I will provide an overview of those results shortly.
Talat Imran: and I will provide an overview of those results. Overall, we are encouraged by the progress we have made with our obesity program, especially in the light of the tolerability challenges that limit the efficacy of first generation and cretin-based therapies, thus highlighting the need for more tolerable options. While our current focus is on the obesity. We have additional assets in development in our pipeline in immunology and endocrinology.
Speaker Change: Overall, we are encouraged by the progress we've made with our obesity program, especially in the light of the Tolerability challenges that limit the efficacy of first generation <unk> based therapies, thus highlighting the need for more tolerable options. While our current focus is on the obesity space, we have additional assets in.
Speaker Change: Development in our pipeline in immunology and endocrinology.
Talat Imran: Overall, we are open to additional opportunities to partner with pharmaceutical companies using our drug agnostic platform to advance oral biologics for Now I will review the data we shared this quarter on RT-114 and RT-116 as we leverage the RaniPill technology to develop the next generation of obesity. please turn to slide nine.
Speaker Change: Overall, we are open to additional opportunities to partner with pharmaceutical companies using our drug agnostic platform to advance oral biologics for patients.
Speaker Change: Now I will review the data we shared this quarter, our tier one 2014, and <unk> 16, as we leverage the <unk> technology to develop the next generation of obesity therapies.
Speaker Change: Let's turn to slide nine.
Speaker Change: In February 2025, Ronny announced preclinical data demonstrating the successful oral delivery of semi retired or RT 116 via the Ronnie pill.
Talat Imran: In February 2025, Rani announced preclinical data demonstrating the successful oral delivery of semaglutide, or RT-116, via the RANI. On this slide, purple represents RT-116 and the teal green represents subcutaneously delivered As you can see, looking at the pharmacokinetic curve on the left, RT-116 achieved comparable pharmacokinetics to subcutaneous administration. As for pharmacodynamics, both groups saw comparable weight loss, which appeared to be driven by decreased food intake. Weight loss coincided with rises in plasma drug levels, thus indicating there's a pharmacodynamic effect. Both groups saw comparable decreases in serum triglycerides and cholesterol. As for biologic activity, the relative bioavailability of orally administered semaglutide versus subcutaneous administration was 107%.
Speaker Change: On this slide purple represents <unk> hundred 16, and Teal Green represents subcutaneously delivered stem a good time.
Speaker Change: As you can see looking at the pharmacokinetic curve on the left <unk> achieved comparable pharmacokinetics to subcutaneous administration.
Speaker Change: As for Pharmacodynamics, both groups saw comparable weight loss, which appear to be driven by decreased food intake.
Speaker Change: Weight loss coincided with rises in plasma drug levels, thus, indicating there's a pharmacodynamic effect to treatment.
Both groups are comparable decreases in serum triglycerides and cholesterol.
Speaker Change: As for biologic activity the relative bioavailability of orally administered <unk> tied versus subcutaneous administration was 107%.
Talat Imran: Furthermore, RP-116 was well-tolerated with no serious adverse events.
Speaker Change: Furthermore, <unk> was well tolerated with no serious adverse events reported.
Talat Imran: Overall, we are pleased with Currently, semaglutide is available exclusively as a subcutaneous injection for the treatment of obesity. marketed in the U.S. under the brand name Wigovi by Novo Nordic. While Rubelsis offers an oral version of semaglutide approved for improving glycemic control in adults with type 2 diabetes. It requires daily administration at a significantly higher dose than its subcutaneous count.
Speaker Change: Overall, we are pleased with this data.
Speaker Change: Currently Semegran tide is available exclusively as a subcutaneous injection for the treatment of obesity market in the U S. Under the brand name, we Gobi by Novo Nordisk, while rebel. This offers an oral version of semi blue tide approved for improving glycemic control in adults with type two diabetes.
Speaker Change: It requires daily administration at a significantly higher dose than it's subcutaneous counterpart.
Talat Imran: In contrast, the target product profile of semaglutide in the RaniPill capsule would be a once weekly oral administration of semaglutide therapy at a dose similar to the injection. which we believe may be more convenient for patients and could lead to improved adhesion.
In contrast, the target product profile of <unk> tied in the <unk> capsule would be a once weekly oral administration of Semgroup type therapy.
Speaker Change: At a dose similar to the injectable, which we believe may be more convenient for patients and could lead to improved again.
Speaker Change: Please turn to slide 10, where I will share the exciting preclinical results of our RT $1 14 data released last week.
Talat Imran: Please turn to slide 10, where I will share the exciting preclinical results of our RT-114 data released last week. Rani released preclinical data evaluating a head-to-head comparison of orally administered PG-102, Progen's GLP-1, GLP-2 molecule delivered via the Rani pill capsule, otherwise known as RT-114, compared to PG-102 delivered subcutaneously in 16 healthy canines. As you can see, when looking at the pharmacokinetic curve for both treatments, RT-114 yielded a higher C-max and earlier T-max with a relative bioavailability of 111% compared to PG-102 delivered subcutaneously. Furthermore, these data confirm bioequivalence of RT-114 to subcutaneously deliver PG-105. The Ronnie pill capsule was well tolerated with no changes and drug related safety profile compared to subcutaneous delivery.
Speaker Change: Ronnie release preclinical data evaluating a head to head comparison of orally administered PG, one or two projects <unk> molecule delivered via the Ronnie pill capsule, otherwise known as our team in 2014 compared to PD, one or two delivered subcutaneously and 16 health.
Speaker Change: <unk> canine.
Speaker Change: As you can see when looking at the pharmacokinetics curve for both treatments.
Speaker Change: <unk> hundred 14 yielded a higher C Max and earlier T. Max with a relative bioavailability of 111% compared to <unk> 102 delivered subcutaneously.
Speaker Change: Furthermore, these data confirm bio equivalents of <unk> 2014 to subcutaneously delivered PG, one or two.
The <unk> capsule was well tolerated with no changes in drug related safety profile compared to subcutaneous delivery.
Talat Imran: On the bar graph on the right hand side, you will see the pharmacodynamics of RT-114 measured by body. Both groups demonstrated an average peak weight loss of 6.7%. However, there was more variability in results with subcutaneous.
Speaker Change: The bar graph on the right hand side, you will see the pharmacodynamics of <unk> hundred 14 measured by body weight.
