Lipella Pharmaceuticals Inc

Lipella Pharmaceuticals, Inc. develops and commercializes lipid-based therapies for common bladder syndromes. It offers LP-08 which consists of Sphingomyelin Phospholipid bilayers separated by aqueous compartments, LP-09, a liposomal formulation of Botulinum toxin, and LP-10, a proprietary liposomal formulation of Tacrolimus, a potent immunosuppressant and anti-inflammatory agent. The company was founded by Leaf Huang, Jonathan Kaufman and Michael Chancellor in 2005 and is headquartered in Pittsburgh, PA.

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Lipella Pharmaceuticals, Inc. develops and commercializes lipid-based therapies for common bladder syndromes. It offers LP-08 which consists of Sphingomyelin Phospholipid bilayers separated by aqueous compartments, LP-09, a liposomal formulation of Botulinum toxin, and LP-10, a proprietary liposomal formulation of Tacrolimus, a potent immunosuppressant and anti-inflammatory agent. The company was founded by Jonathan Kaufman and Michael Chancellor on February 15, 2005 and is headquartered in Pittsburgh, PA.

“GvHD affects approximately 30,000 Americans and oral GvHD causes significant oral pain and discomfort, making it difficult for patients to eat, drink and speak. Oral GvHD is a great unmet need in cancer survivors.

Lipella Pharmaceuticals Granted FDA Orphan Designation for Oral Graft-versus-Host Disease Drug

Lipella Pharmaceuticals' LP-310 clinical stage asset is formulated for delivering active agents to the oral cavity for diseases of the mouth including oral lichen planus and oral graft-versus-host disease PITTSBURGH , Nov. 10, 2023 /PRNewswire/ -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO), a clinical stage pharmaceutical company addressing serious diseases with significant unmet need based in Pittsburgh, PA, announced today that it has been granted "Orphan Drug Designation" from the U.S. Food and Drug Administration (FDA) for its drug candidate, LP-310, which has been designed for the treatment of oral Graft-versus-Host Disease (GvHD).  FDA Grants Orphan Designation for Lipella's LP-310 Drug Candidate for Oral Graft-versus-Host Disease LP-310 is Lipella's clinical stage pipeline asset intended to be indicated for inflammatory diseases of the oral cavity, including oral lichen planus and oral GvHD.

FDA Grants Orphan Designation for Lipella's LP-310 Drug Candidate for Oral Graft-versus-Host Disease

PITTSBURGH , Oct. 25, 2023 /PRNewswire/ -- Lipella Pharmaceuticals Inc. (Nasdaq: "LIPO") ("Lipella," "our," "us" or the "Company"), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, today announced the closing of its previously announced private placement transaction, priced at-the-market under Nasdaq rules, for the purchase and sale of pre-funded warrants to purchase up to an aggregate of 1,315,790 shares and warrants to purchase up to an aggregate of 1,315,790 shares. The purchase price for each pre-funded warrant and accompanying warrant is $1.519.

Lipella Pharmaceuticals Announces Closing of $2 Million Private Placement Priced At-The-Market Under Nasdaq Rules

PITTSBURGH , Oct. 24, 2023 /PRNewswire/ -- Lipella Pharmaceuticals Inc. (Nasdaq: "LIPO") ("Lipella," "our," "us" or the "Company"), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, today announced the entry, on October 23, 2023, into definitive agreements for the purchase and sale, in a private placement transaction priced at-the-market under Nasdaq rules, of pre-funded warrants to purchase up to an aggregate of 1,315,790 shares and warrants to purchase up to an aggregate of 1,315,790 shares. The purchase price for each pre-funded warrant and accompanying warrant is $1.519.

Lipella Pharmaceuticals Announces $2 Million Private Placement Priced At-The-Market Under Nasdaq Rules

Pittsburgh, PA, October 23, 2023 – Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) (“Lipella,” “our, “us” or the “Company”), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, will present at the 2023 virtual Fall Foliage MicroCap Rodeo Conference to be held from October 24th – 27th. Dr.

