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DURHAM, N.C.--(BUSINESS WIRE)--May 1, 2025-- Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies, including gene elimination, gene insertion, and gene excision programs, today announced that five abstracts detailing Precision’s wholly owned or partnered programs have been accepted for presentation at the American Society of Gene and Cell Therapy (ASGCT) Annual Meeting being held May 13-17, 2025, in New Orleans, Louisiana. "We are pleased to present new data at ASGCT from multiple programs across our in vivo gene editing pipeline, highlighting the potentially unmatched breadth and therapeutic potential of our ARCUS gene editing technology,” said Michael Amoroso, President and Chief Executive Officer at Precision BioSciences. “Clinically, we have made progress advancing our lead program, PBGENE-HBV, which is a novel gene editing approach being evaluated in a first-in-human study for chronic hepatitis B, and we look forward to sharing initial safety data from the first two dose cohorts at ASGCT. Additionally, we continue to be excited by the promising clinical results generated thus far by our partner iECURE for ECUR-506 in OTC deficiency, which utilizes an ARCUS nuclease and will also be presenting data at this conference." “We are also excited to share promising preclinical results from two muscle programs, PBGENE-3243 program for m.3243-associated mitochondrial disease and PBGENE-DMD for the treatment of Duchenne Muscular Dystrophy (DMD),” Mr. Amoroso continued. “Collectively, these presentations highlight the progress we are making with ARCUS by deploying a variety of gene edit types, including gene elimination, gene insertion and gene excision across a range of complex genetic diseases as we seek to develop durable, curative treatments for patients." Clinical Program Presentations: Title: Initial Safety Data From ELIMINATE-B, the First Clinical Trial of a Gene Editing Treatment for Chronic Hepatitis B Oral Presentation Session: Gene Therapy Trials - In-Vivo Gene Therapy Modification Date and Time: Friday, May 16, 2025, 4:00 PM CT Location: Room 393-396 Title: ARCUS in vivo OTC, Large Gene Insertion (clinical stage partnered program) Oral Presentation Session: Advances in Genome Editing: Novel Large DNA Insertion Technologies and Their Potential Towards Curative Therapies Date and Time: Wednesday, May 14, 2025, 8:00 AM CT Location: NOLA Theater B Preclinical Program Presentations: Title: Excision of the C9orf72 Hexanucleotide Repeat Expansion Using a Dual-ARCUS Gene Editing Approach Reduces Neurotoxic RNA Foci and Dipeptides in an In Vivo Model of ALS Poster Session: Poster Reception Date and Time: Tuesday, May 13, 2025, 6:00 PM - 7:30 PM CT Location: Poster Hall I2 Title: Systemic Delivery of a Mitochondria-Targeting ARCUS Gene Editing Nuclease by AAV Eliminates Mutant Mitochondrial DNA, Demonstrating Therapeutically Meaningful Heteroplasmy Shifts In Vivo Oral Presentation Session: Gene Editing: New Tools and Technology Advances Date and Time: Wednesday, May 14, 2025, 3:45 PM CT Location: NOLA Theater A Title: ARCUS-Mediated Gene Editing Excision of Exons 45-55 of the Human Dystrophin Gene using PBGENE-DMD Leads to Functional Dystrophin Protein and Durable Restoration of Skeletal Muscle-Function In Vivo for the Treatment of Duchenne Muscular Dystrophy Poster Session: Poster Reception Date and Time: Wednesday, May 14, 2025, 5:30 PM - 7:00 PM CT Location: Poster Hall I2 The abstracts are now publicly accessible through the ASGCT website here. About Precision BioSciences, Inc. Precision BioSciences, Inc. is a clinical stage gene editing company dedicated to improving life (DTIL) with its novel and proprietary ARCUS® genome editing platform that differs from other technologies in the way it cuts, its smaller size, and its simpler structure. Key capabilities and differentiating characteristics may enable ARCUS nucleases to drive more intended, defined therapeutic outcomes. Using ARCUS, the Company’s pipeline is comprised of in vivo gene editing candidates designed to deliver lasting cures for the broadest range of genetic and infectious diseases where no adequate treatments exist. For more information about Precision BioSciences, please visit www.precisionbiosciences.com. The ARCUS® platform is being used to develop in vivo gene editing therapies for sophisticated gene edits, including gene insertion (inserting DNA into gene to cause expression/add function), elimination (removing a genome e.g. viral DNA or mutant mitochondrial DNA), and excision (removing a large portion of a defective gene by delivering two ARCUS nucleases in a single AAV such as in the DMD program). Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the therapeutic potential of ARCUS compared to other gene editing technologies; clinical development and expected safety, efficacy and benefit of our wholly owned gene editing product candidates PBGENE-HBV, PBGENE-DMD, PBGENE-3243, and PBGENE-CNS programs and those being advanced by our collaborators and partners including ECUR-506; our gene editing approaches including editing efficiency, and the suitability of ARCUS nucleases for gene insertion, gene elimination and gene excision and differentiation from other gene editing approaches; the expected timing of regulatory processes and clinical operations for our wholly-owned and partnered product candidates, including filings, studies, enrollment and clinical data; the translatability of preclinical data to development of durable, curative treatments for patients; the initial safety and antiviral activity observed in the