This study is multicenter, primary data collection, non-interventional registry study to assess long-term safety, secondary malignancy risk, and effectiveness of tisagenlecleucel in patients with B-cell malignancies in a routine clinical practice setting in Korea.

开始日期2025-04-10

申办/合作机构

Novartis Pharmaceuticals Canada, Inc.

NCT05541341

/ RecruitingN/A

Effectiveness and Safety of Tisagenlecleucel Therapy in Brazilian Patients With B-lymphocyte Malignancies: a 15-year Prospective Registry Study on Three Cohorts.

This will be a multicenter, national, non-interventional, prospective cohort study

开始日期2023-11-24

申办/合作机构

Novartis Pharmaceuticals Corp.

100 项与 Tisagenlecleucel 相关的临床结果

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100 项与 Tisagenlecleucel 相关的转化医学

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100 项与 Tisagenlecleucel 相关的专利（医药）

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项与 Tisagenlecleucel 相关的文献（医药）

2025-12-31·JOURNAL OF MEDICAL ECONOMICS

Budget impact of introducing glofitamab for treatment of relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy in the United States

Article

作者: Li, Jia ; Mahmoudjafari, Zahra ; Masaquel, Anthony ; Parisé, Hélène ; Bercaw, Eric ; Bognar, Katalin ; Wang, Si-Tien

BACKGROUND:

Glofitamab is a T-cell engaging bispecific monoclonal antibody that was granted accelerated approval from the United States Food and Drug Administration for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified or large B-cell lymphoma arising from follicular lymphoma, after ≥2 lines of systemic therapy (3L+).

METHODS:

A budget impact model was developed for a hypothetical blended commercial/Medicare health plan with 1,000,000 members. Comparators were axicabtagene ciloleucel (Axi-cel), lisocabtagene maraleucel (Liso-cel), tisagenlecleucel (Tisa-cel), loncastuximab tesirine, polatuzumab vedotin + bendamustine + rituximab, rituximab + gemcitabine + oxaliplatin, tafasitamab + lenalidomide, and epcoritamab (Epcor). Total costs included those for drugs, wastage, administration, grade ≥3 adverse reactions, and all-grade cytokine release syndrome) and routine care. Market shares were based on internal projections and expert opinions. Total and per-member per-month (PMPM) net budget impacts over 3 years were calculated.

RESULTS:

Approximately nine patients were projected to be eligible for 3L + DLBCL treatment in a health plan of 1,000,000 members. The introduction of glofitamab as a treatment option resulted in estimated total and PMPM cost savings of $728,697 and -$0.0202, respectively, over 3 years. Costs were reduced across all cost categories but particularly in drug costs. Among the newer therapies, total 3-year cost per treated patient was lowest for glofitamab: $226,658 versus Tisa-cel = $564,113; Axi-cel = $540,002; Liso-cel = $516,272; and Epcor = $335,293. Across all sensitivity analyses, the inclusion of glofitamab had minimal PMPM budget impact, ranging from -$0.0256 to -$0.0108.

CONCLUSIONS:

With the lowest 3-year total cost per treated patient among the newer therapies, glofitamab being an available option in the 3L + DLBCL market is estimated to save a hypothetical 1,000,000-member health plan $728,697 in cumulative total costs and $0.0202 in PMPM costs over 3 years.

2025-04-03·BLOOD

The present and future of CAR T-cell therapy for adult B-cell ALL

Review

作者: Rampotas, Alexandros ; Roddie, Claire

Abstract:

Chimeric antigen receptor T-cell therapy (CAR-T) targeting CD19 has transformed the management of relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL), with the US Food and Drug Administration approval of tisagenlecleucel for pediatric/young adult patients and brexucabtagene autoleucel for adults. Efficacy is contingent upon several factors including disease burden. Emerging data suggest that bridging therapy, lymphodepletion, and, for some patients, consolidation therapy have an important role in the success of treatment. Furthermore, strategies to define and manage immunotoxic side effects including hematotoxicity is critical to safe delivery. Advancements in CAR-T design beyond CD19 represent an ongoing therapeutic evolution. Overall, CAR-T signifies a paradigm shift in B-ALL management, with the potential for improved remission and survival in a historically challenging patient population.

2025-04-01·Nature Reviews Clinical Oncology

Outcome correlates of approved CD19-targeted CAR T cells for large B cell lymphoma

Review

作者: Bock, Tamara J ; Turtle, Cameron J ; Fiorenza, Salvatore ; Colonne, Chanukya K

CD19-targeted chimeric antigen receptor (CAR) T cells have provided a breakthrough in the treatment of patients with relapsed and/or refractory large B cell lymphoma (LBCL). Currently, three CD19-targeted CAR T cell products are approved by the FDA and various other regulators for the treatment of patients with LBCL: axicabtagene ciloleucel, tisagenlecleucel and lisocabtagene maraleucel. Response rates following infusion of these CD19-targeted CAR T cells have been promising; however, approximately half of treated patients show relapse within 2 years. Furthermore, receiving these agents can be associated with serious toxicities, including cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome. In this Review, we summarize the factors associated with the efficacy, including response and survival outcomes, and toxicity of CD19-targeted CAR T cells in pivotal clinical trials and large real-world datasets describing the outcomes of patients with LBCL who received treatment with these products.

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项与 Tisagenlecleucel 相关的新闻（医药）

2025-04-28

·BioSpace

Cell and Gene Therapy Sector Enters ‘Critical’ Period After Marks’ FDA Exit

Created with canva dreamlab † As tariffs, HHS workforce cuts and the ouster of CBER Director Peter Marks threaten the “lifeblood” of the cell and gene therapy space, experts express wariness over the unknowns and optimism that Marks’ legacy will carry on. As head of the FDA’s Center for Biologics Evaluation and Research, Peter Marks was a staunch advocate for cell and gene therapies, particularly their use for rare diseases. Despite Marks’ controversial departure last month, it appears his agenda may at least partly be taken up by the man who reportedly blessed his ouster. In a January 2024 interview with BioSpace , Marks promoted flexibility in gene therapy trials for rare diseases, saying that for many rare diseases affecting small patient populations, “the concept of trying to do a randomized trial is very challenging at best and impossible at worst.” In his first media interview , with former Fox News journalist Megyn Kelly, new FDA Commissioner Marty Makary appeared to echo this sentiment. “When you talk about a genetic issue that affects 52 kids in the world . . . or 15 kids . . . you can’t expect the companies to do a randomized, controlled trial; you’ll kill innovation. You’ll kill investment in those innovative ideas.” Marks similarly suggested to BioSpace last year that non-randomized, single-arm trials could be the best option for rare disease gene therapy. During his interview, Makary said the FDA would be rolling out a conditional approval pathway based on a “plausible scientific mechanism,” for incurable diseases that affect a small number of people. “Even though we don’t have a randomized controlled trial because it’s not feasible, we will allow that and at the same time monitor everybody who gets it so we can make inferences as soon as the data speaks.” This could be good news for the cell and gene therapy (CGT) space as many of these therapies—particularly those for rare indications—rely on surrogate endpoints that make them uniquely tailored to the FDA’s accelerated approval pathway. “We see this as a positive for patients with companies developing drugs for ultra-rare diseases; however, we think expanding this to broader populations could be a slippery slope,” Truist Securities wrote in an investor note on April 22. Jefferies’ Andrew Tsai concurred, telling BioSpace that “you did see a lot of these rare disease stocks move higher” after the interview. Meanwhile, on X on April 20, BowTiedBiotech asked, “Did the FDA just make gene editing investable overnight?” This would certainly be welcome news for the space. Investment in CGT developers “nosedived” in 2024, according to Biopharma Dive , partly due to manufacturing and drug delivery challenges. As of August last year, CGT companies had raised just $500 million across 16 venture rounds, according to data from DealForma, published by Nature Biotechnology . This pales in comparison to the $8.2 billion generated by 121 deals reported by DealForma in 2021. There are also commercial challenges for CGT companies, evidenced by the struggles of bluebird bio, which was compelled to go private earlier this year in a deal valued at just $30 million despite having three gene therapies on the market. Jonathan Wofford, chief commercial officer at CGT software company Title21 Health Solutions, acknowledged that while there is continued interest in cell and gene therapy, “the eagerness or enthusiasm for this space has been tempered,” with investors being more cautious. While cautioning against “jump[ing] to the extreme scenarios,” Wofford said the next few months “will be critical for the CGT sector.” ‘The End of an Era’ Marks was instrumental in the rise of the CGT space, helping to establish regulatory pathways for the novel therapy types and advocating for platform approaches , including the Bespoke Gene Therapy Consortium. The first CAR T cell therapy, Novartis’ Kymriah, was approved by the FDA in August 2017 for acute lymphoblastic leukemia—the year after Marks took the helm at CDER in 2016. “It’s a big loss,” Ignacio Núñez, chief operations officer at CDMO CellReady, told BioSpace . “He did a lot for the field, has been around for a while, so people knew what to expect.” “There is no doubt about the impact that Dr. Marks has had on the CGT space,” Wofford agreed. “He has been instrumental in shaping a regulatory framework that I believe has accelerated not only the advancement of clinical pipeline in the United States and therapy approvals, but also the advancement of the entire CGT sector.” However, “all is not lost,” said Audrey Greenberg, founder of the Center for Breakthrough Medicines, a CGT-focused CDMO. Greenberg noted that Marks leaves behind a group at CBER who are supportive of his vision, values and mission, and said that these therapies are still very much in demand. “If you look at the mid- to long-term demand curve, this is an exponential industry in terms of growth,” she said. For Núñez, “The key is who the new leader will be and how fast he is able to articulate a cohesive direction for the field. After seven years, maybe it’s not bad to have a fresh view of the whole thing. . . . It doesn’t need to be negative. It could also be positive.” Wofford was similarly optimistic, saying that public statements made by Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. and the incoming administration “indicate support for cell and gene therapy development, including advances in treating sickle-cell disease, which are positive.” He pointed to Kennedy’s response to a question by Senator Tim Scott (R-SC) during his Senate confirmation hearing regarding the Cell and Gene Therapy Access Model: “I agree that the cell and gene therapy model is an interesting approach, and was not surprised to see two manufacturers of therapies for sickle cell disease enter the model.” Notably, the Cell and Gene Therapy Access Model is moving forward after appearing to be in jeopardy when President Donald Trump rescinded many of his predecessor’s executive orders after taking office. Sekar Kathiresan, CEO of Verve Therapeutics, likewise appeared unconcerned about the changes. “[Peter Marks] was a great advocate for the field and I was personally sad to see his departure,” he told BioSpace in an email. However, he added that Verve’s recent interactions with the FDA, including an investigational new drug clearance and Fast Track designation for base editing therapy VERVE-102 have so far been “business as usual.” Macro Headwinds A common concern across biopharma so far in 2025 has been Trump’s tariff war . Experts agree that the implementation of global tariffs could have significant effects on the CGT space. “Tariffs are definitely bringing uncertainty on top of everything else,” Núñez said. In the CGT space specifically, “one of the major issues is that the industry operates from a global supply chain, relying heavily on imported materials,” Wofford said. The component parts for cell and gene therapy manufacturing, including viral vectors, plasmids, critical reagents and basic lab supplies, “all come from overseas,” Greenberg added. “And if tariffs hit these key components from China or the EU, we’re going to see increased cost of goods, tighter margins, more volatility and production timelines. And that’s bad news for patients and companies.” Cell and gene therapies are already some of the most expensive medicines on the market. Orchard Therapeutics’ gene therapy Lenmeldy , approved last year for metachromatic leukodystrophy, carries a price tag of $4.25 million for the one-time treatment, while bluebird’s sickle cell therapy Lyfgenia costs $3.1 million. Prices like these make securing coverage, and therefore revenue, difficult. Greenberg shared that some of the companies she works with are “revisiting these sourcing strategies and rethinking capacity allocations, in some cases, relocating mission-critical elements of their manufacturing stack.” “The geopolitical reality is forcing a more resilient but definitely more expensive future,” she said, adding that these expenses will ultimately be passed on to the patient. “As therapies become more expensive, this could limit access for patients and delay development of new cell and gene therapies,” Wofford agreed. Kathiresan noted that Verve’s strategy is to have manufacturers in both the U.S. and Europe. “Verve remains committed to delivering life-changing therapies to patients and we will adapt our operations to navigate the evolving trade landscape effectively,” he said. On the other hand, tariffs could incentivize manufacturing in the U.S., according to Núñez. “I believe bringing as much manufacturing as possible to the U.S. will help the speed and cost of our supply chain, reducing potential lead time and fostering better collaboration and innovation,” he said. As for the recent workforce disruption at HHS, Greenberg said that besides Marks, the layoffs at CBER were minimal. However, she called the cuts to funding at the National Institutes of Health and leading academic programs “short-sighted and dangerous.” “The CGT revolution was born in these academic labs, including Penn . . . Harvard and Stanford, and NIH funding has been the lifeblood of early-stage discovery,” she said. “When you starve the basic research, the ecosystem threatens the pipeline and future breakthroughs. We’re going to see the domino effect of this for years to come.”