Speaker Change: <unk> group's demonstrated an average peak weight loss of six 7%. However, there was more variability in results with subcutaneous dosing.
Talat Imran: Please turn to slide 11. Overall, we believe that Rani has the opportunity to create a truly differentiated product profile with RT-114, combining the potential advantages of PG-102 with the convenience of oral delivery.
Speaker Change: Please turn to slide 11.
Speaker Change: Overall, we believe that Rodney has the opportunity to create a truly differentiated product profile with <unk>, combining the potential advantages of <unk> 102, with the convenience of oral delivery.
Talat Imran: ProGen recently announced preliminary results of the repeat dose portion of its phase one clinical study. In the trial, subcutaneous PG-102 demonstrated weight loss in obese subjects with an average reduction of 4.8% and up to 8.7% following five weeks. Subcutaneous PG-102 demonstrated tolerability while reaching the target dose of 80 milligrams within one month. Even with rapid dose escalation, there were no treatment discontinuations, illustrating a potentially significant tolerability benefit of this molecule. Furthermore, PG-102 has demonstrated improved body composition, fat versus lean mass loss, compared to terzapatide and dapaglutide in a diet-induced obese mouse. We believe this preservation of lean body mass could serve as a key differentiator for PG 102, particularly due to the recent FDA guidance, emphasizing the critical importance of body composition in the development of obesity.
Speaker Change: <unk> recently announced preliminary results of the repeat dose portion of its phase one clinical study in the trial subcutaneous PD, one or two demonstrated weight loss in obese subjects with an average reduction of four 8% and up to eight 7% following five weeks of dosing.
Speaker Change: Subcutaneous PD, one or two demonstrated tolerability, while reaching the target dose of 80 milligrams within one month.
Speaker Change: Even with rapid dose escalation there were no treatment discontinuation illustrating a potentially significant tolerability benefit of this molecule.
Speaker Change: Furthermore, Pte 102 has demonstrated improved body composition fat versus lean mass loss compared to <unk> appetite in <unk> tied in a diet induced obese mouse model.
Speaker Change: We believe this preservation of lean body mass conserve as a key differentiator for PG, one or two.
Speaker Change: Particularly due to the recent FDA guidance, emphasizing the critical importance of body composition and the development of obesity treatment.
Speaker Change: As a result, we believe that <unk> has several potential key advantages and the competitive landscape.
Talat Imran: As a result, we believe that RT-114 has several potential key advantages in the competitive land. First and foremost, we believe RT-114 has the potential to demonstrate comparable weight loss, a better tolerability profile, and greater preservation of lean muscle mass compared to currently approved. Also, a shorter titration schedule may facilitate a quicker onset of a This could address the significant challenge with current GLP-1 treatment. where many patients discontinue therapy before achieving clinically meaningful weight. And finally, the currently available oral therapies and those in clinical development for the treatment of obesity require daily dialysis. In contrast, our target product profile for RT-114 is for less frequent and potentially weekly orals.
Speaker Change: First and foremost we believe <unk> has the potential to demonstrate comparable weight loss, a better tolerability profile and greater preservation of lean muscle mass compared to currently approved products.
Speaker Change: So a shorter titration schedule may facilitate a quicker onset of effect.
Speaker Change: This could address the significant challenge with current GOP, one treatment options, where many patients discontinue therapy before achieving clinically meaningful weight loss and finally, the currently available oral therapies and those in clinical development for the treatment of obesity required daily dosing in contrast, our.
Speaker Change: Target product profile for our Q1 2014 is for less frequent and potentially weekly oral dosing.
Speaker Change: Looking ahead, we intend to move rapidly to advance <unk> into the clinic in mid 2025.
Talat Imran: Looking ahead, we intend to move rapidly to advance RT-114 into the clinic in mid-2020. Overall, we believe that RT-114 has the potential to be a highly differentiated and desirable product in the obesity market due to its potential to have a favorable safety profile and to preserve lean body mass as an oral therapy.
Speaker Change: Overall, we believe that <unk> has the potential to be a highly differentiated and desirable product and the obesity market due to its potential to have a favorable safety profile and to preserve lean body mass as an oral therapy.
Talat Imran: please turn to slide. Our target product profile for RT-114 and RT-116 is to be differentiated and competitive when compared with both subcutaneous and oral formulations of incretin therapy. Illustrated on this chart are approved obesity products and certain molecules in development. On the x-axis is the frequency of administration and the y-axis is the maximum API dose. As you can see in this two-by-two matrix, the oral therapies require daily or twice-daily dosing with doses in the hundreds of milliliters. While for small molecules this dose does not dramatically increase the cost of goods, for the orally available peptides, it has the potential to burden the supply chain and potentially increase COGS dramatically.
Speaker Change: Please turn to slide 12.
Speaker Change: Our target product profile for <unk>, 14, and <unk> 16 is to be differentiated and competitive when compared with both subcutaneous and oral formulations of <unk> therapy ilk.
Speaker Change: Illustrated on this chart are approved obesity products and certain molecules in development on the X axis is the frequency of administration and the Y axis is the maximum API dose per week as we can see in this two by two matrix the oral therapies require daily or twice daily dosing with doses in the one hundreds of milligrams.
Speaker Change: While for small molecule. This dose does not dramatically increase the cost of goods for the orally available peptides. It has the potential to burden the supply chain and potentially increased cogs dramatically.
Talat Imran: Of the therapies listed on the chart, RT-114 and RT-116 are the only proposed orals in development that are expected to utilize similar API quantity and dosing frequency as an injector.
Speaker Change: Other therapies listed on the chart <unk> 14, and <unk> 16 are the only proposed oral <unk> in development that are expected to utilize similar API quantity and dosing frequency as an injectable product.
Speaker Change: Now I would like to pass the call over to slide 13 and to survive Sanford, Our Chief Financial Officer to review our financial results.
Savai Sanford: Now I would like to pass the call over to Slide 13 and to Savai Sanford, our Chief Financial Officer, to review our financial Thank you, Talaat. Good afternoon, everyone, and thank you for joining the call.
Speaker Change: Thank you.
Speaker Change: Good afternoon, everyone and thank you for joining the call earlier today, we issued a press release and filed our Form 10-K with the Securities and Exchange Commission, which contain our financial results for the full year ending December 31, 2024, I will briefly share some key financial highlights on this call.