ELIMINATE-B clinical trial; plans to provide ongoing updates on the PBGENE-HBV study; anticipated timing of clinical data; clinical efficacy and safety data in the OTC-HOPE clinical trial; ability of an ARCUS nuclease to eliminate mutant mitochondrial DNA and achieve therapeutically meaningful heteroplasmy shifts in vivo; the therapeutic potential of PBGENE-DMD and advancement through preclinical studies; and the potential of proof of concept for ARCUS-mediated excision of the C9orf72 gene HRE and further development of PBGENE-CNS for ALS. In some cases, you can identify forward-looking statements by terms such as “aim,” “anticipate,” “appear,” “approach,” “believe,” “contemplate,” “could,” “designed,” “encouraged”, “estimate,” “expect,” “goal,” “intend,” “look,” “may,” “mission,” “plan,” “possible,” “potential,” “predict,” “project,” “promising,” “pursue,” “should,” “strive,” “suggest,” “target,” “will,” “would,” or the negative thereof and similar words and expressions. Forward-looking statements are based on management’s current expectations, beliefs and assumptions and on information currently available to us. These statements are neither promises nor guarantees, but involve number of known and unknown risks, uncertainties and assumptions, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various important factors, including, but not limited to: our ability to become profitable; our ability to procure sufficient funding to advance our programs; risks associated with raising additional capital and requirements under our current debt instruments and effects of restrictions thereunder; our operating expenses and our ability to predict what those expenses will be; our limited operating history; the success of our programs and product candidates in which we expend our resources; our limited ability or inability to assess the safety and efficacy of our product candidates; our dependence on our ARCUS technology; the initiation, cost, timing, progress, achievement of milestones and results of research and development activities, preclinical studies and clinical trials; public perception about genome editing technology and its applications; competition in the genome editing, biopharmaceutical, and biotechnology fields; our or our collaborators’ ability to identify, develop and commercialize product candidates; potential product liability lawsuits and penalties against us or our collaborators related to our technology and our product candidates; the U.S. and foreign regulatory landscape applicable to our and our collaborators’ development of product candidates; our or our collaborators’ or other licensees’ ability to advance product candidates into, and successfully design, implement and complete, clinical or field trials; potential manufacturing problems associated with the development or commercialization of any of our product candidates; delays or difficulties in our and our collaborators’ ability to enroll patients; changes in interim “top-line” and initial data that we announce or publish; if our product candidates do not work as intended or cause undesirable side effects; risks associated with applicable healthcare, data protection, privacy and security regulations and our compliance therewith; our ability to obtain orphan drug designation or fast track designation for our product candidates or to realize the expected benefits of these designations; our or our collaborators’ ability to obtain and maintain regulatory approval of our product candidates, and any related restrictions, limitations and/or warnings in the label of an approved product candidate; the rate and degree of market acceptance of any of our product candidates; our ability to effectively manage the growth of our operations; our ability to attract, retain, and motivate executives and personnel; effects of system failures and security breaches; insurance expenses and exposure to uninsured liabilities; effects of tax rules; effects of any pandemic, epidemic, or outbreak of an infectious disease; the success of our existing collaboration agreements, and our ability to enter into new collaboration arrangements; our current and future relationships with and reliance on third parties including suppliers and manufacturers; our ability to obtain and maintain intellectual property protection for our technology and any of our product candidates; potential litigation relating to infringement or misappropriation of intellectual property rights; effects of natural and manmade disasters, public health emergencies and other natural catastrophic events; effects of sustained inflation, supply chain disruptions and major central bank policy actions; market and economic conditions; risks related to ownership of our common stock, including fluctuations in our stock price; our ability to meet the requirements of and maintain listing of our common stock on NASDAQ or other public stock exchanges; and other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the annual period ended December 31, 2024, as any such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov and the Investors page of our website under SEC Filings at investor.precisionbiosciences.com. All forward-looking statements speak only as of the date of this press release and, except as required by applicable law, we have no obligation to update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. View source version on businesswire.com: https://www.businesswire.com/news/home/20250501903476/en/ Investor and Media Contact: Naresh Tanna Vice President of Investor Relations naresh.tanna@precisionbiosciences.com Source: Precision BioSciences, Inc.