基因疗法快速通道

2025-04-09

·GlobeNewswire-Health Care

Preliminary results for the year ended 31 December 2024

~ Strong commercial momentum underpins transformative financial performance ~ Strong 2024 financial performance in line with guidance Revenue growth of 44% to £128.8 million compared to 2023, organic revenue growth of 81%1Operating EBITDA2 loss of £(15.3) million for the full year in line with expectations, Operating EBITDA profit of £5.0 million achieved in second half of 2024 Contracted value of client orders3 signed during 2024 reached approximately £186 million at 31 December 2024, an increase of c.35% compared to £138 million in 20234, reflecting strong commercial momentum with client baseIncreased demand in all vector segments including momentum in AAV client work, demonstrating successful diversification across viral vector platforms. Lentiviral vector development and manufacturing capabilities now expanded beyond UK into US and FranceFinancial guidance reaffirmed; Revenue CAGR of more than 35% for 2023-2026 and pivot to profitability in FY 2025 Oxford, UK – 9 April 2025: OXB (LSE: OXB), a global quality and innovation-led cell and gene therapy CDMO, today announces preliminary results for the year ended 31 December 2024. Dr. Frank Mathias, Chief Executive Officer of OXB, commented: “2024 was a year of strong commercial progress for OXB as we executed our multi-vector, multi-site strategy as a pure-play CDMO. With revenue growth of 44%, organic revenue growth of 81% and an operating EBITDA profit in the second half of 2024, we have demonstrated effective execution against our objectives. "The acquisition of ABL Europe (renamed OXB France) has expanded our EU operations, adding specialised expertise and manufacturing capacity. With lentiviral vector development and manufacturing capabilities now available across all our sites, including the US and France, we have created a comprehensive global platform. "Our client portfolio continues to expand and diversify, now including over 45 programmes with a well-balanced mix across all geographies, development stages and key viral vector platforms. The contracted value of client orders represents an increase of 35% compared to 2023, reflecting growing demand for our services across all key viral vector types. “With our strong commercial momentum and the successful execution of our strategy, we are on track to achieve significant revenue growth consistent with our medium-term guidance and well above industry levels. Through continued focus on efficiency and a disciplined approach to our cost base, we also expect to achieve operating EBITDA profitability for FY 2025." SUMMARY FINANCIAL PERFORMANCE £'m20242023change Revenue128.889.544%Manufacturing services68.451.034%Development services47.331.849%Procurement services5.8- n/aLicences, milestones and royalties7.36.79%Cost of Sales(75.8)(49.8)52%Gross Margin53.039.733%Operating EBITDA1(15.3)(52.8)71% FINANCIAL HIGHLIGHTS Total revenues reached £128.8 million, representing a 44% increase compared with 2023 (£89.5 million) and an 81% organic growth rate. Organic growth excludes the impact of the acquisition of ABL Europe SAS (OXB France) and the loss of revenues from Homology Medicines, Inc.Revenue growth driven by: Increase in lentiviral vector manufacturing of GMP batches for clinical clients and for clients in preparation for commercial launchClients moving further along their clinical development pathways including an increase in development revenues from process characterisation and validation workProcurement and Storage services to provide stability of supply of raw materials. Significant improvement in Operating EBITDA loss to £(15.3) million (2023: £(52.8) million), which narrowed by £37.5 million. Achieved £5.0 million operating EBITDA profit in the second half of 2024 at Group level. Operating loss of £(39.4) million also represented a significant narrowing compared with 2023 (£(184.2) million) due to a combination of increased revenues and a positive impact of the 2023 reorganisation lowering the overall cost base and the non repeat of the 2023 impairment. Acquisition of ABL Europe SAS (OXB France) from Institut Mérieux for a fair value consideration of €6.6 million (£5.7 million).Cash burn of £68.2 million in 2024 (2023: £39.1 million) arising principally from operating loss and the increased activity in the second half of 2024 resulting in a higher balance of Contract Assets and Trade Receivables which are not yet due as at the year end, offset by the cash inflow of £17.5 million as a result of the investments by Institut Mérieux.Cash at 31 December 2024 was £60.7 million (31 December 2023: £103.7 million); Net cash was £20.6 million (31 December 2023: £65.2 million).In 2024 OXB increased its ownership of OXB US LLC by 10%, from 80% to 90%. This followed the conversion of an existing working capital loan and a capital injection into OXB US LLC, on 26 June 2024. On 1 March 2025, OXB US Inc exercised the call option for the purchase of the remaining 10% of OXB US LLC from Q32 Bio, Inc (which had merged with Homology Medicines, Inc). The transfer of Q32’s remaining 10% holding in OXB US LLC to OXB US Inc is in the process of being finalised. BOARD UPDATE After nine years of service as an Independent Non-Executive Director, Audit Committee Chair and most recently as Vice Chair, Stuart Henderson has informed the Board that he intends to retire from the Board. As such, Mr. Henderson will not seek re-election at the 2025 Annual General Meeting. Mr. Henderson’s intention to retire is driven by the Corporate Governance Code provision that service of nine years or more may impair independence of a Director. The Board thanks Mr. Henderson for his impeccable service, loyalty and defining contributions to OXB’s strategic progress throughout his tenure. Colin Bond, who joined the Board as an Independent Non-Executive Director in January 2025, will succeed Mr. Henderson as Audit Committee Chair. Mr. Bond brings substantial financial expertise to this role from his career as Chief Financial Officer of Sandoz and from senior finance positions at multiple global pharmaceutical and life sciences companies. His extensive experience chairing Audit Committees for public companies positions him well for this role.To ensure a seamless transition and support continuity, Mr. Henderson will remain available to assist Mr. Bond and the Audit Committee. OUTLOOK AND FINANCIAL GUIDANCE Medium-term guidance: Continue to target three-year revenue CAGR of more than 35% for 2023-2026 and Operating EBITDA margins of approximately 20% by the end of 2026.For 2025, revenues are expected to be between £160 million and £170 million, consistent with medium-term revenue guidance. This is expected to be second half-weighted, consistent with prior years.Operating EBITDA profitability is expected for 2025, with a low single digit £ million Operating EBITDA profit.Guidance excludes the impact of FX fluctuations. Analyst briefingOXB's management team, led by Dr. Frank Mathias, CEO, Dr. Lucinda Crabtree, CFO and Dr. Sebastien Ribault, CBO will be hosting a briefing and Q&A session for analysts at 13:00 BST / 8:00 EST today, 9 April 2025, at RBC Capital Markets, 100 Bishopsgate, London, EC2N 4AA, United Kingdom. A live webcast of the presentation will be available via this link. The presentation will be available on OXB's website at www.oxb.com. If you would like to dial in to the call and ask a question during the live Q&A, please email OXB@icrhealthcare.com Organic growth excludes the impact of the acquisition of ABL Europe SAS (OXB France) and the loss of revenues from Homology Medicines, Inc.Operating EBITDA (Earnings Before Interest, Tax, Depreciation, Amortisation, Impairment, revaluation of investments and assets at fair value through profit and loss, and share based payments). A reconciliation to GAAP measures is provided on page 16Contracted value of client orders represent the value of customer orders for which the customer has signed a financial commitment, whereby any changes to agreed values will be subject to either change orders, cancellation fees or the triggering of optional/contingent contractual clausesIncludes contributions from milestones, licensing and royalties NotesUnless otherwise defined, terms used in this announcement shall have the same meaning as those used in the Annual report and accounts. Enquiries: OXB: Sophia Bolhassan, Head of Investor RelationsT: +44 (0) 1865 509 737 / E: ir@oxb.com ICR Healthcare:T: +44 (0)20 3709 5700 / E: oxb@icrhealthcare.comMary-Jane Elliott Angela Gray Davide Salvi RBC Capital Markets (Joint Corporate Broker)T: +44 (0)20 7653 4000Rupert Walford Kathryn Deegan Jefferies (Joint Corporate Broker)T: +44 (0)20 7029 8000Sam Barnett Gil Bar Nauham About OXB OXB (LSE: OXB) is a global quality and innovation-led contract development and manufacturing organisation (CDMO) in cell and gene therapy with a mission to enable its clients to deliver life changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, OXB has 30 years of experience in viral vectors; the driving force behind the majority of cell and gene therapies. OXB collaborates with some of the world's most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV), adenovirus and other viral vector types. OXB's world-class capabilities range from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods and depth of regulatory expertise. OXB offers a vast number of unique technologies for viral vector manufacturing, including a 4th generation lentiviral vector system (the TetraVecta™ system), a dual-plasmid system for AAV production, suspension and perfusion process using process enhancers and stable producer and packaging cell lines. OXB, a FTSE4Good constituent, is headquartered in Oxford, UK. It has development and manufacturing facilities across Oxfordshire, UK, Lyon and Strasbourg, France and Bedford MA, US. Learn more at www.oxb.com, and follow us on LinkedIn and YouTube. Chair's Statement A year of successful delivery following our transformation 2024 was an important year for OXB as we executed our multi-vector, multi-site strategy as a pure-play CDMO which enabled us to deliver excellent financial, commercial and operational progress. Following our successful reorganisation and associated reduction in our cost base, OXB is transitioning towards long term, sustainable profitability as a newly transformed business. With revenue growth of 44% and the delivery of operating EBITDA profitability for the second half of 2024, we have demonstrated effective execution against our objectives. In the year, we have continued to work on strengthening our position across our global network of sites. This included securing a growing number of new clients in the US as well as enabling lentiviral vector development and manufacturing capabilities in the US and France. Market demand for OXB’s specialised services and expertise accelerated in 2024, with an increase of approximately 35% in contracted client orders, driven by a well-balanced portfolio of client programmes spanning all stages of development. Opportunity to grow in an expanding market Our