Azercabtagene Zapreleucel

Preliminary total global full year 2025 revenue of approximately $616 million Preliminary BRIUMVI U.S. fourth quarter and full year 2025 net product revenue of approximately $182 million and $594 million, respectively Full Year 2026 target total global revenue of approximately $875-900 million, including BRIUMVI U.S. net product revenue of approximately $825-850 million NEW YORK, Jan. 13, 2026 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) (the Company or TG Therapeutics), today announced preliminary U.S. net product revenue for BRIUMVI® for the fourth quarter and full year ended December 31, 2025 (unaudited), as well as 2026 financial guidance and development milestones, during a preannounced presentation at the 44th Annual J.P Morgan Healthcare Conference. An audio replay of the event, as well as the corresponding slide presentation, are available on the Investors and Media section of the TG corporate website at ir.tgtherapeutics.com/events. Michael S. Weiss, the Company’s Chairman and Chief Executive Officer stated, “BRIUMVI continued to deliver strong commercial performance in 2025, reinforcing our confidence in the multi-billion dollar opportunity for BRIUMVI. With significant market share capture since launch, we believe TG Therapeutics is well positioned to drive long-term revenue growth and cash flow. Additionally, our development programs for consolidated IV BRIUMVI dosing and self-administered subcutaneous form of BRIUMVI are expected to drive revenue acceleration over the short and mid-term if approved. In parallel, we plan to initiate multiple exploratory studies that could expand BRIUMVI beyond MS, providing an additional lever for growth and underscoring its potential as a ‘pipeline-in-a-product.’ We also remain excited about the potential of azer-cel, our allogeneic CAR-T in autoimmune indications, starting with progressive forms of MS. Taken together, we believe we are executing a strategy designed to deliver sustained growth and long-term value for patients and shareholders.” Preliminary Fourth Quarter and Full Year 2025 Updates (based on unaudited financial information) BRIUMVI U.S. net product revenue expected to be approximately $182 million and $594 million for the fourth quarter and full year of 2025, respectively Total global full year 2025 revenue of approximately $616 million Preliminary selected financial information presented in this release are unaudited, subject to financial closing procedures and adjustment, and provided as an approximation in advance of the Company's announcement of complete financial results 2026 Financial Guidance Full Year 2026 target total global revenue of approximately $875-900 million, including BRIUMVI U.S. net product revenue of approximately $825-850 million Full year 2026 target operating expense, defined as R&D and SG&A, of approximately $350 million excluding non-cash compensation, and approximately $100 million in expenses associated with the subcutaneous BRIUMVI inventory build and secondary manufacturer start-up costs 2026 Development Pipeline Anticipated Milestones Announce pivotal topline 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 pivotal topline data for subcutaneous BRIUMVI (ublituximab) year-end 2026/1Q 2027 Commence registration-directed trial for BRIUMVI in an indication outside of MS Commence additional exploratory studies for BRIUMVI and azer-cel in autoimmune disease (outside MS) 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 www.briumvi.com. 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): Although no cases of PML have occurred in BRIUMVI-treated MS patients, JC virus infection resulting in PML has been observed in patients treated with other anti-CD20 antibodies 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 www.briumvi.com. 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 www.briumvipatientsupport.com. 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, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG Therapeutics has received approval from the U.S. Food and Drug Administration (FDA) for BRIUMVI® (ublituximab-xiiy) for the treatment of adult patients with relapsing forms of multiple sclerosis, 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 www.tgtherapeutics.com, 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. The preliminary, estimated financial results for the fourth quarter and fiscal year ended 2025 and the 2026 guidance estimates contained in this press release contain forward-looking statements and are subject to the completion of management’s and the audit committee’s final reviews and our other financial closing procedures and are therefore subject to change. The preliminary financial information and estimates included herein have not been examined or reviewed by our independent auditors and they are subject to revision as we prepare our financial statements as of and for the quarter and fiscal year ended December 31, 2025, including all disclosures required by U.S. generally accepted accounting principles. You should not place undue reliance on such preliminary information and estimates because they may prove to be materially inaccurate. While we believe that such preliminary information and estimates are based on reasonable assumptions, actual results may vary, and such variations may be material. Forward looking statements include but are not limited to statements regarding the estimated preliminary financial results referred to above, expectations for the timing and success of the commercialization and availability 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 the proposed 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, including feasibility, approvability and commercial acceptance; expectations and timing for our ENHANCE Phase 3 trial combining day 1 and day 15 doses, including, feasibility, approvability and commercial acceptance and impact on BRIUMVI sales; 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; 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 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 and azer-cel following these preliminary studies; the uncertainties generally inherent in research and development; 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, 2024 and in our other filings with the Securities and Exchange Commission. 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 www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only. CONTACT: 1. MS Prevalence. National Multiple Sclerosis Society website. https://www.nationalmssociety.org/About-the-Society/MS-Prevalence. Accessed October 26, 2020. 2. Multiple Sclerosis International Federation, 2013 via Data monitor p. 236.

