Supports late-stage development and scalable manufacturing for LP-310, a non-steroidal oral rinse therapy for Oral Lichen Planus, a condition with no approved treatmentsPITTSBURGH, June 04, 2025 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) (“Lipella” or the “Company”), a clinical-stage biotechnology company focused on developing therapies for diseases with significant unmet need, today announced that it has re-signed its manufacturing collaboration agreement with Cook MyoSite, Inc. (“Cook ...

Lipella Pharmaceuticals to Present Phase 2a Data for LP-310 in Oral Lichen Planus at 2025 AAOM/EAOM International Meeting Statistically significant safety and efficacy data from 0.25 mg and 0.50 mg cohorts to be presentedPresentation scheduled for Thursday, May 15, 2025, at 11:36 a.m. PTPITTSBURGH, May 15, 2025 – PRISM MediaWire – Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) (“Lipella,” “we,” “our,” or the “Company”), a clinical-stage biotechnology company focused on developing therapies for diseases with s ...

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].

Joint meeting to be held in Las Vegas, May 14-17 Presentation will be delivered by Dr. Alessandro Villa of Miami Cancer Institute Topline study results demonstrate clinically meaningful improvements in OLP Visible lesion resolution during treatment; return toward baseline post-dosing supports localized activity PITTSBURGH, April 23, 2025 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) ("Lipella," "we," "our," or the "Company"), a clinical-stage biotechnology company focused on developing the ...

Second Cohort Results Highlight Efficacy Across All Key Measures and Reinforce Safety of Twice-Daily Oral Rinse Phase 2a Study Now Fully Enrolled Across All Three Dose Cohorts Advancing Toward Phase 2b IND Submission and Broader Regulatory Engagement PITTSBURGH, April 22, 2025 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc. (NASDAQ:LIPO) ("Lipella," "our," "us," or the "Company"), a clinical-stage biotechnology company addressing serious diseases with significant unmet needs, today announced positive topli ...

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 - Lipella Pharmaceuticals Inc. is a clinical-stage biotechnology company focused on addressing serious diseases with significant unmet needs [5] - The company recently reported positive topline Phase 2a results for its lead product candidate LP-310, which showed clinically meaningful reductions in pain, ulceration, and inflammation in the treatment of Oral Lichen Planus [4] Company Overview - Lipella Pharmaceuticals specializes in developing new drugs by reformulating active agents in existing generic drugs and optimizing these for new applications [5] - The company targets diseases with significant unmet needs where no approved drug therapies currently exist [5] - Lipella completed its initial public offering in 2022 [5] Leadership Insights - Dr. Michael Chancellor, Co-Founder and Chief Medical Officer, shared insights from his 40-year career in medicine and drug development during an episode of The Pharmaverse Podcast [3] - The podcast episode titled "From Medicine to Biotech Innovation" discusses Dr. Chancellor's journey and the challenges faced in early-stage biotech, including clinical trials and fundraising [2][3]