successful execution comes at an optimal time, as the cell and gene therapy sector is expected to grow at an average compound annual growth rate (CAGR) of approximately 20% from 2025 through to the end of 2030 (GlobalData and company estimates) and this market momentum shows no signs of slowing. This is evidenced by a 32% increase in FDA-approved cell and gene therapy products in 2024 vs. 2023 (www.fda.gov), sustained pipeline development across multiple therapeutic areas and the number of viral vector based cell and gene clinical trials having grown by 25% over the past two years (ARM and GlobalData), with AAV a key growth driver. A transformed pure-play CDMO in cell and gene therapy We have made a number of important strategic decisions throughout the year, guided by our vision to transform lives through cell and gene therapy. With the acquisition of ABL Europe SAS, renamed Oxford Biomedica (France) SAS (OXB France) in January 2024, we expanded OXB's operational footprint, further strengthening our position as a global pure-play cell and gene therapy CDMO. Alongside this, we continue to successfully implement our "One OXB" strategy, creating a comprehensive multi-vector, multi-site network spanning the UK, the US and the EU. Lentiviral vector development and manufacturing capabilities have now been extended beyond the UK, to the US and France. Our global integrated network provides our clients with access to our best-in-class platform technologies and global capabilities across all three geographies. To reflect this evolution, we rebranded as OXB, establishing a stronger, more recognisable brand identity and building on our established world leadership in lentiviral vectors. In addition, we have continued to advance our cutting-edge vector platforms and technologies, with a focus on client-centric innovation that ensures our developments directly address our clients' needs while ultimately benefiting patients. Developments in 2024 include the launch of our inAAVate™ platform for improved AAV production, the continued roll-out of U1 additive technologies in GMP manufacturing that enhance viral vector yield and quality and the rollout of automated testing systems that increase both precision and efficiency. We maintain our focus on client-centric excellence with the goal of being the global partner of choice for pharmaceutical and biotech clients. Governance, sustainability and ethical leadership We made several key appointments to our Board and Corporate Executive Team (CET) during 2024, in line with our new strategy. Dr. Lucinda (Lucy) Crabtree joined as Chief Financial Officer (CFO) and Board member in September, bringing valuable biopharmaceutical and investment industry experience. This was followed by Stuart Paynter's departure after seven years of dedicated service and significant contribution to OXB’s strategic progress as CFO. We further strengthened our Board's CDMO expertise through the appointments of Peter Soelkner, CEO of Vetter Pharma in March 2024, as well as Colin Bond, former CFO of Sandoz, as a Board member in January 2025. We also strengthened our shareholder representation with the appointment of Laurence Espinasse representing Institut Mérieux, now our second largest shareholder. Having played a role in shaping OXB's strategy, Dr. Michael Hayden and Catherine Moukheibir stepped down from the Board at the Annual General Meeting (AGM) in June 2024. Leone Patterson also stepped down from the Board on 31 December 2024 to focus on her new responsibilities as Chief Business and Financial Officer of Zymeworks. After nine years of service as an Independent Non-Executive Director, Audit Committee Chair and most recently as Vice Chair, Stuart Henderson has informed the Board that he intends to retire from the Board. As such, Mr. Henderson will not seek re-election at the 2025 AGM. We thank Michael, Catherine, Leone and Stuart for their impeccable service and defining contribution to the business. Colin Bond will succeed Mr. Henderson as Audit Committee Chair. His extensive experience chairing Audit Committees for public companies positions him well for this role. To ensure a seamless transition and support continuity, Mr. Henderson will remain available to assist Mr. Bond and the Audit Committee. We have also implemented a new robust governance framework through our Environment, Social, Governance and Risk (ESGR) Committee. The new structure comprises an ESGR Committee at the Group level reporting to the CET and the Board, alongside site-level ESGR Committees, ensuring strong governance is integrated with the risk management framework and aligned with our corporate sustainability goals. OXB remains dedicated to ethical and socially responsible operations and as part of the Group's strategic reset as a pure-play CDMO, we have also revised our sustainability reporting framework. The new structure consolidates sustainability activities under Environment, Social and Governance priorities, creating greater transparency and clarity. Looking ahead As we look ahead to 2025 and beyond, the Board and I are confident in our position as a pure-play cell and gene therapy CDMO. At a time of significant growth in the cell and gene therapy market, our capabilities and 30 years of expertise perfectly position us to capture this opportunity. We are meeting our stated financial and operational goals and will continue to focus on increasing revenue opportunities in the US and France, including leveraging our new ability to offer lentiviral development and manufacturing capabilities from all our global sites. The foundations we have cemented in 2024 – operational excellence, an exceptional team, strategic client relationships and technological innovation – provide a robust platform for continuing to scale our business and creating long term value for all stakeholders. I extend my gratitude to our clients for their ongoing trust, our shareholders for their support and our OXB colleagues for their impressive delivery and ability to shape change as we continue to lead the cell and gene therapy CDMO field as a trusted partner with unmatched quality and innovation. Dr. Roch Doliveux Chair Chief Executive Officer's statement Building on three decades of innovation and expertise in viral vector development, our "One OXB" strategy has established a clear trajectory towards our revenue growth and profitability targets. The strong commercial momentum achieved this year, including our growing order book and our deepening reach and relevance to clients with the “One OXB” transformation, underpins our confidence in delivering both attractive growth and sustainable profitability. Enabling clients to deliver life-changing cell and gene therapiesOXB’s client portfolio features a well-balanced mix of client programmes spanning all stages of development, from early stage projects to late stage commercial readiness and commercial manufacturing. Demand for OXB’s specialised services and expertise across all vector segments remained strong in 2024, with new clients including several established biotech companies. Looking ahead, the Group's pipeline of potential revenue opportunities has also grown significantly, increasing by 30% from $438 million at the start of the year to $570 million at the end of 2024. OXB tracks its revenue pipeline through a structured internal process, providing clear visibility on future opportunities. Clients transitioning from early stage manufacturing to late stage and commercial activities have moved from a batch reservation model to a binding forecast model, providing increased revenue visibility for late stage client programmes. The acquisition of ABL Europe SAS (OXB France) in January 2024 has enhanced OXB's ability to meet growing demand across the EU by bringing additional GMP manufacturing facilities and expertise in France to the Group. Since then, we have successfully enabled lentiviral vector development and manufacturing capabilities at our sites in France, complementing the offering of our facilities in the UK and US. The alignment of operations across the UK, the US and France is increasing efficiency and agility, allowing OXB to optimise its capabilities and capacity. Portfolio of client programmes diversified across region and vector typeIn 2024, the Group maintained strong commercial momentum, as reflected in its growing order book. The contracted value of client orders signed during 2024 reached approximately £186 million at 31 December 2024, an increase of approximately 35% compared to £138 million in 2023. This included momentum in AAV client work, with the number of contracts signed for AAV now almost as high as lentiviral vectors. Lentiviral vector orders included commercial orders, including engaging OXB to procure raw materials to de-risk supply as well as securing GMP suite capacity. Orders also included additional batches for late stage programmes with clients preparing for commercialisation of their CAR-T products. Orders for other viral vectors (excluding lentiviral vectors and AAV) have grown and now represent approximately one-third of the number of new contracts. These orders validate OXB’s strong commercial positioning and provide increased revenue visibility. Client programmes in the US and France now account for more than half of OXB’s client programmes (by number of programmes), validating our transition to a global model. While lentiviral vectors remain the majority of clinical-stage and commercial programmes in our portfolio, the number of projects for AAV and other vector types is growing, with earlier stage projects providing the foundation for future growth.Client programmes by stage April 20241April 20252 35 clients40 clients 51 client programmes48 client programmesPre-clinical through to early stage clinical4642Late stage clinical34Commercial agreements22 As per the FY 2023 results releaseAs of this results release (includes post-period events) Innovation: advancing vector platforms and technologiesThe Group focuses on client-centric innovation to address the complex challenges of cell and gene therapy development and manufacturing. At the start of 2024, the Group launched the inAAVate™ platform, which offers a proprietary ‘plug and play’ Dual-Plasmid system for transient transfection, alongside a standard triple transfection system for AAV-based gene therapies. The inAAVate™ platform has demonstrated cell culture titre exceeding 1E15 vg/L for multiple serotypes across multiple genomes and has delivered a significant increase in AAV vector productivity and quality with >50% full capsids in the bioreactor and >90% full capsids in the final drug substance. The Dual-Plasmid system, combined with the Group's proprietary transfection process has been successfully scaled up to 2,000L with multiple GMP runs at 500L scale. This high-quality platform delivers industry-leading productivity, supporting successful AAV product development. The Group also developed an internal AAV production cell line. Initial evaluations with multiple capsids indicate strong potential for high productivity and optimised empty-to-full ratios. This cell line is now in scale-up stage and will