#Lipella Pharmaceutical

[prismmediawire]

Lipella Pharmaceuticals Expands its Advisory Board to Include Oncology Expertise

The new oncology committee will include: Jason Hafron, MD, DDS, PhD, MPH; and Pradeep Tyagi, PhD, MBA

Pittsburgh, PA, April 17, 2024 - Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) (“Lipella” or the “Company”), a clinical-stage biotechnology company, today announced the expansion of its Scientific Advisory Board to include oncology expertise.

The new committee members are: Jason Hafron, MD, DDS, PhD, MPH, the Chief Medical Officer at Michigan Institute of Urology, and Professor of Urology at the William Beaumont School of Medicine; and Pradeep Tyagi, PhD, MBA, Professor of Urology, University of Pittsburgh School of Medicine, Pittsburgh, PA. Drs. Hafron and Tyagi have complementing expertise in both clinical and translational research in cancer treatment, with a focus on urologic oncology.

Dr. Michael Chancellor, M.D., Chief Medical Officer of Lipella, stated, “I look forward to working with Dr. Hafron and Dr. Tyagi in the advancement of our discovery efforts in the treatment of non-muscle invasive bladder cancer (NMIBC), a disease that affects nearly one million Americans.”       

About Lipella Pharmaceuticals Inc.

Lipella is 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. Additionally, the company maintains a therapeutic focus on diseases with significant, unaddressed morbidity and mortality where no approved drug therapy currently exists. Lipella recently completed an initial public offering in December 2022. For more information, please visit www.lipella.com or LinkedIn.

Forward-Looking Statements This press release includes certain "forward-looking statements." All statements, other than statements of historical fact, included in this press release regarding, among other things, our strategy, future operations, financial position, prospects, clinical trials, regulatory approvals, pipeline and opportunities, sources of growth, successful implementation of our proprietary technology, plans and objectives are forward-looking statements. Forward-looking statements can be identified by words such as "may," "will," "could," "continue," "would," "should," "potential," "target," "goal," "anticipates," "intends," "plans," "seeks," "believes," "estimates," "predicts," "expects," "projects" and similar references to future periods. Forward-looking statements are based on our current expectations and assumptions regarding future events and financial trends that we believe may affect among other things, market and other conditions, our financial condition, results of operations, business strategy, short- and long-term business operations and objectives, and financial needs. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Our actual results may differ materially from those contemplated by the forward-looking statements. We caution you, therefore, against relying on any of these forward-looking statements. They are neither statements of historical fact nor guarantees or assurances of future performance. There are risks, uncertainties and other factors, both known and unknown, that could cause actual results to differ materially from those in the forward-looking statements which include, but are not limited to, risks related to the effective application of the use of proceeds from the private placement, general capital market risks, regional, national or global political, economic, business, competitive, market and regulatory conditions, and other factors. Any forward-looking statement made by us is based upon the reasonable judgment of our management at the time such statement is made and speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by applicable law. Nothing contained herein is, or shall be relied upon as, a promise or representation as to the past or future. In addition, the information contained in this press release is as of the date hereof, and the Company has no obligation to update such information, including in the event that such information becomes inaccurate. You should not construe the contents of this press release as legal, tax and financial advisors as to legal and related matters concerning the matters described herein.

CONTACT Dr. Jonathan Kaufman, CEO Lipella Pharmaceuticals [email protected] 1-412-894-1853

Jeff Ramson PCG Advisory [email protected]

SOURCE: Lipella Pharmaceuticals Inc.

#press release #prism mediawire #stock market #investing #prismdigitalmedia #prismmarketview #nasdaq #healthcare #Oncology #Biotech #Pharmaceutical #LIPO #Lipella Pharmaceutical

[fmarkets]

Lipella Pharmaceuticals Inc Sees Decline in Financial Performance, Raises Concerns in Industry https://csimarket.com/stocks/news.php?code=LIPO&date=2024-02-28143231&utm_source=dlvr.it&utm_medium=tumblr

#News #Stocks #Market #Earningsreport #LIPO

[columbianewsupdates]

Cystitis Market expected to rise, Seikagaku Corporation, Lipella Pharmaceuticals, AlloVir, Ironwood Pharmaceuticals, Paratek Pharmaceuticals, Alivio Therapeutics, Vaneltix Pharma, Qu Biologics

http://dlvr.it/SqCYVc

[anjrawat]

Interstitial Cystitis Market Size

Interstitial Cystitis (IC), also known as Bladder Pain Syndrome (BPS) is a chronic syndrome that results in recurring fits of pain and pressure in the bladder and pelvic.

Interstitial Cystitis / bladder pain syndrome pose quite a high treatment burden for patients in terms of both cost and duration. A definite diagnosis of IC/ BPS is still tricky, and the indication remains highly misdiagnosed, especially in men. Often, misdiagnosis leads to the initiation of the treatment regimen of other indications, which eventually adds to the overall cost burden faced by patients.

However, the Interstitial Cystitis market comprises a robust pipeline therapies in late and mid-stage development, which are expected to be launched shortly and provide a better treatment option for people affected with it.