Savai Sanford: Earlier today, we issued a press release and filed a Form 10-K with the Securities and Exchange Commission, which contained our financial results for the full year ending December 31, 2024. I will briefly share some key financial highlights on this call. You can also find additional information in our Form 10-K for the year ended December 31, 2024.
Speaker Change: You can also find additional information.
Speaker Change: All in our Form 10-K for the year ended December 31, 2024, turning to our balance sheet cash cash equivalence and marketable securities as of December 31, 2024 totaled $27 6 million compared to $48 5 million as of December 31.
Savai Sanford: Turning to our balance sheet, cash, cash equivalents, and marketable securities, as of December 31, 2024, total $27.6 million, compared to $48.5 million as of December 31, 2024. We expect the cash, cash equivalent and marketable securities to be sufficient to fund our operation into the third quarter of 2025 without additional funding. For our operating results for the fourth quarter and year ended December 31, 2024, for the fourth quarter and full year 2024, we earned contract revenue of approximately $1 million related to a research evaluation service testing a prospective partner's drug, Imnerani pill. We have performed this service from time to time and have demonstrated successful deliveries of several drugs using the Rani pill.
Speaker Change: 2023.
Speaker Change: We expect the cash cash equivalents and marketable securities to be sufficient to fund our operations into the third quarter of 2025 without additional funding.
Speaker Change: Our operating results for the fourth for the fourth quarter and year ended December 31, 2024 for the fourth quarter and full year 2024, we earned contract revenue of approximately $1 million.
Speaker Change: Related to our research evaluation service testing a prospective partners in their R&D pill.
Speaker Change: We have performed its service from time to time and have demonstrated.
Speaker Change: Successful delivery of several drugs using the Rodney pill.
Savai Sanford: There was no contract revenue for the same period in 2023. Research and development expenses for the fourth quarter and full year 2024 were $6.8 million and $26.7 million, respectively. compared to 7.6 million and 39.6 million for the same period in 2023, respectively. The R&D expenses for the full year 2024 decreased by $12.9 million compared to the prior year due to our cost containment measures. General and administrative expenses for the fourth quarter and full year 2024 were $5.5 million and $23.9 million, respectively, compared to $5.8 million and $26.5 million for the same period in 2023, respectively.
Speaker Change: No our contract revenue for the same period in 2023.
Speaker Change: Research and development expenses for the fourth quarter and full year 2024 were $6 8 million and $26 7 million respectively.
Speaker Change: <unk> 276 million and $39 6 million on hand hearing in 2023, respectively.
Speaker Change: R&D expenses for the full year 2024 decreased by $12 9 million compared to the prior year due to our cost containment measures.
Speaker Change: General and administrative expenses for the fourth quarter and full year 2020 form of $5 5 million and $23 9 million respectively.
Speaker Change: Compared to $5 8 million and $26 5 million for the same periods in 2023, respectively.
Savai Sanford: The GNA expenses for the full year 2024 decreased by $2.5 million compared to the prior year due to our cost containment measures.
Speaker Change: The G&A expenses for the full year 2024 decreased by $2 5 million compared to the prior year due to our cost containment measures.
Savai Sanford: In the fourth quarter and full year 2024, we recorded an impairment loss of 3.7 million related to certain manufacturing property and equipment. which were previously reported as construction and progress assets. We consider a number of factors required by GAAP to assess whether the value of the property and equipment is recoverable. After a thorough assessment, it was determined that the carrying value of the property and equipment has exceeded the fair value, and therefore it was written down to the salvage value.
Speaker Change: In the fourth quarter and full year 2024, we recorded an impairment loss of $3 7 million related to certain manufacturing property and equipment.
Speaker Change: Which were previously reported as construction in progress assets.
Speaker Change: We consider a number of factors required by GAAP.
Speaker Change: Whether the value of the property and equipment is recoverable.
Speaker Change: After a thorough assessment to.
Speaker Change: Determined that the carrying value of the property and equipment has exceeded the fair value.
Speaker Change: And therefore, it was written down to the salvage value.
Savai Sanford: There were no such impairment losses in the comparable periods last year. Net loss for the fourth quarter and full year 2024 was $15.7 million and $56.6 million, respectively, compared to net losses of $14.1 million and $67.9 million for the same period in 2023, respectively. The net losses for the fourth quarter and full year 2024 include non-cash impairment loss of $3.7 million and stock-based compensation expense of $4 million and $16 million respectively. compared to non-cash stock-based compensation expense of $4.5 million and $19 million for the fourth quarter and full year 2023 respectively.
Speaker Change: There were no such impairment losses in the comparable period last year.
Speaker Change: Net loss for the fourth quarter and full year, 2024 was $15 7 million and $56 6 million, respectively compared to net losses of $14 1 million and $67 9 million for the same period in 2023, respectively.
Speaker Change: The net losses for the fourth quarter and full year 2024 include noncash impairment loss of $3 7 million and stock based compensation expense of $4 million and $16 million respectively.
Speaker Change: <unk> two noncash stock based compensation expense of $4 5 million and $19 million for the fourth quarter and full year 2023, respectively.
Savai Sanford: That concludes the financial section and I will return the call back to Talal for closing comments. Thank you, Suvai.
Speaker Change: That concludes the financial section and I will return the call back to <unk> for closing comments.
Speaker Change: Hello.
Speaker Change: Thank you survive.
Talat Imran: Please turn to slide. In conclusion, we take immense pride in the substantial advancements made at Rani Therapeutics and the remarkable opportunity we have to leverage our technology across a diverse array of product candidates within the obese. We believe the preclinical data we have generated with RT-114 and RT-116 provide validation of the potential for the RaniPill oral delivery platform in the obesity.
Speaker Change: Please turn to slide 14.
Speaker Change: In conclusion, we take immense pride in the substantial advancements made it Ronny therapeutics and the remarkable opportunity we have to leverage our technology across a diverse array of product candidates within the obesity sector.
Speaker Change: We believe the preclinical data we have generated with our Q1 2014, and <unk> 16 provide validation of the potential for the <unk> pill oral delivery platform in the obesity space.
Talat Imran: We look forward to bringing RT-114 into the clinic in mid-2025. We are confident that the Rani Pill platform possesses the transformative potential to redefine the treatment paradigm for injectable, large-molecule therapeutics by converting them into accessible oral treatments.
Speaker Change: We look forward to bringing <unk> into the clinic in mid 2025.