24 abstracts, including 1 oral presentation and 4 late-breaking posters on Dupixent, to showcase new clinical and real-world analyses in chronic obstructive pulmonary disease (COPD) and asthma COPD data from the landmark Phase 3 trials will highlight Dupixent impact on lung function and health-related quality of life across broad populations of patients with type 2 inflammation Asthma abstracts include late-breaking data on mucus burden and the first presentation of efficacy results from a Phase 2 trial designed to study Dupixent in allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma TARRYTOWN, N.Y. , May 01, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced 24 abstracts on Dupixent® (dupilumab) clinical data and real-world analyses in respiratory diseases will be presented at the American Thoracic Society (ATS) International Conference 2025 being held from May 18 to 21 in San Francisco, California . The abstracts, presented in collaboration with Sanofi, demonstrate the benefit of targeting IL-4 and IL-13 to address type 2 inflammation in chronic obstructive pulmonary disease (COPD) and asthma – chronic respiratory diseases that can impair lung function and impact daily life. “The data presented at ATS demonstrate Regeneron’s commitment to advancing the scientific understanding of type 2 inflammation across chronic respiratory diseases to ultimately transform care and quality of life for as many appropriate patients as possible,” said Jennifer Maloney , M.D., Therapeutic Area Lead of Immune, Inflammation, and Infectious Disease Global Development at Regeneron . “Among our 24 abstracts at ATS are the latest results from the Dupixent COPD program, which include new analyses of its impact on critical disease measures such as lung function in broad patient populations with type 2 inflammation. We also look forward to sharing new asthma insights in both adult and pediatric populations.” COPD data assess Dupixent impact on lung function and exacerbations in COPD, including patients with or without emphysema Notable abstracts in COPD will highlight new results from the pivotal landmark Phase 3 BOREAS and NOTUS trials, including analyses demonstrating Dupixent reduced exacerbations and improved lung function regardless of whether patients had emphysema. In the pivotal COPD trials, the majority of patients had chronic bronchitis (≥95%) and ≥30% had emphysema. Additional data being presented also demonstrate Dupixent improved multiple spirometry measures of lung function that were sustained through 52 weeks, compared to placebo. Furthermore, a late-breaking poster of a win-ratio post-hoc analysis will assess the likelihood of avoiding a composite of events including death, hospitalization, worsening symptoms and lung function decline in the COPD pivotal trials by comparing each patient on Dupixent to each patient on placebo. The safety results from BOREAS and NOTUS COPD trials were generally consistent with the known safety profile of Dupixent in its other approved indications. In pooled data from both trials, the most common adverse events (AEs; ≥2%) more frequently observed with Dupixent than placebo were viral infection, headache, nasopharyngitis, back pain, diarrhea, arthralgia, urinary tract infection, local administration reaction, rhinitis, eosinophilia, toothache and gastritis. Asthma data reinforce impact of Dupixent on mucus burden, exacerbations and disease control A late-breaking poster on the VESTIGE imaging trial will highlight that Dupixent reduced mucus burden, compared to placebo, as measured by mucus plug scores and volume regardless of fractional exhaled nitric oxide (FeNO) levels. An analysis of the VOYAGE trial also shows that, in children aged 6 to 11 years, Dupixent reduced exacerbations and improved disease control regardless of how long they had the disease. The safety results in the asthma trials were generally consistent with the known safety profile of Dupixent in moderate-to-severe asthma, with the addition of helminth infections in the VOYAGE trial. In VOYAGE, the most common AEs more frequently observed with Dupixent than placebo were injection site reactions, viral upper respiratory tract infections and eosinophilia. In VESTIGE, the most common AEs (≥5%) more frequently observed with Dupixent than placebo included COVID-19 and injection site reactions. Results will also be shared for the first time in an oral presentation from the Phase 2 AIRED trial evaluating the impact of Dupixent on lung function, exacerbations and health-related quality of life in adults and adolescents with allergic bronchopulmonary aspergillosis (ABPA) and asthma. ABPA is a progressive lung disease caused by hypersensitivity to a fungal microorganism that can live in the airways of patients with breathing disorders like asthma. The full list of Regeneron and Sanofi presentations at ATS includes: About DupixentDupixent, which was invented using Regeneron’s proprietary VelocImmune® technology, is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are two of the key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. Dupixent has received regulatory approvals in more than 60 countries in one or more indications including certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic esophagitis (EoE), prurigo nodularis, chronic spontaneous urticaria (CSU) and chronic obstructive pulmonary disease (COPD) in different age populations. More than 1,000,000 patients are being treated with Dupixent globally.1 About Regeneron’s VelocImmune Technology Regeneron 's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron 's co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create a substantial proportion of all original, FDA-approved fully human monoclonal antibodies. This includes Dupixent® (dupilumab), Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb), Inmazeb® (atoltivimab, maftivimab and odesivimab-ebgn) and Veopoz® (pozelimab-bbfg). In addition, REGEN-COV® (casirivimab and imdevimab) had been authorized by the FDA during the COVID-19 pandemic until 2024. Dupilumab Development Program Dupilumab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation. In addition to the currently approved indications, Regeneron and Sanofi are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in Phase 3 trials, including chronic pruritus of unknown origin, bullous pemphigoid and lichen simplex chronicus. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority. U.S. INDICATIONS DUPIXENT is a prescription medicine used: to treat adults and children 6 months of age and older with moderate-to-severe eczema (atopic dermatitis or AD) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. DUPIXENT can be used with or without topical corticosteroids. It is not known if DUPIXENT is safe and effective in children with atopic dermatitis under 6 months of age. with other asthma medicines for the maintenance treatment of moderate-to-severe eosinophilic or oral steroid dependent asthma in adults and children 6 years of age and older whose asthma is not controlled with their current asthma medicines. DUPIXENT helps prevent severe asthma attacks (exacerbations) and can improve your breathing. DUPIXENT may also help reduce the amount of oral corticosteroids you need while preventing severe asthma attacks and improving your breathing. It is not known if DUPIXENT is safe and effective in children with asthma under 6 years of age. with other medicines for the maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adults and children 12 years of age and older whose disease is not controlled. It is not known if DUPIXENT is safe and effective in children with chronic rhinosinusitis with nasal polyps under 12 years of age. to treat adults and children 1 year of age and older with eosinophilic esophagitis (EoE), who weigh at least 33 pounds (15 kg). It is not known if DUPIXENT is safe and effective in children with eosinophilic esophagitis under 1 year of age, or who weigh less than 33 pounds (15 kg). to treat adults with prurigo nodularis (PN). It is not known if DUPIXENT is safe and effective in children with prurigo nodularis under 18 years of age. with other medicines for the maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and a high number of blood eosinophils (a type of white blood cell that may contribute to your COPD). DUPIXENT is used to reduce the number of flare-ups (the worsening of your COPD symptoms for several days) and can improve your breathing. It is not known if DUPIXENT is safe and effective in children with chronic obstructive pulmonary disease under 18 years of age. to treat adults and children 12 years of age and older with chronic spontaneous urticaria (CSU) who continue to have hives that are not controlled with H1 antihistamine treatment. It is not known if DUPIXENT is safe and effective in children with chronic spontaneous urticaria under 12 years of age, or who weigh less than 66 pounds (30 kg). DUPIXENT is not used to relieve sudden breathing problems and will not replace an inhaled rescue medicine. DUPIXENT is not used to treat any other forms of hives (urticaria). IMPORTANT SAFETY INFORMATION Do not use if you are allergic to dupilumab or to any of the ingredients in DUPIXENT®. Before using DUPIXENT, tell your healthcare provider about all your medical conditions, including if you: have eye problems. have a parasitic (helminth) infection. are scheduled to receive any vaccinations. You should not receive a “live vaccine” right before and during treatment with DUPIXENT. are pregnant or plan to become pregnant. It is not known whether DUPIXENT will harm your unborn baby. A pregnancy registry for women who take DUPIXENT during pregnancy collects information about the health of you and your baby. To enroll or get more information call 1-877-311-8972 or go to https://mothertobaby.org/ongoing-study/dupixent/. are breastfeeding or plan to breastfeed. It is not known whether DUPIXENT passes into your breast milk. A pregnancy registry for women who take DUPIXENT during pregnancy collects information about the health of you and your baby. To enroll or get more information call 1-877-311-8972 or go to https://mothertobaby.org/ongoing-study/dupixent/. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you are taking oral, topical, or inhaled corticosteroid medicines; have asthma and use an asthma medicine; or have atopic dermatitis, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, chronic obstructive pulmonary disease, or chronic spontaneous urticaria, and also have asthma. Do not change or stop your other medicines, including corticosteroid medicine or other asthma medicine, without talking to your healthcare provider. This may cause other symptoms that were controlled by those medicines to come back. DUPIXENT can cause serious side effects, including: Allergic reactions. DUPIXENT can cause allergic reactions that can sometimes be severe. Stop using DUPIXENT and tell your healthcare provider or get emergency help right away if you get any of the following signs or symptoms: breathing problems or wheezing, swelling of the face, lips, mouth, tongue or throat, fainting, dizziness, feeling lightheaded, fast pulse, fever, hives, joint pain, general ill feeling, itching, skin rash, swollen lymph nodes, nausea or vomiting, or cramps in your stomach-area. Eye problems. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision, such as blurred vision. Your healthcare provider may send you to an ophthalmologist for an exam if needed Inflammation of your blood vessels. Rarely, this can happen in people with asthma who receive DUPIXENT. This may happen in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered. Tell your healthcare provider right away if you have: rash, chest pain, worsening shortness of breath, brown or dark colored urine, persistent fever, or a feeling of pins and needles or numbness of your arms or legs. Psoriasis. This can happen in people with atopic dermatitis and asthma who receive DUPIXENT. Tell your healthcare provider about any new skin symptoms. Your healthcare provider may send you to a dermatologist for an examination if needed. Joint aches and pain. Some people who use DUPIXENT have had trouble walking or moving due to their joint symptoms, and in some cases needed to be hospitalized. Tell your healthcare provider about any new or worsening joint symptoms. Your healthcare provider may stop DUPIXENT if you develop joint symptoms. The most common side effects include: Eczema: injection site reactions, eye and eyelid inflammation, including redness, swelling, and itching, sometimes with blurred vision, dry eye, cold sores in your mouth or on your lips, and high count of a certain white blood cell (eosinophilia). Asthma: injection site reactions, high count of a certain white blood cell (eosinophilia), pain in the throat (oropharyngeal pain), and parasitic (helminth) infections. Chronic Rhinosinusitis with Nasal Polyps: injection site reactions, eye and eyelid inflammation, including redness, swelling, and itching, sometimes with blurred vision, high count of a certain white blood cell (eosinophilia), gastritis, joint pain (arthralgia), trouble sleeping (insomnia), and toothache. Eosinophilic Esophagitis: injection site reactions, upper respiratory tract infections, cold sores in your mouth or on your lips, and joint pain (arthralgia). Prurigo Nodularis: eye and eyelid inflammation, including redness, swelling, and itching, sometimes with blurred vision, herpes virus infections, common cold symptoms (nasopharyngitis), dizziness, muscle pain, and diarrhea. Chronic Obstructive Pulmonary Disease: injection site reactions, common cold symptoms (nasopharyngitis), high count of a certain white blood cell (eosinophilia), viral infection, back pain, inflammation inside the nose (rhinitis), diarrhea, gastritis, joint pain (arthralgia), toothache, headache, and urinary tract infection. Chronic Spontaneous Urticaria: injection site reactions. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of DUPIXENT. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. Use DUPIXENT exactly as prescribed by your healthcare provider. It’s an injection given under the skin (subcutaneous injection). Your healthcare provider will decide if you or your caregiver can inject DUPIXENT. Do not try to prepare and inject DUPIXENT until you or your caregiver have been trained by your healthcare provider. In children 12 years of age and older, it’s recommended DUPIXENT be administered by or under supervision of an adult. In children 6 months to less than 12 years of age, DUPIXENT should be given by a caregiver. Please see accompanying full Prescribing Information including Patient Information. About Regeneron Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases. Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases. For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook or X. Regeneron Forward-Looking Statements and Use of Digital Media This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Products”) and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Product Candidates”) and research and clinical programs now underway or planned, including without limitation Dupixent® (dupilumab) for the treatment of chronic obstructive pulmonary disease and asthma as discussed in this press release; uncertainty of the utilization, market acceptance, and commercial success of Regeneron’s Products and Regeneron’s Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new indications for Regeneron’s Products, such as Dupixent for the treatment of chronic pruritus of unknown origin, bullous pemphigoid, lichen simplex chronicus, and other potential indications; the ability of Regeneron’s collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron’s Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regeneron’s Products (such as Dupixent) and Regeneron’s Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron’s Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s Products and Regeneron’s Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron’s Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regeneron’s Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; changes in laws, regulations, and policies affecting the healthcare industry; risks associated with tariffs and other trade restrictions; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron’s Products and Regeneron’s Product Candidates (including biosimilar versions of Regeneron’s Products); the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron’s agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics on Regeneron 's business; and risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts ), risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA® (aflibercept) Injection), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S. Securities and Exchange Commission , including its Form 10-K for the year ended December 31, 2024 and its Form 10-Q for the quarterly period ended March 31, 2025 . Any forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron . Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron 's media and investor relations website (https://investor.regeneron.com) and its LinkedIn page (https://www.linkedin.com/company/regeneron-pharmaceuticals). _____________________ 1 Data on File Source: Regeneron Pharmaceuticals, Inc.