Some of the key pharma companies in the Interstitial cystitis market includes KYORIN Pharmaceutical Co., Ltd., UCB, Lipella Pharmaceuticals Inc., Grünenthal Group, Astellas Pharma US, Seikagaku Corporation and many others.

For more details visit: https://www.delveinsight.com/blog/interstitial-cystitis-market/

[kritikarehani]

Interstitial Cystitis Market

The total diagnosed prevalent population of Interstitial Cystitis in the 7MM was 2,264,118 in 2017. The diagnosed prevalent cases of Interstitial Cystitis in the United States were found to be 1,459,502 in 2017. It is observed that womens are more affected with IC as compared to males.

The market size of Interstitial Cystitis in the 7MM was USD 1,599 Million in 2017, which is expected to increase during the forecast period 2017-2030.

FDA approved oral medication, increasing emerging therapies, increasing awareness are some of the key factors expected to drive the IC market in the coming years. 

The key companies in the therapeutics market of Interstitial Cystitis includes KYORIN Pharmaceutical, UCB, Grünenthal, Astellas Pharma, Lipella Pharmaceuticals, SEIKAGAKU CORPORATION and many others. 

For more information visit: https://www.delveinsight.com/report-store/interstitial-cystitis-market

#interstitial cystitis #interstitial cystitis market #interstitial cystitis market share #interstitial cystitis market size #interstitial cystitis key companies

[market-insights-dbmr]

Global Interstitial Cystitis Market Thriving Worldwide, Investigated In Latest Research2027

Global interstitial cystitis market is expected to gain market growth in the forecast period of 2020 to 2027. Data Bridge Market Research analyses the market is growing at a healthy CAGR in the above-mentioned research forecast period. Emerging markets and huge investment in research and development are the factors responsible for the growth of this market.

Market Insights in the Report

To analyze the market size of the market and infer the key trends from it.

Industry Chain Suppliers of interstitial cystitis market with Contact Information

To inspect the market based on product, market share and size of the product share.

The various opportunities in the market.

The report studies the key factors affecting the market.

Get Sample Copy Of This Report + All Important Charts@ https://www.databridgemarketresearch.com/request-a-sample/?dbmr=global-interstitial-cystitis-market

The major players covered in the interstitial cystitis market are Mylan N.V., Johnson & Johnson Services Inc, Astellas Pharma Inc, Lipella Pharmaceuticals Inc, Grnenthal, Liminal BioSciences Inc, Neoleukin Therapeutics, Inc, Aspire Pharmaceuticals, Stellar Pharmaceuticals Inc, Urigen, Xigen and others.

Market Drivers And Restraints:-

The growth of interstitial cystitis market enhanced by the growing cases of interstitial cystitis as well as bladder trauma or overstretching and rise in research and development activities, advances in the technology and adoption of sedentary life-style are some of the impacting factors for the demand of interstitial cystitis drugs.

Nevertheless, high treatment cost coupled with lack of skilled professionals are the factors that hinder the growth of this market.

Table of Contents:

1. Introduction 2. Market Segmentation 3. Market Overview 4. Executive Summary 5. Premium Insights 6. By Component 7. Product Type 8. Delivery 9. Industry Type 10. Geography

Request for Detailed TOC: https://www.databridgemarketresearch.com/toc/?dbmr=global-interstitial-cystitis-market

Breakdown Of Global Interstitial Cystitis Market

Interstitial cystitis market is segmented on the basis of drugs, route of administration, end-users and distribution channel.

Based on drugs, the global interstitial cystitis market is segmented into pentosan polysulfate sodium, dimethyl sulfoxide and others.

Route of administration segment for global interstitial cystitis market is categorized into oral, intravesical and others

On the basis of end-users, the global interstitial cystitis market is segmented into hospitals, homecare, specialty clinics and others.

On the basis of distribution channel, the global interstitial cystitis market has been bifurcated into hospital pharmacy, online pharmacy and retail pharmacy.

About Us:

Data Bridge Market Research set forth itself as an unconventional and neoteric Market research and consulting firm with unparalleled level of resilience and integrated approaches. We are determined to unearth the best market opportunities and foster efficient information for your business to thrive in the market. Data Bridge Market Research provides appropriate solutions to the complex business challenges and initiates an effortless decision-making process.

Data Bridge adepts in creating satisfied clients who reckon upon our services and rely on our hard work with certitude. Get Customization and Discount on Report by emailing [email protected] . We are content with our glorious 99.9 % client satisfying rate.

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[healthcareresearch010-blog]

Interstitial Cystitis Market Projected to Garner Significant Revenues by 2025

Interstitial cystitis (IC), also known as painful bladder syndrome, is a chronic bladder issue often associated with bladder pressure and pain, with occasional pain in either the lower abdomen, pelvic, or lower back. The patient could experience pain raging from mild to severe. The pelvic nerve signal to the brain gets mixed up in an individual suffering from interstitial cystitis. Consequently, an urgency to urinate, often in a small volume, is observed. On an average, a person urinates seven times a day; however, in severe cases of IC, urination may occur around 40-60 times a day. IC is not an infection, but is often mistaken to be a bladder infection.

