Azercabtagene Zapreleucel

First quarter 2026 total global revenue of approximately $205 million, including BRIUMVI U.S. net revenue of approximately $195 million Raises full year 2026 total global revenue target to approximately $925 million and raises full year 2026 BRIUMVI U.S. net product revenue target to $885-900 million Conference call to be held today, Wednesday, May 6, 2026, at 8:30 AM ET NEW YORK, May 06, 2026 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) (the Company or TG Therapeutics) today announced its financial results for the first quarter of 2026, along with recent company developments and provided an update on 2026 financial guidance. Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, stated, “We are off to a strong start in 2026, with BRIUMVI performance exceeding expectations and momentum continuing to build. Growth is being driven by strong underlying demand, record new patient starts, and consistent commercial execution— reinforcing our belief that we remain early in the adoption curve for BRIUMVI. Based on this performance, we are significantly increasing our full-year U.S. BRIUMVI revenue guidance to $885-900 million and continue to see the brand as having a multi-billion-dollar potential before considering the impact of a subcutaneous BRIUMVI currently under development. With multiple near-term clinical catalysts and ongoing efforts to expand the franchise, we believe BRIUMVI is well-positioned to become a leading therapy in MS and a durable, long-term growth driver for TG.” Recent Highlights & Developments BRIUMVI ® (ublituximab-xiiy) Commercialization BRIUMVI U.S. net product revenue of $194.8 million for the first quarter 2026, representing approximately 63% quarterly growth over the same period last year BRIUMVI Data Presentations & Publications Published two articles in medical journals: March 2026: “Efficacy of Ublituximab in People with Highly Active Relapsing Multiple Sclerosis”, published in Neurology and Therapy, highlighting data from a post hoc pooled analysis of the Phase 3 ULTIMATE I and II studies evaluating BRIUMVI in people with highly active RMS. February 2026: “Five Years of Ublituximab in Multiple Sclerosis: ULTIMATE I and II Open-Label Extension (OLE) Study ”, published in JAMA Neurology, highlighting five-year data from the OLE of the ULTIMATE I and II trials. Pipeline Completed patient enrollment into the randomized Phase 3 pivotal program evaluating subcutaneous BRIUMVI Completed patient enrollment into the randomized Phase 3 pivotal program to evaluate a consolidated Day 1 and Day 15 dosing regimen for intravenous (IV) BRIUMVI in the ongoing ENHANCE trial Continued enrollment for patients with progressive multiple sclerosis into the ongoing Phase 1 clinical trial evaluating azer-cel for the treatment of autoimmune diseases Financial Update Secured an additional $500 million in non-dilutive capital from Blue Owl Capital and expanded our second share repurchase program from $100 million to $300 million, of which $200 million is remaining Since the inception of the first share repurchase program in 2024, and as of April 30, 2026, TG has repurchased a total of $200 million of common stock at an average price of $29.28 per share, of which $100 million was completed during the first quarter of 2026 2026 Financial Guidance Raises full year 2026 target total global revenue to approximately $925 million Raises full year 2026 target BRIUMVI U.S. net product revenue to approximately $885 - $900 million (prior guidance of $825-$850 million) Provides second quarter 2026 target BRIUMVI U.S. net product revenue of approximately $220 million Full year 2026 target operating expense, defined as R&D and SG&A, of approximately $350 million excluding non-cash compensation, in addition to approximately $100 million in expenses associated with the subcutaneous BRIUMVI manufacturing costs and secondary manufacturer start-up costs 2026 Development Pipeline Anticipated Milestones Announce topline Phase 3 data for ENHANCE trial combining Day 1 and Day 15 doses of IV BRIUMVI mid-year 2026 Present preliminary Phase 1 azer-cel data in Progressive MS in the second half of 2026 Announce topline Phase 3 data for subcutaneous BRIUMVI (ublituximab) year-end 2026/first quarter 2027 Commence a potentially registration-directed trial for BRIUMVI in Myasthenia Gravis (MG) Commence additional exploratory studies for BRIUMVI and azer-cel in autoimmune disease (outside MS) Financial Results for First Quarter 2026 Product Revenue, net : Product revenue, net was $201.3 million for the three months ended March 31, 2026, compared to $119.7 million for the three months ended March 31, 2025. Product revenue, net consists primarily of net product sales of BRIUMVI in the United States, which totaled $194.8 million during the three months ended March 31, 2026. Also included in product revenue, net for the three months ended March 31, 2026 is sales of BRIUMVI to our ex-U.S. licensing partner, Neuraxpharm, of $6.5 million. License, milestone, royalty and other revenue : License, milestone, royalty and other revenue was approximately $3.6 million for the three months ended March 31, 2026 compared to approximately $1.2 million for the three months ended March 31, 2025. License, milestone, royalty and other revenue for the three months ended March 31, 2026 is predominantly comprised of $2.7 million of royalty revenue recognized under the Commercialization Agreement with Neuraxpharm and $0.9 million of consideration received for development and regulatory activities performed on behalf of Neuraxpharm in accordance with the Commercialization Agreement. R&D Expenses : Total research and development (R&D) expense was approximately $48.4 million for the three months ended March 31, 2026, compared to $46.4 million for the three