Pipeline Programs - LP-10 (Liposomal tacrolimus) is positioned for market exclusivity in treating Hemorrhagic cystitis (HC), with a well-established mechanism and demonstrated safety in Phase 2a studies[11] - LP-310, an oral rinse formulation of LP-10, targets the Oral Lichen Planus (OLP) market, estimated at USD 980 million in 2028 and projected to reach USD 2.7 billion by 2034[14] - LP-410, an alternative oral rinse formulation of LP-10, is intended for the treatment of oral Graft-Versus-Host Disease (GVHD) and has received FDA Orphan Disease Designation[70] - LP-50 is an intravesical liposomal formulation of checkpoint Inhibitor for the treatment of bladder cancer[74] LP-310 Clinical Trial Results and Market Opportunity - Phase 2a multicenter dose escalation study completion of LP-310 for Oral Lichen Planus is anticipated in 2Q25[15] - LP-310 Phase 2a data shows safety with minimal systemic uptake and statistically significant improvement of efficacy[50] - Oral Lichen Planus (OLP) affects approximately 6 million Americans, presenting a substantial target market with no current FDA-approved pharmacotherapy[14, 19, 53, 86] - Projected annual revenue per customer for LP-310 is $8,000[53] LP-10 Market and Revenue Potential - Hemorrhagic cystitis affects approximately 60,000 individuals annually[13] - The company anticipates annual revenue of $20,000 per patient for LP-10 intravesical instillation[13, 91, 92] - Market penetration of 60,000 patients (45%) for LP-10 could yield $1.2 billion in annual revenue[13, 91, 92]

Core Viewpoint - Lipella Pharmaceuticals Inc. is committed to transparency and long-term value creation despite its recent delisting from the Nasdaq Capital Market, with ongoing clinical programs and plans for relisting on a national exchange [2][3]. Company Overview - Lipella Pharmaceuticals is a clinical-stage biotechnology company focused on developing new drugs by reformulating existing generic drugs to address diseases with significant unmet needs [4]. Delisting and Relisting Plans - The company expressed disappointment over the Nasdaq's decision to delist but emphasized that its underlying business remains strong and is actively pursuing relisting on a national exchange [3][6]. - Lipella is evaluating national exchanges that support early-stage innovation and intends to file an initial listing application soon [6]. Operational Status - The company remains fully operational, with clinical programs advancing as planned, and the delisting has not affected clinical timelines or research staffing [6]. Clinical Pipeline - Lipella's lead candidates, LP-310 for oral lichen planus and LP-10 for hemorrhagic cystitis, continue to show promising clinical progress, with final topline data from the Phase 2a trial of LP-310 expected in the second half of 2025 [6]. Financial Position - Lipella maintains a sound financial standing, with sufficient capital to support ongoing development programs and prudent fiscal management in place [6]. Shareholder Engagement - The company will continue to communicate with shareholders through SEC filings, press releases, and investor outreach, including participation in investor conferences and calls [6].

Core Viewpoint - Lipella Pharmaceuticals Inc. has been delisted from The Nasdaq Capital Market due to non-compliance with specific listing rules related to private placement transactions [2][3]. Group 1: Delisting Details - The delisting was triggered by Nasdaq's findings that certain private placement transactions from December 2024 to March 2025 violated Listing Rules 5100, 5635, and 5640 [2]. - The specific issue involved the issuance of Series C voting convertible preferred stock and warrants to the Company's placement agent, which was deemed non-compliant [2]. Group 2: Company Response - Lipella expressed disappointment over the delisting decision, emphasizing its efforts to obtain stockholder approval to address Nasdaq's concerns [3]. - The Company remains operationally sound and is continuing its strategic and clinical development plans, including advancing its lead product candidates LP-10 and LP-310 [4]. Group 3: Future Plans - Lipella is exploring other markets for relisting its common stock to ensure better liquidity and access for investors [5]. - The Company will continue to file periodic reports with the U.S. Securities and Exchange Commission and keep stockholders informed of material developments [5]. Group 4: Company Overview - Lipella Pharmaceuticals is a clinical-stage biotechnology company focused on developing therapies for diseases with significant unmet needs, reformulating existing generic drugs for new applications [6]. - The Company completed its initial public offering in 2022 [6].