Drug Development and Clinical Trials - The company is developing LP-10 for hemorrhagic cystitis (HC) and LP-310 for oral lichen planus (OLP), with no FDA-approved therapies currently available for these conditions[19] - LP-10 has completed a phase 2a clinical trial, showing potential to reduce uncontrolled urinary bleeding in patients with radiation cystitis, with results reported in Q1 2023[21] - LP-310 received FDA investigational new drug (IND) approval in Q3 2023, with a phase 2a trial expected to complete in Q2 2025, and initial results showing no serious adverse events[22] - The phase 2a trial for LP-310's treatment of OLP has top line data selected for presentation at a major medical conference in May 2025[22][34] - The company completed its phase 2a clinical trial of LP-10, reporting top-line results in January 2023, targeting approximately 60,000 patients annually in the U.S. suffering from severe forms of radiation-induced and systemic chemotherapy-induced hemorrhagic cystitis (HC) [36] - The Phase 2a clinical trial for LP-10 involved 13 subjects, with a complete response in 3 subjects and a partial response in 7 subjects, indicating LP-10's potential efficacy in treating hematuria[66] - The company has received FDA approval for a Phase 2b clinical trial for LP-10, focusing on gross hematuria as the primary endpoint[62] - The first cohort of the Phase 2a clinical trial for LP-310 completed dosing in Q4 2024, with eight participants receiving a dose of 0.25 mg, showing promising initial results and no serious adverse events reported[76] - The trial for LP-310 is expected to be completed in Q2 2025, with top line data from the first two dose cohorts set for presentation at a major conference in May 2025[77] Market Potential and Financial Projections - LP-10 targets approximately 1 million cancer survivors in the U.S. who have undergone pelvic radiation therapy, with an addressable market exceeding 120,000 patients annually due to severe chronic bladder bleeding[56] - The estimated average revenue for LP-10 is projected to exceed $20,000 per patient-year, leading to a potential annual gross revenue of up to $1.2 billion with a market penetration of approximately 50%[58] - LP-310 is projected to have a total addressable market exceeding $980 million, with an estimated annual treatment cost of approximately $4,000 per patient[74] Regulatory Designations and Pathways - The company has received orphan drug designation for LP-10 and LP-410, which may provide market exclusivity upon regulatory approval[20][26] - The FDA granted "orphan drug" designation for tacrolimus (including LP-10) for the treatment of HC, which may facilitate accelerated regulatory approval pathways [36] - The FDA granted "orphan drug" designation for LP-10 on July 6, 2012, and for LP-410 on November 11, 2023, which may provide exclusivity for certain indications[172] - The company plans to utilize the 505(b)(2) regulatory pathway for LP-10 and LP-310, leveraging existing data for expedited approval[34] - The company intends to apply for FDA accelerated approval pathways following the successful completion of the phase 2a trial and intends to design a pivotal phase 2b clinical trial [39] - The company intends to apply for Breakthrough Therapy Designation for LP-310 treatment of OLP in the second half of 2025 after the Phase 2a clinical trial[108] Intellectual Property and Competitive Positioning - The company holds multiple patents for its formulations, with expiration dates ranging from 2034 to 2035, and has pending applications for further protection[20][23] - The company relies on market data exclusivity associated with obtaining FDA "orphan drug" designation for LP-10 and its issued patents to maintain competitive advantages[114] - The company has multiple patents protecting its intellectual property, with key patents expiring between 2034 and 2035, ensuring competitive positioning in the market[90] Financial Condition and Funding - As of December 31, 2024, the company had an accumulated deficit of approximately $15,340,107, including a net loss of approximately $5,016,264 for the year ended December 31, 2024[129] - The company expects to incur losses for the foreseeable future and may never achieve or maintain profitability[128] - The company is dependent on raising additional funding to continue its operations and product development, particularly for LP-10 and LP-310[134] - The company has received a notification from Nasdaq regarding its failure to comply with certain continued listing requirements, which could lead to delisting if not resolved[130] - The company has incurred net losses since inception and anticipates significant expenses related to product sales, marketing, and distribution if it receives regulatory approval for its product candidates[134] Operational Challenges and Risks - The company faces significant competition in the pharmaceutical industry, which may affect its ability to commercialize its product candidates[125] - The company must successfully complete clinical trials and obtain regulatory approvals to commercialize its product candidates, which may take several years[133] - The company may need to establish a sales, marketing, and distribution infrastructure to commercialize any product candidates that receive marketing approval[135] - The company’s future capital requirements will depend on various factors, including the progress of clinical trials and the costs associated with manufacturing and regulatory approvals[136] - The company is heavily dependent on the successful commercialization of its lead product candidates, LP-10 and LP-310, which are currently in early clinical development stages[142] - The company faces uncertainties regarding the ability to obtain marketing approvals and successfully commercialize its product candidates, which could materially harm its business[143] - Regulatory authorities may impose limitations on approved indications or require additional post-marketing studies, affecting the commercial prospects of LP-10 and LP-310[153] - The company must navigate extensive and potentially costly clinical trials to demonstrate the safety and efficacy of its drug candidates[146] - Any delays or failures in clinical trials could shorten exclusive commercialization rights and allow competitors to enter the market sooner[148] Compliance and Regulatory Risks - The company is subject to ongoing regulatory oversight even after obtaining marketing approval, which includes compliance with manufacturing and safety requirements[160] - Federal spending reductions could impact the company's ability to secure funding for its programs, particularly affecting Medicare payments and research funding[141] - The regulatory approval process for novel product candidates may be more expensive and time-consuming, complicating the timeline for commercialization[157] - Compliance with cGMP regulations is critical; failure to comply could lead to regulatory sanctions and materially harm the company's financial condition and operations[188] - The company faces challenges in procuring biologically derived raw materials, which could disrupt manufacturing and impact development timelines[190] Employee and Management Considerations - The company considers its relationship with employees to be good, with objectives focused on recruiting, retaining, and incentivizing staff[116] - Retaining key employees and scientific advisors is critical for the company's success, as their loss could materially impact business operations and objectives[214] - The company currently lacks key man insurance for its executives, which may complicate recruitment and retention efforts[215] Environmental and Safety Compliance - The company is subject to numerous environmental, health, and safety laws, and non-compliance could result in substantial fines and impact business operations[218] - Compliance with increasingly stringent environmental regulations may incur substantial costs and impair research and development efforts[220]

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]