Core Points - Lipella Pharmaceuticals Inc. announced that CEO Jonathan Kaufman will present a corporate overview and final results from the Phase 2a trial of LP-10 in oral lichen planus at the Zacks SCR Life Sciences Virtual Investor Forum on September 18, 2025 [1] - The event will be a live, interactive online forum allowing investors to ask questions in real-time, with an archived webcast available for those unable to attend live [2][3] Company Overview - Lipella Pharmaceuticals is a clinical-stage biotechnology company focused on developing new drugs by reformulating active agents in existing generic drugs, targeting diseases with significant unmet needs [4] - The company completed its initial public offering in 2022 and aims to optimize reformulations for new applications [4]

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. 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]

Core Insights - Spartan Capital Securities, LLC successfully completed a $3,788,000 private placement for Lipella Pharmaceuticals Inc. [1] - The proceeds will support Lipella's mission to develop innovative therapies for unmet medical needs and fund general corporate purposes [2] - Spartan Capital's CEO highlighted the strength of Lipella's vision and the firm's commitment to facilitating impactful investment opportunities [3] Company Overview - Lipella Pharmaceuticals is focused on developing groundbreaking clinical therapies aimed at significant medical needs [2] - Spartan Capital Securities is a full-service investment banking firm known for its expertise in capital raising and strategic advisory services [6] Transaction Details - Spartan Capital acted as the sole placement agent for the private offering [1][3] - Legal counsel for the transaction included Sichenzia Ross Ference Carmel LLP for the placement agent and Sullivan & Worcester LLP for Lipella Pharmaceuticals [3] - Further transaction details will be available in Lipella's Form 8-K to be filed with the U.S. Securities and Exchange Commission [4]

Group 1 - Spartan Capital Securities, LLC successfully completed a $3,788,000 private placement for Lipella Pharmaceuticals Inc. [1][2] - The proceeds will support Lipella's mission to develop innovative therapies for unmet medical needs and fund general corporate purposes [2] - Jonathan Kaufman, CEO of Lipella, is focused on advancing the company's clinical pipeline and transformative treatments [2] Group 2 - John Lowry, CEO of Spartan Capital, expressed honor in serving as the sole placement agent and highlighted Lipella's commitment to medical innovation [3] - The transaction reflects the strength of Lipella's vision and Spartan Capital's dedication to impactful investment opportunities [3] - Legal counsel for the transaction included Sichenzia Ross Ference Carmel LLP for the placement agent and Sullivan & Worcester LLP for Lipella [3] Group 3 - Further details on the transaction will be available in Lipella's Form 8-K, to be filed with the U.S. Securities and Exchange Commission [4] - The common shares and related warrants have not been registered under the Securities Act of 1933, limiting their sale until registration or exemption [5] - This press release does not constitute an offer to sell or solicit offers to buy the securities [6]