be available in 2025 for client evaluation. In addition, OXB developed and optimised a robust enrichment process that produces more than 90% full capsids across multiple serotypes and genes of interest. This allows the Group to expedite its clients’ products to the clinic, including novel and engineered capsids, without the need for process development. OXB has developed multiple innovations that improve the productivity and quality of lentiviral vectors. It has launched refined lentiviral vectors both across its 3rd generation and TetraVectaTM platforms, which has led to a two to three fold increase in titre. OXB’s U1 enhancer is also available on these genome plasmids as an option for clients, saving GMP costs for U1 plasmids. The Group has made significant progress in improving impurity removal, particularly DNA clearance, while enhancing process recoveries. These will be scaled up in 2025 and made available to OXB’s clients. As expected, GMP production with the I3A additive which increases both lentiviral particle yield and potency, will begin in the second half of 2025. The Group believes that automation is key to further improving productivity and has therefore developed and implemented automated assays for processes such as PCR, tissue culture and plate-based assays. This approach enhances both the efficiency and rigour of analytical workflows, allowing OXB to release products to clients faster while maintaining robust quality and safety standards. In addition, new assays have been developed to rapidly identify optimal production parameters including timing, plasmid concentrations, additives and harvest times – to maximise the vector potency for target cell types. Furthermore, the Group has introduced mass spectrometry to enable deep proteomic profiling of cellular and vector products ultimately accelerating the development and commercialisation of transformative therapies Delivering “One OXB” and commitment to quality2024 represented the first full year of our transformation. During the year, the Group made significant progress executing its “One OXB” strategy which provides a multi-vector, multi-site offering to its clients. The transformation and integration workstreams that were planned to be completed in 2024 were all successfully finalised and transferred to business functions in 2024. The remaining initiatives are on track for completion by the end of 2025 as planned, providing a unified global operation focused on client-centric excellence. In 2024, the Group harmonised project management practices across the UK, US and France, delivering consistent client experiences and enabling the seamless execution of global projects. OXB also transitioned towards coordinated capex prioritisation, enabling an integrated global approach in place of a site-specific approach. Operationally, lentiviral vector capabilities were expanded to the Bedford MA, US site and OXB's sites in France. An accelerated product introduction process was implemented speeding up transition from clinical stages to GMP manufacturing for clients. Following the successful implementation in the UK and US, the Sales and Operations Planning process was rolled out to our sites in France to optimise project allocation based on delivery requirements and business impact. In July 2024, the FDA carried out a routine GMP inspection at two out of our four manufacturing sites in Oxford, UK, with zero written observations (i.e.: no FDA 483 observations) and few verbal observations. This outcome is a testament to our robust quality management systems (QMS), high-performing delivery and quality teams and our overall commitment to manufacturing products to the highest possible standards. Building an organisation for successThe Group further strengthened its Corporate Executive Team (CET) during 2024 to support its continued growth as a global cell and gene therapy CDMO. Dr. Lucinda (Lucy) Crabtree joined as Chief Financial Officer and Board member in September 2024, bringing extensive experience in the biopharmaceutical and investment sectors. In addition, Dr. Sabine Sydow was promoted to Chief of Staff in April 2024, leveraging her deep industry expertise. The Group also added experienced CDMO site leaders to support the CET in a move to reflect its multi-vector, multi-site strategy: Mark Caswell as Site Head of UK Operations, Stéphanie Colloud as Site Head and General Manager of France Operations and John Maravich as Site Head of US Operations. In January, OXB acquired ABL Europe SAS (OXB France) from Institut Mérieux for a fair value consideration of €6.6 million (£5.7 million), adding over 1,800m2 of GMP manufacturing facilities in Lyon and Strasbourg. The acquisition brought over 100 CDMO experts and expanded the Group's EU presence and expertise in process and analytical development, GMP and early stage manufacturing. This strategic move strengthens OXB's position as a leading cell and gene therapy CDMO while enhancing its ability to serve EU clients and meet growing demand for viral vector manufacturing services across Europe. In September, the Group announced the launch of its new corporate brand identity and rebranding to OXB, unveiling a more modern and recognisable visual identity. In conjunction with the rebrand a revised set of corporate values was also launched, aligned to OXB's mission and vision. Centred on being responsible, responsive, resilient and respectful, these values support OXB's mission to enable our clients to deliver life-changing therapies to patients globally, while advancing our vision of transforming lives through innovative cell and gene therapy solutions.OutlookThe Group saw growing momentum through the year and successfully delivered positive EBITDA profitability in the second half of the year. With the UK business already profitable on an EBITDA level we will continue to work towards sustainable profitability across all our sites. Building on our operational excellence and strong market demand, growing revenue opportunities across our global client portfolio is a key priority. Our 2025 objectives sit across three pillars, namely: One OXB (increasing employee engagement and increasing our Group-wide decarbonisation efforts), Client-Centric Excellence (ensuring on-time and on-quality delivery) and Financials (maintaining our projected revenue growth and achieving EBITDA profitability.) With strong commercial momentum, growing client demand and the successful implementation of the "One OXB" strategy, the Group is on track to achieve significant revenue growth and operating EBITDA profitability in 2025. Dr. Frank Mathias Chief Executive Officer Financial Review In 2024, OXB successfully delivered strong topline growth, with revenues increasing by 44%, as the Group executed its strategy as a pure-play cell and gene therapy CDMO. This topline growth, combined with a streamlined cost base enabled the Group to significantly improve its Operating EBITDA position compared to 2023. OXB has entered 2025 in a position of strength and is well-placed to deliver both attractive growth and sustainable profitability. Selected highlights of the Group's financial results are as follows: Total revenues reached £128.8 million representing a 44% (45% 1CC) increase compared with 2023 (£89.5 million) and an 81%2 organic growth rate. Organic growth excludes the impact of the acquisition of ABL Europe SAS (OXB France) and the loss of revenues from Homology Medicines, Inc.This strong revenue growth was driven by: Increase in lentiviral vector manufacturing of GMP batches for clinical clients and for clients in preparation for commercial launchClients moving further along their clinical development pathways including an increase in development revenues from process characterisation and validation workProcurement and Storage services to provide stability of supply of raw materialsComplemented by new contributions from OXB France (£11.5 million) on an inorganic basis. Significant improvement in Operating EBITDA3 loss to £(15.3) million (2023: £(52.8) million), which narrowed by £37.5 million. Achieved £5.0 million operating EBITDA profit in the second half of 2024 at Group level. Operating loss of £(39.4) million (including operating loss from OXB (France) (£11.8 million) also represented a significant narrowing compared with 2023 (£(184.2) million) due to a combination of increased revenues and a positive impact of the 2023 reorganisation lowering the overall cost base. The 2023 operating loss was also negatively impacted by an impairment of the US business of £99.3 million.Acquisition of ABL Europe SAS (OXB France) from Institut Mérieux for a fair value consideration of €6.6 million (£5.7 million) by means of a share-for-share exchange increasing net assets of the Group by £7.4 million and giving rise to a bargain purchase gain of £1.7 million.Cash burn4 of £68.2 million in 2024 (2023: £39.1 million) arising principally from operating loss and the increased activity in the second half of 2024 resulting in a higher balance of Contract Assets and Trade Receivables which are not yet due as at the year end, offset by the cash inflow of £17.5 million as a result of the investments by Institut Mérieux.Cash at 31 December 2024 was £60.7 million (2023: £103.7 million); net cash at 31 December 2024 was £20.6 million (2023: £65.2 million).Expansion of OXB's lentiviral development and manufacturing capabilities to its US and France sites completed, establishing a fully operational multi-site platform that will support geographic diversification of revenue streams going forward. This strategic expansion is now generating revenue momentum across all three key regions.In 2024 OXB increased its ownership of OXB US LLC by 10%, from 80% to 90%. This followed the conversion of an existing working capital loan and a capital injection into OXB US LLC, on 26 June 2024. On 1 March 2025, OXB US Inc exercised the call option for the purchase of the remaining 10% of OXB US LLC from Q32 Bio, Inc. (Q32). At the date of this report, the transfer of Q32’s remaining 10% holding in OXB US to OXB US Inc is in the process of being finalised. CC refers to Constant Currency, which refers to the equivalent growth based on the prior year exchange rates.Comparative revenues adjusted for the non-recurrence of 2023 revenues in the US from Homology in the US (£23.2 million) and the impact of the acquisition of ABL Europe SAS (OXB France).Operating EBITDA (Earnings Before Interest, Tax, Depreciation, Amortisation, Impairment, revaluation of investments and assets at fair value through profit and loss and share based payments) is a non-GAAP measure often used as a surrogate for operational cash flow as it excludes from operating profit or loss all non-cash items, including the charge for share based payments. However, deferred bonus share option charges are not added back to operating profits in the determination of Operating EBITDA as they may be paid in cash upon the instruction of the Remuneration Committee. A reconciliation to GAAP measures is provided on page 16.Cash (burn)/accretion is net cash generated from operations plus net interest paid plus capital expenditure. A