months ended March 31, 2025. The increase in R&D expense during the three months ended March 31, 2026 was primarily attributable to license and milestone expense pertaining to our license agreement with Precision BioSciences, Inc., as well as increased clinical trial related expenses and increased personnel costs during the period ended March 31, 2026. These increases were partially offset by lower manufacturing and development costs in connection with our subcutaneous ublituximab development work incurred during the period ended March 31, 2026. SG&A Expenses : Total selling, general and administrative (SG&A) expense was approximately $88.2 million for the three months ended March 31, 2026, compared to $50.3 million for the three months ended March 31, 2025. The increase in selling, general and administrative costs during the three months ended March 31, 2026 was primarily due to an increase in marketing and media spend, and personnel and external costs associated with the commercialization of BRIUMVI. Net income: Net income was $19.8 million for the three months ended March 31, 2026, compared to net income of $5.1 million for the three months ended March 31, 2025. Cash Position and Financial Guidance : Cash, cash equivalents and investment securities were $572.8 million as of March 31, 2026. We anticipate that our cash, cash equivalents and investment securities as of March 31, 2026, combined with the projected revenues from BRIUMVI, will be sufficient to fund our business based on our current operating plan. CONFERENCE CALL INFORMATION The Company will host a conference call today, May 6, 2026, at 8:30 AM ET, to discuss the Company’s financial results from first quarter of 2026. To participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics. A live audio webcast will be available on the Events page, located within the Investors & Media section, of the Company's website at . An audio recording of the conference call will also be available for a period of 30 days after the call. ABOUT BRIUMVI ® (ublituximab-xiiy) 150 mg/6 mL Injection for IV BRIUMVI is a novel monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of autoimmune disorders, such as RMS. BRIUMVI is uniquely designed to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, allows for efficient B-cell depletion at low doses. BRIUMVI is indicated in the U.S. for the treatment of adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease and in several countries outside of the U.S. for the treatment of adult patients with RMS with active disease defined by clinical or imaging features. A list of authorized specialty distributors can be found at . IMPORTANT SAFETY INFORMATION Contraindications: BRIUMVI is contraindicated in patients with: Active Hepatitis B Virus infection A history of life-threatening infusion reaction to BRIUMVI WARNINGS AND PRECAUTIONS Infusion Reactions: BRIUMVI can cause infusion reactions, which can include pyrexia, chills, headache, influenza-like illness, tachycardia, nausea, throat irritation, erythema, and an anaphylactic reaction. In MS clinical trials, the incidence of infusion reactions in BRIUMVI-treated patients who received infusion reaction-limiting premedication prior to each infusion was 48%, with the highest incidence within 24 hours of the first infusion. 0.6% of BRIUMVI-treated patients experienced infusion reactions that were serious, some requiring hospitalization. Observe treated patients for infusion reactions during the infusion and for at least one hour after the completion of the first two infusions unless infusion reaction and/or hypersensitivity has been observed in association with the current or any prior infusion. Inform patients that infusion reactions can occur up to 24 hours after the infusion. Administer the recommended pre-medication to reduce the frequency and severity of infusion reactions. If life-threatening, stop the infusion immediately, permanently discontinue BRIUMVI, and administer appropriate supportive treatment. Less severe infusion reactions may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment. Infections: Serious, life-threatening or fatal, bacterial and viral infections have been reported in BRIUMVI-treated patients. In MS clinical trials, the overall rate of infections in BRIUMVI-treated patients was 56% compared to 54% in teriflunomide-treated patients. The rate of serious infections was 5% compared to 3% respectively. There were 3 infection-related deaths in BRIUMVI-treated patients. The most common infections in BRIUMVI-treated patients included upper respiratory tract infection (45%) and urinary tract infection (10%). Delay BRIUMVI administration in patients with an active infection until the infection is resolved. Consider the potential for increased immunosuppressive effects when initiating BRIUMVI after immunosuppressive therapy or initiating an immunosuppressive therapy after BRIUMVI. Hepatitis B Virus (HBV) Reactivation: HBV reactivation occurred in an MS patient treated with BRIUMVI in clinical trials. Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation have occurred in patients treated with anti-CD20 antibodies. Perform HBV screening in all patients before initiation of treatment with BRIUMVI. Do not start treatment with BRIUMVI in patients with active HBV confirmed by positive results for HB surface antigen (HBsAg) and anti-HB tests. For patients who are negative for HBsAg and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult a liver disease expert before starting and during treatment. Progressive Multifocal Leukoencephalopathy (PML): PML is an opportunistic viral infection of the brain caused by the JC virus (JCV) that typically only occurs in patients who are immunocompromised, and that usually leads to death or severe disability. JCV infection resulting in PML has been observed in patients treated with anti-CD20 antibodies, including BRIUMVI, and other MS therapies. If PML is suspected, withhold BRIUMVI and perform an appropriate diagnostic evaluation. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. MRI findings may be apparent before clinical signs or symptoms; monitoring for signs consistent with PML may be useful. Further investigate suspicious findings to allow for an early diagnosis of PML, if present. Following discontinuation of another MS medication associated with PML, lower PML-related mortality and morbidity have been reported in patients who were initially asymptomatic at diagnosis compared to patients who had characteristic clinical signs and symptoms at diagnosis. If PML is confirmed, treatment with BRIUMVI should be discontinued. Vaccinations: Administer all immunizations according to immunization guidelines: for live or live-attenuated vaccines, at least 4 weeks and, whenever possible, at least 2 weeks prior to initiation of BRIUMVI for non-live vaccines. BRIUMVI may interfere with the effectiveness of non-live vaccines. The safety of immunization with live or live-attenuated vaccines during or following administration of BRIUMVI has not been studied. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion. Vaccination of Infants Born to Mothers Treated with BRIUMVI During Pregnancy: In infants of mothers exposed to BRIUMVI during pregnancy, assess B-cell counts prior to administration of live or live-attenuated vaccines as measured by CD19 + B-cells. Depletion of B-cells in these infants may increase the risks from live or live-attenuated vaccines. Inactivated or non-live vaccines may be administered prior to B-cell recovery. Assessment of vaccine immune responses, including consultation with a qualified specialist, should be considered to determine whether a protective immune response was mounted. Fetal Risk: Based on data from animal studies, BRIUMVI may cause fetal harm when administered to a pregnant woman. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 B-cell depleting antibodies during pregnancy. Advise females of reproductive potential to use effective contraception during BRIUMVI treatment and for 6 months after the last dose. Reduction in Immunoglobulins: As expected with any B-cell depleting therapy, decreased immunoglobulin levels were observed. Decrease in immunoglobulin M (IgM) was reported in 0.6% of BRIUMVI-treated patients compared to none of the patients treated with teriflunomide in RMS clinical trials. Monitor the levels of quantitative serum immunoglobulins during treatment, especially in patients with opportunistic or recurrent infections, and after discontinuation of therapy, until B-cell repletion. Consider discontinuing BRIUMVI therapy if a patient with low immunoglobulins develops a serious opportunistic infection or recurrent infections, or if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins. Liver Injury: Clinically significant liver injury, without findings of viral hepatitis, has been reported in the postmarketing setting in patients treated with anti-CD20 B-cell depleting therapies approved for the treatment of MS, including BRIUMVI. Signs of liver injury, including markedly elevated serum hepatic enzymes with elevated total bilirubin, have occurred from weeks to months after administration. Patients treated with BRIUMVI found to have an alanine aminotransaminase (ALT) or aspartate aminotransferase (AST) greater than 3x the upper limit of normal (ULN) with serum total bilirubin greater than 2x ULN are potentially at risk for severe drug-induced liver injury. Obtain liver function tests prior to initiating treatment with BRIUMVI, and monitor for signs and symptoms of any hepatic injury during treatment. Measure serum aminotransferases, alkaline phosphatase, and bilirubin levels promptly in patients who report symptoms that may indicate liver injury, including new or worsening fatigue, anorexia, nausea, vomiting, right upper abdominal discomfort, dark urine, or jaundice. If liver injury is present and an alternative etiology is not identified, discontinue BRIUMVI. Most Common Adverse Reactions: The most common adverse reactions in RMS trials (incidence of at least 10%) were infusion reactions and upper respiratory tract infections. Physicians, pharmacists, or other healthcare professionals with questions about BRIUMVI should visit ABOUT BRIUMVI PATIENT SUPPORT in the U.S. BRIUMVI Patient Support is a flexible program designed by TG Therapeutics to support U.S. patients through their treatment journey in a way that works best for them. More information about the BRIUMVI Patient Support program can be accessed at ABOUT MULTIPLE SCLEROSIS Relapsing multiple sclerosis (RMS) is a chronic demyelinating disease of the central nervous system (CNS) and includes people with relapsing-remitting multiple sclerosis (RRMS) and people with secondary progressive multiple sclerosis (SPMS) who continue to experience relapses. RRMS is the most common form of multiple sclerosis (MS) and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. It is estimated that nearly 1 million people are living with MS in the United States and approximately 85% are initially diagnosed with RRMS. 1,2 The majority of people who are diagnosed with RRMS will eventually transition to SPMS, in which they experience steadily worsening disability over time. Worldwide, more than 2.3 million people have a diagnosis of MS. 1 ABOUT TG THERAPEUTICS TG Therapeutics is a fully integrated, commercial stage, biotechnology company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline, TG Therapeutics has received approval from the U.S. Food and Drug Administration (FDA) for BRIUMVI ® (ublituximab-xiiy) to treat adult patients with relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval from several regulatory agencies outside of the U.S. for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features. For more information, visit , and follow us on X (formerly Twitter) @TGTherapeutics and on LinkedIn . BRIUMVI ® is a registered trademark of TG Therapeutics, Inc. Cautionary Statement This press release contains forward-looking statements that involve a number of risks and uncertainties. All statements contained in this press release other than statements of historical facts, including statements regarding our future results of operations and financial position, our strategic and financial initiatives, our business strategy, and objectives for future operations may constitute forward-looking statements. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release. In addition to the risk factors identified from time to time in our reports filed with the U.S. Securities and Exchange Commission (SEC), factors that could cause our actual results to differ materially include the below. Such forward looking statements include but are not limited to statements regarding our plans, business strategies and operations related to the commercialization of BRIUMVI ® (ublituximab-xiiy) for RMS in the United States, or any jurisdictions outside of the United States; anticipated healthcare professional (HCP) and patient acceptance and use of BRIUMVI for the approved indications; expectations of future revenue for BRIUMVI, or TG expenses or profit estimates or targets; our ability to execute our share repurchase program; expectations and timing for our clinical trials of subcutaneous ublituximab (the active ingredient in BRIUMVI), and sometimes referred to as subcutaneous BRIUMVI; expectations and timing for our ENHANCE Phase 3 pivotal program to evaluate a consolidated day 1 and day 15 dosing regimen for IV BRIUMVI; and expectations and timing for any of our pipeline products or programs, including Azer-cel or BRIUMVI in MG. Additional factors that could cause our actual results to differ materially include the following: the Company’s ability to continue to commercialize BRIUMVI; the risk that trends in prescriptions are not maintained or that prescriptions are not filled; the failure to obtain and maintain payor coverage; the risk that HCP interest in BRIUMVI will not be sustained; the risk that momentum in sales for BRIUMVI will not be sustained during the course of the year; the risk that the commercialization of BRIUMVI does not continue to exceed expectations; the risk that our BRIUMVI revenue targets will not be achieved; the failure to obtain and maintain requisite regulatory approvals, including the risk that the Company fails to satisfy post-approval regulatory requirements, the potential for variations from the Company’s projections and estimates about the potential market for BRIUMVI due to a number of factors, including, further limitations that regulators may impose on the required labeling for BRIUMVI (such as modifications, resulting from safety signals that arise in the post-marketing setting or in the long-term extension study from the ULTIMATE I and II clinical trials); the Company’s ability to meet post-approval compliance obligations (on topics including but not limited to product quality, product distribution and supply chain, pharmacovigilance, and sales and marketing); the Company’s reliance on third parties for manufacturing, distribution and supply, and other support functions for our clinical and commercial products, including BRIUMVI, and the ability of the Company and its manufacturers and suppliers to produce and deliver BRIUMVI to meet the market demand for BRIUMVI; the risk that any individual patient’s clinical experience in the post-marketing setting, or the aggregate patient experience in the post-marketing setting, may differ from that demonstrated in controlled clinical trials such as ULTIMATE I and II; the risk that the Company does not achieve its 2026 development pipeline anticipated milestones or goals in the timeframe projected or at all, including (i) completing a pivotal program for subcutaneous ublituximab, (ii) completing a pivotal program based on data from the ENHANCE trial to consolidate day 1 and day 15 dosing, (iii) enrolling patients into a trial evaluating BRIUMVI in MG, or (iv) enrolling patients into a trial evaluating azer-cel; the risk that clinical trial data readouts may be delayed due to a number of factors including enrollment, data collection, data maturity or other factors; the risk that the subcutaneous Phase 3 program will not be successful or if successful still will not be approved by the FDA or achieve commercial acceptance; the risk that, if subcutaneous BRIUMV is approved, the anticipated expansion of the addressable market will not be realized; the risk that the ENHANCE Phase 3 trial will not be successful or if successful will not be approved by the FDA or achieve commercial acceptance; the risk that we will not move forward with the development of BRIUMVI in MG or schizophrenia and azer-cel in progressive MS following preliminary studies; the uncertainties generally inherent in research and development and early stage exploratory programs; the risk that the collaboration with Christina Applegate is not able to be implemented or does not go as planned for regulatory or other reasons; the risk that the platform does not gain traction or ceases to exist; regulatory developments, legislative actions, executive orders, including the imposition of tariffs and policy changes in the U.S. and other jurisdictions; and general political, economic and business conditions. Further discussion about these and other risks and uncertainties can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and in our other filings with the SEC. