UGT1A1

MINNEAPOLIS--(BUSINESS WIRE)-- OneOme announces its new approach to improving medication safety for cancer patients through focused germline pharmacogenomics (PGx) testing.1,2 RightMed Oncology is uniquely designed to help oncologists elevate their standard of care – to decrease the risk of chemotherapy-induced toxicity and improve medication safety and efficacy for supportive care medications for mental health, pain management, and chemotherapy-induced nausea and vomiting. This may be achieved by tailoring medications and dosages to match the unique genetic makeup of individual patients based on established guidelines. The RightMed oncology portfolio empowers innovative health systems, oncology practices and prescribers to be as focused or comprehensive as their program requires. OneOme offers single-gene RightMed tests including DPYD (c.557A>G, HapB3, *2A, *13, and c.2846A>T variants), UGT1A1 and TMPT/NUDT15, as well as the RightMed Oncology panel test, which covers dozens of medications used as chemotherapy and supportive care. Fluorouracil injection, one chemotherapy medication covered by the RightMed Oncology test and DPYD single-gene test, recently updated labeling in collaboration with FDA to include: “Patients with certain homozygous or compound heterozygous variants in the DPYD gene are at increased risk for acute early-onset toxicity and serious, including fatal, adverse reactions... Inform patients of the potential for serious and life-threatening adverse reactions due to DPD deficiency and discuss with your patient whether they should be tested for genetic variants of DPYD that are associated with an increased risk of serious adverse reactions from the use of fluorouracil.”3 OneOme’s Chief Medical Officer, James Kelley, MD, PhD, said, “Precision medicine is enabling cancer treatment to become personalized. Using PGx can inform usage and dosage decisions for a wide range of chemotherapy and supportive care medications. It is another tool in reducing adverse drug events, predicting drug efficacy, and improving patient care.” RightMed Oncology incorporates insights from practicing oncology clinicians, a feasibility study with Mayo Clinic4, recent scientific and clinical literature, and established PGx guidelines such as the Clinical Pharmacogenetics Implementation Consortium (CPIC®) and FDA labeling. For more information about RightMed Oncology, please visit OneOmeInstitute.com/Oncology or reach out directly to discuss a PGx program for your health system. OneOme is a leader in precision medicine, providing pharmacogenomic solutions, population-level value-based care analyses, and clinical decision support solutions to health systems, health insurers, and self-insured employers. OneOme aims to improve patient safety, reduce overall cost of care, and improve patients' health outcomes. Co-founded by the Mayo Clinic, from its headquarters in Minneapolis, OneOme offers its services to clients around the world. For more information, visit . 1. Deenen MJ, Meulendijks D, Cats A, et al. Upfront genotyping of DPYD*2A to individualize fluoropyrimidine therapy: a safety and cost analysis. J Clin Oncol. 2016;34(3):227-34. 2. Hulshof EC, de With M, de Man FM, et al. UGT1A1 genotype-guided dosing of irinotecan: A prospective safety and cost analysis in poor metaboliser patients. Eur J Cancer. 2022;162:148-57. 3. FDA approves safety labeling changes regarding DPD deficiency for fluorouracil injection products, available at: . (March 21, 2024). 4. Kasi PM, Koep T, Schnettler E, Shahjehan F, Kamatham V, Baldeo C, Hughes CL. Feasibility of Integrating Panel-Based Pharmacogenomics Testing for Chemotherapy and Supportive Care in Patients With Colorectal Cancer. Technol Cancer Res Treat. 2019 Jan 1;18:1533033819873924. doi: 10.1177/1533033819873924. PMID: 31533552; PMCID: PMC6753511. View source version on businesswire.com: Contacts Travis Thompson Senior Director of Marketing, OneOme, LLC travisthompson@oneome.com Source: OneOme View this news release online at:

OXFORD, U.K.--(BUSINESS WIRE)-- Exscientia plc (Nasdaq: EXAI) Recent advancements in the Company’s pipeline, collaborations and operations, as well as financial results for the fourth quarter and full year 2023, are summarised below. Exscientia will host a conference call Thursday, March 21 at 12:30 p.m. GMT / 8:30 a.m. EDT. “In 2023, we significantly expanded our technological capabilities with the opening of our automation facility, concentrated our internal research on high value oncology targets and steadily progressed multiple new and existing programmes with our large pharma partners,” said Dr. David Hallett, interim Chief Executive Officer and Chief Scientific Officer of Exscientia. “In 2024 we will continue to advance our pipeline programmes through clinical development. This includes GTAEXS617 (‘617), our CDK7 inhibitor currently in a Phase 1/2 clinical trial; LSD1, for which we anticipate initiating a Phase 1 patient study this year; and MALT1, which continues to progress through IND-enabling studies. In addition, we look forward to advancing our partnered programmes through