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: September 30, 2023, or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-41575 Lipella Pharmaceuticals Inc. (Exact name of registrant as specified in its charter) | Delaware | 20-2388040 | | --- ...

As filed with the U.S. Securities and Exchange Commission on November 1, 2023 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 LIPELLA PHARMACEUTICALS INC. (Exact name of registrant as specified in its charter) Jonathan Kaufman Chief Executive Officer 7800 Susquehanna St. Suite 505 Pittsburgh, PA 15208 (412) 894-1853 (Name, address including zip code, and telephone number, including area code, of ag ...

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, 2023, or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-41575 Lipella Pharmaceuticals Inc. (Exact name of registrant as specified in its charter) Delaware 20-2388040 (State or other ...

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: March 31, 2023, or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-41575 Lipella Pharmaceuticals Inc. (Exact name of registrant as specified in its charter) | Delaware | 20-2388040 | | --- | - ...

Product Development and Clinical Trials - The company is developing LP-10 for the treatment of hemorrhagic cystitis (HC), a condition affecting approximately 72,000 patients annually in the U.S. due to radiation therapy and 60,000 patients from systemic chemotherapy[32]. - A phase 2a clinical trial for LP-10 commenced on February 15, 2021, with top-line results reported in January 2023 indicating proof-of-concept in humans[23][32]. - The phase 2a clinical trial for LP-10 involved 13 subjects, with a median age of 67 years, and demonstrated a complete response in 3 subjects and a partial response in 7 subjects[61]. - The phase 2a trial for LP-10 reported no related adverse events or elevated blood tacrolimus levels, indicating good tolerability[61]. - The company concluded phase 2a clinical trials for LP-10, demonstrating no serious adverse events and improved urinary symptoms, with full results expected in Q2 2023[111]. - LP-310 is currently in pre-clinical development, targeting a chronic immune-mediated mucosal disease affecting over 6 million people in the U.S. and Europe[65]. Regulatory Approvals and Designations - The company received FDA "orphan drug" designation for LP-10, which is expected to expedite the regulatory approval process[22]. - The FDA granted IND approval for LP-10 on December 23, 2019, allowing for a phase 2a clinical trial to be conducted at eight clinical sites[34]. - The company intends to apply for FDA accelerated approval pathways, including Breakthrough Therapy designation, for LP-10[34]. - The company plans to submit a new request for Fast Track designation for LP-10 following the reporting of phase 2a clinical trial summary results in January 2023[96]. - The initial request for Fast Track designation for LP-10 was denied by the FDA in September 2021[96]. - The company plans to submit a marketing authorization application to the EMA for LP-10, but the process is lengthy and costly[156]. - The company intends to pursue the 505(b)(2) regulatory pathway for LP-10, but there is no guarantee that this pathway will be available[164]. Market Opportunity and Financial Projections - LP-10 is projected to have a price exceeding $20,000 per patient-year, with potential annual gross revenue of up to $1.2 billion based on a 50% market penetration[52]. - Approximately 72,000 cancer survivors experience severe chronic bladder bleeding annually, with an additional 60,000 patients suffering from chemotherapy-related cystitis, indicating an addressable market exceeding 120,000 patients[49]. - The company estimates that the peak demand for LP-10 could be approximately 60,000 patients annually in the U.S.[52]. - LP-310 is projected to cost approximately $4,000 annually per patient, resulting in a total addressable market exceeding $980 million for the treatment of OLP[70]. Competitive Landscape and Intellectual Property - The proprietary platform technology is protected by patents in the U.S., Australia, and Canada, with additional applications pending in the U.S. and Europe[26]. - The company has received U.S. patent number 10,639,278, which expires on July 11, 2035, and U.S. patent number 11,357,725, expiring on November 9, 2034, covering aspects of its Platform technology[81]. - The company intends to rely on FDA "orphan drug" designation and issued patents to maintain competitive advantages in the biotechnology space[105]. - The company faces significant competition in the biotechnology sector, with competitors potentially achieving regulatory approval faster[172]. - The company faces risks related to patent expirations, which could increase competition and limit demand for its product candidates[173]. Financial Condition and Funding Needs - As of December 31, 2022, the company had an accumulated deficit of approximately $5.7 million, with a net loss of about $2.6 million for the year[121]. - The company has incurred net losses since inception and expects to continue incurring losses for the foreseeable future[120]. - The company will need to raise additional funding to receive approval for LP-10 and to build the necessary sales and marketing infrastructure[124]. - The company may require additional financing to achieve its business objectives, which could dilute existing stockholders' holdings[127]. Manufacturing and Compliance - The facility includes approximately 2,000 square feet of space with cGMP-capable manufacturing capabilities[72]. - The company is continuously enhancing its manufacturing compliance to meet increasing regulatory requirements as LP-10 progresses through clinical trials[75]. - Manufacturing processes for product candidates, including LP-10, are complex and may face delays due to regulatory approvals and compliance with cGMP standards[174]. - The company may need to rely on third-party manufacturers, which poses risks if they fail to meet contractual obligations or regulatory requirements[176]. Risks and Challenges - The company may face significant delays or inability to commercialize LP-10 if it does not achieve timely regulatory approvals[132]. - The company is currently supported by government grant awards, which may be reduced or eliminated in the future, impacting research funding[128]. - The uncertainty of third-party coverage and reimbursement for newly approved products may limit the company's ability to generate product revenue[186]. - Legislative reforms in healthcare could materially affect the company's ability to market and profit from its product candidates[192]. - The ongoing COVID-19 pandemic may disrupt clinical trial operations and patient recruitment, adversely affecting the company's ability to obtain regulatory approvals[213]. - Unfavorable global economic conditions, including inflation and supply chain disruptions, could negatively impact the company's financial condition and operations[214]. Employee and Operational Considerations - The company has five full-time employees and two part-time employees as of March 27, 2023[106]. - Retaining key employees and scientific advisors is critical for the company's success, as their loss could materially impact business operations and objectives[203]. - The company does not currently hold key man insurance for its executives, which could pose risks if key personnel leave[204]. Legal and Compliance Issues - The company is subject to rigorous FDA regulations post-approval, including compliance with cGMP requirements[101]. - The company may face substantial penalties if unable to comply with federal and state healthcare fraud and abuse laws, including the federal Anti-Kickback Statute and false claims laws[197]. - Compliance with healthcare laws and regulations will involve significant costs, and violations could lead to civil, criminal, and administrative penalties, including exclusion from government healthcare programs[200]. - The company is at risk of being found in violation of various laws due to their broad interpretations and the complexity of compliance across multiple jurisdictions[201].