View Report -

https://www.transparencymarketresearch.com/interstitial-cystitis-market.html

Factors contributing to interstitial cystitis are: a defect of the epithelium layer of the bladder, leaking epithelium allows toxic agents in urine to irritate the bladder wall. Other anticipated, but not clear, contributing factors include heredity, an autoimmune reaction, infection or allergy. Various therapies and medication may provide relief from the symptoms for IC; however, there is still no cure for this disease.

Studies conducted on interstitial cystitis and associated data have shown that it is thrice more prevalent in women than in men, and the risk increases with age. The female-to-male ratio is estimated to be 10:1. It is estimated that around 1 to4 million men and 3 to8 million women suffer from IC. Rise in prevalence of IC stimulates the research and development on the drug, as it is likely to provide an appropriate environment for newer products to be profitable. The prevalence of IC is estimated to be between 2.7% to 6.53% among older women in the United States. Patients suffering from other conditions such as fibromyalgia, irritable bowel syndrome, or allergies often experience IC. According to a publication by National Institutes of Health (NIH), in 2012, the annual expenditure for medication for the geriatric population aged ≥65 years who are Medicare beneficiaries was US$ 249,160,233 (nonspecific and specific IC combined).

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IC is mainly diagnosed by urine analysis, bladder ultrasound, cystoscopy, biopsy of bladder and urethra, bladder stretching, and prostrate fluid culture. The main goal is to relieve the symptoms of IC, and thus treatment is segmented into five phases: First phase by Physical therapy, second phase treatment by oral medication such as Amitriptyline – to regulate the bladder spasms, Pentosan (Elmiron) – helps rebuild the tissue lining the bladder, hydroxyzine, use of steroids, and dimethyl sulfoxide to treat severe IC conditions by blocking the pain and reducing the inflammation is also recommended. The third phase is neurostimulation - transcutaneous electrical nerve stimulation or sacral nerve stimulation.

The fourth phase includes administering cyclosporine to alter the immune response on the bladder, and the fifth phase involves bladder detention or surgery. The market currently has only two approved treatment options for IC: Elmiron (pentosan polysulfate sodium) and Rimso-50 (dimethyl sulfoxide). Elmiron was approved on September 26, 1996, and its patent expired on January 19, 2010. Similarly, Rimso-50 was approved prior to January 1, 1982, and its patent expired before 2002. The current line of treatment is dominated by off-label drug options such as antidepressants (amitriptyline), antihistamines (hydroxyzine), and analgesics (opioid and non-steroidal) due to the limited availability of approved therapies.

The IC therapeutics market is currently weak due to limitations regarding the efficacy and compliance of available products. Other factors contributing to the significant unmet needs include limited approved treatment options, lack of awareness, and need for disease modifying therapies. Current pipeline for the IC therapeutics market is very weak with a majority of the molecules in the early stage of development. These significant unmet needs and weak pipeline with a majority of the molecules in early stage pose new opportunities for new entrants.

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In terms of geography, the interstitial cystitis market can be segmented into North America, Europe, Asia Pacific, and Rest of the World (RoW). The interstitial cystitis market is estimated to expand at a sluggish rate primarily due to the limited availability of approved products, low diagnosis rate, and lack of new product approvals.

Key players operating in the interstitial cystitis market are Aquinox Pharmaceuticals Inc., Astellas Pharma Inc, Merck & Co Inc, Allergan Plc., Kytogenics Pharmaceuticals Inc., BELLUS Health Inc, UCB SA, Lipella Pharmaceuticals Inc, Urigen Pharmaceuticals Inc, and Xigen SA.

[pharmamktnet]

Lipella Pharmaceuticals Received FDA IND Approval for Phase-2a Oncology Supportive Care Drug Study

Lipella Pharmaceuticals Received FDA IND Approval for Phase-2a Oncology Supportive Care Drug Study

PITTSBURGH–(BUSINESS WIRE)–Lipella has IND approval for a phase-2a clinical trial to study an orphan drug for hemorrhagic cystitis, a rare disease affecting cancer survivors. http://www.businesswire.com/news/home/20190326005181/en/Lipella-Pharmaceuticals-Received-FDA-IND-Approval-Phase-2a/?feedref=JjAwJuNHiystnCoBq_hl-QyNsUQ29c24MKpwrFSKUOTZQK86VRF04E6aMvZHPoaH7fxFuNFTHSunhvli30RlBNXya2izy9YOgHlB…

View On WordPress

[awesomerohitpatilme-blog]

Interstitial Cystitis Market Growth Analysis, Trends and Scope till 2025

Interstitial cystitis (IC), also known as painful bladder syndrome, is a chronic bladder issue often associated with bladder pressure and pain, with occasional pain in either the lower abdomen, pelvic, or lower back. The patient could experience pain raging from mild to severe. The pelvic nerve signal to the brain gets mixed up in an individual suffering from interstitial cystitis.