potential milestones, while simultaneously inking new partnerships and expanding our technological capabilities to further cement our leadership in AI-powered drug design and development.” Key Business Highlights Pipeline Patient enrolment is continuing to progress for the dose escalation phase of ELUCIDATE, the adaptive Phase 1/2 trial studying ‘617, a potential best-in-class CDK7 inhibitor, for the treatment of advanced solid tumours. The Company expects to announce a transition from the dose escalation to dose expansion phase in the second half of 2024 EXS74539 (‘539), a highly differentiated LSD1 inhibitor, is continuing through IND/CTA enabling studies, and the Company anticipates initiating a Phase 1 clinical trial in cancer patients in 2024. ‘539 was precision designed by Exscientia to optimise the therapeutic window by combining reversible binding, brain penetration and a short half-life EXS4318 (‘4318), a PKC-theta inhibitor designed by Exscientia and in-licensed by Bristol Myers Squibb for immunology and inflammation indications, is continuing to advance in a Phase 1 study. Exscientia retains rights to receive milestone payments and potential royalties for ‘4318 EXS73565 (‘565), the Company’s differentiated MALT1 inhibitor, precision designed with selectivity over UGT1A1, is also advancing through IND/CTA-enabling studies. The Company expects to provide further updates in 1H 2024 Collaborations & Partnerships In December 2023, the Company announced the addition of an existing Exscientia programme to its Sanofi collaboration Preliminary data show these compounds have good potency and selectivity towards the target and differentiated molecular properties The addition of this discovery stage programme, identified and initially advanced by Exscientia, includes financial milestones over and above programmes initiated as part of the collaboration agreement Exscientia received a $4 million upfront payment in the first quarter of 2024 for this programme. In addition to the upfront payment, the Company is eligible to receive up to $41 million in preclinical milestone payments, as well as over $300 million in further milestone payments if the programme achieves all milestones under the agreement Exscientia is also eligible to receive tiered royalties on sales of products that may be developed from this programme In October 2023, Exscientia also announced the achievement of the first discovery stage milestone from a different programme within the Sanofi collaboration Exscientia’s collaboration with Merck KGaA, Darmstadt, Germany, initially announced in September 2023, is ongoing, leveraging Exscientia’s precision design capabilities to design and discover novel small molecule drug candidates across oncology and immunology In December 2023, Exscientia announced that it had received a $2.3 million grant from Open Philanthropy to drive research on the host-interferon response as a pathway to treating and preventing pandemic influenza Focus aligns with Exscientia’s ongoing commitment to pandemic preparedness, initiated with support from the Bill & Melinda Gates Foundation in 2021 DSP-2342, a dual 5-HT2A/5-HT7 antagonist designed by Exscientia for Sumitomo Pharma for the treatment of psychiatric diseases, entered Phase I studies in April 2023 DSP-2342 is the third compound designed by Exscientia that Sumitomo Pharma has advanced into the clinic Platform Exscientia opened its novel automated discovery laboratory in mid-2023. This facility has the capability to integrate AI design methods with chemical synthesis and biological testing. This integration has the potential to bring significant further efficiencies to the drug design process and enhance the rate of learning of Exscientia’s generative design platform Exscientia continues to drive the development of its functional precision medicine platform with new studies and collaborations In January 2024, Exscientia launched EXCYTE-2, a multi-centre observational study to evaluate the precision medicine platform in patients with acute myeloid leukaemia. This study has the potential to support the ongoing development of ‘539, Exscientia’s LSD1 inhibitor In July 2023, Exscientia launched EXCYTE-1, a first-of-its-kind prospective observational study in ovarian cancer. This ongoing trial is the first trial evaluating the potential of Exscientia’s functional precision medicine platform in a solid tumour indication The collaboration with Charité – Universitätsmedizin Berlin, announced in March 2023, evaluating Exscientia’s precision medicine platform as a tool to predict response in haematological cancers is also ongoing. This collaboration highlights the scalability of the primary patient tissue platform as Charité will be able to utilise cloud-based AI to analyse samples imaged onsite In the fourth quarter of 2023, Exscientia deployed large language models (LLMs) internally for the use of target hypothesis generation. These LLMs, based on both public and proprietary datasets, have been integrated with the Company’s existing target identification infrastructure with the aim to further enhance the productivity