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at . The information found on our website is not incorporated by reference into this press release and is included for reference purposes only. CONTACT: Investor Relations Email: ir@tgtxinc.com Telephone: 1.877.575.TGTX (8489), Option 4 Media Relations: Email: media@tgtxinc.com Telephone: 1.877.575.TGTX (8489), Option 6 1. MS Prevalence. National Multiple Sclerosis Society website. . Accessed October 26, 2020. 2. Multiple Sclerosis International Federation, 2013 via Data monitor p. 236. TG Therapeutics, Inc. Selected Condensed Consolidated Financial Data Statements of Operations Information (in thousands, except share and per share amounts; unaudited): Three months ended March 31, 2026 2025 Revenue: Product revenue, net $ 201,308 $ 119,655 License, milestone, royalty and other revenue 3,610 1,201 Total revenue $ 204,918 $ 120,856 Costs and expenses: Cost of revenue 33,510 15,541 Research and development: Stock-based compensation 4,875 3,331 Other research and development 43,521 43,031 Total research and development 48,396 46,362 Selling, general and administrative: Stock-based compensation 15,075 11,640 Other selling, general and administrative 73,142 38,691 Total selling, general and administrative 88,217 50,331 Total costs and expenses 170,123 112,234 Operating income 34,795 8,622 Other expense (income): Interest expense 7,666 6,757 Loss on extinguishment of debt 9,153 — Other income (2,387 ) (3,603 ) Total other expense, net 14,432 3,154 Net income before taxes $ 20,363 $ 5,468 Income tax expense (586 ) (408 ) Net income $ 19,777 $ 5,060 Net income per common share: Basic $ 0.14 $ 0.03 Diluted $ 0.12 $ 0.03 Weighted-average shares of common stock outstanding Basic 144,439,370 146,677,783 Diluted 160,062,326 162,769,202 Condensed Balance Sheet Information (in thousands): March 31, 2026 (Unaudited) December 31, 2025* Cash, cash equivalents and investment securities 572,835 199,511 Total assets 1,528,837 1,063,253 Total equity 583,131 648,020 * Condensed from audited financial statements

- Continued advancement of the Phase 1/2a ELIMINATE-B trial of PBGENE-HBV across multiple dosing cohorts; Late-Breaking poster presentation for PBGENE-HBV accepted at European Association for the Study of the Liver Congress 2026 - - Advanced PBGENE-DMD toward clinical evaluation in the Phase 1/2 FUNCTION-DMD trial following U.S. FDA IND clearance and Fast Track designation; First clinical trial site activated and enrolling patients - - Cash balance of $125.8 million including cash, cash equivalents and restricted cash as of March 31, 2026, expected to enable data milestones from two wholly owned clinical stage in vivo gene editing programs – PBGENE-HBV and PBGENE-DMD through 2028 - DURHAM, N.C.--(BUSINESS WIRE)--Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS ® platform to develop in vivo gene editing therapies for high unmet need diseases, today reported financial results for the first quarter ended March 31, 2026, and provided a business update. “During the first quarter, we continued to execute on our two clinical stage in vivo gene editing programs. We advanced PBGENE-HBV into new cohorts in the ELIMINATE-B trial and drove PBGENE-DMD through Investigational New Drug (IND) approval and activated our first clinical site as we prepare to dose the first patient in the FUNCTION-DMD trial,” said Michael Amoroso, Chief Executive Officer of Precision BioSciences. “We remain focused on disciplined execution in 2026 as we generate additional clinical data from the ELIMINATE-B trial and enroll more sites and patients in the FUNCTION-DMD trial. We believe our ARCUS platform and targeted development strategy position us to deliver multiple important clinical and operational milestones this year.” Wholly Owned Portfolio: PBGENE-HBV (Hepatitis B Viral Elimination Program) PBGENE-HBV is Precision’s wholly owned in vivo gene editing program being evaluated in a global first-in-human clinical trial as a potential curative treatment for chronic hepatitis B. PBGENE-HBV is the only clinical stage program that targets the elimination of cccDNA, the sole source of viral replication, leading to sustained loss of HBV DNA and other downstream viral transcripts. PBGENE-HBV is the first in vivo gene editing approach to prospectively employ repeat administrations of lipid nanoparticle (LNP) in chronic hepatitis B. As part of the ongoing assessment of the safety and efficacy pro PBGENE-HBV after repeat doses in Part 1 dose finding, Precision has treated 16 patients with 38 administrations of PBGENE-HBV across five cohorts evaluating the impact of escalating dose levels as well as 8-week and 4-week dosing intervals. The goal during Part 1 of the study is to select the dose and schedule that achieves the desired therapeutic index to move to the expansion phase of the ELIMINATE-B trial. Looking ahead, Precision expects to share further clinical data from the PBGENE-HBV program at hepatitis-focused medical conferences throughout 2026, starting with the European Association for the Study of the Liver (EASL). On April 22 nd , Precision BioSciences announced that a late-breaking poster for PBGENE-HBV was accepted for presentation at the EASL Congress 2026 taking place on May 27-30 in Barcelona, Spain. The poster titled, “ First evidence of elimination and inactivation of cccDNA in liver biopsies collected from patients with chronic hepatitis B treated with PBGENE-HBV” will be presented by investigator, Man-Fung Yuen, Chair and Professor of Gastroenterology and Hepatology at The University of Hong Kong. The poster will be presented on May 27-30, 2026 during the Late-Breaker poster session. In addition, in April the Company announced that it received Clinical Trial Application approval to expand ELIMINATE-B into France and Romania, broadening the study’s