Core Insights - Lipella Pharmaceuticals Inc. has been granted U.S. Patent No. 12,326,492 for a method to detect interstitial cystitis using MRI, providing protection until at least 2045 [1][2] - The patented method aims to enhance outcome assessments for mucosal disorders, including existing programs for oral lichen planus, hemorrhagic cystitis, and bladder cancer [2] - The patent strengthens Lipella's strategic position in drug delivery, allowing non-invasive monitoring of body cavity lesions, which could serve as an early detection tool [3] Company Overview - Lipella Pharmaceuticals is a clinical-stage biotechnology company focused on developing new drugs by reformulating existing generic drugs for new applications [3] - The company targets diseases with significant unmet needs where no approved drug therapies currently exist [3] - Lipella completed its initial public offering in 2022 [3]

Core Insights - Lipella Pharmaceuticals has renewed its manufacturing collaboration agreement with Cook MyoSite to support the Chemistry, Manufacturing and Control (CMC) documentation for its clinical products LP-10 and LP-310, which is a non-steroidal oral rinse therapy for Oral Lichen Planus, a condition currently lacking approved treatments [1][2][4] Company Overview - Lipella Pharmaceuticals is a clinical-stage biotechnology company focused on developing new drugs by reformulating existing generic drugs to address diseases with significant unmet needs [4] - The company completed its initial public offering in 2022 and aims to optimize reformulations for new applications [4] Collaboration Details - The collaboration with Cook MyoSite is seen as increasingly valuable as Lipella's clinical pipeline matures towards commercializable assets [2] - Cook MyoSite specializes in the development and commercialization of technology related to human skeletal muscle cells and offers a range of custom services including contract manufacturing and quality control testing [3]

Core Viewpoint - Lipella Pharmaceuticals is set to present statistically significant safety and efficacy data from its Phase 2a trial of LP-310 for Oral Lichen Planus at the 2025 AAOM/EAOM International Meeting, highlighting the potential of LP-310 as a localized, non-steroidal treatment option [3][6]. Presentation Details - The presentation will take place on May 15, 2025, at 11:36 a.m. PT, in Las Vegas, NV [3][7]. - The data includes findings from the 0.25 mg and 0.50 mg dose cohorts, administered once daily over four weeks to adults with symptomatic Oral Lichen Planus [4][8]. Efficacy and Safety Findings - The 0.50 mg dose cohort showed statistically significant improvements in multiple endpoints, including: - Investigator Global Assessment (IGA) improved from 3.42 at baseline to 1.71 at Week 4 (p=0.007) [7]. - Reticulation, Erythema, Ulceration (REU) Score reduced from 26.91 to 11.88 at Week 4 (p=0.003) [7]. - Oral Lichen Planus Symptom Severity Measure (OLPSSM) dropped from 14.92 to 4.88 at Week 4 (p=0.003) [7]. - Pain Numerical Rating Scale (NRS) improved from 6.42 to 2.25 at Week 4 (p=0.003) [7]. - LP-310 was well tolerated, with no treatment-related serious adverse events, no patient discontinuations, and no detectable systemic tacrolimus levels [5][6]. Company Overview - Lipella Pharmaceuticals is a clinical-stage biotechnology company focused on developing therapies for diseases with significant unmet needs, reformulating existing generic drugs for new applications [9].