of Exscientia’s discovery platform Investor Call and Webcast Information Exscientia will host a conference call on Thursday, March 21 at 12:30 p.m. GMT / 8:30 a.m. EDT. A webcast of the live call can be accessed by visiting the “Investors and Media” section of the Company’s website at investors.exscientia.ai. Alternatively, the live conference call can be accessed by dialling +1 (888) 596 4144 (U.S.), +44 800 358 0970 (U.K.), +1 (646) 968 2525 (International) and entering the conference ID: 8333895. A replay will be available for 90 days under “Events and Presentations” in the “Investors and Media” section of the Exscientia website. Fourth Quarter and Full Year 2023 Financial Results For the convenience of the reader, the Company has translated pound sterling amounts to U.S. dollars at the rate of £1.000 to $1.2743, which was the noon buying rate of the Federal Reserve Bank of New York on December 29, 2023. Revenue: Revenue for the three and twelve months ended December 31, 2023 was $3.1 million and $25.6 million respectively, compared to $8.7 million and $34.7 million for the three and twelve months ended December 31, 2022. The decrease in revenue quarter on quarter and year on year is primarily the result of multiple new programmes starting with partners in the second half of 2023 with revenue recognition constrained by the early nature of these programmes, as well as pipeline prioritisation activities. Research and development expenses: R&D expenses for the three and twelve months ended December 31, 2023 were $37.5 million and $163.7 million respectively, as compared to $45.4 million and $164.2 million for the same period ended December 31, 2022. The current quarter over quarter decrease in research and development expenses was primarily due to pipeline prioritisation activities and cost efficiency savings, including achieving faster cycle times and lower outsourcing costs. General and administrative expenses: G&A expenses for the three and twelve months ended December 31, 2023, were $14.8 million, or 24.7% of total operating expenses, and $57.8 million, or 22.5% of total operating expenses respectively. For the three and twelve months ended December 31, 2022, G&A expenses increased by $4.3 million and $8.8 million compared to the three and twelve months ended December 31, 2022, primarily associated with increased personnel expenses. Cash inflows: For the full year 2023, Exscientia received $27.4 million in cash inflows from its collaborations as compared to $117.8 million during the full year 2022, when the upfront payment for the Sanofi collaboration was received. Net operating cash flow and cash balance: For the full year ending December 31, 2023, net operating cash outflows were $149.9 million, in comparison to $77.1 million for the full year 2022. Cash, cash equivalents and short term bank deposits as of December 31, 2023 were $462.6 million, as compared to $644.6 million as of December 31, 2022 using the December 29, 2023 constant currency rate. Based on our current operating plans, the Company believes that its existing cash, cash equivalents and short-term bank deposits and anticipated milestones will be sufficient to fund its operations and capital expenditure requirements well into 2026. SELECTED CONSOLIDATED STATEMENT OF OPERATIONS, CONSTANT CURRENCY CONVERSION (unaudited) ($ millions, except per share data, at the rate of £1.000 to $1.2743) Three months ended December 31, Twelve months ended December 31, 2023 2022 2023 2022 Revenue 3.1 8.7 25.6 34.7 Cost of sales (7.6) (12.2) (34.9) (42.4) Research and development expenses (37.5) (45.4) (163.7) (164.2) General and administrative expenses (14.8) (10.5) (57.8) (49.0) Operating expenses (59.9) (68.1) (256.4) (255.6) Foreign exchange gains/(losses) (4.0) (8.0) (2.0) 28.4 Other income 1.4 2.0 8.5 7.3 Operating loss (59.4) (65.4) (224.3) (185.2) Finance income/(expense) 5.2 3.7 19.9 6.9 Share of loss on joint ventures (0.6) (0.0) (2.1) (0.9) Loss before taxation (54.8) (61.7) (206.5) (179.2) Income tax benefit 2.4 11.9 20.5 27.9 Loss for the period (52.4) (49.8) (186.0) (151.3) Net loss per share (0.42) (0.41) (1.50) (1.24) Weighted average shares outstanding (basic and diluted) 125,243,445 122,912,943 124,197,000 122,119,635 SELECTED CONSOLIDATED BALANCE SHEET, CONSTANT CURRENCY CONVERSION (unaudited) ($ millions, except per share data, at the rate of £1.000 to $1.2743) December 31, 2023 December 31, 2022 Cash, cash equivalents & short-term bank deposits 462.6 644.6 Total assets 650.8 827.8 Total equity 453.3 610.2 Total liabilities 197.5 217.6 Total equity and liabilities 650.8 827.8 SELECTED CONSOLIDATED STATEMENT OF CASH FLOWS, CONSTANT CURRENCY CONVERSION (unaudited) ($ millions, except per share data, at the rate of £1.000 to $1.2743) Twelve months ended December 31, 2023 2022 Net cash outflows from operating activities (149.9) (77.1) Net cash flows used in investing activities (27.4) (156.3) Net cash used in financing activities (4.3) (5.1) Net decrease in cash and cash equivalents (181.6) (238.5) Exchange (loss)/gain on cash and cash equivalents (3.3) 37.7 Net decrease in cash, cash