reconciliation to GAAP measures is provided on page 17. Key Financial and Non-Financial Performance Indicators The Group evaluates its performance inter alia by making use of alternative performance measures as part of its Key Financial and Non-Financial Performance Indicators as disclosed in the table below. The Group believes that these Non-GAAP measures, together with the relevant GAAP measures, provide a comprehensive, accurate reflection of the Group's performance over time. The Board has taken the decision that the Key Financial Performance Indicators against which the business will be assessed are Revenue, Operating EBITDA and Operating profit/(loss). The figures presented in this section for prior years are those reported in the Annual Reports for those years. £'m20242023202220212020Revenue128.889.5140.0142.887.7Operations Operating EBITDA1(15.3)(52.8)1.635.97.3Operating (loss) / profit(39.4)(184.2)(30.2)20.8(5.7) Cash Flow Cash (used in) / generated from operations(50.7)(36.0)(13.2)24.5(3.9)Capex27.59.816.39.513.4Cash (burn) / accretion3(68.2)(39.1)(33.0)16.0(7.8) Financing Cash60.7103.7141.3108.946.7Loan40.138.539.8-- Non-Financial Key Indicators Headcount Year end861714904815673Average845854929759609 Operating EBITDA (Earnings Before Interest, Tax, Depreciation, Amortisation, Impairment, revaluation of investments and assets at fair value through profit and loss and share based payments) is a non-GAAP measure often used as a surrogate for operational cash flow as it excludes from operating profit or loss all non-cash items, including the charge for share based payments. However, deferred bonus share option charges are not added back to operating profits in the determination of Operating EBITDA as they may be paid in cash upon the instruction of the Remuneration Committee. A reconciliation to GAAP measures is provided on page 16.This is purchases of property, plant and equipment as per the cash flow statement which excludes additions to right-of-use assets. A reconciliation to GAAP measures is provided on page 25.Cash (burn)/accretion is net cash generated from operations plus net interest paid plus capital expenditure. A reconciliation to GAAP measures is provided on page 17. Revenue Group revenue of £128.8 million was a 44% increase on 2023 (£89.5 million). Comparative growth was 81%, once adjusted for the non-recurrence of 2023 revenues from Homology in the US (£23.2 million). This comparative growth is driven by a 76% revenue growth in lentiviral vector projects in the UK and new client work in the US. OXB France provided a contribution to overall revenue of £11.5 million. In order to provide the users of the accounts with a more detailed understanding of the revenue streams the table below provides a breakdown of the key streams individually. Revenue generated from manufacturing increased by 34% to £68.4 million (2023: £51.0 million) due to an increase in the number of batches manufactured for clinical clients and for clients in preparation for commercial launch; and the new contributions from OXB France (£5.5 million). Homology contributed £17.1 million of manufacturing revenue in 2023. Revenue generated from development services increased by 49% to £47.3 million (2023: £31.8 million) due to client products moving further along their clinical development pathways including an increase in development revenues from process characterisation and validation work; and the new contributions from OXB France (£6.1 million). Homology contributed £6.1 million of development services revenue in 2023. Revenues from licence fees, milestones and royalties increased by 9% to £7.3 million (2023: £6.7 million). Milestones and licence fees increased to £4.1 million (2023: 2.7 million) due to the timing of milestones achieved from existing clients. Royalties decreased to £3.2 million (2023: £4.0 million) as the Kymriah product matures through its life cycle. In 2024, Procurement and Storage services generated £5.8 million in revenue (2023: £ nil). This revenue line, recognised as point in time, represents additional procurement and storage services from clients undergoing commercial preparation activities, representing our readiness to provide clients stability of supply and the maturity of the Group in its capacity as a CDMO. Gross Margin in 2024 was 41% (2023: 44%) due to product mix with the transition to higher volume manufacturing contracts and the positive margin impact of the contract closure for Homology in the prior year. £'m20242023202220212020Revenue Manufacturing services68.451.093.8111.145.4Development services47.331.834.317.323.1Procurement services5.8----Licences, milestones and royalties7.36.711.914.419.2Total revenue128.889.5140.0142.887.7Cost of Sales Manufacturing services(42.2)(33.1)(52.3)(50.4)(29.0)Development Services(29.0)(16.7)(18.6)(10.0)(12.4)Procurement services(4.6) Total Cost of Sales(75.8)(49.8)(70.9)(60.4)(41.4) Gross Profit53.039.769.182.446.3Gross Margin41%44%49%58%53% Operating EBITDA 2024 Operating EBITDA loss of £(15.3) million, is £37.5 million lower than 2023 (£(52.8) million), as a result of revenues increasing by 44%, whilst the Group's cost base including raw materials included in cost of sales increased by 2% to £149.3 million. The costs included a decrease in operational spend due to cost saving initiatives, the restructuring and the closure of the Product division at the end of 2023. These cost savings were partly offset by an increase in operational spend due to the consolidation of the results of OXB France for 11 months, acquisition-related due diligence costs of £0.2 million and inflationary increases. In 2024, the Group benefited, in Other Income, from a £1.7 million one-off gain as a result of the bargain purchase accounting relating to the acquisition in France. In 2023, the Group benefited from a one-off profit on sale of its Harrow House facility of £0.5 million in a sale and lease back transaction. Other income also includes sub lease rental income £2.5 million (£2023: £2.2 million) and grant income to further develop supply chain capabilities of £1.1 million (2023: £0.6m). £'m20242023202220212020Revenue128.889.5140.0142.887.7Other income5.32.82.30.90.8Gain on sale of property(0.1)1.021.4--Total expenses1(149.3)(146.1)(162.0)(107.8)(81.1)Operating EBITDA2(15.3)(52.8)1.635.97.3Impairment-(99.3)---Non cash items3(24.1)(32.1)(31.8)(15.1)(13.0)Operating (loss)/profit(39.4)(184.2)(30.2)20.8(5.7) Total expenses are operational expenses including cost of goods incurred by the Group. A reconciliation to GAAP measures is provided on page 15.Operating EBITDA (Earnings Before Interest, Tax, Depreciation, Amortisation, Impairment, revaluation of investments and assets at fair value through profit and loss and share based payments) is a non-GAAP measure often used as a surrogate for operational cash flow as it excludes from operating profit or loss all non-cash items, including the charge for share based payments. However, deferred bonus share option charges are not added back to operating profits in the determination of Operating EBITDA as they may be paid in cash upon the instruction of the Remuneration Committee. A reconciliation to GAAP measures is provided on page 16.Non-cash items include depreciation, amortisation, revaluation of investments, fair value adjustments of available-for-sale assets and the share based payment charge. A reconciliation to GAAP measures is provided on page 15. Total Expenses In 2024, the Group has pivoted to a pure-play CDMO and as a result, the classification of the expenditure types has been reviewed and represented in a more meaningful way. Note 22 provides a reconciliation of the Re-presentation. The costs previously disclosed as Bioprocessing and the element of Research and Development which related to Development services are now included as operating costs.Innovation costs relate to the internal development work undertaken on OXB platforms.Commercial costs relate to the teams engaged in business development activities.Administration expenses are those departments who support the operational teams across the Group. In order to provide the users of the accounts with a more detailed explanation of the reasons for the year on year movements of the Group's operational expenses included within Operating EBITDA, the Group has removed depreciation, amortisation and the share option charge as these are non-cash items which do not form part of the Operating EBITDA alternative performance measure. As Operating (loss)/profit is assessed separately as a key financial performance measure, the year on year movement in these non-cash items is then individually analysed and explained specifically in the Operating and Net (loss)/profit section. Expense items included within Total Expenses are then categorised according to their relevant nature with the year on year movement explained in the second table on the next page. £'m20242023202220212020Operating costs157.386.260.940.229.7Innovation costs4.511.533.97.210.7Commercial costs6.43.9---Administrative expenses29.426.928.215.111.3Impairment-99.3---Operating expenses97.6227.8123.062.551.7Depreciation(20.1)(21.5)(20.3)(12.4)(9.8)Amortisation(2.3)(7.2)(6.1)--Impairment-(99.3)2---Share option charge(1.7)(3.5)(5.4)(2.5)(2.4)Adjusted Operating expenses373.596.391.247.639.5Cost of sales75.849.870.860.241.7Total Expenses4149.3146.1162.0107.881.2 Includes benefit of the RDEC tax credit.Impairment on the US LLC business following the decision of Homology to cease clinical activities.Research, development, manufacturing and administrative expenses excluding depreciation, amortisation, impairment and the share option charge.Cost of sales plus research, development, manufacturing and administrative expenses excluding depreciation, amortisation, impairment and the share option charge. £'m20242023202220212020Raw materials, consumables and other external manufacturing services costs47.032.445.634.222.0Manpower-related76.983.284.455.045.3External R&D expenditure0.72.53.62.51.4Acquisition costs0.21.45.11.2-Other costs31.932.827.820.017.1RDEC Credit(7.4)(6.3)(4.5)(5.1)(4.6)Total Expenses1149.3146.1162.0107.881.2 Total expenses are operational expenses including cost of goods incurred by the Group. A reconciliation to GAAP measures is provided above. Raw materials, consumables and other external manufacturing costs have increased by 45% as a direct result of the increase in the number of lentivector batches produced and development activities. 