Lichen Planus

Patent application covers key technology innovations for delivering therapeutic agentsProprietary technology enables precise delivery to improve safety and efficacy in oncology, cancer survivorship and immunotherapyAllowance provides broad IP protection for drug-delivery platform and extends market exclusivity for two lead clinical assets currently in Phase 2 trials PITTSBURGH, Oct. 15, 2024 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO), a clinical-stage biotechnology company focused on developing therapies for serious diseases with unmet medical needs, today announced the receipt of a notice of allowance from the U.S. Patent and Trademark Office (USPTO) for its proprietary liposomal drug delivery platform. The patent application, U.S. Patent No. 17/829,960, titled "Delivery of Agents Using Metastable Liposomes," covers key innovations in Lipella’s platform technology for delivering therapeutic agents via liposome-based vehicles. The patent allows claims that cover Lipella’s method for using metastable liposomes to deliver a variety of therapeutic agents, including the company’s lead assets, LP-10 and LP-310. This breakthrough technology enables precise, targeted delivery, improving the safety and efficacy of treatments across multiple therapeutic areas, including oncology, cancer survivorship, and immunotherapy. Dr. Michael Chancellor, Chief Medical Officer of Lipella Pharmaceuticals, commented, "The allowance of this patent is a significant milestone for Lipella as it strengthens our intellectual property portfolio and supports our ongoing efforts to advance therapies for conditions such as hemorrhagic cystitis and oral lichen planus. Our liposomal drug delivery system offers a safer and more effective means of administering therapeutics like tacrolimus by targeting disease sites directly and minimizing the systemic side effects typically associated with these treatments." This newly allowed patent provides broad intellectual property protection for Lipella’s drug delivery platform, which optimizes delivery to epithelial tissues such as those lining the mouth, bladder, colon, esophagus, vagina, and urethra. It extends market exclusivity and strengthens Lipella’s competitive position, particularly for its two lead clinical assets currently in Phase 2 trials. With additional patents covering the company's formulations in the U.S., Australia, and Canada until 2035, Lipella is poised for further growth and development as it continues to advance its clinical pipeline. About Lipella’s Lead Clinical Assets: LP-10 and LP-310 LP-10 is a liposomal formulation of tacrolimus designed for intravesical administration to treat hemorrhagic cystitis (HC), a rare but severe condition characterized by bleeding from the bladder. LP-10 has shown promising safety and efficacy results in a multicenter Phase 2a trial, where it improved urinary symptoms in patients. The FDA has granted Orphan Drug Designation to LP-10 for the treatment of moderate to severe HC, further underscoring its potential to address this critical unmet need. A Phase 2b multicenter placebo-controlled trial is ready to begin.LP-310 is an innovative oral rinse formulation of LP-10, designed to treat oral lichen planus (OLP), a chronic autoimmune disease affecting the mucous membranes of the mouth. LP-310 offers a promising new approach to treating OLP, which affects millions of Americans and currently lacks an approved pharmacotherapy. A Phase 2a multicenter trial is underway with anticipated top-line data by year-end and trial completion by mid-2025. About Hemorrhagic Cystitis (HC)Hemorrhagic cystitis is a serious condition often resulting from radiation therapy or chemotherapy, marked by severe bleeding in the bladder. With no FDA-approved drug treatments available, LP-10 is positioned to become a breakthrough therapy for patients suffering from this debilitating condition. About Oral Lichen Planus (OLP)Oral lichen planus is a chronic autoimmune disease that causes inflammation and lesions in the oral mucosa. It can lead to significant discomfort, scarring, and increased risk of oral cancer. Despite affecting six to seven million people in the U.S., there are no approved treatments, and current therapies offer only symptomatic relief. 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. CONTACTDr. Jonathan Kaufman, CEOLipella PharmaceuticalsInfo@Lipella.com 1-412-894-1853 PCG AdvisoryJeff Ramsonjramson@pcgadvisory.com