Speaker Change: We are confident that the writing pill platform possesses the transformative potential to redefine the treatment paradigm for injectable large molecule therapeutics by converting them into accessible oral treatments.
Talat Imran: I would like to convey my sincere appreciation to our stakeholders for their unwavering support of Rani and commitment to our vision of making oral biologics a reality.
Speaker Change: I'd like to convey my sincere appreciation to our stakeholders for their unwavering support of Ronnie and commitment to our vision of making oral biologics a reality.
Operator: With that, I will now open the call up for questions. Operator. As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced. After all your questions, please press star 1 1 again. Please stand by while we compile the Q&A room.
With that I will now open the call up for questions.
Speaker Change: Operator.
Speaker Change: As a reminder to ask a question. Please press star one one on your telephone and wait for your name to be announced to withdraw your.
Speaker Change: Your question. Please press Star one one again please.
Speaker Change: Please standby, while we compile the Q&A roster.
Annabelle Samimi: Our first question comes from Annabelle Samimi with Stiefel, your line is open. Hi, guys. Thanks for taking my questions. So, a few here.
Annabel: Our first question comes from Annabel <unk> with Stifel. Your line is open.
Annabel: Hi, guys. Thanks for taking my question so.
Speaker Change: A few here so first on oral southern tide.
Annabelle Samimi: So, first, on the oral semaglutide that's in development, are you developing this individually or are you using it as a validation tool for the other incretins so you can investigate the dual GLP-1, GLP-2? So, I just want to understand the rationale of doing – of developing a GLP-1 when, I guess, by the time you could even potentially get on the market, there's going to be a number of oral GLP-1s, whether it's daily or weekly. I just want to understand the rationale of doing that, given your capital constraints.
Annabel: That's in development.
Annabel: Are you developing this.
Annabel: Individually or are you using it as a validation tool for the other income and Christian. So you can investigate the dual <unk>. So I just wanted to understand.
Annabel: On the rationale I was giving.
Speaker Change: Helping NGL tier one win.
Speaker Change: I guess by the time, you could even potentially get on the market. There is going to be a number of oral <unk> ones.
Speaker Change: Whether it's daily or weekly.
Speaker Change: I just wanted to understand the rationale of doing that given your capital constraints.
Annabelle Samimi: What are the costs to conduct the next Phase 1 trial? Could you do that with the capital that you have?
Speaker Change: What are the costs to conduct the next phase one trial.
Speaker Change: Could you do that with the capital that you have.
Speaker Change: And I guess there is no real update on the other programs are those put aside for 114.
Annabelle Samimi: And I guess there's no real update on the other programs. So, are those put aside for 114 prioritization? Thanks.
Speaker Change: <unk>. Thanks.
Talat Imran: Hi, Annabelle. Thank you for the questions. I'll take the last one first. Our primary focus is on RT-114 for this year because of the capital constraints that you alluded to. We are still excited about those programs, the immunology programs in particular, and as more capital becomes available, we can advance those in the clinic. And I think on the RT-114 front, that sort of alludes to your other question around RT-116, the semaglutide program. That is a discovery program. We are not planning to run a clinical study for that program at this time. We did do it, as you said, to validate the delivery of an incretin and be able to show PD effect as well, which we were able to do both of those successfully in that study.
Annabel: Hi, Annabel.
Speaker Change: Thank you for the questions.
Speaker Change: I'll take the last one first.
Speaker Change: We are our primary focus is on our team $1 14 for this year because of the capital constraints that you alluded to.
Speaker Change: Sure.
Speaker Change: Still excited about those programs the immunology programs in particular.
Speaker Change: And as more capital that comes available we can advance us in the clinic and I think on the <unk> hundred 14 upfront that sort of alludes to your other question around RG 116, the Semicon type program.
Speaker Change: That is a discovery program we are not.
Speaker Change: Lanning to run a clinical study for that program at this time.
Speaker Change: We did do it as you said to validate the delivery of an <unk>.
Speaker Change: And be able to show PD effect, as well, which we were able to do both of those successfully in that study, 107% bioavailability relative to sub Q.
Talat Imran: 107% bioavailability relative to sub-Q and equivalent weight loss in those canines.
Speaker Change: And.
Speaker Change: Equivalent weight loss.
Speaker Change: Those canines.
Talat Imran: In terms of development, our primary focus is RT-114. As I said, it is a GLP-1, GLP-2, a novel mechanism. The obesity data that Progen put out last week for their clinical study is very promising. The only additional comment I'd make on RT-116, the semaglutide program, is you are correct that by the time you would be able to bring that onto the market in the US, there will be many other incretins that are better suited, RT-114 potentially included in that list for patients. Having said that, the semaglutide molecule is less than 40 amino acids. The composition of matter in many jurisdictions goes off patent next year.
Speaker Change: In terms of development.
Speaker Change: Our primary focus is our Q1 2014 as I said.
Speaker Change: It is <unk> a novel mechanism.
Speaker Change: The.
Speaker Change: <unk>.
Speaker Change: <unk> data that project put out last week for their clinical study is very promising.
Speaker Change: Only additional comment I'd make on the <unk> hundred 16. The Semicon type program is you are correct that by the time, you would be able to bring that onto the market in the U S.
Speaker Change: There will be many other things that are.
Speaker Change: Better suited.
<unk> hundred 14 potentially included in that list.
Speaker Change: For patients having said that it is.
Speaker Change: I mean, good type molecule is less than 40 amino acids. The composition of matter in many jurisdictions goes off patent next year and so there is a potential to develop it.
Talat Imran: And so there is a potential to develop it in an accelerated fashion for those markets, thinking of places like the GCC, the Middle East, Brazil, and the like, where you can command a decent price and there's very large obese populations. And in that scenario, though we're not committing to it right now, there's a potential to launch that kind of product much sooner than you would with a novel NCE or NME.
Speaker Change: In an accelerated fashion.
Speaker Change: For those markets.
Speaker Change: Thinking of places like the GCC, the middle East, Brazil and.
Speaker Change: And the like where you can command.
Speaker Change: A decent price and there is very large obese populations.
Speaker Change: And in that scenario, but we're not committing to it right now there is a potential to launch that kind of product much sooner than you would with a novel and.
Speaker Change: <unk> our enemy.