Financial Performance - Revenue for the three months ended March 31, 2025, was $129,000, a decrease of $17,000 (approximately 11.6%) compared to $146,000 for the same period in 2024[102]. - General and administrative expenses decreased by $57,000 (approximately 10.9%) to $464,000 in Q1 2025 from $521,000 in Q1 2024[102]. - Total operating expenses for Q1 2025 were $1,457,000, an increase of $93,000 (approximately 6.8%) compared to $1,364,000 in Q1 2024[102]. - The net loss for the three months ended March 31, 2025, was $1,307,000, an increase of $115,000 (approximately 9.6%) from a net loss of $1,192,000 in Q1 2024[102]. - Revenue from the 2022 NIH Grant recognized for Q1 2025 was $129,390, a decrease of approximately 11% from $145,880 in Q1 2024[104]. - Net loss for Q1 2025 was $1,306,523, compared to a net loss of $1,191,809 for Q1 2024, indicating an increase in losses year-over-year[115]. Research and Development (R&D) - Research and Development (R&D) expenses increased by $150,000 (approximately 17.8%) to $993,000 in Q1 2025 from $843,000 in Q1 2024[102]. - R&D expenses increased by approximately $150,000 to $993,475 for Q1 2025, compared to $842,600 in Q1 2024, primarily due to increased outside services for the LP-310 clinical trial[110]. - The company expects substantial increases in R&D expenses as it advances clinical trials for LP-10 and LP-310[121]. - The company anticipates continued operating losses and negative cash flows for the foreseeable future due to ongoing R&D activities[116]. - The company bases R&D expenses on estimates from contracts with vendors, which may lead to uneven payment flows[134]. - There have been no material differences between the company's estimates of R&D expenses and the actual amounts incurred to date[135]. Clinical Trials and Drug Development - The company is developing LP-10 and LP-310 for hemorrhagic cystitis and oral lichen planus, respectively, with no FDA-approved therapies currently available for these conditions[87][88]. - LP-310's Phase 2a clinical trial dosing was completed in Q4 2024, with no serious adverse events reported, and results are expected to be presented at a conference in May 2025[90]. - The company received "orphan drug" designation from the FDA for LP-410 for oral graft-versus-host disease on November 11, 2023[91]. Cash Flow and Financing - Cash and cash equivalents totaled $4,225,012 as of March 31, 2025, providing liquidity for ongoing operations[114]. - Net cash used in operating activities for Q1 2025 was approximately $1,426,000, slightly higher than $1,388,000 in Q1 2024[118]. - Net cash provided by financing activities for Q1 2025 was approximately $3,466,000, a significant increase from $200,000 in Q1 2024[120]. - The company entered into an At The Market Offering Agreement to sell shares with an aggregate sales price of up to $2,641,881[96]. Stock-Based Compensation and Accounting - Stock-based compensation expense is expected to increase due to unrecognized expenses and additional stock awards to attract and retain employees[137]. - The fair value of stock options is estimated using the Black-Scholes model, with inputs based on subjective assumptions such as expected volatility and risk-free interest rates[139]. - The company adopted ASU 2018-07 for non-employee stock awards, which did not materially affect financial statements[136]. - The estimated fair value of Common Stock prior to the IPO was determined using independent valuations and various methodologies, including the back-solve method[140]. - The company has elected to take advantage of the extended transition period for adopting new accounting standards as an emerging growth company[145]. - The company may utilize reduced disclosure requirements applicable to emerging growth companies, including R&D progress and market conditions affecting the biotechnology industry[146]. - Recent accounting pronouncements reviewed by the company are not expected to have a material impact on financial statements[149]. - As a smaller reporting company, the company is not required to provide certain market risk disclosures[150]. Compliance and Regulatory - The company believes it regained compliance with Nasdaq's Stockholders' Equity Requirement as of April 14, 2025[100]. - The company has no off-balance sheet arrangements or material contractual obligations as of March 31, 2025[126][127].

Core Insights - Lipella Pharmaceuticals Inc. announced that its abstract on LP-10 for treating Oral Lichen Planus (OLP) has been accepted for presentation at the 2025 joint international meeting of the American Academy of Oral Medicine and European Association of Oral Medicine [1][2] - The study results indicate that LP-10, a liposomal formulation of tacrolimus, shows clinically meaningful improvements in patients with symptomatic OLP, including visible lesion resolution and reduced inflammation [2][3] Study Details - The Phase 2a trial is a multicenter, dose-ranging study assessing the safety, tolerability, and efficacy of LP-10 oral rinse in adults with symptomatic OLP, evaluating three dose levels: 0.25 mg, 0.5 mg, and 1.0 mg [4] - Topline findings from the 0.5 mg cohort demonstrated statistically significant improvement (p < 0.05) at the primary endpoint, with all outcome measures showing significance at Week 4 [4] Company Overview - Lipella Pharmaceuticals is a clinical-stage biotechnology company focused on developing new drugs by reformulating existing generic drugs for new applications, targeting diseases with significant unmet needs [5]

