Rani Therapeutics Holdings Inc (RANI) 2024 Q4 法說會逐字稿

Welcome to the Rani fourth-quarter and full-year 2024 financial results and corporate update conference call. (Operator Instructions) As a reminder, this call is being recorded today, March 31, 2025.

歡迎參加 Rani 2024 年第四季及全年財務表現及公司更新電話會議。（操作員指示）提醒一下，本次通話於今天（2025 年 3 月 31 日）進行錄音。

I would now like to turn the conference over to Kiki Patel at Gilmartin Group. Please go ahead.

現在我想將會議交給 Gilmartin Group 的 Kiki Patel。請繼續。

Thank you, operator. Please turn to slide 2. Joining us on the call today from Rani Therapeutics, our Chief Executive Officer, Talat Imran; and Chief Financial Officer, Svai Sanford.

謝謝您，接線生。請翻到投影片 2。今天參加電話會議的還有 Rani Therapeutics、我們的執行長 Talat Imran 和財務長 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 factor 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.

在本次電話會議中，管理階層將做出前瞻性陳述，這些陳述受風險、不確定性和假設的影響，例如但不限於公司向美國證券交易委員會提交的文件的風險因素部分中討論的風險、不確定性和假設，包括公司 10-K 表年度報告和 10-Q 表季度報告，其中確定了可能導致實際結果或事件與這些前瞻性因素中描述的具體風險陳述中描述的具體風險或事件。

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. Actual results and the timing of events could differ materially from those projected in such forward-looking statements.

這些聲明可能包括但不限於有關產品開發和臨床試驗、產品潛力、市場規模、平台進度、平台潛力、某些商業策略、資本資源、融資計劃或經營績效的聲明。實際結果和事件發生的時間可能與此類前瞻性陳述中的預測有重大差異。

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

說完這些，我把電話轉到第三張幻燈片，向你們介紹 Rani Therapeutics 的執行長 Talat Imran。塔拉特？

Thank you, Kiki. Good afternoon, everyone, and thank you for joining our earnings call for the fourth quarter and full year of 2024. 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. Our RaniPill technology is currently being evaluated across several high-value indications, including the obesity and immunology spaces.

謝謝你，琪琪。大家下午好，感謝大家參加我們 2024 年第四季和全年財報電話會議。Rani Therapeutics 是一家臨床階段的生物技術公司，開發了一種口服生物製劑的平台技術，其生物利​​用度已證實可與皮下注射相媲美。我們的 RaniPill 技術目前正在針對多種高價值適應症進行評估，包括肥胖和免疫學領域。

I will start the call by providing a brief overview of our RaniPill capsule technology platform and highlight the important advancements that Rani has achieved in its pipeline over the past year. Then I will share how we are leveraging the RaniPill technology to develop the next generation of obesity therapies, including our RT114 and semaglutide programs. And then finally, Svai Sanford, our CFO, will provide an update on our financial results for the fourth quarter and full year 2024.

我將在電話會議開始時簡要介紹我們的 RaniPill 膠囊技術平台，並強調 Rani 在過去一年中在其產品線中取得的重要進展。然後我將分享我們如何利用 RaniPill 技術開發下一代肥胖療法，包括我們的 RT114 和 semaglutide 計畫。最後，我們的財務長 Svai Sanford 將提供我們 2024 年第四季和全年財務業績的最新情況。

So let's begin. Please turn to slide 5. 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 indications.

那麼就讓我們開始吧。請翻到投影片 5。在 Rani Therapeutics，我們的使命是讓數百萬患有慢性病的患者不再遭受注射的痛苦。牢記這項使命，自 Rani 成立十餘年以來，我們已經取得了長足的進步。RaniPill 膠囊經過了廣泛的測試和臨床驗證，代表了口服生物製劑的突破，能夠在多種適應症中匹配注射生物利用度。

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 the stomach. Previous attempts at delivering biologics orally have struggled to pass through the stomach, and as a result, have been unsuccessful.

RaniPill 技術由一種創新的機器人藥丸組成，該藥丸具有專有的腸溶衣，易於吞嚥並能穿過胃的酸性環境。以前嘗試口服生物製劑的嘗試都難以通過胃部，因此沒有成功。

Once in the small intestines, the higher pH level breaks down the enteric coating and outer shell of the RaniPill capsule which exposes the delivery mechanism to intestinal fluid. In the small intestine, a self-inflating balloon creates the pressure needed to inject the dissolvable microneedle and deliver the drug via a transenteric painless injection.

一旦進入小腸，較高的 pH 值會破壞 RaniPill 膠囊的腸溶衣和外殼，使輸送機制暴露於腸液中。在小腸中，自充氣球囊產生注射可溶解微針所需的壓力，並透過經腸無痛注射輸送藥物。

Once delivered, the drug is quickly absorbed by the vascular system and the device deflates and is safely passed out. Our platform technology is intended to enable the oral administration of any biologic with bioavailability comparable to a subcutaneous injection, resulting in a potential for broad application across multiple indications. Our RaniPill technology is currently being evaluated in several high-value indications across the immunology and obesity spaces. Furthermore, Rani has a robust patent portfolio with over 450 granted patents and pending applications.