View Report-

https://www.transparencymarketresearch.com/interstitial-cystitis-market.html

Consequently, an urgency to urinate, often in a small volume, is observed. On an average, a person urinates seven times a day; however, in severe cases of IC, urination may occur around 40-60 times a day. IC is not an infection, but is often mistaken to be a bladder infection. Factors contributing to interstitial cystitis are: a defect of the epithelium layer of the bladder, leaking epithelium allows toxic agents in urine to irritate the bladder wall. Other anticipated, but not clear, contributing factors include heredity, an autoimmune reaction, infection or allergy. Various therapies and medication may provide relief from the symptoms for IC; however, there is still no cure for this disease.

Studies conducted on interstitial cystitis and associated data have shown that it is thrice more prevalent in women than in men, and the risk increases with age. The female-to-male ratio is estimated to be 10:1. It is estimated that around 1 to4 million men and 3 to8 million women suffer from IC. Rise in prevalence of IC stimulates the research and development on the drug, as it is likely to provide an appropriate environment for newer products to be profitable. The prevalence of IC is estimated to be between 2.7% to 6.53% among older women in the United States. Patients suffering from other conditions such as fibromyalgia, irritable bowel syndrome, or allergies often experience IC. According to a publication by National Institutes of Health (NIH), in 2012, the annual expenditure for medication for the geriatric population aged ≥65 years who are Medicare beneficiaries was US$ 249,160,233 (nonspecific and specific IC combined).

Request Brochure-

https://www.transparencymarketresearch.com/sample/sample.php?flag=B&rep_id=25523

IC is mainly diagnosed by urine analysis, bladder ultrasound, cystoscopy, biopsy of bladder and urethra, bladder stretching, and prostrate fluid culture. The main goal is to relieve the symptoms of IC, and thus treatment is segmented into five phases: First phase by Physical therapy, second phase treatment by oral medication such as Amitriptyline – to regulate the bladder spasms, Pentosan (Elmiron) – helps rebuild the tissue lining the bladder, hydroxyzine, use of steroids, and dimethyl sulfoxide to treat severe IC conditions by blocking the pain and reducing the inflammation is also recommended. The third phase is neurostimulation – transcutaneous electrical nerve stimulation or sacral nerve stimulation. The fourth phase includes administering cyclosporine to alter the immune response on the bladder, and the fifth phase involves bladder detention or surgery.

The market currently has only two approved treatment options for IC: Elmiron (pentosan polysulfate sodium) and Rimso-50 (dimethyl sulfoxide). Elmiron was approved on September 26, 1996, and its patent expired on January 19, 2010. Similarly, Rimso-50 was approved prior to January 1, 1982, and its patent expired before 2002. The current line of treatment is dominated by off-label drug options such as antidepressants (amitriptyline), antihistamines (hydroxyzine), and analgesics (opioid and non-steroidal) due to the limited availability of approved therapies.

Request for TOC containing Tables and Figures:

https://www.transparencymarketresearch.com/sample/sample.php?flag=T&rep_id=25523

The IC therapeutics market is currently weak due to limitations regarding the efficacy and compliance of available products. Other factors contributing to the significant unmet needs include limited approved treatment options, lack of awareness, and need for disease modifying therapies. Current pipeline for the IC therapeutics market is very weak with a majority of the molecules in the early stage of development. These significant unmet needs and weak pipeline with a majority of the molecules in early stage pose new opportunities for new entrants.

In terms of geography, the interstitial cystitis market can be segmented into North America, Europe, Asia Pacific, and Rest of the World (RoW). The interstitial cystitis market is estimated to expand at a sluggish rate primarily due to the limited availability of approved products, low diagnosis rate, and lack of new product approvals.

Key players operating in the interstitial cystitis market are Aquinox Pharmaceuticals Inc., Astellas Pharma Inc, Merck & Co Inc, Allergan Plc., Kytogenics Pharmaceuticals Inc., BELLUS Health Inc, UCB SA, Lipella Pharmaceuticals Inc, Urigen Pharmaceuticals Inc, and Xigen SA.

[paletriumpharbiter-blog]

[ander-sonadam-blog]

[prismmediawire]

Lipella Pharmaceuticals to Publish Abstract Detailing Compelling Preclinical Support for New Product Candidate at ASCO 2024

Pittsburgh, PA, April 05, 2024 - 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 its abstract has been accepted for the 2024 American Society of Clinical Oncology (ASCO) meeting on May 31 through June 4 in Chicago, Illinois. Lipella’s abstract, “Intravesical local administration of pembrolizumab for treatment of bladder cancer: A novel strategy to minimize toxicity” will be published at www.asco.org/abstracts.

Dr. Jonathan Kaufman, Chief Executive Officer of Lipella, said, “ASCO’s 2024 meeting is the ideal venue for dissemination of our recent progress in the treatment of bladder cancer. Lipella’s new product candidate, LP-50 (intravesical pembrolizumab), is intended to be indicated for non-muscle invasive bladder cancer (NMIBC). Our abstract includes preclinical data demonstrating the efficacy of intravesical pembrolizumab in mice, including size-reduction in bladder tumors measured via T2 weighted MRI.”

ASCO is the world's leading professional organization for physicians and oncology professionals caring for people with cancer. Its annual meeting is the most significant gathering of oncology professionals worldwide, and aims to change the landscape of cancer care.