footprint in Europe. Site initiation activities are underway and initial patient screening in those countries is expected in the second quarter of 2026. In March, Precision BioSciences received two Notices of Allowance from the U.S. Patent and Trademark Office (USPTO) for patent applications relating to the Company’s PBGENE-HBV program. When issued, each patent arising from these applications is expected to have a standard expiration date in November 2044. PBGENE-DMD (Muscle Targeted Gene Excision Program) PBGENE-DMD is Precision’s development program for Duchenne muscular dystrophy (DMD), designed to restore a near full-length functional dystrophin protein through a gene excision approach using two ARCUS nucleases delivered in a single AAV. Following U.S. Food and Drug Administration (FDA) IND clearance in early 2026, Precision advanced Institutional Review Board (IRB) activities and clinical trial site activation for the Phase 1/2 FUNCTION-DMD clinical trial. In April, the company activated Arkansas Children’s Hospital as the first clinical trial site and is now actively enrolling patients in the FUNCTION-DMD study of PBGENE-DMD. Arkansas Children’s is a Parent Project Muscular Dystrophy (PPMD)-certified Duchenne Care Center, recognized for delivering specialized, multidisciplinary care for patients with DMD. PPMD’s Certified Duchenne Care Center Program is intended to help ensure that participating centers maintain high standards in clinical and sub-specialty services, rapidly incorporate evidence-based knowledge, and provide standardized multidisciplinary Duchenne care. Additionally, Arkansas Children’s is a designated Muscular Dystrophy Association (MDA) Care Center, providing specialized, multidisciplinary care for neuromuscular diseases including diagnosis, personalized treatment plans, and comprehensive support for patients. In March 2026, PBGENE-DMD also received FDA Fast Track designation and hosted a DMD investor event, the replay is accessible here . In addition, Precision presented preclinical PBGENE-DMD data highlighting durable dystrophin expression and functional benefit at the Muscular Dystrophy Association Clinical & Scientific Conference 2026 in March. Partnered In Vivo Programs: iECURE-OTC (Gene Insertion Program) Led by iECURE, Inc. (iECURE) ECUR-506 is an ARCUS-mediated in vivo targeted gene insertion program currently in a first-in-human trial (OTC-HOPE) evaluating ECUR-506 as a potential treatment for neonatal onset ornithine transcarbamylase (OTC) deficiency. iECURE previously announced alignment with the FDA on key study elements could support a potential Biologics License Application (BLA). The OTC-HOPE study is ongoing in the U.K., the U.S., Australia, and Spain. iECURE expects to present clinical data from the ongoing OTC-HOPE clinical trial at the American Society of Gene & Cell Therapy (ASGCT) Annual Meeting taking place May 11-15, 2026 in Boston. The oral presentation at ASGCT will include preliminary data from study participants in the first three dose cohorts (n=7) of the ongoing OTC-HOPE study, including a decreased rate of hyperammonemic crises (HAC) following ECUR-506 administration. In addition, iECURE plans to present a poster at the Society for Inherited Metabolic Disorders (SIMD) Annual Meeting taking place May 17-20, 2026 in Puerto Rico featuring one-year post-treatment data from the first infant dosed in the study who achieved a complete clinical response as defined by study protocol, including sustained discontinuation of standard-of-care therapies. Partnered Ex Vivo Programs: Azer-Cel (Azercabtagene Zapreleucel Allogeneic CAR T Treatment for Cancer) Imugene Limited continues development of Azer-Cel in diffuse large B-cell lymphoma and has received written guidance from the FDA regarding the registrational pathway for Azer-Cel. The guidance provided clear alignment with the FDA across key elements required to support advancement into a pivotal study, including dosing regimen, patient population, endpoints, and manufacturing readiness. Azer-Cel has been selected for oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting being held on May 29-June 2, in Chicago. Azer-Cel (Azercabtagene Zapreleucel Allogeneic CAR T Treatment for Multiple Sclerosis) Separately, Azer-Cel is being evaluated by TG Therapeutics, Inc. (Nasdaq: TGTX) in a Phase 1 trial in progressive multiple sclerosis. In April 2026, Precision received a clinical milestone cash payment under its license agreement with TG Therapeutics. The payment of $7.5 million was inclusive of $5.25 million cash and $2.25 million for the purchase of shares of Precision common stock by TG Therapeutics. Anticipated 2026 events include presentation of preliminary Phase 1 Azer-Cel data in progressive multiple sclerosis in the second half of 2026 and commencement of additional exploratory studies in autoimmune diseases outside of multiple sclerosis. Quarter Ended March 31, 2026 Financial Results: Cash, Cash Equivalents, and Restricted Cash: As of March 31, 2026, Precision had approximately $125.8 million in cash, cash equivalents, and restricted cash. The Company expects that existing cash and cash equivalents, continued fiscal and operating discipline, and availability of Precision’s at-the-market (ATM) facility will fund the Company’s cash runway through 2028. Based on its expected cash runway, Precision believes it is sufficiently capitalized to achieve PBGENE-HBV and PBGENE-DMD data milestones through 2028. Revenues: Total revenues for the quarter ended March 31, 2026, were $10.8 million, as compared to less than $0.1 million for the quarter ended March 31, 2025. The increase in revenue was the result of milestone revenue recognized under our license agreement with TG Therapeutics, Inc. and a legacy ARCUS agriculture gene editing collaboration