equivalents and short-term bank deposits* (181.9) (71.8) * Includes both increases in short term bank deposits and foreign exchange (losses)/gains on cash and cash equivalents About Exscientia Exscientia is an AI-driven precision medicine company committed to discovering, designing, and developing the best possible drugs in the fastest and most effective manner. Exscientia developed the first-ever functional precision oncology platform to successfully guide treatment selection and improve patient outcomes in a prospective interventional clinical study, as well as to progress AI-designed small molecules into the clinical setting. Our internal pipeline is focused on leveraging our precision medicine platform in oncology, while our partnered pipeline broadens our approach to other therapeutic areas. By pioneering a new approach to medicine creation, we believe the best ideas of science can rapidly become the best medicines for patients. For more information visit us on or follow us on LinkedIn @ex-scientia and X @exscientiaAI. Forward-Looking Statements This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” "believes," “expects,” "intends," "projects," and "future" or similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements with regard to Exscientia’s expectations regarding: the initiation, timing and progress of, and data collected during and reported from, preclinical and clinical trials of the Company’s and its partners’ product candidates and the Company’s precision medicine platform; the performance of Exscientia’s technology and its discovery platform; and the sufficiency of the Company’s existing cash, cash equivalents and short term bank deposits and anticipated milestones to fund its operations into 2026. Such statements are subject to a number of risks, uncertainties and assumptions, including those related to: the initiation, scope and progress of Exscientia’s and its partners’ planned and ongoing preclinical studies and clinical trials and ramifications for the cost thereof; clinical, scientific, regulatory and technical developments; the process of discovering, developing and commercialising product candidates that are safe and effective for use as human therapeutics and the endeavour of building a business around such product candidates; and the Company’s use of its existing cash, cash equivalents and short term bank deposits and achievement of milestones. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section of Exscientia’s Annual Report on Form 20-F for the fiscal year ended December 31, 2023, and in other filings that Exscientia makes with the SEC from time to time (which are available at ), the events and circumstances discussed in such forward-looking statements may not occur, and Exscientia’s actual results could differ materially and adversely from those anticipated or implied thereby. Although Exscientia’s forward-looking statements reflect the good faith judgement of its management, these statements are based only on facts and factors currently known by the Company. As a result, you are cautioned not to rely on these forward-looking statements. Exscientia undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

LONDON--( BUSINESS WIRE )--ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced data from a planned interim analysis of the LATITUDE phase III trial, indicating that their long-acting injectable antiretroviral treatment (ART) for HIV, Cabenuva (cabotegravir + rilpivirine), demonstrated superior efficacy in maintaining viral load suppression compared to daily oral therapy in individuals with a history of ART adherence challenges. The data were presented by the Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (ACTG) network at the Conference on Retroviruses and Opportunistic Infections (CROI 2024) , in Denver, Colorado. Kimberly Smith, MD, MPH, Head of Research & Development at ViiV Healthcare, said: “It’s estimated that one-third of people living with HIV in the United States struggle with maintaining viral suppression. The findings of the LATITUDE study show that long-acting injectable cabotegravir + rilpivirine could be important for some people in this group, giving them another option to help keep their virus under control and improve their health. Further, since we know that individuals whose virus is undetectable don’t transmit to sexual partners, this could be an important contribution to ending the HIV epidemic.” LATITUDE is a phase III, randomised, open-label study. Participants received comprehensive and incentivised adherence support while taking guideline-recommended, three-drug regimen oral ART, including dolutegravir and bictegravir-based regimens, to achieve viral suppression. Those who achieved viral suppression were eligible to randomise to staying on oral standard of care (SOC) regimens or switch to long-acting injectable cabotegravir + rilpivirine (LA-ART) dosed monthly. During the randomised phase of the study, 146 participants received monthly LA-ART and 148 continued on SOC. The primary endpoint was a comparison of regimen failure, defined as a combination of virologic