(Note: This IPO is an initial public offering of common stock – under the proposed symbol “LIPO” – for listing on the NASDAQ – plus one non-tradeable, non-listed warrant to buy a share of common stock.)

We are a clinical-stage biotechnology company focused on developing new drugs by reformulating the active agents in existing generic drugs and optimizing these reformulations for new applications. 

Our two lead product candidates are:

-LP-10, which we are developing to treat “hemorrhagic cystitis” (“HC”), which is chronic uncontrolled urinary blood loss that results from certain chemotherapies (such as alkylating agents) or pelvic radiation therapy (also called “radiation cystitis”). Many radiation cystitis patients experience severe morbidity (and in some cases, mortality) and currently, there is no therapy for their condition approved by the U.S. Food and Drug Administration (“FDA”), or, to our knowledge, any other regulatory body. LP-10 is the development name of our reformulation of tacrolimus (an approved generic active agent) specifically optimized for topical deposition to the internal surface of the urinary bladder lumen using a proprietary drug delivery platform that we have developed and that we refer to as our metastable liposome drug delivery platform (our “Platform”). We are developing LP-10 and our Platform to be, to our knowledge, the first drug candidate and drug delivery technology that could be successful in treating cancer survivors who acquire HC. We expect to report top-line data from LP-10’s Phase 2a clinical trial in the fourth quarter of 2022.

–LP-310, which we are developing to treat oral lichen planus (“OLP”). OLP is a chronic T-cell-mediated autoimmune oral mucosal disease, and LP-310 contains tacrolimus, which inhibits T-lymphocyte activation. Symptoms of OLP include painful burning sensations, bleeding and irritation with tooth brushing, painful thickened patches on the tongue, and discomfort when speaking, chewing or swallowing. These symptoms frequently cause weight loss, nutritional deficiency, anxiety, depression and scarring from erosive lesions. OLP can also be a precursor to cancer, predominately squamous cell carcinoma, with a malignant transformation rate of approximately 1 percent. LP-310 is the development name of our oral liposomal formulation of tacrolimus (the same approved generic active agent in LP-10) specifically optimized for local delivery to oral mucosa. We believe that our approach of using metastable liposomal tacrolimus as a treatment for OLP is novel. To date, upon review of relevant FDA public data resources on approved drugs and biologics, we are not aware of any other liposomal products developed to treat such disease. We have completed a pre-investigational new drug (“IND”) meeting with the FDA and intend to submit the full IND application to the FDA for LP-310 in the first half of 2023.

Our Platform includes proprietary drug delivery technologies optimized for use with epithelial tissues that coat lumenal surfaces such as the various tissues lining the mouth and esophagus and the tissues lining the bladder and urethra. The Company has two issued patents in the U.S. that should exclude competitors from making, selling or using our LP-10 and LP-310 formulations in the U.S. until July 11, 2035. We also have an issued patent in Australia that does not expire until Oct. 22, 2034. A corresponding patent application in Canada has been allowed. Corresponding patent applications are pending in the U.S. and European Patent Offices.

*Note: For the year ended Dec. 31, 2021, Lipella Pharmaceuticals reported a net loss of $1.87 million on grant revenue of $259,347, according to the prospectus.

(Note: Lipella Pharmaceuticals Inc. slightly upsized its IPO  at pricing on Dec. 19, 2022, by pricing 1.22 million shares (1,217,391 shares) –  up from 1.17 million shares in the prospectus – at $5.75 – the bottom of its $5.75-to-$6.25 price range – to raise $6.99 million. Lipella Pharmaceuticals had adjusted its IPO price range to $5.75 to $6.25 – from its initial price range of $5.25 to $6.75 – and kept the number of shares at 1.17 million shares (1,166,667 shares) in an S-1/A filing dated Dec. 15, 2022. Estimated IPO proceeds were unchanged at $7.0 million. Lipella Pharmaceuticals Inc. disclosed terms for its IPO in an S-1/A filing dated Dec. 13, 2022: 1.17 million shares (1,166,667 shares) at $5.25 to $6.75 to raise $7.0 million. A 1-for-2.5 reverse stock split will take place before the IPO is completed. Lipella Pharmaceuticals Inc. filed its S-1 on July 29, 2022; the company filed confidential IPO documents on Feb. 14, 2022.)