一旦輸送，藥物就會被血管系統迅速吸收，裝置就會放氣並安全地排出。我們的平台技術旨在實現任何生物製劑的口服給藥，其生物利​​用度與皮下注射相當，從而有可能廣泛應用於多種適應症。我們的 RaniPill 技術目前正在免疫學和肥胖領域的幾個高價值適應症中進行評估。此外，Rani 擁有強大的專利組合，其中已授權專利和正在申請的專利超過 450 項。

Please turn to slide 6. Today, our platform technology stands as a proven success, demonstrating consistency across a wide range of preclinical and clinical trials. In preclinical studies, the RaniPill 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 RaniPill was well tolerated and there were no serious adverse events.

請翻到幻燈片 6。如今，我們的平台技術已被證明是成功的，並在廣泛的臨床前和臨床試驗中展現了一致性。在臨床前研究中，與皮下注射相比，RaniPill 對 19 種分子（包括抗體、勝肽和大蛋白）具有更高的生物利用度。此外，我們還進行了為期 60 天的重複給藥 GLP 研究，其中 RaniPill 耐受性良好，沒有出現嚴重不良事件。

Clinically, we have completed three phase one studies. And in these studies, the RaniPill has been well tolerated with no serious adverse events reported with more than 200 pills administered to 146 subjects. Overall, we believe the RaniPill 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. We believe this represents a distinct advantage that positions Rani programs for future success.

臨床上，我們已經完成了三項第一階段研究。在這些研究中，RaniPill 耐受性良好，146 名受試者服用了 200 多顆藥丸，未報告任何嚴重不良事件。總體而言，我們相信 RaniPill 具有輸送高生物利用度藥物以及與皮下注射類似的劑量大小和頻率的潛力，解決了基於化學的口服給藥所面臨的挑戰。我們相信，這代表著 Rani 計畫在未來取得成功的獨特優勢。

Now on to slide 7. 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 space, a market projected to reach $100 billion by 2030, where oral alternatives could redefine the treatment paradigm.

現在看投影片 7。談到我們的產品線，我們為 2024 年以及 2025 年迄今所取得的成就感到自豪，特別是我們在肥胖領域的產品線所取得的進展，預計到 2030 年，該市場的規模將達到 1000 億美元，口服替代品可能會重新定義治療模式。

To date, Rani has successfully evaluated four and cretin-based molecules in preclinical studies. 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 and cretin therapies, as well as semiglutide and RT-114. 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 RaniPill technology.

迄今為止，Rani 已在臨床前研究中成功評估了四種基於克汀病的分子。這些研究強調了 RaniPill 平台的潛力，它可以透過口服的方式提供多種肥胖症治療藥物，包括單一療法、三角療法和克汀病療法，以及塞米魯肽和 RT-114。我們相信，過去一年我們在產品線中取得的重大進展使我們能夠進一步擴大肥胖症產品組合，並實現 RaniPill 技術的變革潛力。

As a reminder, in June of 2024, Rani announced that it entered into a definitive agreement for the co-development and commercialization of RT114 with ProGen Limited, a South Korean clinical stage biotech company developing next generation, long acting, multi-specific fusion protein therapeutics. RT-114 combines ProGen's FC fusion protein conjugated GLP-1/GLP-2 dual agonist PG-102 with the RaniPill. 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 RaniPill to create a strongly differentiated singular product in the obesity market.

提醒一下，2024 年 6 月，Rani 宣布與韓國臨床階段生物技術公司 ProGen Limited 達成最終協議，共同開發和商業化 RT114，ProGen Limited 致力於開發下一代長效、多特異性融合蛋白療法。RT-114 將 ProGen 的 FC 融合蛋白結合 GLP-1/GLP-2 雙重激動劑 PG-102 與 RaniPill 結合在一起。此次策略合作背後的原理是將潛在的最佳 GLP-1/GLP-2 資產與 RaniPill 的便利性和劑量靈活性相結合，從而在肥胖市場中創造出具有強烈差異化的單一產品。

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 Conference. I will review the results and next steps for our RT-114 program later on in the call.

上週，Rani 分享了 RT-114 的臨床前更新，ProGen 在亞洲糖尿病研究協會會議上展示了 PG-102 的數據。我將在稍後的電話會議中回顧我們的 RT-114 計劃的結果和後續步驟。

Beyond RT-114, one of the most significant advancements in our pipeline over the past year is the introduction of RT-116, an orally administered version of semaglutides. Semaglutides selectively binds to and activates the GLP-1 receptor, mimicking its natural activity. GLP-1 is an incretin hormone, an enterogasterone that plays a crucial role in regulating appetite and food intake by stimulating insulin secretion, inhibiting glucagon secretion, and delaying gastric empty. Last month, we shared encouraging preclinical data demonstrating the successful delivery of semaglutide via the RaniPill. And I will provide an overview of those results shortly.

除了 RT-114 之外，我們過去一年來在產品線中取得的最重大進展之一是推出了 RT-116，一種口服的司美格魯肽。司美格魯肽選擇性結合並活化 GLP-1 受體，模仿其天然活性。GLP-1 是一種腸促胰島素激素，一種腸固酮，透過刺激胰島素分泌、抑制胰高血糖素分泌和延緩胃排空，在調節食慾和食物攝取方面發揮至關重要的作用。上個月，我們分享了令人鼓舞的臨床前數據，證明透過 RaniPill 成功輸送了司美格魯肽。我將很快概述這些結果。

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 incretin-based therapies, thus highlighting the need for more tolerable options. While our current focus is on the obesity space, we have additional assets in development in our pipeline in immunology and endocrinology. Overall, we are open to additional opportunities to partner with pharmaceutical companies using our drug agnostic platform to advance oral biologics for patients.