Dr. Michael Chancellor, Lipella’s Chief Medical Officer, emphasized the significance of this milestone for advancing the company’s LP-50 program. He stated, “There exists a critical unmet need for patients with non-muscle invasive bladder cancer. Our proprietary liposomal drug delivery technology enables localized delivery of therapeutics such as pembrolizumab, which can have severe adverse effects when absorbed systemically.”

About LP-50

LP-50 is an intravesical formulation of immunoglobulins including local, intravesical PD-1 (i.e. checkpoint) inhibition, intended for the treatment of non-muscle invasive bladder cancer (NMIBC), offering the potential for increasing efficacy while minimizing systemic toxicity.

About Lipella Pharmaceuticals Inc.

Lipella Pharmaceuticals is 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. Additionally, Lipella maintains a therapeutic focus on diseases with significant, unaddressed morbidity and mortality where no approved drug therapy currently exists. Lipella completed its initial public offering in December 2022. For more information, please visit www.lipella.com or LinkedIn.

Forward-Looking Statements This press release includes certain "forward-looking statements." All statements, other than statements of historical fact, included in this press release regarding, among other things, our strategy, future operations, financial position, prospects, clinical trials, regulatory approvals, pipeline and opportunities, sources of growth, successful implementation of our proprietary technology, plans and objectives are forward-looking statements. Forward-looking statements can be identified by words such as "may," "will," "could," "continue," "would," "should," "potential," "target," "goal," "anticipates," "intends," "plans," "seeks," "believes," "estimates," "predicts," "expects," "projects" and similar references to future periods. Forward-looking statements are based on our current expectations and assumptions regarding future events and financial trends that we believe may affect among other things, market and other conditions, our financial condition, results of operations, business strategy, short- and long-term business operations and objectives, and financial needs. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Our actual results may differ materially from those contemplated by the forward-looking statements. We caution you, therefore, against relying on any of these forward-looking statements. They are neither statements of historical fact nor guarantees or assurances of future performance. There are risks, uncertainties and other factors, both known and unknown, that could cause actual results to differ materially from those in the forward-looking statements which include, but are not limited to, risks related to the effective application of the use of proceeds from the private placement, general capital market risks, regional, national or global political, economic, business, competitive, market and regulatory conditions, and other factors. Any forward-looking statement made by us is based upon the reasonable judgment of our management at the time such statement is made and speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by applicable law. Nothing contained herein is, or shall be relied upon as, a promise or representation as to the past or future. In addition, the information contained in this press release is as of the date hereof, and the Company has no obligation to update such information, including in the event that such information becomes inaccurate. You should not construe the contents of this press release as legal, tax and financial advisors as to legal and related matters concerning the matters described herein.

CONTACT Dr. Jonathan Kaufman, CEO Lipella Pharmaceuticals [email protected] 1-412-894-1853

Jeff Ramson PCG Advisory [email protected]

SOURCE: Lipella Pharmaceuticals Inc

#press release #prism mediawire #stock market #investing #prismdigitalmedia #prismmarketview #nasdaq #healthcare #LIPO #Lipella Pharmaceutical #Biopharmaceutical #Pharmaceutical #Biotech

[prismmediawire]

Lipella Pharmaceuticals Announces FDA Clearance of IND for LP-410 for Oral Graft-Versus-Host Disease, Advancing Clinical Pipeline

Clinical testing of LP-410 expected to commence in Q2 2024

Pittsburgh, PA, March 05, 2024 - 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 clinical testing of LP-410 in the treatment of oral Graft-Versus-Host Disease (GVHD).

Lipella’s clinical study, titled, A Multicenter, Dose-Ranging Trial Evaluating the Safety, Tolerability, and Efficacy of LP-410 in Subjects with Symptomatic Oral GVHD, is expected to commence in the second half of 2024.

Dr. Jonathan Kaufman, CEO of Lipella, said, “We are extremely pleased to announce the approval of our IND application, and we look forward to initiating clinical testing in patients in 2024. This is an important milestone for Lipella as we pursue a potential treatment for this patient population.”

Dr. Michael Chancellor, Lipella’s Chief Medical Officer, said, “Oral GVHD is a rare but serious oral mucosal disease that currently has no approved therapy. We believe that Lipella’s proprietary oral rinse formulation of liposomal tacrolimus has the potential to effectively treat oral GVHD, while minimizing systemic toxicity.  The addition of this clinical asset is a significant expansion to our pipeline, which now comprises three IND-approved assets, two of which have been granted Orphan Disease Designation by the FDA. We are enthusiastic about our path forward.”

LP-410 targets the underlying mechanisms of oral GVHD, potentially providing a safe and effective treatment option for affected individuals.  Lipella received FDA Orphan Drug Designation on tacrolimus for treatment of GVHD on November 8, 2023.

About Oral GVHD

Oral GVHD is a rare and serious disease. GVHD is a major cause of morbidity and mortality with chronic GVHD being the leading cause of nonmalignant fatality post Hematopoietic Cell transplantation (HCT). It is a clinical syndrome where donor-derived T-cells attack the patient's own tissues, in this case, the oral mucosa.  There is currently no FDA approved local drug treatment of oral GVHD. 