Phase 1/2a ELIMINATE-B trial for PBGENE-HBV ongoing across multiple dosing cohorts; Data updates expected at medical conferences in 2026 PBGENE-DMD expecting IND clearance in Q1 2026 for Phase 1/2 FUNCTION-DMD study with initial data from multiple patients expected in 2026 Unaudited cash, cash equivalents, and restricted cash of approximately $137 million as of December 31, 2025, anticipated to fund PBGENE-HBV and PBGENE-DMD data milestones through 2028 DURHAM, N.C.--(BUSINESS WIRE)--Jan. 12, 2026-- 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 provided a business update and announced strategic priorities for 2026, highlighting recent progress for its two lead programs, upcoming clinical milestones, and a strong financial position supporting execution through key value-inflection points. “We continue to make steady, disciplined progress across our clinical-stage programs,” said Michael Amoroso, Chief Executive Officer of Precision BioSciences. “With multiple dosing cohorts underway in our global Phase 1/2a ELIMINATE-B trial, our first-in-class gene editing approach for DMD entering the clinic in early 2026, and cash runway through 2028, we expect continued operational excellence this year with clear clinical and regulatory milestones for these potentially transformative therapies.” PBGENE-HBV -Dose Finding Phase 1/2a ELIMINATE-B Trial in Chronic Hepatitis B PBGENE-HBV is uniquely designed to potentially achieve a complete cure of hepatitis B by eliminating cccDNA, preventing the chance of viral relapse, and inactivating integrated HBV DNA. The data reported at AASLD in November 2025 as of the October 31st cutoff date showed clear positive evidence of dose-dependent effects and antiviral activity in all patients. The data also included paired biopsies providing the first molecular evidence of successful viral DNA gene editing in patients with hepatitis B. The safety data showed PBGENE-HBV to have no dose-limiting toxicities at doses up to 0.8 mg/kg (Cohort 3) following the first administration. Adverse events across 22 total administered doses in 9 patients in the first 3 dose cohorts (0.2 mg/kg, 0.4 mg/kg, and 0.8 mg/kg) were predictable, manageable, and transient, including hypotension in the higher dose cohorts. Transaminase elevations were transient without elevations in bilirubin and resolved without intervention, and platelet fluctuations were transient and asymptomatic. Given the safety profile after multiple repeat doses and durability of response with PBGENE-HBV, Precision has administered additional doses in Cohort 3 and in parallel commenced dosing two additional cohorts as previously planned to investigate a shorter dosing interval. Cohort 4 is being dosed at 0.4 mg/kg every 4 weeks and Cohort 5 at 0.65 mg/kg every 4 weeks to evaluate the potential for an optimized therapeutic index. To date, 12 participants have completed at least one dose administration of PBGENE-HBV across Cohorts 1 through 5. Additional biopsy data is expected in the first half of 2026 building upon the first clinical evidence of viral gene editing for PBGENE-HBV which was shared at AASLD. In addition, Precision expects to complete dosing Cohorts 3, 4, and 5 and choose the optimal dosing regimen to achieve the goal of stopping nucleos(t)ide analog treatment and begin Part 2 expansion of the trial. “We continue to advance PBGENE-HBV through Part 1 of the ELIMINATE-B dose-finding study and are encouraged by the activity we are seeing at all dose levels,” said Cindy Atwell, Chief Development and Business Officer. “As part of our dose optimization efforts, we are evaluating different levers for PBGENE-HBV across escalating doses, frequency of doses, and number of administrations in order to maximize the therapeutic index of PBGENE-HBV and start the expansion phase. We look forward to sharing further details at hepatitis-focused medical conferences in 2026.” PBGENE-DMD - Phase 1/2 FUNCTION-DMD Trial in Duchenne Muscular Dystrophy (DMD) Patients PBGENE-DMD, a novel first-in-class gene editing therapy, utilizes a gene excision approach, which is clearly differentiated from existing microdystrophin and exon skipping treatments. PBGENE-DMD is designed to potentially provide durable functional muscle improvement for DMD patients with mutations in exons 45-55 impacting up to 60% of boys with DMD. A single AAV encodes two ARCUS proteins designed to permanently edit a patient’s DNA within the dystrophin gene, resulting in a naturally-expressed, near full-length, functional dystrophin protein. Supported by robust preclinical evidence, PBGENE-DMD is designed to drive functional improvement over time by targeting muscle satellite cells. Following clearance of the investigational new drug (IND) application, the FUNCTION-DMD Phase 1/2 clinical trial is expected to dose the first patient in late-Q1 or early-Q2 2026. The study will employ an appropriate immune modulation regimen and safety monitoring program to treat ambulatory patients with mutations in exons 45-55 at world class specialized DMD clinical sites. Initial data from multiple patients is expected by year end 2026, with early efficacy assessed by the percentage of near full-length dystrophin protein expression from muscle biopsies. Following supportive data from at least 10 DMD patients, the company would meet with the FDA to align on a regulatory path forward. Partnered Programs ECUR-506, being developed by iECURE, uses Precision BioSciences’ ARCUS nuclease and is being evaluated as a potentially curative treatment for neonatal onset OTC deficiency in the ongoing OTC-HOPE study. Recently, iECURE reached alignment