總體而言，我們對肥胖症治療計劃所取得的進展感到鼓舞，特別是考慮到耐受性挑戰限制了第一代基於腸促胰島素的療法的療效，從而凸顯了對更多耐受性選擇的需要。雖然我們目前的重點是肥胖領域，但我們在免疫學和內分泌學領域還有其他資產正在開發中。整體而言，我們願意尋求更多機會與製藥公司合作，利用我們的藥物無關平台為患者推進口服生物製劑的發展。

Now, I will review the data we shared this quarter on RT-114 and RT-116 as we leverage the RaniPIL technology to develop the next generation of obesity therapy.

現在，我將回顧我們本季在 RT-114 和 RT-116 上分享的數據，因為我們利用 RaniPIL 技術開發下一代肥胖療法。

Please turn to slide 9. In February 2025, Rani announced preclinical data demonstrating the successful oral delivery of stemaglutide or RT-116 via the RaniPill. On this slide, purple represents RT-116 and the teal green represents subcutaneously delivered stemaglutide.

請翻到第 9 張投影片。2025 年 2 月，Rani 公佈了臨床前數據，證明透過 RaniPill 成功口服了 Stemaglutide 或 RT-116。在此投影片上，紫色代表 RT-116，青綠色代表皮下輸送的司他格魯肽。

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 is a pharmacodynamic effect to treatment.

如您所見，從左側的藥物動力學曲線來看，RT-116 實現了與皮下給藥相當的藥物動力學。至於藥效學，兩組的體重都有類似的減輕，這似乎是由於食物攝取量減少所致。體重減輕與血漿藥物水平升高同時發生，顯示治療具有藥效學作用。

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%. Furthermore, RT-116 was well tolerated with no serious adverse events reported. Overall, we are pleased with this data.

兩組的血清三酸甘油酯和膽固醇均有相應下降。至於生物活性，口服司美格魯肽與皮下給藥的相對生物利用度為 107%。此外，RT-116 耐受性良好，未報告嚴重不良事件。總體而言，我們對這些數據感到滿意。

Currently, semaglutide is available exclusively as a subcutaneous injection for the treatment of obesity. marketed in the US under the brand name Wegovy by Novo Nordisk. While Rybelsus 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 counterpart. 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 injectable, which we believe may be more convenient for patients and could lead to improved adherence.

目前，司美格魯肽僅以皮下注射劑的形式用於治療肥胖症。由諾和諾德公司在美國以 Wegovy 品牌銷售。雖然 Rybelsus 提供了一種口服的司美格魯肽，該藥物已被批准用於改善 2 型糖尿病成人患者的血糖控制，但它需要每天服用比皮下注射劑量高得多的劑量。相較之下，RaniPill 膠囊中司美格魯肽的目標產品特性是每週口服一次司美格魯肽治療，劑量與注射劑相似，我們認為這可能對患者更方便，並可提高依從性。

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 RaniPill capsule, otherwise known as RT-114, compared to PG-102 delivered subcutaneously in 16 healthy canines.

請翻到第 10 張投影片，我將分享我們上週發布的 RT-114 數據的令人興奮的臨床前結果。Rani 發布了臨床前數據，對 16 隻健康犬進行了頭對頭比較，對比了透過 RaniPill 膠囊遞送的口服 PG-102（ProGen 的 GLP-1/GLP-2 分子，也稱為 RT-114）和皮下遞送的 PG-102。

As you can see when looking at the pharmacokinetic curve for both treatments, RT-114 yielded a higher Cmax and earlier Tmax with a relative bioavailability of 111% compared to PG-102 delivered subcutaneously. Furthermore, These data confirm bioequivalence of RT-114 to subcutaneously deliver PG-102. The RaniPill capsule was well tolerated with no changes in drug-related safety profile compared to subcutaneous delivery.

從兩種治療方法的藥物動力學曲線可以看出，與皮下注射的 PG-102 相比，RT-114 產生了更高的 Cmax 和更早的 Tmax，相對生物利用度為 111%。此外，這些數據證實了 RT-114 與皮下輸送 PG-102 的生物等效性。與皮下注射相比，RaniPill 膠囊耐受性良好，藥物相關的安全性沒有變化。

On the bar graph on the right-hand side, you will see the pharmacodynamics of RT-114 measured by body weight. Both groups demonstrated an average peak weight loss of 6.7%. However, there was more variability in results with subcutaneous dosing.

在右側的長條圖上，您將看到以體重衡量的 RT-114 藥效動力學。兩組的平均峰值體重減輕量均為 6.7%。然而，皮下給藥的結果變化較大。

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 PG102 with the convenience of oral delivery. ProGen recently announced preliminary results of the repeat dose portion of its Phase 1 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 of dosing.

請翻到第 11 張投影片。總體而言，我們相信 Rani 有機會利用 RT-114 創造真正差異化的產品組合，將 PG102 的潛在優勢與口服的便利性相結合。ProGen 最近公佈了其第一階段臨床研究重複劑量部分的初步結果。試驗中，皮下注射 PG-102 治療肥胖患者五週後，體重平均減少 4.8%，最高減少 8.7%。

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 tirzepatide and DAPIglutide in a diet-induced obese mouse mob.

皮下注射 PG-102 表現出耐受性，並在一個月內達到 80 毫克的目標劑量。即使劑量迅速增加，也沒有停止治療，這表明該分子具有潛在的顯著耐受性優勢。此外，與飲食誘導的肥胖小鼠模型中的 tirzepatide 和 DAPIglutide 相比，PG-102 已證明能夠改善小鼠的身體組成，減少脂肪與瘦體重。

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 treatments.

