UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: June 30, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 7800 Susquehanna St., Suite 505 Pittsburgh, PA 15208 (Address of principal executive offices) (Zip Code) (412) 894-1853 (Registrant's telephone number, including area code) N/A For the tran ...

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].

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 "As the global oral medicine community gathers this spring, we're proud to present promising new data toward the goal of providing a safe and effective treatment for Oral Lichen Planus," said Jonatha ...

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]