Core Insights - Lipella Pharmaceuticals announced positive topline results from the second cohort of its Phase 2a trial for LP-310, a liposomal-tacrolimus oral rinse for treating oral lichen planus (OLP) [1][2] - The trial has fully enrolled participants across all three planned dose cohorts, with the next step being the submission of an Investigational New Drug (IND) application for a Phase 2b trial [3][8] Efficacy and Safety - Treatment with LP-310 at the 0.50 mg dose showed statistically significant improvements in multiple efficacy endpoints, indicating its potential as a non-steroidal therapy for OLP [2][5] - The safety profile of LP-310 remains strong, with no treatment-related serious adverse events (SAEs) and full adherence to the treatment regimen [5][6] Clinical Data - Key findings from the 0.50 mg cohort include: - Investigator Global Assessment (IGA) improved from 3.42 ± 0.21 at baseline to 2.71 ± 0.30 at week 1 (p=0.029) and 1.71 ± 0.43 at week 4 (p=0.007) [7] - Reticulation, Erythema and Ulceration (REU) Score decreased from 26.91 ± 2.54 at baseline to 17.02 ± 2.36 at week 1 (p=0.003) [7] - Oral Lichen Planus Symptom Severity Measure (OLPSSM) decreased from 14.92 ± 2.10 at baseline to 9.87 ± 2.27 at week 1 (p=0.032) [7] - Pain Numerical Rating Scale (NRS) improved from 6.42 ± 0.75 at baseline to 4.25 ± 0.89 at week 1 (p=0.003) [7] Future Development - The company is preparing to report final topline results from the 1.0 mg cohort in Q2 2025, which will inform regulatory interactions and further clinical advancement [8][9] - Lipella aims to pursue FDA Breakthrough Therapy designation to expedite the development process for LP-310 [9] Company Overview - Lipella Pharmaceuticals is focused on developing innovative therapies for serious diseases with significant unmet needs, utilizing reformulated existing drugs for new applications [13]

Core Insights - Lipella Pharmaceuticals has completed enrollment in its Phase 2a trial for LP-310, a liposomal tacrolimus oral rinse aimed at treating oral lichen planus (OLP) [1][2] - The trial includes three dose cohorts (0.25 mg, 0.50 mg, and 1.0 mg) and has fully enrolled participants across seven U.S. study sites [1][3] - Topline results from the final cohort (1.0 mg) are expected in the second quarter of 2025, which will provide the most comprehensive clinical dataset for LP-310 to date [1][2] Phase 2a Trial Details - The Phase 2a trial is a multicenter, dose-ranging study assessing the safety, tolerability, and preliminary efficacy of LP-310 in adult patients with symptomatic OLP [3] - The trial consists of three dose levels (0.25 mg, 0.50 mg, and 1.0 mg), administered as a twice-daily 10-milliliter oral rinse over four weeks [3] - Primary objectives include evaluating LP-310's safety profile and pharmacokinetics, while secondary endpoints focus on pain, inflammation, and oral ulceration [3] Oral Lichen Planus (OLP) Overview - OLP is a chronic autoimmune disorder affecting the oral mucosa, causing painful erosions, inflammation, and ulcerative lesions [4] - The condition impacts an estimated 6 million Americans, with no FDA-approved treatments currently available [4] Next Steps in Development - Following the completion of enrollment, Lipella plans to report topline results from the 1.0 mg cohort in the first half of 2025 [7] - The company aims to submit an Investigational New Drug (IND) application for a Phase 2b trial in late 2025 [7] - Lipella will explore potential regulatory designations, including Breakthrough Therapy designation [7] Company Background - Lipella Pharmaceuticals is a clinical-stage biotechnology company focused on developing new drugs by reformulating existing generic drugs for new applications [5] - The company targets diseases with significant unmet needs where no approved drug therapies exist [5] - Lipella completed its initial public offering in 2022 [5]