我們相信，這種瘦體重的維持可以成為 PG-102 的關鍵區別因素。特別是由於最近的 FDA 指南強調了身體組成在肥胖治療發展中的關鍵重要性。

As a result, we believe that RT-114 has several potential key advantages in the competitive landscape. 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 products. Also, a shorter titration schedule may facilitate a quicker onset of effect. This could address the significant challenge with current GLP-1 treatment options, where many patients discontinue therapy before achieving clinically meaningful weight loss.

因此，我們認為 RT-114 在競爭格局中具有幾個潛在的關鍵優勢。首先，我們相信 RT-114 與目前批准的產品相比，有潛力表現出相當的減肥效果、更好的耐受性以及更好的瘦肌肉質量維持效果。此外，較短的滴定計劃可能有助於更快地起效。這可以解決目前 GLP-1 治療方案面臨的重大挑戰，即許多患者在實現具有臨床意義的減肥之前就停止了治療。

And finally, the currently available oral therapies and those in clinical development for the treatment of obesity require daily dosing. In contrast, our target product profile for RT-114 is for less frequent and potentially weekly oral dosing. Looking ahead, we intend to move rapidly to advance RT-114 into the clinic in mid-2025. 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.

最後，目前可用的口服療法和臨床開發的治療肥胖症的療法都需要每天服用。相較之下，我們對 RT-114 的目標產品特性是較低頻率的口服給藥，可能每週一次。展望未來，我們打算迅速採取行動，在 2025 年中期將 RT-114 推進到臨床階段。總體而言，我們認為 RT-114 有可能成為肥胖市場上高度差異化且受歡迎的產品，因為它具有良好的安全性，並且作為口服療法可以維持瘦體重。

Please turn to slide 12. 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 therapies. Illustrated on this chart are approved obesity products and certain molecules in development.

請翻到第 12 張投影片。我們對 RT-114 和 RT-116 的目標產品特性是與皮下和口服腸促胰島素療法相比具有差異化和競爭力。這張圖表顯示了已批准的減肥產品和正在開發的某些分子。

On the x-axis is the frequency of administration, and the y-axis is the maximum API dose per week. 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 milligrams. 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. 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 injectable product.

x 軸是給藥頻率，y 軸是每週最大 API 劑量。正如您在這個二乘二矩陣中所看到的，口服療法需要每天或每天兩次服用數百毫克的劑量。雖然對於小分子來說，這個劑量不會顯著增加商品成本，但對於口服勝肽來說，它可能會給供應鏈帶來負擔，並可能大幅增加銷貨成本。在圖表列出的療法中，RT-114 和 RT-116 是唯一正在開發的口服藥物，預計將使用與注射產品類似的 API 數量和給藥頻率。

Now, I would like to pass the call over to slide 13 and to Svai Sanford, our Chief Financial Officer, to review our financial results.

現在，我想將電話轉到第 13 張投影片，並交給我們的財務長 Svai Sanford 來審查我們的財務結果。

Thank you, Talat. Good afternoon, everyone, and thank you for joining the call. Earlier today, we issued a press release and filed a 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. You can also find additional information in our Form 10-K for the year ended December 31, 2024.

謝謝你，塔拉特。大家下午好，感謝大家參加電話會議。今天早些時候，我們發布了一份新聞稿，並向美國證券交易委員會提交了一份 10-K 表格，其中包含我們截至 2024 年 12 月 31 日的全年財務業績。我將在本次電話會議上簡要分享一些關鍵的財務亮點。您也可以在截至 2024 年 12 月 31 日的 10-K 表中找到更多資訊。

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, 2023. 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.

回顧我們的資產負債表，截至 2024 年 12 月 31 日的現金、現金等價物和有價證券總額為 2,760 萬美元，而截至 2023 年 12 月 31 日為 4,850 萬美元。我們預計，現金、現金等價物和有價證券足以支持我們到 2025 年第三季的運營，而無需額外資金。

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 in the RaniPill. We have performed this service from time to time and have demonstrated successful deliveries of several drugs using the RaniPill. There was no contract revenue for the same period in 2023.

對於我們截至 2024 年 12 月 31 日的第四季度和全年的經營業績，對於 2024 年第四季度和全年，我們獲得了約 100 萬美元的合約收入，該收入與測試 RaniPill 中潛在合作夥伴藥物的研究評估服務有關。我們不時提供這項服務，並已證明使用 RaniPill 成功輸送了多種藥物。2023年同期無合約收入。

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.

2024 年第四季和全年研發費用分別為 680 萬美元和 2,670 萬美元，而 2023 年同期分別為 760 萬美元和 3,960 萬美元。由於我們採取了成本控制措施，2024 年全年研發費用與前一年相比減少了 1,290 萬美元。

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. 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.

2024 年第四季及全年的一般及行政費用分別為 550 萬美元及 2,390 萬美元，而 2023 年同期分別為 580 萬美元及 2,650 萬美元。由於我們採取了成本控制措施，2024 年全年的 G&A 費用與前一年相比減少了 250 萬美元。

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.

在 2024 年第四季和全年，我們記錄了與某些製造財產和設備相關的 370 萬美元的減損損失，這些財產和設備之前被報告為建設和進度資產。

We consider a number of factors required by GAP 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. There were no such impairment losses in the comparable periods last year.

我們考慮了 GAP 要求的多種因素來評估財產和設備的價值是否可收回。經過全面評估，確定該財產和設備的帳面價值已超過公允價值，因此，將其減記為殘值。去年同期無此類減損損失。

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.