with the U.S Food and Drug Administration (FDA) on the primary and key secondary efficacy endpoints, comparators and study size for the ongoing OTC-HOPE study which could support a Biologics License Application. In addition, ECUR-506 was granted FDA Regenerative Medicine Advanced Therapy (RMAT) designation for neonatal onset OTC deficiency. iECURE’s receipt of these regulatory milestones is supported by encouraging clinical data from the ongoing OTC-HOPE clinical study, including a complete clinical response observed in the first infant treated with ECUR-506. iECURE expects to release data from the ongoing clinical trial in the first half of 2026. Azer-Cel, a novel allogeneic CAR T treatment originally created by Precision, is being developed by Imugene for diffuse large B-cell lymphoma. Imugene’s recent FDA discussions have reached clear alignment across key elements required to advance azer-cel into a pivotal study including dosing regimen, patient population, endpoints, and manufacturing readiness. Precision received an $8 million milestone payment in the fourth quarter of 2025 as a result of Imugene’s progress with Azer-Cel. Azer-Cel is also being developed by TG Therapeutics. Enrollment for patients with progressive multiple sclerosis is ongoing in a Phase 1 clinical trial evaluating azer-cel for the treatment of autoimmune diseases. Precision is eligible for additional milestone payments from TG Therapeutics, including a $7.5M near term clinical milestone. Financial Position Although it has not finalized its full financial results for the year ended December 31, 2025, Precision expects to report it had approximately $137 million in cash, cash equivalents, and restricted cash. Existing cash and cash equivalents, potential near-term consideration to be received from licensees, continued fiscal and operating discipline, and availability of its ATM facility are expected to provide sufficient cash runway through 2028. About the ELIMINATE-B Trial: The Phase 1/2a ELIMINATE-B study is currently enrolling HBeAg-negative chronic hepatitis B patients at world-class sites in Hong Kong, New Zealand, United States and Moldova. The goal of the study is to define the optimal dose and number of dose administrations for safely eliminating cccDNA and inactivating integrated HBV DNA. With regulatory approval already granted, Precision expects to expand the study to clinical trial sites in the U.K. and continue accelerating recruitment and evaluation of a genetically diverse patient population in the Phase 1/2a study. About FUNCTION-DMD Trial: The Phase 1/2 FUNCTION-DMD study is expected to enroll ambulatory DMD patients with mutations in exons 45-55 impacting up to 60% of boys with DMD. Pending IND clearance, the clinical trial is anticipated to begin dosing patients at world class sites starting in late Q1/early-Q2 with initial clinical data from multiple patients expected later in 2026. 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 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 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, expectations about operational initiatives, strategies, further development including dose expansion, and timing of additional updates or data releases of PBGENE-HBV, PBGENE-DMD, and the OTC-HOPE trial; translation of results in preclinical studies of ARCUS nucleases to clinical studies in humans; the design of PBGENE-HBV to potentially achieve a complete cure of hepatitis B by eliminating cccDNA and inactivating integrated HBV DNA at the source of hepatitis B, preventing the chance of viral relapse; the potential tolerability and hepatic safety for repeat administrations of PBGENE-HBV to drive antiviral responses; the expectation of biopsy data in the first half of 2026 and to complete dosing Cohorts 3, 4, and 5 and choose the optimal dosing regimen to achieve the goal of stopping nucleos(t)ide analog treatment and begin Part 2 expansion of the ELIMINATE-B trial; expected regulatory processes, including an investigational new drug (IND) clearance for PBGENE-DMD; expected dosing of the first patient in the Phase 1 clinical trial of PBGENE-DMD in late Q1 or early Q2 of 2026; expectations of initial data for multiple patients in the PBGENE-DMD program by year end 2026; expected communication with the FDA and alignment on regulatory path forward following supportive data from at least 10 DMD patients; the expected cash, cash equivalents, and restricted cash balance as of December 31, 2025; and the expected cash runway and the sufficiency of the cash runway to fund of data milestones for PBGENE-HBV and PBGENE-DMD through 2028. 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, 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; 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; our ability to advance product candidates into, and successfully design, implement and complete, clinical trials; changes in interim “top-line” and initial data that we announce or publish; our current and future relationships with and reliance on third parties including suppliers and manufacturers; and other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024 and our Quarterly Reports on Form 10-Q for the quarterly periods ended March 31, 2025, June 30, 2025, and September 30, 2025 as any such factors may be updated from time to time in our other filings with the U.S. Securities and Exchange Commission (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/20260112331937/en/ Investor and Media Contact: Naresh Tanna Vice President of Investor Relations naresh.tanna@precisionbiosciences.com Source: Precision BioSciences, Inc.