Generated $78.3 million in net product sales of XDEMVY®, an increase of 217% year over year and 18% over Q4 2024, and dispensed approximately 72,000 bottles to patients Strengthened financial position with approximately $135 million raised in public equity offering; cash, cash equivalents and marketable securities of approximately $408 million as of March 31, 2025 On-track to initiate a Phase 2 trial of TP-04 (lotilaner ophthalmic gel) for the potential treatment of Ocular Rosacea in H2 2025 Management to host conference call today, May 1, 2025, at 1:30 p.m. P.T. / 4:30 p.m. E.T. IRVINE, Calif., May 01, 2025 (GLOBE NEWSWIRE) -- Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), today announced financial results for the first quarter ended March 31, 2025. “Tarsus has entered 2025 with incredible momentum, driven by strong execution of our category-creating strategic blueprint for success and a focused commitment to leadership in eye care. The XDEMVY launch is continuing to exceed our expectations and is on track to potentially become one of the best-selling anterior segment medicines,” said Bobak Azamian, M.D., Ph.D., Chief Executive Officer and Chairman of Tarsus. “Building on a foundation of strong commercial performance and the success of our recent equity offering, we believe we are well positioned to accelerate the growth of XDEMVY, create another new category in Ocular Rosacea and continue to advance our pipeline.” Recent Business and Clinical Highlights XDEMVY is on track to potentially be one of the fastest growing and best-selling anterior segment medicines. In the first quarter, the Company: Generated $78.3 million in XDEMVY net product sales, an increase of 217% year over year and 18% over Q4 2024. Dispensed approximately 72,000 bottles of XDEMVY to patients, an increase of 23% over Q4 2024. Broad commercial, Medicare and Medicaid reimbursement of XDEMVY now extends to more than 90% of covered lives. Recognized a gross-to-net discount of approximately 47%. Substantially increased the depth of prescribing among our target Eye Care Professionals (ECPs). At the end of Q1 2025, the number of ECPs writing more than one prescription per week increased by nearly 110% compared to Q3 2024. Direct-To-Consumer (DTC) advertising drove a 140% increase in the average weekly website visits in March 2025 compared to December 2024. Ongoing investment expected to increase alongside leading indicators of utilization. Presented new data showing the global prevalence and real-world patient burden of Demodex blepharitis (DB). The Elara study showed the high prevalence and significant impact of DB in Japan, consistent with the U.S. Results of the Orion registry showed XDEMVY-treated patients experienced meaningful improvements in some of the most impactful symptoms of disease, including fluctuating vision, redness, itchy eyelids, burning or stinging, dryness and crusted eyes. The combined data from the Ersa and Rhea studies in DB patients with Meibomian Gland Disease (MGD) showed statistically significant and clinically meaningful improvements of the meibomian glands, with at least three times more glands secreting normal or clear liquid in XDEMVY-treated patients compared to vehicle at day 43. Strengthened financial position with a $134.8 million upsized public equity offering which will continue to fund the launch of XDEMVY and ongoing pipeline investment. Continued to advance a robust pipeline with multiple catalysts expected in 2025. On-track to initiate a Phase 2 study of TP-04 (lotilaner ophthalmic gel) for Ocular Rosacea, a highly prevalent and underserved eye disease with no FDA-approved therapy, in H2 2025. Anticipated to meet with regulatory authorities in Japan in H2 2025 to help determine a regulatory path forward for XDEMVY in Japan. On-track for potential European regulatory approval in 2027 of a preservative-free formulation of XDEMVY. On-track to initiate a Phase 2 study of TP-05 (an investigational oral tablet) for the potential prevention of Lyme disease in 2026. Generated $78.3 million in XDEMVY net product sales, an increase of 217% year over year and 18% over Q4 2024. Dispensed approximately 72,000 bottles of XDEMVY to patients, an increase of 23% over Q4 2024. Recognized a gross-to-net discount of approximately 47%. At the end of Q1 2025, the number of ECPs writing more than one prescription per week increased by nearly 110% compared to Q3 2024. Ongoing investment expected to increase alongside leading indicators of utilization. The Elara study showed the high prevalence and significant impact of DB in Japan, consistent with the U.S. Results of the Orion registry showed XDEMVY-treated patients experienced meaningful improvements in some of the most impactful symptoms of disease, including fluctuating vision, redness, itchy eyelids, burning or stinging, dryness and crusted eyes. The combined data from the Ersa and Rhea studies in DB patients with Meibomian Gland Disease (MGD) showed statistically significant and clinically meaningful improvements of the meibomian glands, with at least three times more glands secreting normal or clear liquid