2024 年第四季和全年淨虧損分別為 1,570 萬美元和 5,660 萬美元，而 2023 年同期淨虧損分別為 1,410 萬美元和 6,790 萬美元。2024 年第四季和全年的淨虧損分別包括 370 萬美元的非現金減損損失和 400 萬美元和 1,600 萬美元的股票薪酬費用，而 2023 年第四季和全年的非現金股票薪酬費用分別為 450 萬美元和 1,900 萬美元。

That concludes. the financial section, and I will return the call back to Talad for closing comments. Talad?

財務部分到此結束，我將回電給塔拉德，請他發表最後評論。塔拉德？

Thank you, Svai. Please turn to slide 14. 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 obesity sector. 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 space.

謝謝你，Svai。請翻到第 14 張投影片。總而言之，我們對 Rani Therapeutics 的重大進步以及我們在肥胖領域利用我們的技術開發多種候選產品的絕佳機會感到無比自豪。我們相信，我們透過 RT-114 和 RT-116 產生的臨床前數據驗證了 RaniPill 口服給藥平台在肥胖領域的潛力。

We look forward to bringing RT-114 into the clinic in mid-2025. We are confident that the RaniPill platform possesses the transformative potential to redefine the treatment paradigm for injectable large molecule therapeutics. by converting them into accessible oral treatments. 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.

我們期待在 2025 年中期將 RT-114 引入臨床。我們相信，RaniPill 平台具有變革潛力，可以透過將注射大分子療法轉化為可獲得的口服治療方法來重新定義注射大分子療法的治療模式。我要向我們的利害關係人表示最誠摯的感謝，感謝他們對 Rani 的堅定支持以及對我們將口服生物製劑變為現實的願景的承諾。

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

現在，我開始回答大家的提問。操作員？

(Operator Instructions) Annabel Samimi, Stifel.

（操作員指示）Annabel Samimi，Stifel。

Hi, guys. Thanks for taking my questions. So a few here. 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 developing a GLP-1 when, I guess, by the time you could even potentially get on the market, there's going be a number of oral GLP-1s, whether it's daily or weekly.

嗨，大家好。感謝您回答我的問題。這裡有幾個。首先介紹正在研發的口服司美格魯肽。您是單獨開發這個產品還是將其用作其他腸促胰島素的驗證工具，以便研究雙重 GLP-1/GLP-2？因此，我只是想了解開發 GLP-1 的理由，我想，等到它有可能上市時，就會有大量口服 GLP-1，無論是每日服用還是每週服用。

I just want to understand the rationale of doing that, given your capital constraints. What are the costs to conduct the next phase one trial? Could you do that with the capital that you have? And I guess there's no real update on the other programs. So are those put aside for 114 prioritization? Thanks.

我只是想了解在資金限制的情況下這樣做的理由。進行下一階段試驗的費用是多少？你能用你現有的資本做到這一點嗎？我猜其他程式沒有真正的更新。那麼這些是否被放在一邊作為 114 的優先順序？謝謝。

Hi, Annabel. 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.

你好，安娜貝爾。謝謝您的提問。我先拿最後一個。由於您提到的資金限制，我們今年的主要關注點是 RT-114。我們仍然對這些項目感到興奮，特別是免疫學項目，隨著更多資金的到位，我們可以在臨床上推進這些項目。

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, 107% bioavailability relative to subcu and equivalent weight loss in those canines.

我認為在 RT-114 方面，這有點暗示了您關於 RT-116 的另一個問題，即司美格魯肽計劃。這是一個發現計劃。我們目前不打算對該項目進行臨床研究。正如您所說，我們確實這樣做了，以驗證腸促胰島素的輸送，並能夠顯示 PD 效應，我們在該研究中成功地做到了這兩項，相對於皮下注射，生物利用度為 107%，並且這些犬的體重減輕相當。

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 encretins that are better suited, RT-114 potentially included in that list for patients.

在開發方面，正如我所說，我們的主要關注點是 RT-114。它是一種 GLP-1/GLP-2，一種新機制。Progen 上週發布的臨床研究肥胖數據非常令人鼓舞。關於 RT-116（司美格魯肽計畫），我唯一要補充的是，您說得對，等到您能夠將其推向美國市場時，將會有許多其他更適合的腸促胰島素，RT-114 可能會被列入患者的名單中。

Having said that, semaglutide 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 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.

話雖如此，司美格魯肽分子少於40個胺基酸。許多司法管轄區的物質組成專利將於明年到期。因此，這些市場有潛力以加速的方式發展它，想想海灣合作委員會、中東、巴西等地，在那裡你可以獲得合理的價格，而且那裡有大量肥胖人口。在這種情況下，儘管我們現在還沒有做出承諾，但有可能比推出新型 NCE 或 NME 更快推出此類產品。

Okay. If I can ask one more follow-up, please. Do you have the capital to conduct the Phase 1 trials? I guess that was one question that you missed answering.

好的。如果我可以再問一個後續問題，請告訴我。你們有資金進行第一階段試驗嗎？我想這是你錯過回答的問題。

But secondly, can you tell us what would be expected cost of goods sold would be on a product like this? 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.

但其次，您能告訴我們這種產品的預期銷售成本是多少嗎？考慮到可能存在的潛在小分子，您是否可能在商品成本方面具有成本優勢或任何靈活性？因為這看起來可能很難製造，但也許我在這一點上錯了。

Yeah, so apologize. When you asked about the Phase 1, I thought you were referring to the RT-116 Phase 1. And as I said, we don't have plans to move that into the clinic at this point. The RT-114 Phase 1, if that's what you were referring to, yes, we do have that in the budget as it's currently constituted.