About Lipella Pharmaceuticals Inc.

Lipella Pharmaceuticals is 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. Additionally, Lipella maintains a therapeutic focus on diseases with significant, unaddressed morbidity and mortality where no approved drug therapy currently exists. Lipella completed its initial public offering in December 2022. For more information, please visit www.lipella.com or LinkedIn.

Forward-Looking Statements This press release includes certain “forward-looking statements.” All statements, other than statements of historical fact, included in this press release regarding, among other things, our strategy, future operations, financial position, prospects, pipeline and opportunities, sources of growth, successful implementation of our proprietary technology, plans and objectives are forward-looking statements. Forward-looking statements can be identified by words such as “may,” “will,” “could,” “continue,” “would,” “should,” “potential,” “target,” “goal,” “anticipates,” “intends,” “plans,” “seeks,” “believes,” “estimates,” “predicts,” “expects,” “projects” and similar references to future periods. Forward-looking statements are based on our current expectations and assumptions regarding future events and financial trends that we believe may affect among other things, our financial condition, results of operations, business strategy, short- and long-term business operations and objectives, and financial needs. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Our actual results may differ materially from those contemplated by the forward-looking statements. We caution you, therefore, against relying on any of these forward-looking statements. They are neither statements of historical fact nor guarantees or assurances of future performance. There are risks, uncertainties and other factors, both known and unknown, that could cause actual results to differ materially from those in the forward-looking statements which include, but are not limited to, regional, national or global political, economic, business, competitive, market and regulatory conditions, and other factors. Any forward-looking statement made by us is based upon the reasonable judgment of our management at the time such statement is made and speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by applicable law. Nothing contained herein is, or shall be relied upon as, a promise or representation as to the past or future. In addition, the information contained in this press release is as of the date hereof, and the Company has no obligation to update such information, including in the event that such information becomes inaccurate. You should not construe the contents of this press release as legal, tax and financial advisors as to legal and related matters concerning the matters described herein.

CONTACT Dr. Jonathan Kaufman, CEO Lipella Pharmaceuticals [email protected] 1-412-894-1853

Jeff Ramson PCG Advisory [email protected]

SOURCE: Lipella Pharmaceuticals Inc.

#press release #prism mediawire #stock market #investing #prismdigitalmedia #prismmarketview #healthcare #nasdaq #pharmaceutical #biotechnology #biopharma #LIPO #Lipella Pharmaceutical

[prismmediawire]

Lipella Pharmaceuticals Announces FDA Type C Meeting for LP-10 for Hemorrhagic Cystitis

Pittsburgh, PA, April 03, 2024 - 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 the U.S. Food and Drug Administration (“FDA”) has granted a Type C meeting request to discuss the company’s proposed Phase-2b clinical trial design for the evaluation of LP-10, an intravesical liposomal formulation of tacrolimus, as a potential treatment for moderate to severe hemorrhagic cystitis (HC). Lipella expects to meet with the FDA on May 21, 2024.

HC is a serious, life-threatening form of gross hematuria (i.e. visible blood in urine) caused by cancer treatments including pelvic radiation therapy, and certain chemotherapies including cyclophosphamide and ifosfamide, which are most commonly used for the treatment of breast cancer.

Dr. Michael Chancellor, Lipella’s Chief Medical Officer, expressed anticipation for advancing the LP-10 program, stating, “We are eager to advance our LP-10 program efficiently, and our scheduled FDA meeting in the second quarter of 2024 will play a pivotal role in enhancing the regulatory prospects of LP-10.”

Lipella successfully completed a Phase-2a open-label, dose-escalation clinical trial in early 2023 demonstrating the safety, and the potential efficacy of LP-10 in 13 patients with a history of HC. The study demonstrated preliminary efficacy in multiple measures, including urine microscopy,  urinalysis, urinary urgency, as well as a potential dose response in the reduction of bleeding sites observed during bladder cystoscopy. Lipella published these results in the peer-reviewed journal, International Urology and Nephrology, in September 2023, and received preliminary guidance from the FDA regarding potential registration endpoints.

The company’s anticipated Type C meeting with the FDA will focus on reaching an agreement for the proposed Phase-2b trial design, which Lipella expects to be a 36-subject, prospective, double-blind, placebo-controlled study with a primary efficacy assessment derived from the reduction in patient-reported frequency of gross hematuria episodes over a seven-day period.

About LP-10, LP-310 and LP-410

LP-10 is a liposomal tacrolimus formulation for intravesical administration to treat hemorrhagic cystitis (HC). LP-10 has been evaluated in a multicenter Phase 2a dose escalation trial of 13 subjects with moderate to severe refractory HC, with positive top line results demonstrating safety and efficacy, short duration of systemic uptake of LP-10, and a dose response including decreased hematuria, decreased cystoscopic bleeding and ulceration sites, and improved urinary symptoms in patients. Lipella has been granted Orphan Disease Designation by the FDA for LP-10 in the treatment of moderate to severe hemorrhagic cystitis. LP-310/LP-410 liposomal tacrolimus is a proprietary oral rinse formulation of Lipella’s lead drug candidate, LP-10, for the indications of oral lichen planus (OLP) and oral Graft-versus-Host Disease (GvHD). Lipella has been granted orphan drug designation by the FDA for LP-310 in the treatment of GvHD.