Talat Imran: Okay, if I can ask one more follow up, please, I guess, or do you have a capital to conduct a phase one trials? I guess that was one question that you missed answering. But secondly, can you tell us what would be expected cost of goods sold would be on a product like this, you know, in light of potential small molecules that might be out? Would you potentially have cost advantages or any kind of flexibility in terms of your cost of goods here? Because it seems like this would be possibly difficult to manufacture, but maybe I'm wrong on that point.
Speaker Change: Okay. If I can ask one more follow up.
Speaker Change: Please I guess alright.
Speaker Change: Have a capital to conduct a phase one trials.
I guess that was one question that you missed answering but secondly can you tell us what the expected cost of goods sold would be on a product like this.
Speaker Change: In light of potential small molecules that might be out.
Speaker Change: Would you potentially have.
Speaker Change: Cost advantages or any kind of flexibility in terms of your cost of goods here because it seems like this would be possibly difficult to manufacture, but maybe I'm wrong on that point, yes, so apologize.
Talat Imran: Yeah, so apologize when you asked about the phase one, I thought you were referring to the R. T. one, sixteen phase one. And as I said, we don't have plans to move that into the clinic at this point. The R. T. one, fourteen phase one, if that's what you were referring to. Yes, we do have that in the budget as as it's currently constituted in terms of cost of goods. We look at this as compared to the biologics because you're right. It's very cheap to make small molecules and to claim even just the, the API of a biologic to be competitive in pricing with a small molecule.
Speaker Change: You asked about the phase one I thought you were referring to.
Speaker Change: <unk> phase one and as I said, we don't have plans to move that into the clinic at this point.
Speaker Change: The <unk> hundred 14 phase one if that's what you're referring to yes, we do have that in the budget.
Speaker Change: As it's currently constituted.
Speaker Change: <unk>.
Speaker Change: In terms of cost of goods, we look at this as compared to the biologics because youre right. Its very cheap to make small molecules and to claim even just the API of a biologic to be competitive in pricing with the small molecule wouldn't be wouldn't be fair justified having said that the small molecule.
Talat Imran: Wouldn't be wouldn't be fair or justified. Having said that the small molecules have their own issues, which are around tolerability. So what we're targeting here is developing a weekly oral with one, fourteen, that will be competitive on a cost of goods perspective with the injectables. We have invested in our manufacturing automation and scale and we're confident we'll be able to achieve a cost target that that will make the product competitive, even as the price comes down in the market overall.
Speaker Change: <unk> have their own issues, which are around tolerability. So what we're targeting here is developing.
Speaker Change: Weekly oral with 114.
Speaker Change: That will be competitive on a cost of goods perspective with the injectables.
Speaker Change: We have invested in our manufacturing automation and scale.
Speaker Change: We're confident we'll be able to achieve a cogs target that debt.
Speaker Change: That will make the product competitive even as the price comes down in the market overall.
Speaker Change: Okay. Thank you, yes, absolutely.
Talat Imran: Thank you. Yeah, absolutely. Thank you.
Speaker Change: Thank you. Our next question comes from Andreas <unk> with Oppenheimer. Your line is open.
Eka: Our next question comes from And thank you.
Speaker Change: Thank you hi, everyone. This is ed on for Andrew today, Thanks for taking our questions.
Eka: Hi, everyone. This is Eka on for Andreas today. Thanks for taking our question. I want to ask on the variability that you mentioned compared to PG-102 subcutaneous injection. RT-114 had less variability in comparable weight loss. Can you talk about the different reasons behind this, in your opinion, and how do you see this translating into patients? And then I have one follow-up.
Speaker Change: I wanted to ask on the variability that you mentioned.
Speaker Change: Compared to <unk> 102 subcutaneous injection.
Speaker Change: <unk> has less variability.
Speaker Change: <unk>.
Speaker Change: Comparable weight loss can you talk about different reasons behind this in your opinion and how do you see this translating into patients and then I have one follow up sure.
Talat Imran: Sure. So, Ita, thank you for the question. The transenteric route, we have tested 19 molecules now, and several of them are larger proteins like monoclonal antibodies. And we've observed that it is a more efficient route than subcutaneous. It's where we evolve to take up nutrients. And so you see rapid onset. And as you alluded to, less variability than you see with subcutaneous, typically. That's what we've observed in our preclinical studies. And RT-114 is in line with those prior findings. Now, what do we expect in the clinical study? I think the clinical study will tell us.
Speaker Change: So thank you for the question.
Speaker Change: Ed.
Speaker Change: Transom Terek route we have tested 19 molecules now in several of them are larger proteins like monoclonal antibodies.
Speaker Change: We observed that it is a more efficient route the subcutaneous.
Speaker Change: It's where we evolve to take up nutrients and so you'll see rapid onset and as you alluded to less variability than you see with subcutaneous typically that's what we've observed in our preclinical studies.
Speaker Change: <unk> hundred 14 is in line with those prior findings now what do we expect in the clinical study I think the clinical study will tell us, but if it if it tracks the way that prior work has like ours Tomorrow Biosimilar as an example that we tested we are pretty excited about.
Eka: But if it tracks the way that prior work has, like our Solaro biosimilar, as an example, that we tested, we're pretty excited about being able to show perhaps less variability in humans. Got it. Thank you. That's helpful.
Speaker Change: Being able to show, perhaps less variability in humans as well.
Speaker Change: Got it. Thank you that's helpful.
Eka: And for the phase one study for our team, can you talk about the patients that you that you envision enrolling in the study? And then what subsequent studies you plan to conduct?
Speaker Change: And for the Phase one study for <unk> one for Keith can you talk about the patients that you that you envision enrolling in the study and then.
Speaker Change: Our subsequent of that ACO plan too.
Talat Imran: Thank you. Sure. Absolutely. So the phase 1 is gonna be a single ascending dose and then a multi ascending dose. We're considering running a 2 month study in obese patients of patients with a BMI above 30. these will be non diabetics to start with. And we're gonna be looking at the tolerability of repeat dose and the overall weight loss in terms of subsequent studies. After that, our expectation, we'll have to review the data. But most likely would be to do a phase to a 12 week study with a larger patient population and and test perhaps 2 doses in the Ronnie pill versus a placebo.
Speaker Change: Sure sure absolutely. So the phase one is going to be a single ascending dose and then a multi ascending dose with.
Speaker Change: We're considering running a two month.