是的，所以道歉。當您詢問第一階段時，我以為您指的是 RT-116 第一階段。正如我所說，我們目前還沒有將其轉移到診所的計劃。RT-114 第一階段，如果這是您提到的，是的，我們目前的預算中確實有這個內容。

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 API of a biologic to be competitive in pricing with a small molecule wouldn't be fair or justified. Having said that, the small molecules have their own issues which are around tolerability.

就商品成本而言，我們將其與生物製劑進行比較。因為你是對的，製造小分子非常便宜，並聲稱即使只是生物製劑的 API 在價格上與小分子具有競爭力也是不公平或不合理的。話雖如此，小分子也有其自身的耐受性問題。

So what we're targeting here is developing a weekly oral with 114 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 COGS target that will make the product competitive even as the price comes down in the market overall.

因此，我們的目標是開發一種每週服用 114 劑的口服藥物，從商品成本角度來看，該藥物將與注射劑具有競爭力。我們已經在製造自動化和規模方面進行了投資，我們有信心實現 COGS 目標，即使整個市場價格下降，我們的產品仍具有競爭力。

Thank you.

謝謝。

Yeah, absolutely.

是的，絕對是如此。

Andreas Argyrides, Oppenheimer.

安德烈亞斯·阿吉里德斯，奧本海默。

Thank you. Hi everyone, this is Eka on for Andreas today. Thanks for taking our questions. 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 different reasons behind this in your opinion? And how do you see this translating into patients? And then I have one follow-up.

謝謝。大家好，我是 Eka，今天為 Andreas 播報節目。感謝您回答我們的問題。我想問您提到的變異性，與 PG-102 皮下注射相比，RT-114 在可比體重減輕方面的變異性較小。您能談談您認為背後的不同原因嗎？您認為這對患者有何影響？然後我還有一個後續問題。

Sure. So Eka, 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 evolved to take up nutrients. And so you see rapid onset and as you alluded to less variability than you see with subcutaneous.

當然。Eka，謝謝你的提問。透過腸道途徑，我們現在已經測試了 19 種分子，其中一些是較大的蛋白質，如單株抗體。我們觀察到，這是比皮下注射更有效的途徑。這是我們進化吸收營養的地方。因此，您會看到其快速起效，正如您所提到的，其變化性比皮下注射要小。

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, but if it tracks the way that, that, that prior work has, like our STELLARA biosimilar as an example that we tested, we're pretty excited about being able to show perhaps less variability in humans as well.

通常，這就是我們在臨床前研究中觀察到的，而 RT-114 與先前的發現一致。現在我們對臨床研究有何期待？我認為臨床研究會告訴我們，但如果它能追蹤先前的研究方式，例如我們測試的 STELLARA 生物相似藥，我們就會非常興奮地發現，在人類身上也可能存在更少的變異性。

Got it. Thank you. That's helpful. And for the Phase 1 study for RT-114, can you talk about the patients that you envision enrolling in the study and then what subsequent studies you plan to conduct? Thank you.

知道了。謝謝。這很有幫助。對於 RT-114 的第一階段研究，您能談談您設想參與研究的患者以及您計劃進行哪些後續研究嗎？謝謝。

Sure. Absolutely. So the Phase 1 is going to be a single ascending dose and then a multi-ascending dose. We're considering running a two-month MAD 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.

當然。絕對地。因此，第一階段將採用單次遞增劑量，然後採用多次遞增劑量。我們正在考慮對肥胖患者進行為期兩個月的 MAD 研究。因此，BMI 超過 30 的患者首先不是糖尿病患者。我們將觀察重複劑量的耐受性和整體減肥效果。

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 2a 12 weeks study with a larger patient population and test perhaps two doses in the RaniPill versus a placebo.

對於隨後的研究，我們期望，我們必須審查數據，但最有可能的是對更大的患者群體進行為期 12 週的 2a 期研究，並測試 RaniPill 的兩種劑量與安慰劑的對比。

Thank you.

謝謝。

Julian Harrison, BTIG.

朱利安·哈里森（Julian Harrison），BTIG。

Hi, thank you for taking my questions. 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?

你好，謝謝你回答我的問題。我很好奇耐受性將在多大程度上指導 RT-114 的早期臨床開發，以及您期望在劑量方面有多大的靈活性來優化耐受性？

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 1 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.

嘿，朱利安，謝謝你的提問。你提出了一個很好的觀點。耐受性確實是這裡的關鍵。這就是我們看到的潛在差異化之處。如果我們查看 PG-102 臨床數據，它們在第 1 階段重複劑量研究中表現出了出色的耐受性。並且透過非常快速的滴定達到最大劑量。我們在研究中要關注的是匹配這些結果或盡可能接近這些結果。

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.

就靈活性而言，口服製劑的優點在於您可以隨時服用另一片藥丸。例如，如果一種藥丸的耐受性問題較大，我們可以將其分成兩劑，降低峰值，提高谷值，並在必要時提高耐受性。

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, 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. And so we have that same flexibility built in to the fact that we have an oral formulation.

因此，我們不僅可以在更長的時間內使用滴定的載體來分散每個注射劑的劑量。這只是一則軼事。我讀到過有關複方索馬魯肽的文章，美國有很多患者正在服用這種藥物，其中一些患者由於耐受性問題，開始分開劑量，每週注射幾次，應該說，可以用針頭和注射器或小瓶和注射器來注射。因此，我們擁有相同的靈活性，因為我們有口服製劑。

Very helpful. Thank you.