Board-certified dermatologist, Dr. Sandra Lee , widely known as Dr. Pimple Popper , among others, details her journey with mild-moderate atopic dermatitis, the most common form of eczema, and her experience on Opzelura® (ruxolitinib) cream 1.5% WILMINGTON, Del. --(BUSINESS WIRE)--Oct. 10, 2024-- Incyte (Nasdaq:INCY) announced today the expansion of its Moments of Clarity program, an educational initiative highlighting stories of people living with mild to moderate atopic dermatitis (AD) and their paths to finding relief. Building on last year’s program launch in partnership with Mandy Moore , the Moments of Clarity program will now feature several additional real-life patient perspectives, including that of Dr. Sandra Lee and Emily, a mom of three, who share their emotional experiences and the impact AD has had on their lives. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20241009443934/en/ In the new program content, each patient shares defining moments throughout their journeys including how they finally found relief with Opzelura® (ruxolitinib) cream 1.5%. Opzelura is a nonsteroidal, twice-daily cream that is indicated for the short-term and non-continuous treatment of mild to moderate eczema in certain people 12 and older whose disease is not well-controlled with topical prescription therapies or when those therapies are not recommended. Use of Opzelura in combination with biologics, other JAK inhibitors or potent immunosuppressants is not recommended. “While many people know me as a dermatologist from my TV show, most probably don’t know that I live with eczema and have struggled with symptoms like persistent itch and skin inflammation throughout my life,” said Dr. Lee . “I started using Opzelura, a non-steroidal topical option, to treat my eczema flares, which helped alleviate some of my worst symptoms like itch. In the pivotal clinical trial for mild to moderate AD, 54% of patients had clear to almost clear skin at 8 weeks and 52% of patients had a significant reduction in their itch, compared to 15% of patients who used a cream that did not contain medication. I partnered with Incyte on their Moments of Clarity program to share my story and to empower others to seek out a treatment that is right for them.” AD – the most common type of eczema – is a chronic condition characterized by inflammation of the skin, which can manifest as persistent itch, dry and scaly patches or red lesions on the body1. AD affects more than 21 million people aged 12 years and older in the U.S. Signs and symptoms include irritated and itchy skin that can cause red lesions that may ooze and crust. “We understand the impact eczema can have on daily life, which furthers the need for patients to find a treatment to address their individual symptoms,” said Matteo Trotta , Executive Vice President, General Manager, U.S. Dermatology, Incyte . “We are proud to elevate the patient voice and share the real, lived experience with Opzelura as part of our commitment to patients and to providing a treatment that can help address some of the most burdensome symptoms of AD. Our hope is that the Moments of Clarity program helps those living with eczema connect with others and inspires them to have conversations with their doctor.” OPZELURA is not for everyone. See below for IMPORTANT SAFETY INFORMATION including boxed Warning for Serious Infections, Increased Risk of Death, Lymphoma and other Cancers, Major Cardiovascular Events and Blood Clots. To hear more visit MyMomentsofClarity.com. All individuals were compensated for their participation. About Opzelura® (ruxolitinib) Cream Opzelura® (ruxolitinib) cream, a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, approved by the U.S. Food & Drug Administration for the topical treatment of nonsegmental vitiligo in patients 12 years of age and older, is the first and only treatment for repigmentation approved for use in the United States . Opzelura is also approved in the U.S. for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Use of Opzelura in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants, such as azathioprine or cyclosporine, is not recommended. Incyte has worldwide rights for the development and commercialization of ruxolitinib cream, marketed in the United States as Opzelura. In April 2022 , Incyte entered into a strategic alliance agreement with Maruho Co., Ltd. for the development, manufacturing and exclusive commercialization of ruxolitinib cream for treatment of autoimmune and inflammatory dermatology indications in Japan . Opzelura is a registered