Speaker Change: This study in obese patients so patients with a BMI above 30, these will be non diabetics to start with and we're going to be looking at the tolerability of repeat dose and the overall weight loss in terms of subsequent studies after that our expectation we will have to.
Speaker Change: View of the data, but most likely would be to do a phase Iia 12 week study with a larger patient population.
Speaker Change: And in test.
Speaker Change: Perhaps two doses in the rotting pill versus placebo.
Speaker Change: Placebo.
Eka: Thank you.
Speaker Change: Thank you.
Speaker Change: Thank you.
Speaker Change: Thank you. Our next question comes from Julian Harrison with <unk>. Your line is open.
Julian Harrison: Our next question comes from Julian Harrison with BTIG. Your line is open. Hi, thank you for taking my questions.
Speaker Change: Alright. Thank you for taking my questions I'm curious how much Tolerability April guide early clinical development of <unk> and how much flexibility do you expect to have in dosing to optimize tolerability.
Talat Imran: I'm curious how much tolerability will guide early clinical development of RT-114 and how much flexibility you expect to have in dosing to optimize tolerability. Hey, Julian. And thank you for the question. You bring up a great point. Tolerability is really the key here. This is where we see the potential differentiation. If we look at the PG 102 clinical data, they showed excellent tolerability in their phase one repeat dose study. And that was with a very rapid titration to maximum dose. What we'll be looking at in our study is to match those results or come as close as possible.
Speaker Change: Hey, Julian and thank you for the question.
Speaker Change: You bring up a great point Tolerability is really the key here is this is where we see the potential differentiation. If we look at the PG, one or two clinical data.
Speaker Change: <unk> excellent tolerability in their phase one repeat dose study.
Speaker Change: And that was with a very rapid titration to maximum dose what we'll be looking at in our study as to match those results or come as close as possible and in terms of the flexibility and the beauty of an oral formulation as you can always take another pill. If if one pill has greater tolerability issues for instance, we could.
Talat Imran: And in terms of flexibility, the beauty of an oral formulation is you can always take another pill. If one pill has greater tolerability issues, for instance, we could split it into two doses and bring the peak down, bring the trough up and potentially improve tolerability if that's necessary. So not only the vector that every injectable uses of titrating over a greater period of time, we can also spread out the dose. Just one anecdote on that, I was reading about the compounded semaglutide that a number of patients are on in the US. And some of these patients, because of tolerability issues, have started splitting their dose and taking a couple of injections a week, which you can do with a needle and syringe or a vial and syringe, I should say.
Speaker Change: Split it into two doses.
Speaker Change: And bring the peaks down bring the trough up and potentially.
Speaker Change: Improved tolerability.
Speaker Change: Sorry, so not only be the vector that every injectable users of tie.
Speaker Change: Tight trading over a greater period of time, we can also spread out the dose.
Speaker Change: One anecdote on that.
Speaker Change: Reading about.
Speaker Change: The compounded.
Speaker Change: <unk> tied.
Speaker Change: A number of patients are on in the U S.
Speaker Change: Some of these patients because of Tolerability issues have started splitting their dose and taking a couple of injections a week, which you can do with the with a needle and syringe or a vial and syringe I should say.
Talat Imran: And so we have that same flexibility built in to the fact that we have an oral formulation.
Speaker Change: And so we have that same flexibility built in.
Speaker Change: So the fact that we have an oral formulation.
Talat Imran: Very helpful. Thank you. Yeah. Thank you, Julie. Thank you.
Speaker Change: Very helpful. Thank you.
Speaker Change: Yeah. Thank you Julien.
Speaker Change: Thank you. Our next question comes from Mitchell Kapoor with H C. Wainwright Your line is open.
Mitchell Kapoor: Our next question comes from Mitchell Kapoor with HC Wainwright. Your line is open. Hi, everyone. Thanks for taking the questions. First one is I wanted to ask about the higher peak concentration of 1, 1, 4 that you show versus subcutaneous and just kind of the implications for that. I think we've seen, you know, with the RaniPill formulated drugs that they can get to this higher peak concentration initially. Is there something that we should be thinking about in terms of, you know, the implications there and what that could mean?
Mitchell Kapoor: Hey, everyone. Thanks for taking the questions.
Mitchell Kapoor: First one is I wanted to ask about the concentration of 114.
Mitchell Kapoor: That you show versus subcutaneous and just kind of the implications for that I think we've seen with.
Mitchell Kapoor: With the Ronnie pill formulated drugs that they can get to this higher peak concentration. Initially is there something that we should be thinking about in terms of the implications there and what that means.
Talat Imran: So we didn't see a statistic. Hey, Mitchell, by the way, good to talk to you. We didn't see a statistical difference between the nausea or vomiting in the canines. I think in the clinical study, we will look at titration schedules because there is a higher peak. And as you're alluding to, there is a correlation across studies with higher peaks and incidents of nausea and vomiting. I think this is something that can, first, we'll have to see if that's an issue because the route of administration is different. And then secondly, if there is, we can always just titrate a little bit slower given how quick the titration was with PG-102 in their injectable study or split it into two pills.
Mitchell Kapoor: So we didn't see a statistic he mentioned by the way good to talk to you we didn't see a statistical difference between the nausea, vomiting, and Mccain items I think in the clinical study, we will look at titration schedules because there is a higher peak and as Youre alluding to there is a.
Mitchell Kapoor: Correlation across study is with higher peaks.
Mitchell Kapoor: The Haynesville nausea, and vomiting, I think this is something that can first we will have to see if thats an issue.
Mitchell Kapoor: Because of the route of administration is different and then secondly, if.
Mitchell Kapoor: There is we can always just tie trade a little bit slower given how quick the titration was with PD, one or two in their injectable study or split it into two pills and that that will bring the.
Talat Imran: And that will bring the nausea and vomiting potentially under control. What was interesting, we didn't do this with the Rani pill, but in the subcutaneous, when we were doing dose findings so that we could select the right dose for the Rani pill for the RT-114 preclinical study, we tested lower doses of PG-102 subcutaneous. And if you go down half a dose or by half, I should say, there were no AEs whatsoever. So I think that would be potentially a really successful approach if there is some issue.
Mitchell Kapoor: The <unk>.
Mitchell Kapoor: <unk> vomiting, potentially under control what was interesting we didn't do this with the Ronnie pill, but in the subcutaneous.