非常有幫助。謝謝。

Mitchell Kapoor, H.C. Wainwright.

米切爾·卡普爾、H.C. 溫賴特。

Hey, everyone, thanks for taking the questions. First one is I wanted to ask about the higher peak concentration of 114 that you show versus subcutaneous and just kind of the implications for that, I think we've seen 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 the implications there and what that means?

大家好，感謝你們回答問題。首先，我想問一下您展示的 114 峰值濃度相對於皮下注射的更高，以及這其中的含義，我認為我們已經看到 RaniPill 配製的藥物最初可以達到這個更高的峰值濃度。我們是否應該思考一下這其中的含義以及這意味著什麼？

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 and the canines. I think in the clinical study, we will look at titration schedules because there is a higher peak.

所以我們沒有看到統計數據——嘿，米切爾，順便說一句，很高興和你交談。我們沒有發現噁心或嘔吐與犬科動物之間有統計學差異。我認為在臨床研究中，我們會研究滴定時間表，因為有一個更高的峰值。

And as you're alluding to, there is a correlation across studies with higher peaks and incidence 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 and that that will bring the nausea and vomiting potentially under control.

正如您所暗示的，各項研究都顯示噁心和嘔吐的峰值和發生率較高之間存在相關性。我認為這是可以的——首先，我們必須看看這是否會成為一個問題，因為給藥途徑不同。其次，如果有的話，考慮到 PG-102 在註射研究中的滴定速度有多快，我們可以稍微慢一點滴定，或者把它分成兩粒藥丸，這樣就可以控制噁心和嘔吐。

What was interesting, we didn't do this with the RaniPill but in the subcutaneous we -- when we were doing dose findings so that we could select the right dose for the RaniPill. 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 with the peak.

有趣的是，我們並沒有對 RaniPill 進行這樣的處理，而是在皮下進行——當我們進行劑量研究時，我們可以為 RaniPill 選擇正確的劑量。對於 RT-114 臨床前研究，我們測試了較低劑量的 PG-102 皮下注射。如果你減少一半劑量或一半，我應該說根本不存在 AES。因此，我認為，如果峰值存在問題，這可能是一種真正成功的方法。

Okay. Perfect. Very helpful. And then 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? 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.

好的。完美的。非常有幫助。然後在 BD 方面，您能否談談您收到的任何興趣或興趣的類型，或者自上次您向華爾街更新該方面以來可能發生的任何變化？然後，您優先考慮將 RaniPill 開發為一個平台，並嘗試使其涵蓋多種適應症，而不僅僅是我們目前關注的產品。

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 PG-102 that partnership with ProGen was to bring a really novel and potentially best-in-class GLP-1/GLP-2 in to the market. So that was a BD deal that we did last year.

當然。謝謝你問這個問題。合作仍然是我們公司關注的重點。我們所做的開發工作部分是為了驗證該平台，我認為 PG-102 與 ProGen 的合作是為了將一種真正新穎且可能成為同類最佳的 GLP-1/GLP-2 推向市場。這是我們去年達成的一項 BD 交易。

As you heard from Svai, we can't disclose the partner but we have been doing some research collaboration with a large pharma company. 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, I should say.

正如您從 Svai 那裡聽到的，我們不能透露合作夥伴，但我們一直在與一家大型製藥公司進行一些研究合作。除此之外，人們對 RaniPill 產生了濃厚的興趣，這些興趣涉及肥胖症、免疫學和罕見疾病。我應該說，在這兩個領域——在所有這些領域——都有多個潛在的合作夥伴。

Great. Thank you very much, Talat and Svai.

偉大的。非常感謝，Talat 和 Svai。

Thank you. Thank you, Mitchell.

謝謝。謝謝你，米切爾。

(Operator Instruction) Michael Okunewitch, Maxim Group.

（操作員指示）Michael Okunewitch，Maxim Group。

Hi, this is Chad on for Michael. Thanks for taking the questions. We were just wondering how does ProGen's PG-102 weight loss and speed of titration compare to Zealand's GLP-1/GLP-2.

大家好，我是查德，接聽麥可的電話。感謝您回答這些問題。我們只是想知道 ProGen 的 PG-102 減肥和滴定速度與 Zealand 的 GLP-1/GLP-2 相比如何。

Yes. Good question, Chad. It's hard to compare across studies. I will caveat that. The -- in their Phase 1 multi dose there, meaning Zealand's, I think they showed similar, maybe slightly lower weight loss if my recollection serves me. But then it was the little bit more muted in the repeat dose study or the longer-term repeat dose study that they ran. And then they tested higher doses which led to better weight loss.

是的。問得好，查德。不同研究之間很難比較。我要對此提出警告。在我的記憶中，在第一階段的多劑量試驗中，也就是紐西蘭的試驗中，我認為他們表現出了類似的、甚至可能略低的體重減輕效果。但在他們進行的重複劑量研究或長期重複劑量研究中，這種影響就變得稍微緩和一些了。然後他們測試了更高的劑量，結果減肥效果更好。

What we saw in the preclinical or what ProGen saw in their preclinical DIO work with both the Zealand's peptide, they got a research grade version of that of dapiglutide versus the FC fusion protein version of the GLP-1 and GLP-2 ProGen's drug was that PG-102 had much more sustained weight loss over time. And the dapiglutide product at those doses plateaued, which is what we ended up seeing in the clinical studies from Zealand, the sort of intermediate repeat dose study. So it's hard to draw a conclusion from that.