trademark of Incyte . IMPORTANT SAFETY INFORMATION OPZELURA is for use on the skin only. Do not use OPZELURA in your eyes, mouth, or vagina. OPZELURA may cause serious side effects, including: Serious Infections: OPZELURA contains ruxolitinib. Ruxolitinib belongs to a class of medicines called Janus kinase (JAK) inhibitors. JAK inhibitors are medicines that affect your immune system. JAK inhibitors can lower the ability of your immune system to fight infections. Some people have had serious infections while taking JAK inhibitors by mouth, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have been hospitalized or died from these infections. Some people have had serious infections of their lungs while taking OPZELURA. Your healthcare provider should watch you closely for signs and symptoms of TB during treatment with OPZELURA. OPZELURA should not be used in people with an active, serious infection, including localized infections. You should not start using OPZELURA if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles (herpes zoster) while using OPZELURA. Increased risk of death due to any reason (all causes): Increased risk of death has happened in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking a medicine in the class of medicines called JAK inhibitors by mouth. Cancer and immune system problems: OPZELURA may increase your risk of certain cancers by changing the way your immune system works. Lymphoma and other cancers have happened in people taking a medicine in the class of medicines called JAK inhibitors by mouth. People taking JAK inhibitors by mouth have a higher risk of certain cancers including lymphoma and lung cancer, especially if they are a current or past smoker. Some people have had skin cancers while using OPZELURA. Your healthcare provider will regularly check your skin during your treatment with OPZELURA. Limit the amount of time you spend in the sunlight. Wear protective clothing when you are in the sun and use a broad-spectrum sunscreen. Increased risk of major cardiovascular events: Increased risk of major cardiovascular events such as heart attack, stroke, or death have happened in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and taking a medicine in the class of medicines called JAK inhibitors by mouth, especially in current or past smokers. Blood clots: Blood clots in the veins of your legs (deep vein thrombosis, DVT) or lungs (pulmonary embolism, PE) can happen in some people taking OPZELURA. This may be life-threatening. Blood clots in the vein of the legs (deep vein thrombosis, DVT) and lungs (pulmonary embolism, PE) have happened more often in people who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking a medicine in the class of medicines called JAK inhibitors by mouth. Low blood cell counts: OPZELURA may cause low platelet counts (thrombocytopenia), low red blood cell counts (anemia), and low white blood cell counts (neutropenia). If needed, your healthcare provider will do a blood test to check your blood cell counts during your treatment with OPZELURA and may stop your treatment if signs or symptoms of low blood cell counts happen. Cholesterol increases: Cholesterol increase has happened in people when ruxolitinib is taken by mouth. Tell your healthcare provider if you have high cholesterol or triglycerides. Before starting OPZELURA, tell your healthcare provider if you: After starting OPZELURA: Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. The most common side effects of OPZELURA in people treated for atopic dermatitis include: common cold (nasopharyngitis), diarrhea, bronchitis, ear infection, increase in a type of white blood cell (eosinophil) count, hives, inflamed hair pores (folliculitis), swelling of the tonsils (tonsillitis), and runny nose (rhinorrhea). The most common side effects of OPZELURA in people treated for nonsegmental vitiligo include: acne at the application site, itching at the application site, common cold (nasopharyngitis), headache, urinary tract infection, redness at the application site, and fever. These are not all of the possible side effects of OPZELURA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Incyte Corporation at 1-855-463-3463. INDICATIONS AND USAGE OPZELURA is a prescription medicine used on the skin (topical) for: The use of OPZELURA along with therapeutic biologics, other JAK inhibitors, or strong immunosuppressants such as azathioprine or cyclosporine is not recommended. It is not known if OPZELURA is safe and effective in children less