85% of these costs are classified as cost of sales and increase with revenue.Manpower-related costs are lower than 2023 driven by the restructuring completed at the end of 2023, which included redundancy costs incurred (£5.6 million) with the loss of approximately 200 roles across the UK and the US business, as well as the fact that no bonuses accrued with regards to 2023 performance. The lower costs were partly offset by inclusion of 11-month impact of the 151 roles in OXB France and a bonus has been accrued on 2024 performance as the Group achieved its targets.External R&D expenditure decreased as a result of the closure of the Product division during 2024.Due diligence costs incurred in 2024 and in 2023 were as a result of the acquisition of ABL Europe SAS (OXB France). Due diligence costs incurred in 2022 related to the establishment of OXB US.Other costs were in line with 2023 despite the 11-month impact of the inclusion of the administrative expenditure of OXB France and inflationary increases.The RDEC credit has increased to £7.4 million (2023: £6.3 million) due to an increase in activity which qualifies for supporting the resolution of scientific uncertainty. Operating and Net profit/(loss) £'m20242023202220212020Operating EBITDA1(15.3)(52.8)1.635.97.3Depreciation, Amortisation and share option charge(24.1)(32.2)(31.8)(14.9)(12.2)Impairment-(99.3)---Revaluation of investments/Change in fair value of available for sale assets-0.1-(0.2)(0.8)Operating (loss)/profit(39.4)(184.2)(30.2)20.8(5.7)Interest(7.2)(6.3)(7.8)(0.9)(0.8)Foreign exchange(0.7)1.9(8.0)--Taxation(1.3)4.40.8(0.9)0.3Net(loss)/profit(48.6)(184.2)(45.2)19.0(6.2) Operating EBITDA (Earnings Before Interest, Tax, Depreciation, Amortisation, Impairment, revaluation of investments and assets at fair value through profit and loss and share based payments) is a non-GAAP measure often used as a surrogate for operational cash flow as it excludes from operating profit or loss all non-cash items, including the charge for share based payments. However, deferred bonus share option charges are not added back to operating profits in the determination of Operating EBITDA as they may be paid in cash upon the instruction of the Remuneration Committee. In arriving at Operating (loss)/profit it is necessary to deduct from Operating EBITDA the non-cash items referred to above. The depreciation (£20.1 million) and amortisation (£2.3 million) charge are lower than prior year due to the OXB US impairment at the end of 2023 offset by the 11-month impact of the acquisition of the fixed assets of OXB France. The share option charge £1.7 million (2023: £3.5 million) decreased due to the impacts of staff turnover and lower share price. The impact of these charges increased the operating EBITDA loss and resulted in an operating loss of £39.4 million in 2024. This compared to an operating loss of £(184.2) million in the prior year primarily driven by the impairment of £99.3 million. The net interest charge increased by £0.9 million as a result of a decrease in bank interest received of £1.7 million to £3.2 million due to a lower cash balance and a reduction in the interest on finance leases as the lease balances decrease. Foreign exchange losses of £0.7 million were recognised in 2024 on the loan from Oaktree Capital Management, L.P. (Oaktree loan or Oaktree loan facility), as opposed to foreign exchange gains of £1.9 million in 2023. The corporation tax charge is impacted by an increase in the notional tax charge due to an increase in the RDEC tax credit expected for 2024 offset by the release of the deferred tax liability on the US intangibles. Other Comprehensive Income The Group recognised a loss within other comprehensive income in 2024 of £0.7 million (2023: £5.3 million) in relation to movements on the foreign currency translation reserve. The translation reserve comprises all foreign currency differences arising from the translation of the financial statements of foreign operations, including gains arising from monetary items that in substance form part of the net investment in foreign operations. Cash flow £'m20242023202220212020Operating (loss)/profit(39.4)(184.2)(30.2)20.8(5.7)Non-cash items included in operating loss124.1131.431.815.113.0Operating EBITDA2(15.3)(52.8)1.635.97.3Working capital movement3(35.4)16.8(14.8)(11.4)(11.2)Cash (used in)/ generated from operations(50.7)(36.0)(13.2)24.5(3.9)R&D tax credit received-7.50.61.07.0Net Cash (used in)/ generated from operations(50.7)(28.5)(12.6)25.53.1Interest paid, less received-0.1(4.1)--Sale of Investment Asset----2.5Lease payments(10.1)(9.2)---Capex4(7.5)(1.4)(16.3)(9.5)(13.4)Net cash (burn) / accretion5(68.2)(39.1)(33.0)16.0(7.8)Acquisition of subsidiary9.0-(99.2)--Sale of building--60.0--Net proceeds from financing617.10.6104.646.238.3Movement in year(42.1)(38.4)32.462.230.5 Depreciation, Amortisation, Impairment, revaluation of investments and assets at fair value through profit and loss, and share based payments.Operating EBITDA (Earnings Before Interest, Tax, Depreciation, Amortisation, Impairment, revaluation of investments and assets at fair value through profit and loss and share based payments) is a non-GAAP measure often used as a surrogate for operational cash flow as it excludes from operating profit or loss all non-cash items, including the charge for share based payments. However, deferred bonus share option charges are not added back to operating profits in the determination of Operating EBITDA as they may be paid in cash upon the instruction of the Remuneration Committee. A reconciliation to GAAP measures is provided on page 16.This is Changes in working capital and reversal of the Gain on sale of building as outlined in note 17: Cash flow from operating activities on page 40.This is Purchases of property, plant and equipment as per the cash flow statement which excludes additions to Right-of-use assets. A reconciliation to GAAP measures is provided on page 25.Cash (burn)/accretion is net cash generated from operations plus net interest paid plus capital expenditure.This is net cash generated from financing activities as per the Cash flow statement on page 40 excluding interest paid and lease liability payments. The Group held £60.7 million of cash at 31 December 2024 (2023: £103.7 million). Significant movements across the year, further to the EBITDA movements, are explained below: The operating EBITDA loss of £(15.3) millionA negative working capital movement of £(35.4) million principally driven by: An increase in Trade and other receivables of £34.3 million to £59.0 million (2023: £24.7 million), of which £3.2 million relates to OXB France. This significant increase on 2023 is directly related to increased activity in the second half of 2024, which resulted in £23.3 million of Trade receivables at the end of 2024 for invoices not yet due (2023: £8.1 million) and £18.0 million of contract assets (2023: £5.2 million) from inflight manufacturing batches and in progress development projects all of which will be invoiced in 2025An increase in Trade and other payables of £8.4 million to £26.2 million (2023: £17.8 million), of which £5.9 million relates to OXB France. The accruals in 2024 include a corporate bonus accrual which was nil in 2023.A decrease in Contract Liabilities and Deferred Income of £2.1 million to £25.3 million (2023: £27.4 million) of which £3.0 million relates to OXB France. This reduction is driven by the utilisation of opening contract liabilities relating to batch deposits by £6.2 million for batches which have been manufactured during 2024. The 2023 UK RDEC refund from HMRC was received in March 2025, therefore is outstanding at the year end, but in the comparable period both the 2021 and 2022 RDEC tax credits were received in 2023. Purchases of property, plant and equipment increased to £7.5 million from £9.8 million, as the Group invested in the expansion of lentiviral development and manufacturing to the sites in the US and France as part of the execution of its "One OXB" strategy.Lease payments of £10.1 million (2023: £9.2 million) for all facilities which have increased due to the inclusion of leases related to OXB France and the full year impact of the sale and leaseback of the Group's UK Harrow House facilities.The acquisition of the ABL Europe SAS (OXB France) in January 2024 resulted in an inflow of £9.0 million.The net proceeds from financing (excluding finance leases and interest) during 2024 was £17.1 million, consisting of proceeds from the share subscription associated with the OXB France acquisition £17.5 million offset by repayment of short term OXB France loans £0.4 million. The result of the above movements is a net decrease of £42.1 million which, together with a negative movement in foreign currency balances of £0.9 million, leads to a decrease in cash from £103.7 million to £60.7 million. Subsequent events On 1 March 2025, OXB US Inc exercised the call option for the purchase of the remaining 10% of OXB US LLC from Q32. At the date of this report, the transfer of Q32’s remaining 10% holding in OXB US to OXB US Inc is in the process of being finalised. Financial outlook Near-term outlook Financial metric2025 guidance (CC1) Revenue£160 million - £170 million Operating EBITDA profitLow single-digit million 1 CC refers to Constant Currency, which refers to the equivalent growth based on the prior year exchange rates. The Group expects 2025 revenues to be between £160 million and £170 million, with contracted client orders providing a high degree of visibility. Revenues for 2025 are expected to be second half-weighted, in line with prior years, due to holiday shutdown and annual routine maintenance that occurs at the start of each year. The Group's revenue backlog stood1 at approximately £150 million as at 31 December 2024 compared to £94 million as at 31 December 2023. This is the amount of future revenue available to earn from current orders. The contracted value of client orders signed in 2024 was approximately £186 million, an increase of approximately 35% compared to £138 million in 2023, which instils confidence in the Group's ability to deliver further revenue growth in 2025 and 2026. This includes £141 million to be recognised in 2025, subject to revenue performance obligations. This compares to £82 million at the same time last year (equivalent to 64% of FY 2024 Revenues of £128.8 million). With our strong business development pipeline and sufficient manufacturing and development capacity, we have strong visibility of the remaining 2025 revenue guidance. Capital expenditure for 2025 is expected to be low double-digit £ million, limited to maintenance capex required as well as disciplined spend on certain key capital expenditure projects.Operating EBITDA profitability is expected in 2025, with a low single digit £ million Operating EBITDA profit for the full year. This is expected to be second half weighted, in line with revenues and with the benefits of the streamlined cost base to increase through the course of the year. The business is sensitive to FX fluctuations due to the revenues being receivable in Sterling, Euro and US Dollars with certain expenditures payable in Euro and US Dollars, including the loan payments due to the Oaktree loan facility being denominated in dollars. Financial guidance excludes the impact of FX fluctuations. Medium term financial guidance and long term ambitionBuilding on its track record and competitive advantage as a viral vector specialist, the Group aims to ultimately have a market leading position in the viral vector supply market across all key vector types. The Group continues to target a three-year revenue CAGR of more than 35% for 2023-2026. The Group’s expectations for 2026 include an increase in manufacture of GMP batches compared with 2025, primarily driven by commercial and late-stage client activity in the UK. Early stage GMP manufacturing is expected to increase as programmes from new and existing clients advance into the clinic across UK, US and France sites. To support the high growth in GMP manufacturing demands, driven by late stage and commercialisation activities, OXB expects to make investments in headcount in 2026 to increase manned GMP suite capacity. With ongoing focus on efficiency and a disciplined approach to our cost base; and planned targeted investment, the Group continues to target Operating EBITDA margins of approximately 20% by the end of 2026. Beyond 2026, the Group is targeting revenue growth in excess of the broader viral vector market. Manufacturing revenues as a proportion of total revenues are expected to increase, from approx. 