agreement. Research and Development Expenses: Research and development expenses were $13.1 million for the quarter ended March 31, 2026, as compared to $13.6 million for the quarter ended March 31, 2025. The decrease of $0.5 million was primarily due to decreases in platform development and research expenses, partially offset by increases in PBGENE-DMD program costs as the Company initiated IRB activities and clinical trial site activation for the FUNCTION-DMD Phase 1/2 clinical trial and PBGENE-HBV program costs General and Administrative Expenses: General and administrative expenses were $6.8 million for the quarter ended March 31, 2026, as compared to $8.6 million for the quarter ended March 31, 2025. The decrease of $1.8 million was primarily a result of operational discipline and lower employee-related costs. Other (Expense) Income : Total other expense was $9.4 million for the quarter ended March 31, 2026, compared to $1.5 million total other income for the quarter ended March 31, 2025. The decrease of $10.9 million was primarily due to fair value adjustments which did not impact cash, including a loss on change in fair value of the warrant liability, and a decrease in interest income. Additionally, in the quarter ended March 31, 2026, there was no gain or loss recognized from the Company’s equity method investment compared to $1.3 million gain recognized during the quarter ended March 31, 2025. Net Loss: Net loss was $18.4 million, or $(0.75) per share (basic and diluted), for the quarter ended March 31, 2026. Net loss was $20.6 million, or $(2.21) per share (basic and diluted), for the quarter ended March 31, 2025. About Chronic Hepatitis B Chronic hepatitis B virus causes inflammation and damage to the liver, leading to chronic infection and increased risk of death from liver cancer or cirrhosis. There is no cure for chronic hepatitis B, and current treatments rarely result in a functional cure, primarily due to persistence of viral DNA in the liver. In patients with chronic hepatitis B, genetic material of the virus is converted within infected liver cells into cccDNA that acts as the only template to make new infectious viral particles. Hepatitis B virus also inserts fragments of its DNA into the human genome of infected liver cells. These integrated fragments are viral replication incompetent and cannot produce new infectious virus. Both cccDNA and integrated HBV DNA produce the viral protein, hepatitis B surface antigen (HBsAg), which is secreted in the blood. Historically, the focus for drug development and regulatory approval of drugs for chronic hepatitis B has relied on the temporary suppression of HBsAg. Achieving undetectable HBsAg may lead to a functional cure if there is no rebound in HBV DNA or HBsAg after drug treatment has been discontinued for at least six months, but this is achieved in less than three out of 100 patients treated with the current standard of care. Since cccDNA is the only source of infectious particles (HBV DNA), elimination of cccDNA results in a cure of chronic hepatitis B. Sustained loss of HBV DNA alone as a result of cccDNA elimination is an approvable endpoint for the FDA and highly relevant for PBGENE-HBV. About PBGENE-HBV, A Viral Elimination Program PBGENE-HBV is Precision’s wholly owned in vivo gene editing program under investigation in a global first-in-human clinical trial, which is designed to be a potentially curative treatment for chronic Hepatitis B infection. PBGENE-HBV is the first and only potentially curative gene editing program to enter the clinic that is specifically designed to eliminate the root cause of chronic hepatitis B, cccDNA, while inactivating integrated HBV DNA. Elimination of cccDNA results in HBV cure as cccDNA is the only source of infectious replication (HBV DNA). The ELIMINATE-B trial is investigating PBGENE-HBV at multiple dose levels across a number of administrations per dose level in patients with chronic Hepatitis B. PBGENE-HBV has been granted Fast Track designation by the FDA. PBGENE-HBV is the only clinical stage program targeting the elimination of cccDNA leading to sustained loss of HBV DNA. The FDA has previously provided guidance that sustained loss of HBV DNA is an approvable endpoint for chronic hepatitis B. Further details on the trial can be found on Precision’s website and on clinicaltrials.gov identifier NCT06680232. About PBGENE-DMD, A Muscle-Targeted Excision Program PBGENE-DMD is Precision’s development program for the treatment of DMD. DMD is a genetic disease caused by mutations in the dystrophin gene that prevent production of the dystrophin protein and affects approximately 15,000 patients in the U.S. alone. There are currently no approved therapies that can drive durable and significant functional improvements over time. PBGENE-DMD is designed to improve function for approximately 60% of patients afflicted with DMD by employing two complementary ARCUS nucleases delivered in a single AAV to excise exons 45-55 of the dystrophin gene. Compared with DMD, deletion of exons 45-55 is often associated with a more mild prognosis for patients. The aim of this approach is to restore a near full-length functional dystrophin protein within the body that more closely resembles normal dystrophin as opposed to synthetic, truncated microdystrophin approaches with minimal functional benefit. The Phase 1/2 FUNCTION-DMD study is expected to enroll ambulatory DMD patients with mutations between exons 45 and 55 impacting up to 60% of boys with DMD. The clinical trial will employ an appropriate immune modulation regimen and safety monitoring program to treat ambulatory patients at world class specialized DMD clinical sites. PBGENE-DMD was granted Orphan Drug Designation by the FDA in July 2025. The PBGENE-DMD program is eligible for a Priority Review Voucher (PRV) via the Rare Pediatric Disease Priority Review Voucher (PRV) program, which was signed into law on February 3, 2026, as part of the Consolidated Appropriations Act of 2026. PBGENE-DMD received Fast Track designation from the FDA in February 2026. Further details on the trial can be found on Precision’s website and on clinicaltrials.gov identifier NCT07429240. 