Lipella Pharmaceuticals to Present at the Fall Foliage MicroCap Rodeo Conference

Shares of Lipella Pharmaceuticals Inc. LIPO, +51.55% rocketed 52.2% higher in very active tracing Friday, after the Pittsburgh-based biotechnology company's investigational new drug application for its oral lichen planus treatment was approved by the U.S. Food and Drug Administration. Trading volume in the stock, which was the best performer on the major U.S. exchanges, blasted higher to 30.7 million shares, compared with the full-day average of about 6,400 shares.

Lipella Pharmaceuticals stock more than doubles in 3 days as FDA approves IND for OLP treatment

LP-310 is an oral formulation of Lipella's lead asset LP-10. PITTSBURGH , Oct. 20, 2023 /PRNewswire/ -- Lipella Pharmaceuticals Inc. (Nasdaq: "LIPO") ("Lipella," "our, "us" or the "Company"), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, today announces that the U.S. Food and Drug Administration (FDA) has approved an Investigational New Drug (IND) application for a multi-center, phase-2a, dose-escalation clinical trial to assess the safety and efficacy of LP-310 in patients with symptomatic oral lichen planus (OLP), a highly morbid condition with no effective treatment.

Lipella Pharmaceuticals Announces FDA Clearance of IND for LP-310 for Oral Lichen Planus

Article highlights results from successful Phase 2a clinical trial for lead candidate, LP-10 Lipella expects to initiate Phase 2b clinical trial in LP-10 in early 2024 PITTSBURGH, Pa. , Sept. 21, 2023 /PRNewswire/ -- Lipella Pharmaceuticals Inc. (Nasdaq: "LIPO") ("Lipella," "our, "us" or the "Company"), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, today announces that the results of its successful Phase 2a clinical trial have been the published in the peer-reviewed Journal of Urology and Nephrology.

Lipella Pharmaceuticals' Phase 2a Clinical Study Results Published in the Journal of Urology and Nephrology

Successful top line results from Phase 2a clinical trial for lead candidate LP-10 Oral Health Scientific Advisory Board established to focus on development of LP-310 for oral lichen planus Late-breaking presentation of Phase 2a study results at the American Urological Association Annual Meeting Manufacturing collaboration agreement with Cook MyoSite in anticipation of Lipella's forthcoming Investigational New Drug (IND) application PITTSBURGH , May 15, 2023 /PRNewswire/ -- Lipella Pharmaceuticals Inc. (Nasdaq: "LIPO") ("Lipella," "our, "us" or the "Company"), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, today provides a corporate update and announces its first quarter 2023 financial results. Dr. Jonathan Kaufman, CEO of Lipella, said, "Lipella has had a strong start to 2023 with the release of positive top line results from our Phase 2a clinical trial evaluating the safety and efficacy of LP-10 as a treatment for hemorrhagic cystitis.

Lipella Pharmaceuticals Reports First Quarter 2023 Financial Results and Corporate Update

Presentation Focused on Positive Results from Recent Phase 2a Study PITTSBURGH , May 1, 2023 /PRNewswire/ -- Lipella Pharmaceuticals Inc. (Nasdaq: "LIPO") ("Lipella," "our, "us" or the "Company"), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, today announced that it has delivered a late-breaking presentation at the annual meeting of the American Urological Association (AUA) Annual Meeting in Chicago on April 30, 2023. The Phase 2a study data was presented by Dr. Jason Hafron, Principal Investigator for Lipella's national trial, and a urologist specializing in the minimally invasive treatment of cancers involving the prostate, kidney and bladder, utilizing robotic surgery.

Lipella Pharmaceuticals Delivers Late-Breaking Presentation at the American Urological Association Annual Meeting

PITTSBURGH, April 17, 2023 /PRNewswire/ -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) ("Lipella" or the "Company"), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, has entered into a manufacturing collaboration agreement with Cook MyoSite, Inc. ("Cook MyoSite") to facilitate Chemistry, Manufacturing, and Control ("CMC") documentation for Lipella's drug candidate LP-10 (liposomal tacrolimus), aimed at treating hemorrhagic cystitis. LP-10 has been granted Orphan Drug Designation by the FDA.

