- Lipella Pharmaceuticals Inc. leverages proprietary **liposomal formulations** for targeted delivery to mucosal tissue and utilizes the **505(b)(2) regulatory pathway** to accelerate clinical development.  **[1347242_2147436_1]** 
- Their lead asset, **LP-10 oral rinse**, a tacrolimus formulation, is being developed for **Oral Lichen Planus (OLP)**, a T-cell-mediated autoimmune disorder affecting up to **2% of U.S. adults** with no approved therapies.  **[1347242_2147436_1]** 
- A **Phase 2 clinical trial** for LP-10 in OLP patients demonstrated **positive safety and efficacy signals**, including significant improvements in patient-reported outcomes and minimal systemic absorption of tacrolimus, with no serious adverse events.  **[1347242_2147436_2]** **[1347242_2147436_4]** **[1347242_2147436_5]** 
- LP-10 for OLP is projected to achieve **$750 million in peak sales by 2035**, with a **$350 million risk-adjusted net present value**, targeting an addressable U.S. patient population of **1.2 million** and an anticipated monthly wholesale acquisition cost of **$1,000**.  **[1347242_2147436_6]** 
- The company reported **$1 million to $2 million in cash** in its last quarterly statement and estimates needing approximately **$20 million** to bring LP-10 oral rinse to commercialization.  **[1347242_2147436_7]**

Lipella Pharmaceuticals Highlights LP-10 Phase 2 Results and Market Potential

- Lipella Pharmaceuticals Inc. announced **positive final results** from its Phase 2a study of **LP-10 in Oral Lichen Planus (OLP)** on **September 18, 2025**, successfully meeting its primary safety endpoint and achieving statistically significant improvements across all efficacy measures.  **[1347242_0001753926-25-001525_g084955_ex99-1.htm:0]** **[1347242_0001753926-25-001525_g084955_8k.htm:2]** 
- The study reported **no serious adverse events** among the **27 patients** who completed treatment, with **minimal systemic exposure** of the drug.  **[1347242_0001753926-25-001525_g084955_ex99-1.htm:0]** **[1347242_0001753926-25-001525_g084955_8k.htm:2]** 
- Based on these results, the company is preparing to initiate a **pivotal Phase 2b study** for LP-10, which has the potential to become the **first FDA-approved therapy for OLP**, a condition affecting an estimated **6 million Americans** with no current approved treatments.  **[1347242_0001753926-25-001525_g084955_ex99-1.htm:0]** **[1347242_0001753926-25-001525_g084955_8k.htm:2]** 
- The company's common stock was **suspended from Nasdaq on June 20, 2025**, and is currently quoted on the **OTCID Market** under the symbol "LIPO".  **[1347242_0001753926-25-001525_g084955_8k.htm:0]**

LIPELLA PHARMACEUTICALS (LIPO)