failures (VF) and regimen discontinuations, between arms. 24.1% of participants on LA-ART experienced regimen failure compared to 38.5% on SOC {difference -14.4 (98.75% CI–29.8%, -0.8%)}. Although the primary endpoint did not meet the strict predefined stopping criterion for the interim analysis, key secondary endpoints of virologic failure (7.2% LA-ART vs. 25.4% SOC {difference -18.2% (98.75% CI-31.1%, -5.4%}) and treatment-related failure (9.6% LA-ART vs. 26.2% SOC {difference -16.6% (98.75% CI-29.9%, -3.3%)} favoured the LA-ART regimen. The study’s Data Safety Monitoring Board (DSMB) considered the totality of all the study endpoints together and concluded that the evidence indicated superior efficacy of long-acting ART over daily oral standard of care. The DSMB recommended that all eligible participants should be offered long-acting injectable cabotegravir + rilpivirine. The rate of adverse events (AEs) was similar in both arms. Three participants in the LA-ART arm had serious injection site reactions (ISR) and one participant discontinued due to an ISR. Two confirmed virologic failures in each arm had new resistance associated mutations (RAMS), including at least two new integrase inhibitor RAMs in both LA-ART participants. The LATITUDE (Long-Acting Therapy to Improve Treatment Success in Daily Life) study is ongoing across 31 sites in the U.S. including Puerto Rico, implemented through ACTG. The median age of study participants was 40 years old; 40 percent of participants were male, 64 percent were Black/African American, 17 percent were Hispanic, 5 percent were transgender, and 14 percent currently or previously used injection drugs. The study is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and is being conducted by ACTG, with additional support from the National Institute of Mental Health, the National Institute on Drug Abuse, ViiV Healthcare and the Janssen Pharmaceutical Companies of Johnson & Johnson. About Cabenuva (cabotegravir + rilpivirine) Cabenuva is indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 c/ml) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. The complete regimen combines the integrase strand transfer inhibitor (INSTI) cabotegravir, developed by ViiV Healthcare, with rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) developed by Janssen Sciences Ireland Unlimited Company. Rilpivirine tablets are approved in the US as a 25mg tablet taken once a day to treat HIV-1 in combination with other antiretroviral agents in antiretroviral treatment-naïve patients 12 years of age and older and weighing at least 35kg with a viral load ≤100,000 HIV RNA c/ml. INSTIs inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic disease. Rilpivirine is an NNRTI that works by interfering with an enzyme called reverse transcriptase, which stops the virus from multiplying. Trademarks are owned by or licensed to the ViiV Healthcare group of companies. Please consult the full Prescribing Information. CABENUVA (cabotegravir; rilpivirine) extended-release injectable suspensions Professional Indication and Important Safety Information INDICATION CABENUVA is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Do not use CABENUVA in patients with previous hypersensitivity reaction to cabotegravir or rilpivirine Do not use CABENUVA in patients receiving carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, systemic dexamethasone (>1 dose), and St John’s wort WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Serious or severe hypersensitivity reactions have been reported in association with other integrase inhibitors and could occur with CABENUVA Hypersensitivity reactions, including cases of drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during postmarketing experience with rilpivirine-containing regimens. While some skin reactions were accompanied by constitutional symptoms such as fever, other skin reactions were associated with organ dysfunctions, including elevations in hepatic serum biochemistries Discontinue CABENUVA immediately if signs or symptoms of hypersensitivity reactions develop. Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated. Cabotegravir and rilpivirine oral lead-in may be used to help identify patients who may be at risk of a hypersensitivity reaction Post-Injection Reactions: Serious post-injection reactions (reported in less than 1% of subjects) were reported within minutes after the injection of rilpivirine, including dyspnea, bronchospasm, agitation, abdominal cramping, rash/urticaria, dizziness, flushing, sweating, oral numbness, changes in blood pressure, and pain (e.g., back and chest). These events may have been associated with accidental intravenous administration and began to resolve within a few minutes after the injection Carefully follow the Instructions for Use when preparing and administering CABENUVA . The suspensions should be injected slowly via intramuscular injection and avoid accidental intravenous administration. Observe patients briefly (approximately 10 minutes) after the injection. If a post-injection reaction occurs, monitor and treat as clinically indicated