Lipella Pharmaceuticals Enters Manufacturing Collaboration Agreement with Cook MyoSite

Lipella awarded $1.35m grant in 2022 for development of intravesical contrast-enhanced magnetic resonance imaging (ICE-MRI) technology. PITTSBURGH , April 5, 2023 /PRNewswire/ -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) ("Lipella" or the "Company"), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, today announces it has dosed the first patient in its human clinical study of a novel bladder MRI contrast agent.

Lipella Pharmaceuticals Doses First Patient in Human Study of Innovative Contrast Agent

Company Successfully Completes Phase 2a Clinical Trial Fourth Quarter or Full Year Highlights • Appointed Douglas Johnston as CFO in November 2022 • Successfully completed Initial Public Offering, attained NASDAQ CM listing • Year-end cash balance in excess of $5 million Subsequent Events • Attended Biotech Showcase announcing successful top line results for lead candidate LP-10 during Phase 2A clinical trial • Created Oral Health Scientific Advisory Board to focus on development of LP-310 for oral lichen planus • Announced the successful completion of Phase 2A clinical trial of LP-10 • Dr. Jason Hafron of the Michigan institute of Urology will present the Phase 2A results at the American Urological Association Annual Meeting on April 30 PITTSBURGH , March 31, 2023 /PRNewswire/ -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) ("Lipella" or the "Company"), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, today provided a business update and reported financial results for the year ended December 31, 2022. Jonathan Kaufman, Co-founder and CEO of Lipella Pharmaceuticals, commented, "Last year we focused on developing our corporate profile and scientific mission to address serious diseases with significant unmet need.

Lipella Provides Business Update and Reports 2022 Financial Results

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PITTSBURGH, March 16, 2023 /PRNewswire/ -- Lipella Pharmaceuticals Inc. (Nasdaq: "LIPO") ("Lipella," "our, "us" or the "Company") today announced the successful completion of a Phase 2A clinical trial evaluating the safety and efficacy of its drug candidate LP-10 for hemorrhagic cystitis.

Lipella Pharmaceuticals Successfully Completes Phase 2a Clinical Trial; Announces Late-Breaking Presentation at the Annual Meeting of the American Urological Association

Five-member Board will initially focus on the development of LP-310 PITTSBURGH , March 1, 2023 /PRNewswire/ -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) ("Lipella" or the "Company"), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, today announced the creation of a Scientific Advisory Board in oral health.   The five-member Board will initially focus on the development of LP-310, Lipella's product candidate for the treatment of symptomatic oral lichen planus (OLP).

Lipella Pharmaceuticals Announces Creation of Oral Health Scientific Advisory Board

Results to be Presented at BIOTECH SHOWCASETM 2023 on Wednesday, January 11 th at 2:00pm PST PITTSBURGH , Jan. 11, 2023 /PRNewswire/ -- Lipella Pharmaceuticals Inc. (Nasdaq: "LIPO") ("Lipella," "our, "us" or the "Company"), 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, today announced top line results of the Company's recently completed Phase 2a clinical trial evaluating the safety and efficacy of its drug candidate LP-10 for Hemorrhagic Cystitis, a rare but highly morbid disease for which there are currently no FDA approved treatments. Jonathan Kaufman, Chief Executive Officer, will present a corporate overview including the top-line results, at Biotech Showcase 2023™ on Wednesday, January 11th at 2:00pm PST at the Hilton San Francisco - Union Square, 333 O'Farrell Street, San Francisco, CA.

Lipella Pharmaceuticals Announces Successful Top Line Results of Phase 2A Clinical Trial of LP-10

PITTSBURGH, Jan. 9, 2023 /PRNewswire/ -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) ("Lipella," "our, "us" or the "Company"), 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, today announced that Dr. Jonathan Kaufman, Co-Founder, Chairman, and CEO will be presenting at Biotech Showcase™ 2023. The Biotech Showcase Conference is taking place in San Francisco in parallel to the J.P. Morgan (JPM) 41st Annual HealthCare Conference.

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