我們在臨床前或 ProGen 在其臨床前 DIO 工作中看到，他們使用了 Zealand 的勝肽，獲得了達匹魯肽的研究級版本，而 GLP-1 和 GLP-2 ProGen 的藥物是 FC 融合蛋白版本，PG-102 隨著時間的推移具有更持久的減肥效果。達匹魯肽產品在這些劑量下達到了穩定狀態，這正是我們在西蘭臨床研究中看到的，這是一種中間重複劑量研究。因此很難由此得出結論。

But what I would say is that the 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 potentially.

但我想說的是，從我們現在從 ProGen 獲得的臨床前數據和臨床數據來看，我們對這個計畫感到非常興奮。然後，您提到的最後一部分是滴定。這是這種藥物極具吸引力的地方。它是一種FC融合蛋白，而不是勝肽。與安進的 MariTide 類似，它不需要滴定，能夠在一個月內達到最大劑量，這對患者來說可能是個好兆頭。

Great. Thanks for taking the question, Talat.

偉大的。感謝塔拉特回答這個問題。

Thank you.

謝謝。

Xinwei An, Canaccord Genuity.

Xinwei An，Canaccord Genuity。

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? Thank you.

嘿，恭喜你取得進展，謝謝你回答我的問題。我有兩個關於 114 計劃的問題。第一個問題是，在進入臨床之前，您是否計劃進行任何額外的動物研究？那麼，您有多大信心我們會看到人類數據模仿我們迄今為止所看到的情況？謝謝。

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.

嗨，新偉。所以，對於第一個問題，這很簡單。不，我們不打算為了進入臨床而做任何臨床前工作。

On the second one, it's hard to speculate. What I will say is we have -- this will be our fourth Phase 1 study and we have shown very good bioavailability in those prior studies. And with the preclinical data that we put out showing similar weight loss and similar PK as compared to the SubQ, we have a lot of confidence going into it, but the clinical study will ultimately tell the story.

對於第二個問題，很難推測。我想說的是，這是我們的第四階段第一階段研究，我們在先前的研究中已經證明了非常好的生物利用度。我們發布的臨床前數據顯示，與 SubQ 相比，其減肥效果和 PK 效果相似，我們對此充滿信心，但臨床研究最終會告訴我們一切。

John Vandermosten, Zacks.

約翰·范德莫斯滕，Zacks。

Thank you, and hello, Talat and Svai. So regarding PG-102, do we expect to see the standard Phase 1, Phase 2 and pivotal studies before that goes in front of the regulatory agencies, or is there some twist to that at all?

謝謝，你好，Talat 和 Svai。那麼關於 PG-102，我們是否希望在提交給監管機構之前看到標準的第 1 階段、第 2 階段和關鍵研究，或者其中是否存在一些曲折？

Hi, John. So you're asking about the subcutaneous version of…

你好，約翰。所以你問的是皮下注射的…

Right.

正確的。

Yes.

是的。

Exactly. Yes. What ProGen is going to do?

確切地。是的。ProGen 將要做什麼？

Got it, 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 subcu in the US in I want to say it's the next year. We can come back to you on the exact public guidance that they've given.

明白了，明白了。是的。所以我只是想確保我理解得正確。所以他們公開表示並且我可以說的是他們已經完成了第一階段，對嗎？他們上周公布了數據。他們目前處於第 2a 階段，我相信他們計劃在美國為其 subcu 提交 IND，我想說這是明年。我們可以向您報告他們給予的具體公共指導。

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.

但他們確實計劃推進這項進程。RT-114 計畫的吸引力之一在於，儘管這是一種新型分子，但我們能夠像生物相似藥一樣，在某種程度上跟上其發展步伐。我們可以查看他們測試過的劑量，可以觀察滴定計劃以及他們遇到的任何改進和挑戰，並且可以應用這些改進和挑戰，從而使我們的臨床研究更快、更有效率。

Okay. And then I guess, you'll be trailing behind them by just a certain fixed margin, I guess, in terms of timing. So as soon as they complete their pivotal studies then and submit, you would submit following that or how would that look when we get.

好的。然後我想，從時間上來說，你將會落後他們一定的固定幅度。因此，一旦他們完成關鍵研究並提交，您也會隨之提交，或者當我們得到結果時會是什麼樣子。

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, time will tell as we go through development, which one gets prioritized more by ProGen as well.

是的，又一個好問題。由於分子相同，所以情況很有可能如此。我們可以從他們已經提交的內容中獲得一些好處。同樣，隨著我們不斷開發，時間會告訴我們哪一個會更受 ProGen 的重視。

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 partnership.

我認為，從 Rani 的角度來看，RT-114 與注射用 GLP-1/GLP-2 在更廣泛的市場背景下存在巨大差異。他們必須做出這個決定。但如果他們確實加入 Rani ProGen 合作夥伴關係，確實會帶來一些優勢。

Thanks, Talat.

謝謝，塔拉特。

Yeah, absolutely.

是的，絕對是如此。

Thank you. I'm showing no further questions at this time. I would now like to turn it back to Talat Imran for closing remarks.

謝謝。我目前沒有其他問題。現在我想請塔拉特·伊姆蘭 (Talat Imran) 致最後總結。

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.

謝謝您，接線生。我們的 2024 年第四季及全年財務業績及公司更新電話會議到此結束。再次感謝大家今天下午的參加。

This concludes today's conference call. Thank you for participating. You may now disconnect.

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。