in XDEMVY-treated patients compared to vehicle at day 43. On-track to initiate a Phase 2 study of TP-04 (lotilaner ophthalmic gel) for Ocular Rosacea, a highly prevalent and underserved eye disease with no FDA-approved therapy, in H2 2025. Anticipated to meet with regulatory authorities in Japan in H2 2025 to help determine a regulatory path forward for XDEMVY in Japan. On-track for potential European regulatory approval in 2027 of a preservative-free formulation of XDEMVY. On-track to initiate a Phase 2 study of TP-05 (an investigational oral tablet) for the potential prevention of Lyme disease in 2026. First Quarter 2025 Financial Results Product sales, net: were $78.3 million compared to $24.7 million for the same period in 2024, driven by approximately 72,000 bottles of XDEMVY delivered to patients compared to approximately 26,000 bottles delivered in the prior year period. Cost of sales: were $5.2 million compared to $1.7 million for the same period in 2024, due to manufacturing costs incurred after the approval of XDEMVY, the royalty we pay on net product sales, and the amortization of the milestones paid to our licensor, which is being amortized over its remaining useful life of 8.4 years. Research and development (R&D) expenses: were $14.4 million compared to $12.1 million for the same period in 2024. The increase was primarily due to $0.5 million of increased TP-04 program expenses, $0.9 million of increased payroll and personnel-related costs, $0.9 million of increased early-stage programs, and $0.3 million of increased other indirect expenses. These increases were partially offset by $0.4 million of decreased TP-03 program expenses. Total R&D non-cash stock compensation expense was $1.5 million, which was consistent with $1.5 million in the same period in 2024. Selling, general and administrative (SG&A) expenses: were $85.0 million compared to $51.6 million for the same period in 2024. The increase was due primarily to $9.6 million of increased payroll and personnel-related costs (including non-cash stock-based compensation), and $25.6 million of increased commercial and marketing costs, including direct-to-consumer advertising costs, as we continued our commercial expansion of XDEMVY. These increases were partially offset by $1.9 million of decreased information technology applications, legal, professional and other corporate expenses. Total SG&A non-cash stock compensation expense was $5.3 million, compared with $3.9 million in the same period in 2024. Net loss: was $25.1 million, compared to $35.7 million for the same period in 2024. Basic and diluted net loss per share for the quarter ended March 31, 2025 was $(0.64), compared with $(1.01) for the same period in 2024. Cash position: As of March 31, 2025, cash, cash equivalents and marketable securities were $407.9 million. Conference Call and WebcastTarsus will host a conference call and webcast to discuss its first quarter 2025 financial results and business highlights today, May 1, 2025, at 1:30 p.m. P.T. / 4:30 p.m. ET. A live webcast will be available on the events section of the Tarsus website. A recorded version of the call will be available on the website shortly after the completion of the call and will be archived there for at least 90 days. About XDEMVY® XDEMVY (lotilaner ophthalmic solution) 0.25%, formerly known as TP-03, is a novel prescription eye drop designed to treat Demodex blepharitis by targeting and eradicating the root cause of the disease – Demodex mite infestation. XDEMVY was evaluated in two pivotal trials collectively involving more than 800 patients. Both trials met the primary endpoint and all secondary endpoints, with statistical significance and no serious treatment-related adverse events. Most patients found the XDEMVY eye drop to be neutral to very comfortable. The most common ocular adverse reactions observed in the studies were instillation site stinging and burning which was reported in 10% of patients. Other ocular adverse reactions reported by less than 2% of patients were chalazion/hordeolum (stye) and punctate keratitis. XDEMVY Indication and Important Safety Information INDICATIONS AND USAGEXDEMVY is indicated for the treatment of Demodex blepharitis. Most common side effects: The most common side effect in clinical trials was stinging and burning in 10% of patients. Other side effects in less than 2% of patients were chalazion/hordeolum and punctate keratitis. For additional information, please see full prescribing information available at: https://xdemvy.com/. About TP-03TP-03 (lotilaner ophthalmic solution) 0.25% is a novel therapeutic designed to treat Demodex blepharitis by targeting and eradicating the root cause of disease – Demodex mite infestation. It was approved by the FDA in 2023 under the brand name XDEMVY® for the treatment of Demodex blepharitis. Lotilaner is a well-characterized anti-parasitic agent that paralyzes and eradicates Demodex mites by selectively inhibiting parasite-specific gamma-aminobutyric acid-gated chloride (GABA-Cl) channels. It is a highly lipophilic molecule, which may promote its uptake in the oily sebum of the eye lash follicles where the mites reside. About TP-04TP-04 is an investigational aqueous gel formulation of lotilaner, a well-characterized anti-parasitic agent that paralyzes and kills mites by selectively inhibiting parasite-specific GABA-Cl channels. Tarsus is studying TP-04 for the treatment of Ocular Rosacea (OR). About TP-05TP-05 is an investigational oral systemic formulation of lotilaner, a well-characterized anti-parasitic agent that selectively inhibits parasite-specific GABA-Cl