50% in 2024 to c.70% in 2029. OXB is targeting continued margin expansion following the pivot to positive operating EBITDA in 2025, as the Group continues to grow top line and benefits from operating leverage. Financial metricMedium-term guidanceRevenue CAGR (2023-2026)>35%Operating EBITDA margins~20% by end of 2026 1 Revenue backlog represents the ordered gross value of CDMO revenues available to earn. The value of customer orders included in revenue backlog only includes the value of work for which the customer has signed a financial commitment for OXB to undertake, whereby any changes to agreed values will be subject to change orders, cancellation fees or the triggering of optional/contingent contractual clauses. Viability Statement The Directors have assessed the prospects of the Group over the three years to December 2027. They believe three years to be appropriate due to the inherent significant uncertainties of forecasting within and beyond this time horizon given the nature of the business sector in which the Group operates. The assessment has been performed by developing and updating the Long Range Plan that covers the viability assessment period which the Board has scrutinised in depth together with its financial advisers prior to the publication of this statement. The Group’s strategy is to exploit its platform technologies in lentiviral vector ( LentiVector®), AAV and others to support the development of other companies’ cell and gene therapy products. The Group is generating growing cell and gene therapy revenues from providing process development and manufacturing services to other companies and fees for licensing its platform technology, generating upfront receipts and royalties. Over the three years to December 2027 the Directors believe that revenues from providing process development and manufacturing services to its clients and from licensing its technology to third parties will be sufficient to support a sustainable Group. The following factors are considered both in the formulation of the Group’s strategy and in the assessment of the Group’s prospects over the three-year period: The principal risks and uncertainties faced by the Group, including emerging risks as they are identified (such as climate change) and the Group’s response to these.The prevailing economic climate and global economy, competitor activity, market dynamics and changing client behaviours.How the Group can best position itself to take advantage of the current opportunities within the cell and gene therapy and adenovirus markets.Opportunities for further technology investment and innovation.The resilience afforded by the Group’s enviable technology platform and innovation capabilities.The financial viability of the Group, taking into account its current financial position and ability to secure future financing either to repay or refinance the existing Oaktree loan when it falls due in 2026. Going concern The financial position of the Group and the Company, their cash flows and liquidity position are described in the Financial Statements and notes to the financial statements section of the Annual report and accounts. The Group and the Company made a loss after tax for the year ended 31 December 2024 of £(48.6) million and £(12.8) million respectively and consumed net cash flows from operating activities for the year of £50.7 million and £2.0 million. The Group also: Closed the acquisition of ABL Europe SAS (OXB France) in January 2024 for a consideration of €15 million, (including €10million of pre-completion cash funding from Institut Mérieux).Ended the period with cash and cash equivalents of £60.7 million. In considering the basis of preparation of the FY24 Annual report and accounts, the Directors have prepared cash flow forecasts for a period of at least 12 months from the date of approval of these financial statements, based in the first instance on the Group’s 2025 latest forecast and forecasts for 2026. The Directors have undertaken a rigorous assessment of the forecasts in a base case scenario and assessed identified downside risks and mitigating actions. These cash flow forecasts also take into consideration severe but plausible downside scenarios including: Commercial challenges leading to a substantial manufacturing and development revenue downside affecting both the LentiVector® platform and AAV businesses.Considerable reduction in revenues from new clients.Removal of any future licence revenues.The potential impacts of a downturn in the biotechnology sector on the Group and its clients including expected revenues from existing clients under long term arrangements. Under both the base case and mitigated downside scenario, the Group and the Company have sufficient cash resources to continue in operation for a period of at least 12 months from the date of approval of these financial statements. In the event of all the downside scenarios above crystallising, the Group and Company would continue to comply with its existing loan covenants until the maturity of the Oaktree loan without taking any mitigating actions, but the Board has mitigating actions in place that are largely within its control that would enable the Group to reduce its spend within a reasonably short time-frame to increase the Group and the Company's cash covenant headroom as required by the Oaktree loan facility. Specifically, the Group will continue to monitor its performance against the base case scenario and if base case cash-flows do not crystallise, start taking mitigating action by the end of Q4 2025 which may include rationalisation of facilities and rightsizing the workforce.In addition, the Board has confidence in the Group and the Company's ability to continue as a going concern for the following reasons: As noted above, the Group has cash balances of £60.7 million at the end of December 2024.£141 million of 2025 forecasted revenues are covered by contracted client orders which give confidence in the level of revenues forecast over the next 12 months.The Group intends to delay the construction element of its Oxbox manufacturing facility expansion to take place during 2028 and 2029.The Group's ability to continue to be successful in winning new clients and building its brand as demonstrated by successfully entering into new client agreements including with multiple new clients over the last 6 months.The Group has the ability to control capital expenditure costs and lower other operational spend, as necessary. Taking account of the matters described above, the Directors are confident that the Group and the Company will have sufficient funds to continue to meet their liabilities as they fall due for at least 12 months from the date of approval of the financial statements and therefore have prepared the financial statements on a going concern basis. Dr. Lucinda Crabtree Chief Financial Officer Consolidated statement of comprehensive income Dec-24Dec-23 Re-presented1 Notes£'000£'000Continuing operations Revenue 128,79789,539Cost of sales (75,776)(49,812)Gross profit 53,02139,727 Operating costs (57,261)(86,163)Innovation costs (4,544)(11,471)Commercial costs (6,356)(3,911)Administration expenses (29,420)(26,893)Impairment of assets -(99,284)Other operating income 5,2542,803(Loss)/ gain on sale and leaseback (69)1,018Operating (loss) (39,375)(184,174) Finance income 3,2364,910Finance costs5(11,126)(9,263)(Loss) before tax (47,265)(188,527)Taxation (expense)/credit (1,344)4,365(Loss) for the period (48,609)(184,162) Other comprehensive (expense) Foreign currency translation differences (737)(5,307)Other comprehensive (expense) (737)(5,307) Total comprehensive (expense) (49,346)(189,469) (Loss) attributable to: Owners of the Company (43,190)(157,490)Non-controlling interest18(5,419)(26,672) (48,609)(184,162) Total comprehensive expense attributable to: Owners of the Company (43,878)(161,359)Non-controlling interest18(5,468)(28,110) (49,346)(189,469) Basic and Diluted (loss) per ordinary share (41.75)(163.11) 1 The prior year has been re-presented - please refer to Note 22 Statement of financial position Group Dec-24Dec-23 Notes£'000£'000 Assets Non-current assets Intangible assets & goodwill629,21930,981Property, plant and equipment764,29675,692Trade and other receivables 4,9344,340 98,449111,013Current assets Inventories813,57312,872Trade and other receivables958,97124,741Cash and cash equivalents 60,650103,716 133,194141,329Current liabilities Trade and other payables1026,16917,802Provisions121,152747Contract liabilities1123,63021,598Deferred income11562514Loans13281-Lease liabilities 4,1393,654Put/ call option liability142,388- 58,32144,315Net current assets / (liabilities) 74,87397,014 Non-current liabilities Provisions127,4247,710Contract liabilities11504,494Deferred income111,020837Loans1339,79038,534Lease liabilities 64,55169,270Put/ call option liability14-9,348 112,835130,193Net assets 60,48777,834 Equity attributable to owners of the parent Ordinary shares 52,98148,403Share premium account 394,856380,333Other reserves 8,709(1,812)Accumulated losses (399,500)(352,918)Equity attributable to owners of the Company 57,04674,006Non-controlling interest183,4413,828Total equity 60,48777,834 Statement of cash flows Group 20242023 Notes£’000£’000 Cash flows from operating activities Cash (consumed in) operations17(50,666)(36,027)Tax credit received -7,510Net cash used in operating activities (50,666)(28,517) Cash flows from investing activities Acquisition of subsidiary, net of cash acquired 9,004-Purchases of property, plant and equipment (7,496)(9,832)Proceeds on disposal of property, plant and equipment -8,390Interest received 4,1244,248Net cash generated from/(used) in investing activities 5,6322,806 Cash flows from financing activities Proceeds from issue of ordinary share capital 17,526651Interest paid (4,086)(4,136)Loans repaid (466)-Payment of lease liabilities (4,723)(3,117)Payment of lease liabilities interest (5,343)(6,101)Net cash generated from/(used in) financing activities 2,908(12,703) Net decrease in cash and cash equivalents (42,126)(38,414)Cash and cash equivalents at 1 January 103,716141,285Movement in foreign currency balances (940)845Cash and cash equivalents at 31 December 60,650103,716 Statement of changes in equity attributable to owners of the parent company Reserves Ordinary sharesShare premium accountMergerOther