than 12 years of age with atopic dermatitis or nonsegmental vitiligo. Please see the Full Prescribing Information, including Boxed Warning, and Medication Guide for OPZELURA. About Incyte Dermatology Incyte’s science-first approach and expertise in immunology has formed the foundation of the company. Today, we are building on this legacy as we discover and develop innovative dermatology treatments to bring solutions to patients in need. We strive to identify and develop therapies to modulate immune pathways driving uncontrolled inflammation to help restore normal immune function and bring the body closer to homeostasis. Specifically, our efforts in dermatology are focused on a number of immune-mediated dermatologic conditions with a high unmet medical need, including atopic dermatitis, vitiligo, hidradenitis suppurativa, lichen planus, lichen sclerosus and prurigo nodularis To learn more, visit the Dermatology section of Incyte.com. About Incyte A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Headquartered in Wilmington, Delaware , Incyte has operations in North America , Europe and Asia . For additional information on Incyte , please visit Incyte.com or follow us on social media: LinkedIn, X, Instagram, Facebook, YouTube. Forward-Looking Statements Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the partnership between Incyte and Dr. Sandra Lee Incyte’s goal of improving the lives of patients, whether and when Opzelura might provide a successful treatment option for patients with atopic dermatitis, and Incyte’s dermatology program generally, contain predictions, estimates and other forward-looking statements. These forward-looking statements are based on Incyte’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA and other regulatory authorities outside of the United States ; the efficacy or safety of Incyte’s products; the acceptance of Incyte’s products in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; and other risks detailed from time to time in Incyte’s reports filed with the Securities and Exchange Commission , including its annual report and its quarterly report on Form 10-Q for the quarter ended June 30, 2024 . Incyte disclaims any intent or obligation to update these forward-looking statements. 1 National Eczema Association . What is atopic dermatitis? https://nationaleczema.org/eczema/types-of-eczema/atopic-dermatitis/ View source version on businesswire.com: https://www.businesswire.com/news/home/20241009443934/en/ Media media@incyte.com Investors ir@incyte.com Source: Incyte

WILMINGTON, Del.--(BUSINESS WIRE)--Sep. 25, 2024-- Incyte (Nasdaq:INCY) today announced that key data from across its dermatology portfolio, including multiple late-breaking abstracts, will be presented at the upcoming European Academy of Dermatology and Venereology (EADV) Congress 2024 held September 25-28 in Amsterdam. “We’re excited to present five late-breaking oral presentations at this year’s congress, featuring data that could further expand treatment options for those living with immune-mediated dermatologic conditions, including vitiligo, atopic dermatitis, hidradenitis suppurativa and prurigo nodularis,” said Pablo J. Cagnoni, M.D., President and Head of Research and Development, Incyte. “The data highlight our ongoing efforts to evaluate the efficacy and safety of ruxolitinib cream in new patient populations, as well as deepen our understanding of povorcitinib in patients impacted by debilitating immune-mediated dermatologic conditions.” Key abstracts from Incyte-sponsored programs include: Late-breaking Oral Presentations Vitiligo Impact of Treatment Duration on Response Durability: A Post Hoc Analysis of the TRuE-V Long-Term Extension Study of Ruxolitinib Cream in Vitiligo Abstract #8077. Session: D2T01.3: Late breaking news. Presentation Time: 9:15 – 9:30 a.m. ET (3:15 – 3:30 p.m. CET), September 26, 2024 Atopic Dermatitis 52-Week Safety and Disease Control With Ruxolitinib Cream in Children Aged 2 to 11 Years With Atopic Dermatitis: Results From the Phase 3 TRuE-AD3 Study Abstract #8082. Session: D2T01.4: Late breaking news. Presentation Time: 10:00 – 10:15 a.m. ET (4:00 – 4:15 p.m. CET), September 26, 2024 Hidradenitis Suppurativa Ruxolitinib Cream for Mild-to-Moderate Hidradenitis Suppurativa: 32-Week Data From a Randomized Phase 2 Study Abstract #8071. Session: D2T01.3: Late breaking news. Presentation Time: 9:00 – 9:15 p.m. ET (3:00 – 3:15 p.m. CET), September 26, 2024 Prurigo Nodularis Efficacy and Safety of Oral Povorcitinib