Mitchell Kapoor: We were doing dose finding so that we could select the right dose for the radical for the <unk> hundred 14 preclinical study, we tested lower doses of <unk> 102, subcutaneous and if you go down half a dose bye bye bye have I should say there were no aes whatsoever. So.
Mitchell Kapoor: I think that would be potentially a really successful approach. If there is some issue with the peak.
Mitchell Kapoor: Okay, perfect. Very helpful.
Speaker Change: Okay perfect very helpful and then on the.
Mitchell Kapoor: And then on the on the BD front, can you just talk about any interest you're receiving or kind of the types of interest or anything that may have changed since the last time you updated the street on that front?
Speaker Change: On the BD front can you just talk about any interest you are receiving or kind of the types of interest or anything that may have changed since.
Speaker Change: Since the last time, you updated the street on that front and then just the priorities you have for developing <unk> as a platform.
Talat Imran: And then just the priorities you have for developing the RaniPill as a platform and trying to get this across many indications versus just the product that we're currently focused on? Sure. So thank you for asking that. And partnering is still a primary focus for us as a company. We've done the development work we have, in part, to prove out the platform. I think with PG102, that partnership with ProGen was to bring a really novel and potentially best-in-class GLP-1, GLP-2 to the market. So that was a BD deal that we did last year. As you heard from Savai, we can't dispose the partner, but we have been doing some research collaboration with a large pharma company.
Speaker Change: Trying to get this.
Across many indications versus just the product.
Speaker Change: Currently.
Speaker Change: Sure. So thank you for asking that in partnering is still.
Speaker Change: Our primary focus for us as a company we've done the development work we have.
Speaker Change: Part to prove out the platform I think with PD, one or two that partnership with program was to bring a really novel and potentially best in class <unk> <unk>.
Speaker Change: Yes.
Speaker Change: To the market. So that was a BD deal that we did last year.
Speaker Change: As you heard from survive, we can't disclose the partner, but we have been doing some research collaboration with large pharma company.
Talat Imran: And then beyond that, there's a tremendous amount of interest in the RaniPill. And that interest is in obesity, in immunology, and in rare disease. And there's multiple potential partners in both of those, in all of those categories.
Speaker Change: And then beyond that there is a tremendous amount of interest in the Raleigh pill that interest us into obesity.
Speaker Change: The immunology.
Speaker Change: In rare disease, and there is multiple potential partners in both of those all of those categories I should say.
Talat Imran: Great. Thank you very much, Talat and Fai. Thank you.
Speaker Change: Great. Thank you very much still on site.
Speaker Change: Thank you. Thank you Mitchell.
Speaker Change: Thank you.
Operator: As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced. Again, that is star 11 to ask a question.
Speaker Change: As a reminder to ask a question. Please press star one one on your telephone and wafer your name to be announced again that is star one one to ask question.
Chad: Our next question comes from Michael Akunowich with Maxim Group. Your line is open. Hi, this is Chad on for Michael. Thanks for taking the questions. We're just wondering, how does Progen's PG-102 weight loss and speed of titration compare to Xelan's GLP-1, GLP-2? Yeah, good question, Chad. It's hard to compare across studies. I will caveat that. In their phase one multidose there, meaning Xelans, I think they showed similar, maybe slightly lower weight loss, if my recollection serves me. But then it was a little bit more muted in the repeat dose study or the longer-term repeat dose study that they ran.
Michael <unk>: Our next question comes from Michael <unk> with Maxim Group. Your line is open.
Speaker Change: Yes.
Chad: Hi, This is Chad on for Michael Thanks for taking the questions.
Speaker Change: We're just wondering how do you project the PG 100 to weight loss and speed of titration Comparative Zealand's <unk> DLP too.
Speaker Change: Yeah. Good question Chad.
Speaker Change: It's hard to compare across studies I'll caveat that.
Speaker Change: B in their phase one.
Speaker Change: Multi dose there meaning zealand's.
Speaker Change: I think they showed similar maybe slightly lower weight loss. If my recollection serves me.
Speaker Change: But then.
Speaker Change: It was a little bit more muted in the repeat dose study or the longer term repeat dose study that they ran and then they.
Talat Imran: And then they tested higher doses, which led to better weight loss.
Tested higher doses, which led to better weight loss.
Talat Imran: What we saw in the preclinical, or what Progen saw in their preclinical DIO work with both the zeoland peptide, they got a research-grade version of that, of dapaglutide versus the Fc-fusion protein version of the GLP-1, GLP-2, Progen's drug was that PG-102 had much more sustained weight loss over time. And the dapaglutide product at those doses plateaued, which is what we ended up seeing in the clinical studies from zeoland, the sort of intermediate repeat dose study. So it's hard to draw a conclusion from that.
Speaker Change: What we saw in the preclinical or what projects on their preclinical DIR work with both the.
Speaker Change: Zealand peptide they got a research grade version of that of <unk> versus the.
Speaker Change: The FC fusion protein version.
Speaker Change: The <unk> <unk> to <unk>.
Speaker Change: <unk> drug.
Speaker Change: Is that P. G 102 had much more sustained weight loss over time.
Speaker Change: And the <unk> tied.
Speaker Change: Product at those doses plateaued, which is what we ended up seeing in the in the clinical studies from <unk> sort of intermediate repeat dose study.
Speaker Change: So it's hard to draw a conclusion from that but what I would say is that.
Talat Imran: But what I would say is that looking at the preclinical data and the clinical data we now have from Progen, we're very excited about this program. And then the final part that you alluded to as well was the titration. This is something that is incredibly attractive about this drug. It is an Fc-fusion protein, not a peptide. And so similar to maritide from Amgen, which requires no titration, they were able to get to a maximum dose within a month. And that bodes well for patients. Great. Thanks for taking the question, Paul. Thank you.
Speaker Change: Looking at the preclinical data and preclinical data we now have.
Speaker Change: From projects, we're very excited about this program and then the final part that you alluded to as well was the titration.
Speaker Change: <unk>.
Speaker Change: Something that is incredibly attractive about this drug it is FC fusion protein not not a peptide and so.
Speaker Change: Similar to <unk>.
Speaker Change: <unk> from from Amgen, which requires no titration, they were able to get to a maximum dose within within a month.
Speaker Change: And that bodes well for patients potentially.
Speaker Change: Great. Thanks for taking the question Paul Thank you.
