Lipella Pharmaceuticals Inc., a clinical-stage biotechnology company, reported a net loss of approximately $5.02 million for the fiscal year ending December 31, 2024, compared to a net loss of about $4.62 million in the previous year. The company's total revenue for 2024 was approximately $536,000, primarily derived from grants, which marked an increase from $450,000 in 2023. Operating expenses rose to $5.62 million, up from $5.20 million in 2023, driven mainly by increased research and development costs associated with ongoing clinical trials for its lead product candidates, LP-10 and LP-310.

Significant developments during the fiscal year included the completion of a Phase 2a clinical trial for LP-10, which targets hemorrhagic cystitis, and the initiation of a Phase 2a trial for LP-310, aimed at treating oral lichen planus. The company received FDA orphan drug designation for both LP-10 and LP-410, which is being developed for oral graft-versus-host disease. These designations are expected to provide market exclusivity and facilitate the regulatory approval process. Additionally, Lipella completed a private placement offering of Series B Preferred Stock, raising approximately $5.9 million, which will support its ongoing research and development efforts.

Operationally, Lipella's cash and cash equivalents totaled approximately $2.18 million as of December 31, 2024, a decrease from $3.29 million in the previous year. The company has been actively managing its expenses, with research and development costs increasing due to the advancement of clinical trials. The total number of shares outstanding increased to 1,208,919 by the end of 2024, reflecting the issuance of new shares in connection with various financing activities.

Looking ahead, Lipella anticipates continued operating losses as it progresses through clinical trials and prepares for potential commercialization of its product candidates. The company plans to seek additional funding through equity offerings and collaborations to support its operations and development activities. The management has expressed confidence in the potential of its proprietary drug delivery platform and product pipeline, which targets significant unmet medical needs in urology and oncology. However, the company acknowledges the inherent risks and uncertainties associated with drug development and regulatory approval processes.

About LIPELLA PHARMACEUTICALS INC.

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