in Patients With Prurigo Nodularis: 40-Week Results From a Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Abstract #8081. Session: D2T01.3: Late breaking news. Presentation Time: 9:30 – 9:45 a.m. ET (3:30 – 3:45 p.m. CET), September 26, 2024 Lichen Planus Efficacy and Safety of Ruxolitinib Cream in Patients With Cutaneous Lichen Planus: Results From a Phase 2, Randomized, Vehicle-Controlled Study Abstract #7974. Session: D3T01.4: Late breaking news. Presentation Time: 10:30 – 10:45 a.m. ET (4:30 – 4:45 p.m. CET), September 27, 2024 ePosters Vitiligo Efficacy and Safety of Ruxolitinib Cream for the Treatment of Vitiligo Through 2 Years in the TRuE-V Studies Poster #P2983. Characterizing Maintenance of Repigmentation in a Post Hoc Analysis of the TRuE-V Long-Term Extension Study of Ruxolitinib Cream in Vitiligo Poster #P2984. Effect of Povorcitinib on Achievement of VASI50 by Body Region in Patients With Extensive Nonsegmental Vitiligo: Post Hoc Analysis of a 52-Week Phase 2 Study Poster #P3016. Effect of Povorcitinib on Achievement of VESplus50 by Body Region in Patients With Extensive Nonsegmental Vitiligo: Post Hoc Analysis of a 52-Week Phase 2 Study Poster #P3017. Full session details and data presentation listings, please see the EADV 2024 Congress online program here: https://eadvapps.m-anage.com/eadvcongress2024/en-GB/pag/ About Opzelura® (ruxolitinib) Cream 1.5% Opzelura, a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, approved by the U.S. Food & Drug Administration for the topical treatment of nonsegmental vitiligo in patients 12 years of age and older, is the first and only treatment for repigmentation approved for use in the United States. Opzelura is also approved in the U.S. for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Use of Opzelura in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants, such as azathioprine or cyclosporine, is not recommended. In Europe, Opzelura (ruxolitinib) cream 15mg/g is approved for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age. Incyte has worldwide rights for the development and commercialization of ruxolitinib cream, marketed in the United States and Europe as Opzelura. Opzelura and the Opzelura logo are registered trademarks of Incyte. About Povorcitinib (INCB54707) Povorcitinib (INCB54707) is an oral small-molecule JAK1 inhibitor currently in Phase 3 clinical trials for vitiligo, hidradenitis suppurativa (HS) and prurigo nodularis. About Incyte A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe and Asia. For additional information on Incyte, please visit Incyte.com or follow us on social media: LinkedIn, X, Instagram, Facebook, YouTube. Incyte Forward-Looking Statements Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the presentation of data from Incyte’s clinical development pipeline, the promise presented by that pipeline, whether or when any development compounds or combinations will be approved or commercially available for use in humans anywhere in the world outside of the already approved indications in specific regions and Incyte’s goal of improving the lives of patients, contain predictions, estimates, and other forward-looking statements. These forward-looking statements are based on our current expectations and are subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials and the ability to enroll subjects in accordance with planned schedules; determinations made by the FDA and regulatory agencies outside of the United States; the efficacy or safety of our products; the acceptance of our products in the marketplace; market competition; unexpected variations in the demand for our products and the products of our collaboration partners; the effects of announced or unexpected price regulation or limitations on reimbursement or coverage for our products; sales, marketing, manufacturing, and distribution requirements, including our ability to successfully commercialize and build commercial infrastructure for newly approved products and any additional new products that become approved; and other risks detailed from time to time in our reports filed with the U.S. Securities and Exchange Commission, including our annual report on Form 10-K and our quarterly report on Form 10-Q for the quarter ended June 30, 2024. We disclaim any intent or obligation to update these forward-looking statements. View source version on businesswire.com: https://www.businesswire.com/news/home/20240925048109/en/ Media media@incyte.com Investors ir@incyte.com Source: Incyte