Speaker Change: Thank you our next question comes from.
Xinwei: Our next question comes from Hey, congrats on the progress, and thank you for taking my questions. I have two regarding the 114 program. The first one is, do you plan to conduct any additional animal studies before you go into the clinics? And then, how confident you are that we will see the human data mimicking what we have seen so far?
Speaker Change: <unk> <unk> with Canaccord Genuity your line is open.
Speaker Change: Hey, congrats on the progress and thank you for taking my questions.
Two regarding the <unk> program. The first one is do you plan to conduct any additional animal studies before you go into the clinic and then how confident you are that we will see the human data on mimicking what we have seen.
Xinwei: Thank you.
Speaker Change: So far thank you.
Talat Imran: Hi, Xinwei. So on the first question, that's easy. No, we don't plan to do any more preclinical work in order to get into the clinic. On the second one, it's hard to speculate. What I will say is, this will be our fourth. Phase I study, and we have shown very good bioavailability in those prior studies, and with the preclinical data that we've put out showing similar weight loss and similar PK as compared to the sub-Q, we have a lot of confidence going into it. But, you know, the clinical study will ultimately tell the story.
Speaker Change: Passion way.
Speaker Change: So on the first question Thats easy no. We don't plan to do anymore preclinical work in order to get into the clinic on the second one it's hard to speculate.
Speaker Change: What I will say is we have this will be our fourth.
Speaker Change: Phase one study and we have shown very good bioavailability in those prior studies.
Speaker Change: With the preclinical data that we've put out showing similar weight loss and similar.
Speaker Change: K as compared to the sub Q, we have a lot of confidence going into it but the clinical study will ultimately tell the story.
Xinwei: Thank you.
Speaker Change: Thank you. Our next question comes from Sean <unk> with Zacks. Your line is open.
John Vandermusen: Our next question comes from John Vandermusen with VEX, your line is Thank you and hello to all. So regarding PG-102, do we expect to see the standard phase one, phase two, and pivotal studies before that goes in front of the regulatory agencies? Or is there some twist to that?
Speaker Change: Thank you and Hello, Todd.
Speaker Change: Hi.
Speaker Change: So regarding PD 102, do we expect to see the standard phase one phase II and pivotal studies before that goes in front of the regulatory agencies or is there some twist to that at all.
Talat Imran: Hi, John. So, you're asking about the subcutaneous version of... Right. Exactly. Yeah, what ProGen is going to do. Got it. Yeah. So, I just want to make sure I was catching that right. So, what they have said publicly and what I can speak to is they have completed their Phase 1, right? They put out the data last week. They are in a Phase 2a and they plan on filing an IND, I believe, for their subcue in the U.S. I want to say it's the next year. We can come back to you on the exact public guidance that they've given.
Speaker Change: Hi, John So you are asking about the subcutaneous version of <unk>.
Speaker Change: Yeah exactly yeah, what project is going to do got it got it yes. So I just want to make sure I was catching that right. So what they have said publicly.
Speaker Change: What I can speak to us they have completed their phase one right. They put out the data last week.
They are in a phase two a M.
Speaker Change: And they plan on filing an IND I believe for their sub Q in the U S and I want to say, it's the next year, we can come back to you on the exact public guidance that <unk>, given but they do plan to move that forward and that's one of the attractive things about the <unk> hundred 14 program as we get to as we do with Biosimilars.
Talat Imran: But they do plan to move that forward. And that's one of the attractive things about the RT-114 program is we get to, as we do with biosimilars, though this is a novel molecule, we get to sort of tread in their wake. We can look at the doses that they have tested. We can observe the titration schedules and any improvements, challenges that they have, and we can apply those, which should make our clinical studies faster and more efficient. And then I guess you'll be trailing behind them by just a certain fixed margin, I guess, in terms of timing.
Speaker Change: This is a novel molecule, we get to sort of trend in their wake.
Speaker Change: We can look at the doses that they have tested we can we can observe the dose titration schedules and any any improvements challenges that they have and we can apply those which should make our clinical studies faster and more efficient.
Speaker Change: Okay, and then I guess youll be trailing behind them by a certain fixed margin I guess in terms of timing. So as soon as they complete their pivotal studies, then and submit you would you would submit following that or how would that look like yeah.
Talat Imran: So as soon as they complete their pivotal studies, then and submit, you would you would submit following that? Or how would that look? When we, yeah, another good question that that is very likely the case, since the molecule is the same, we could get some advantages from them having submitted already again. And time will tell as we go through development, which one gets prioritized more by Progen as well. I think the differentiation, speaking from Rani's perspective, of RT-114 is tremendous as compared to an injectable GLP-1, GLP-2 against the backdrop of the broader market. They'll have to make that determination, but it does confer some advantages if they do submit to the Rani-Progen partner.
Speaker Change: Another good question.
Speaker Change: That is very likely the case since the molecule is the same we could get some advantages from them having submitted already.
Speaker Change: Again time will tell as we go through development.
Speaker Change: Which one gets prioritized more by pro Gen as well I think the differentiation.
Ronnie Therapeutics: Speaking from Ronnie's perspective of Archie $1 14.
Ronnie Therapeutics: Is tremendous as compared to an injectable <unk> against the backdrop of the broader market.
Ronnie Therapeutics: They'll have to make that determination, but it does confer some advantages if they do submit.
Ronnie Therapeutics: To the Ronnie approach in partnership.
Talat Imran: Thanks a lot. Yeah. Absolutely. Thank you.
Speaker Change: Okay. Thanks, a lot yes, absolutely.
Ronnie Therapeutics: Thank you.
Operator: I'm showing no further questions at this time.
Martin: Showing no further questions at this time I would now like to turn it back to Martin for closing remarks.
Talat Imran: Oh, now I'd like to turn it back to Talat Imran for closing remarks. Thank you, operator. This concludes our fourth quarter and full year 2024 financial results and corporate update conference call. Thank you again, everyone for joining us this afternoon. This concludes today's conference. Thank you for participating. You may now. Thank you for watching!
Martin: Thank you operator.
Martin: This concludes our fourth quarter and full year 2024 financial results and corporate update update conference call.
Martin: Thank you again, everyone for joining us this afternoon.
Martin: This concludes today's conference call.
Martin: Thank you for participating you may now disconnect.
Martin: [music].
Martin: Yeah.
Martin: Okay.
Martin: [music].