About Lipella Pharmaceuticals Inc.

Lipella Pharmaceuticals is 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. Additionally, Lipella maintains a therapeutic focus on diseases with significant, unaddressed morbidity and mortality where no approved drug therapy currently exists. Lipella completed its initial public offering in December 2022. For more information, please visit www.lipella.com or LinkedIn.

Forward-Looking Statements This press release includes certain "forward-looking statements." All statements, other than statements of historical fact, included in this press release regarding, among other things, our strategy, future operations, financial position, prospects, clinical trials, regulatory approvals, pipeline and opportunities, sources of growth, successful implementation of our proprietary technology, plans and objectives are forward-looking statements. Forward-looking statements can be identified by words such as "may," "will," "could," "continue," "would," "should," "potential," "target," "goal," "anticipates," "intends," "plans," "seeks," "believes," "estimates," "predicts," "expects," "projects" and similar references to future periods. Forward-looking statements are based on our current expectations and assumptions regarding future events and financial trends that we believe may affect among other things, market and other conditions, our financial condition, results of operations, business strategy, short- and long-term business operations and objectives, and financial needs. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Our actual results may differ materially from those contemplated by the forward-looking statements. We caution you, therefore, against relying on any of these forward-looking statements. They are neither statements of historical fact nor guarantees or assurances of future performance. There are risks, uncertainties and other factors, both known and unknown, that could cause actual results to differ materially from those in the forward-looking statements which include, but are not limited to, risks related to the effective application of the use of proceeds from the private placement, general capital market risks, regional, national or global political, economic, business, competitive, market and regulatory conditions, and other factors. Any forward-looking statement made by us is based upon the reasonable judgment of our management at the time such statement is made and speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by applicable law. Nothing contained herein is, or shall be relied upon as, a promise or representation as to the past or future. In addition, the information contained in this press release is as of the date hereof, and the Company has no obligation to update such information, including in the event that such information becomes inaccurate. You should not construe the contents of this press release as legal, tax and financial advisors as to legal and related matters concerning the matters described herein.

CONTACT Dr. Jonathan Kaufman, CEO Lipella Pharmaceuticals [email protected] 1-412-894-1853

Jeff Ramson PCG Advisory [email protected]

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[prismmediawire]

PRISM MarketView Spotlights Lipella Pharmaceuticals as it Seizes Opportunities in Rare Disease

New York, N.Y., March 07, 2024 - PRISM MarketView announces the release of an insightful interview with Lipella Pharmaceuticals’ CEO, Dr. Jonathan Kaufman, discussing the company's recent regulatory accomplishments and how investors stand to benefit.

Lipella Pharmaceuticals was recently granted Orphan Drug Designation by the FDA for LP-410, its drug candidate for oral Graft-versus-Host Disease (GvHD) and previously received Orphan Drug Designation for LP-10 in 2023. With these nods from the FDA, the company is on track to deliver two safe and effective treatments to cancer survivors, with a third therapeutic in its pipeline.

Dr. Kaufman remarked, “Orphan drug development can often be more profitable, entail lower risk and result in faster time to approval than non-orphan therapeutics. Our strategy involves leveraging the 505(b)(2) pathway which we believe will lower cost and allow for a faster approval process by allowing us to bypass Phase 1 trials and immediately initiate Phase 2 clinical trials. It also potentially mitigates risk from a CMC, safety and clinical development standpoint, and offers greater flexibility from the FDA.”

In conversation with PRISM MarketView, Dr. Kaufman discusses the strength of the company’s clinical pipeline, which has expanded significantly over the past 12 months. “We are excited to have been granted Orphan Drug Designation for two candidates targeting serious rare diseases that have a significant impact on patients’ lives and currently have no approved treatment. Our goal is to deliver safe and effective treatments as quickly as possible to the patients who need them most,”  said Dr. Kaufman.

The full interview can be found at https://prismmarketview.com/lipella-pharmaceuticals-expanded-clinical-pipeline-targets-significant-unmet-need/

About Lipella Pharmaceuticals Lipella is 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. Additionally, Lipella maintains a therapeutic focus on diseases with significant, unaddressed morbidity and mortality where no approved drug therapy currently exists. Lipella completed its initial public offering in December 2022. For more information, please visit www.lipella.com or LinkedIn.

About PRISM MarketView:

Established in 2020, PRISM MarketView is dedicated to the monitoring and analysis of small cap stocks in burgeoning sectors. We deliver up-to-the-minute financial market news, provide comprehensive investor tools and foster a dynamic investor community. Central to our offerings are proprietary indexes that observe emerging sectors, including biotech, clean energy, next-generation tech, medical devices and beyond. Visit us at prismmarketview.com and follow us on Twitter.

PRISM MarketView does not provide investment advice.