Hepatotoxicity: Hepatotoxicity has been reported in patients receiving cabotegravir or rilpivirine with or without known pre-existing hepatic disease or identifiable risk factors Patients with underlying liver disease or marked elevations in transaminases prior to treatment may be at increased risk for worsening or development of transaminase elevations Monitoring of liver chemistries is recommended and treatment with CABENUVA should be discontinued if hepatotoxicity is suspected Depressive Disorders: Depressive disorders (including depressed mood, depression, major depression, mood altered, mood swings, dysphoria, negative thoughts, suicidal ideation, suicide attempt) have been reported with CABENUVA or the individual products Promptly evaluate patients with depressive symptoms Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions: The concomitant use of CABENUVA and other drugs may result in known or potentially significant drug interactions (see Contraindications and Drug Interactions) Rilpivirine doses 3 and 12 times higher than the recommended oral dosage can prolong the QTc interval CABENUVA should be used with caution in combination with drugs with a known risk of Torsade de Pointes Long-Acting Properties and Potential Associated Risks with CABENUVA : Residual concentrations of cabotegravir and rilpivirine may remain in the systemic circulation of patients for prolonged periods (up to 12 months or longer). Select appropriate patients who agree to the required monthly or every-2-month injection dosing schedule because non-adherence could lead to loss of virologic response and development of resistance To minimize the potential risk of developing viral resistance, it is essential to initiate an alternative, fully suppressive antiretroviral regimen no later than 1 month after the final injection doses of CABENUVA when dosed monthly and no later than 2 months after the final injections of CABENUVA when dosed every 2 months. If virologic failure is suspected, switch the patient to an alternative regimen as soon as possible ADVERSE REACTIONS The most common adverse reactions in adults (incidence ≥2%, all grades) treated with CABENUVA were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash The safety of CABENUVA in adolescents is expected to be similar to adults DRUG INTERACTIONS Refer to the applicable full Prescribing Information for important drug interactions with CABENUVA, VOCABRIA (cabotegravir), or EDURANT (rilpivirine) Because CABENUVA is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended Drugs that are strong inducers of UGT1A1 or UGT1A9 are expected to decrease the plasma concentrations of cabotegravir. Drugs that induce or inhibit CYP3A may affect the plasma concentrations of rilpivirine CABENUVA should be used with caution in combination with drugs with a known risk of Torsade de Pointes USE IN SPECIFIC POPULATIONS Pregnancy: There are insufficient human data on the use of CABENUVA during pregnancy to adequately assess a drug-associated risk for birth defects and miscarriage. Discuss the benefit-risk of using CABENUVA during pregnancy and conception and consider that cabotegravir and rilpivirine are detected in systemic circulation for up to 12 months or longer after discontinuing injections of CABENUVA . An Antiretroviral Pregnancy Registry has been established Lactation: Potential risks of breastfeeding include HIV-1 transmission, developing viral resistance in HIV-positive infants, and adverse reactions in a breastfed infant About ACTG ACTG is the world’s largest and longest running clinical trials network focused on HIV and other infectious diseases and the people living with them. It is funded by NIAID and collaborating NIH Institutes. Founded in 1987, ACTG conducts research to improve the management of HIV and its comorbidities; develop a cure for HIV; and innovate treatments for tuberculosis, hepatitis B, and emerging infectious diseases. It comprises thousands of dedicated researchers, staff, and community members who are pursuing research into novel treatments and cures for infectious diseases at hundreds of locations across four continents, with the ultimate goal of advancing science that meaningfully impacts the lives of the people we serve. About ViiV Healthcare ViiV Healthcare is a global specialist HIV company established in November 2009 by GSK (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of acquiring HIV. Shionogi became a ViiV shareholder in October 2012. The company’s aims are to take a deeper and broader interest in HIV and AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline, and commitment, please visit viivhealthcare.com. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com. Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D “Risk factors” in the company's Annual Report on Form 20-F for 2023. Registered in England & Wales: GSK plc No. 3888792 ViiV Healthcare Limited No. 06876960 Registered Office: GSK plc 980 Great West Road Brentford, Middlesex United Kingdom TW8 9GS ViiV Healthcare Limited GSK Medicines Research Centre Gunnels Wood Road, Stevenage United Kingdom SG1 2NY