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. These features are intended for ARCUS nucleases to drive more defined therapeutic outcomes. Using ARCUS, the Company’s pipeline is comprised of clinical stage 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 . The ARCUS ® platform is being used to develop in vivo gene editing therapies for sophisticated gene edits, including gene elimination (removing a genome e.g. viral DNA such as in the Company’s PBGENE-HBV program), and excision (removing a large portion of a defective gene by delivering two ARCUS nucleases in a single AAV such as in the Company’s PBGENE-DMD program) and gene insertion (inserting DNA into gene to cause expression/add function). 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 key advantages of ARCUS and its key capabilities and differentiating characteristics; expectations about operational initiatives, strategies, further development, or timing of additional updates or data releases of PBGENE-HBV and PBGENE-DMD, timing and progress of IRB processes and site activations following IND clearance for the PBGENE-DMD program and FUNCTION-DMD trial; administrations of PBGENE-HBV across cohorts and the evaluation on the impact of escalating dose levels and dosing intervals; the goal during Part 1 of the study is to select the dose and schedule that achieves the desired therapeutic index to move to the expansion phase of the ELIMINATE-B trial; expectations to share further clinical data from the PBGENE-HBV programs at hepatitis-focused medical conferences throughout 2026; planned site initiation activities and initial patient screening expected in the second quarter of 2026 in France and Romania; the design of PBGENE-HBV to eliminate cccDNA and inactivate integrated HBV DNA with high specificity, potentially leading to cure; the suitability of PBGENE-HBV for the treatment of hepatitis B and the targeting of the root cause of the disease; the design of PBGENE-DMD to improve function over time and address more than 60% of patients with DMD; the potential for PBGENE-DMD to provide durable functional improvement with a single dose of AAV; translation of results in preclinical studies of ARCUS nucleases to clinical studies in humans; the preclinical and clinical development and demonstrated, potential and expected safety, efficacy, durability, and benefit of PBGENE-HBV and PBGENE-DMD, as well as our other product candidates and those being developed by partners; expectations of additional data presentations by IECURE from the ongoing OTC-HOPE clinical trial at ASGCT and SIMD; expectations of a presentation by Imugene Limited from their Azer-Cel clinical trial at ASCO; expectations of TG Therapeutics to present preliminary Phase 1 Azer-Cel data in progressive multiple sclerosis in the second half of 2026 and commencement of additional exploratory studies in autoimmune disease outside multiple sclerosis; and the sufficiency of our expected cash runway extending through 2028 to fund PBGENE-HBV and PBGENE-DMD data milestones. In some cases, you can identify forward-looking statements by terms such as “aim,” “anticipate,” “approach,” “belief”, “believe,” “contemplate,” “could,” “design,” “designed,” “estimate,” “expect,” “goal,” “intend,” “look,” “may,” “mission,” “plan,” “possible,” “potential,” “predict,” “project,” “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, and involve a 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 our capital requirements, anticipated cash runway, requirements under our current debt instruments and effects of restrictions thereunder, including our ability to raise additional capital due to market conditions and/or our market capitalization; our operating expenses and our ability to predict what those expenses will be; our limited operating history; the progression and 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; the risk that other genome-editing technologies may provide significant advantages over our ARCUS technology; our dependence on our ARCUS technology; the initiation, cost, timing, progress, achievement of milestones and results of research and development activities and preclinical and clinical studies, including clinical trial and investigational new drug applications; public perception about genome editing technology and its applications; competition in the genome editing, biopharmaceutical, and biotechnology fields; our or our collaborators’ or other licensees’ ability to identify, develop and commercialize product candidates; pending and potential product liability lawsuits and penalties against us or our collaborators or other licensees related to our technology and our product candidates; the U.S. and foreign regulatory landscape applicable to our and our collaborators’ or other licensees’ development of product candidates; our or our collaborators’ or other licensees’ ability to advance product candidates into, and successfully design, implement and complete, clinical trials; potential manufacturing problems associated with the development or commercialization of any of our product candidates; delays or difficulties in our and our collaborators’ and other licensees’ 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 or our licensees’ ability to obtain orphan drug designation or fas Contacts Investor and Media Contact: Naresh Tanna Vice President of Investor Relations naresh.tanna@precisionbiosciences.com Read full story here