Disclaimer:

This communication was produced by PRISM MarketView, an affiliate of PCG Advisory Inc., (together "PCG"). PCG is not a registered or licensed broker-dealer nor investment adviser. No information contained in this communication constitutes an offer to sell, a solicitation of an offer to buy, or a recommendation of any security. PCG may be compensated by respective clients for publicizing information relating to its clients’ securities. See www.pcgadvisory.com/disclosures

Media Contact Company Name: Prism MarketView Email: [email protected] Phone: [phone] Website: https://prismmarketview.com

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[prismmediawire]

Lipella Pharmaceuticals to Present at PropThink Digital Investor Conference

Chief Medical Officer Dr. Michael Chancellor will discuss hemorrhagic cystitis and the company’s lead candidate, LP-10

Pittsburgh, PA, February 20, 2023 - Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) ("Lipella," "our," "us" or the "Company") a pioneering, clinical-stage pharmaceutical company, announced today that Chief Medical Officer Dr. Michael Chancellor will present at the PropThink Digital Investor Conference’s key opinion leader (KOL) discussion on Friday, February 23, 2024, at 2 PM ET. Dr. Chancellor’s presentation will be titled: “Urologist Talks Bladder Cancer and Lasting Side Effects”.

PropThink is a leading online destination for investors seeking insights on publicly-traded, emerging growth companies in the healthcare sector.

Webinar Information:

Date:                                   Friday, February 23, 2024

Time:                                   2:00 pm Eastern Time

Register Here:                   Urologist Talks Bladder Cancer & Lasting Side Effects

Presenters:                        Dr. Michael Chancellor, CMO, Lipella Pharmaceuticals Inc.

                                            Deniel Mero, Editor PropThink Conferences (Moderator)

Topic to include:

Following the presentation, investors will have an opportunity to ask relevant questions through an interactive Q&A portal. The webcast link will also be posted on the Investors section of Lipella’s company website, and archived following the event. The above listed dates and times are subject to change.

About LP-10

LP-10 is a liposomal tacrolimus formulation for intravesical administration to treat hemorrhagic cystitis (HC). LP-10 has been evaluated in a multi-center Phase 2a dose escalation trial of 13 subjects with moderate to severe refractory HC. Positive top line results demonstrated safety and efficacy, short duration of systemic uptake of LP-10, and a dose response including decreased hematuria, decreased cystoscopic bleeding and ulceration sites, and improved urinary symptoms in patients. Lipella has been granted Orphan Disease Designation by the FDA for LP-10 in the treatment of moderate to severe hemorrhagic cystitis.

About Hemorrhagic Cystitis

Hemorrhagic cystitis (HC), a severe yet rare condition often triggered by pelvic radiation therapy and specific chemotherapies, is characterized by gross hematuria and currently lacks approved drug treatment. Lipella's LP-10 stands at the forefront of addressing this unmet medical need.

About Lipella Pharmaceuticals Inc.

Lipella Pharmaceuticals is 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. Additionally, Lipella maintains a therapeutic focus on diseases with significant, unaddressed morbidity and mortality where no approved drug therapy currently exists. Lipella completed its initial public offering in December 2022. For more information, please visit www.lipella.com or LinkedIn.

Forward-Looking Statements This press release includes certain "forward-looking statements." All statements, other than statements of historical fact, included in this press release regarding, among other things, our strategy, future operations, financial position, prospects, clinical trials, regulatory approvals, pipeline and opportunities, sources of growth, successful implementation of our proprietary technology, plans and objectives are forward-looking statements. Forward-looking statements can be identified by words such as "may," "will," "could," "continue," "would," "should," "potential," "target," "goal," "anticipates," "intends," "plans," "seeks," "believes," "estimates," "predicts," "expects," "projects" and similar references to future periods. Forward-looking statements are based on our current expectations and assumptions regarding future events and financial trends that we believe may affect among other things, market and other conditions, our financial condition, results of operations, business strategy, short- and long-term business operations and objectives, and financial needs. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Our actual results may differ materially from those contemplated by the forward-looking statements. We caution you, therefore, against relying on any of these forward-looking statements. They are neither statements of historical fact nor guarantees or assurances of future performance. There are risks, uncertainties and other factors, both known and unknown, that could cause actual results to differ materially from those in the forward-looking statements which include, but are not limited to, risks related to the effective application of the use of proceeds from the private placement, general capital market risks, regional, national or global political, economic, business, competitive, market and regulatory conditions, and other factors. Any forward-looking statement made by us is based upon the reasonable judgment of our management at the time such statement is made and speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by applicable law. Nothing contained herein is, or shall be relied upon as, a promise or representation as to the past or future. In addition, the information contained in this press release is as of the date hereof, and the Company has no obligation to update such information, including in the event that such information becomes inaccurate. You should not construe the contents of this press release as legal, tax and financial advisors as to legal and related matters concerning the matters described herein.

CONTACT Dr. Jonathan Kaufman, CEO Lipella Pharmaceuticals [email protected] 1-412-894-1853

Jeff Ramson PCG Advisory [email protected]

SOURCE: Lipella Pharmaceuticals Inc.

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