channels. TP-05 is believed to be the only non-vaccine, drug-based, preventative therapeutic in development designed to kill ticks to potentially prevent Lyme disease transmission. About Tarsus Pharmaceuticals, Inc.Tarsus Pharmaceuticals, Inc. applies proven science and new technology to revolutionize treatment for patients, starting with eye care. Tarsus is advancing its pipeline to address several diseases with high unmet need across a range of therapeutic categories, including eye care, dermatology, and infectious disease prevention. XDEMVY (lotilaner ophthalmic solution) 0.25% is FDA approved in the United States for the treatment of Demodex blepharitis. Tarsus is also developing TP-04 for the potential treatment of Ocular Rosacea and TP-05 as an oral tablet for the prevention of Lyme disease, all of which are in Phase 2. Forward-Looking StatementsStatements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include statements regarding the potential commercial success and growth of XDEMVY in Demodex blepharitis, including market size, acceptance, demand, prescription fill rate and adoption rate for XDEMVY; our ability to successfully implement and continue our new direct-to-consumer campaign; our ability to achieve and maintain distribution and patient access for XDEMVY and timing and breadth of payer coverage; our ability to continue to educate the market about Demodex blepharitis; our ability to initiate planned clinical studies; anticipated regulatory and development milestones including potential Europe and Japan regulatory pathways and approval for XDEMVY; the results of our clinical studies; the test results of our pipeline formulations; our ability to continue investing in our business, and the quotations of Tarsus’ management. The words, without limitation, “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would,” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Important factors that could cause actual results to differ materially from those in the forward-looking statements include: Tarsus is heavily dependent on the successful commercialization of its lead product, XDEMVY for the treatment of Demodex blepharitis and the development and regulatory approval and commercialization of its current and future product candidates; Tarsus’ ability to obtain and maintain regulatory approval for and successfully commercialize its products, including XDEMVY for the treatment of Demodex blepharitis, and its product candidates to meet existing and future regulatory standards; Tarsus has incurred significant losses and negative cash flows from operations since inception and anticipates that it will continue to incur significant expenses and losses for the foreseeable future; Tarsus’ capital requirements are difficult to predict and may change; Tarsus may need to obtain additional funding to achieve its goals and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force Tarsus to delay, reduce, or eliminate its product development programs, commercialization efforts or other operations; Tarsus may not be successful in educating healthcare professionals and the market about the need for treatments specifically for Demodex blepharitis and other diseases targeted by XDEMVY or our product candidates; the development and commercialization of Tarsus products is dependent on intellectual property it licenses from Elanco Tiergesundheit AG; Tarsus expects to expand its development, regulatory, operational, sales, and marketing capabilities and Tarsus may encounter difficulties in managing its growth, which could disrupt its operations; the sizes of the market opportunity for XDEMVY and Tarsus’ product candidates, particularly TP-04 for the treatment of Ocular Rosacea, as well as TP-05 for the prevention of Lyme disease, have not been established with precision and may be smaller than estimated; the results of Tarsus’ earlier studies and trials may not be predictive of future results; any termination or suspension of, or delays in the commencement or completion of, Tarsus’ planned clinical trials could result in increased costs, delay or limit its ability to generate revenue and adversely affect its commercial prospects; if Tarsus is unable to obtain and maintain sufficient intellectual property protection for its product candidates, or if the scope of the intellectual property protection is not sufficiently broad, Tarsus’ competitors could develop and commercialize products similar or identical to Tarsus’ products; and if Tarsus is unable to access capital (including but not limited to cash, cash equivalents, and credit facilities) and/or loses capital, as a result of potential failure of any financial institutions that Tarsus does business with directly or indirectly. Further, there are other risks and uncertainties that could cause actual results to differ from those set forth in the forward-looking statements and they are detailed from time to time in the reports Tarsus files with the Securities and Exchange Commission, including Tarsus’ Form 10-K for the year ended December 31, 2024 filed on February 25, 2025 and the most recent Form 10-Q quarterly filing filed with the SEC on May 1, 2025, which Tarsus incorporates by reference into this press release, copies of which are posted on its website and are available from Tarsus without charge. However, new risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. Any forward-looking statements contained in this earnings release are based on the current expectations of Tarsus’ management team and speak only as of the date hereof, and Tarsus specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.