EquityTranslationAccumulated lossesTotalNon-controlling interestTotal equityGroupNotes£'000£'000£'000£'000£'000£'000£'000£'000£'000At 1 January 2023 48,132379,9532,291(35,003)7,825(198,545)204,65331,539236,192Loss for period -----(157,490)(157,490)(26,672)(184,162)Foreign currency translation differences ----(3,869)-(3,869)(1,438)(5,307)Other comprehensive expense ----(3,869)-(3,869)(1,438)(5,307)Total comprehensive expense for the period ----(3,869)(157,490)(161,359)(28,110)(189,469)Transactions with owners: Share options Proceeds from shares issued 271380----651-651Value of employee services -----3,1173,1173993,516Total contributions 271380---3,1173,7683994,167Changes in ownership interests: -Put/ call option revaluation ---26,944--26,944-26,944At 31 December 2023 48,403380,3332,291(8,059)3,956(352,918)74,0063,82877,834 At 31 December 2023 48,403380,3332,291(8,059)3,956(352,918)74,0063,82877,834Loss for period -----(43,190)(43,190)(5,419)(48,609)Foreign currency translation differences ----(688)-(688)(49)(737)Other comprehensive income ----(688)-(688)(49)(737)Total comprehensive expense for the period ----(688)(43,190)(43,878)(5,468)(49,346)Transactions with owners: Shares Proceeds from shares issued 4,57814,5234,126--(394)22,833-22,833Value of employee services -----2,0792,07942,083Total contributions 4,57814,5234,126--1,68524,912424,916Changes in ownership interests: -NCI recapitalisation -----(5,077)(5,077)5,077-Put/ call option revaluation ---7,083--7,083-7,083At 31 December 2024 52,981394,8566,417(976)3,268(399,500)57,0463,44160,487 NOTES TO THE PRELIMINARY FINANCIAL INFORMATION 1. Basis of preparationThis preliminary announcement was approved by the Board of Directors on 9 April 2025. The financial information set out above does not constitute the Company’s statutory accounts for the years ended 31 December 2023 or 2024 but is derived from those accounts. The preparation of the financial statements in conformity with IFRS requires the use of certain critical accounting estimates. Statutory accounts for 2023 have been delivered to the registrar of companies, and those for 2024 will be delivered in due course. The numbers presented in this released have been audited. The auditor has reported on the 2024 accounts; their report was (i) unqualified, (ii) did not include a reference to any matters to which the auditor drew attention by way of emphasis without qualifying their report; and (iii) did not contain a statement under Section 498 (2) or (3) of the Companies Act 2006. The consolidated statement of comprehensive income for 2023 has been re-presented to present the accounts in a more meaningful way as detailed in note 22. Going concernThe financial position of the Group and the Company, their cash flows and the liquidity position are described in the Financial Statements and notes to the financial statements section of the Annual report and accounts. The Group and the Company made a loss after tax for the year ended 31 December 2024 of £(48.6) million and £(12.8) million respectively and consumed net cash flows from operating activities for the year of £50.7 million and £2.0 million. The Group also: Closed the acquisition of ABL Europe SAS (OXB France) in January 2024 for a consideration of €15 million, (including €10million of pre-completion cash funding from Institut Mérieux).Ended the period with cash and cash equivalents of £60.7 million. In considering the basis of preparation of the FY24 Report and full-year accounts, the Directors have prepared cash flow forecasts for a period of at least 12 months from the date of approval of these financial statements, based in the first instance on the Group’s 2025 latest forecast and forecasts for 2026. The Directors have undertaken a rigorous assessment of the forecasts in a base case scenario and assessed identified downside risks and mitigating actions. These cash flow forecasts also take into consideration severe but plausible downside scenarios including: Commercial challenges leading to a substantial manufacturing and development revenue downside affecting both the LentiVector® platform and AAV businesses.Considerable reduction in revenues from new clients.Removal of any future licence revenues.The potential impacts of a downturn in the biotechnology sector on the Group and its clients including expected revenues from existing clients under long term arrangements. Under both the base case and mitigated downside scenario, the Group and the Company have sufficient cash resources to continue in operation for a period of at least 12 months from the date of approval of these financial statements. In the event of all the downside scenarios above crystallising, the Group and the Company would continue to comply with its existing loan covenants until the maturity of the Oaktree loan without taking any mitigating actions, but the Board has mitigating actions in place that are largely within its control that would enable the Group to reduce its spend within a reasonably short time-frame to increase the Group and the Company’s cash covenant headroom as required by the Oaktree loan facility. Specifically, the Group will continue to monitor its performance against the base case scenario and if base case cash-flows do not crystallise, start taking mitigating action by the end of Q4 2025 which may include rationalisation of facilities and rightsizing the workforce. In addition, the Board has confidence in the Group and the Company’s ability to continue as a going concern for the following reasons: As noted above, the Group has cash balances of £60.7 million at the end of December 2024. £141 million of 2025 forecasted revenues are covered by contracted client orders which give confidence in the level of revenues forecast over the next 12 months.The Group intends to delay the construction element of its Oxbox manufacturing facility expansion to now take place during 2028 and 2029.The Group’s ability to continue to be successful in winning new clients and building its brand as demonstrated by successfully entering into new client agreements including with multiple new clients over the last six months.The Group has the ability to control capital expenditure costs and lower other operational spend, as necessary. Taking account of the matters described above, the Directors are confident that the Group and the Company will have sufficient funds to continue to meet their liabilities as they fall due for at least 12 months from the date of approval of the financial statements and therefore have prepared the financial statements on a going concern basis. 2. Critical accounting judgements and estimatesIn applying the Group's accounting policies, management is required to make judgements and assumptions concerning the future in a number of areas. Actual results may be different from those estimated using these judgements and assumptions. The key sources of estimation uncertainty and the critical accounting judgements that have a significant risk of causing a material adjustment to the carrying amounts of assets and liabilities within the next financial year are discussed below. Key accounting matters Judgements Acquisition date of OXB FranceThe acquisition date of ABL Europe SAS (OXB France) has been deemed to be 29 January 2024 and is the date that control passed to OXB. This is due to multiple substantive conditions which existed in the Sale and Purchase Agreement, which were not all fully completed until this date. Contract revenues: Identification of performance obligations, allocation of revenue and timing of revenue recognitionThe Group has identified three key areas of judgement within the collaboration agreements entered into during the period. Firstly, in relation to the number of distinct performance obligations contained within each collaboration agreement; secondly the fair value allocation of revenue to each performance obligation based on its relative stand alone selling price; and thirdly the timing of revenue recognition based on the achievement of the relevant performance obligation. The sales royalties contained within the collaboration agreements qualify for the royalty exemption available under IFRS 15 and will only be recognised as the underlying sales are made even though the performance obligation, in terms of the technology licence, has already been met. The judgements with regards to the number of distinct performance obligations and the fair value allocation of revenue to each performance obligation, based on relative stand alone selling price, takes place on a contract-by-contract basis across numerous contracts entered into by the Group. Procurement and storage services: revenue recognitionThe Group has identified requirements within certain agreements that necessitate the procurement and storage of key materials. In these cases, the Group has determined that there are 2 distinct performance obligations; the procurement of the materials and their storage. These are contractual obligations which are reportable to the Clients.On completion of the procurement activities, control is passed over to the client as the materials are quality checked then segregated within Group premises and solely for the use of the specified client under the contractual terms. The determination of the passing of control is a key judgement, which dictates the timing of the revenue recognition, as at this point, revenue is recognised. Once control passes to the client, the storage services commence and revenue is recognised over time in accordance with IFRS 15. The Group has made a judgement that it considers itself to be the principal in such cases since: The Group is solely responsible for order, acceptance and testing inventories of the quantum required to meet the customer confirmed orders.The Group bears risk before the control of the materials are passed over to clients which includes the completion of quality testing and compliance with regulatory requirements. These tasks are not deemed to be solely trivial or administrative in nature and therefore the principal judgement is appropriate.Further, the Group negotiates the purchase price with suppliers of the materials and bears pricing risk as the selling price is agreed and can only be renegotiated annually subject to breaching certain thresholds. EstimationsThe key assumptions concerning the future and other key sources of estimation uncertainty at the reporting date, that have a significant risk of causing a material adjustment to the carrying amounts of assets and liabilities within the next financial year, are discussed below. The nature of estimation means that actual outcomes could differ from those estimates. Revenue recognition: Percentage of completion of manufacturing batch revenuesManufacturing of clinical/commercial product for clients is recognised on a percentage of completion basis over time as the processes are carried out. Progress is determined based on the achievement of verifiable stages of the manufacturing process. Revenues are recognised on a percentage of completion basis and as such require estimation in terms of the assessment of the correct stage of completion including the expected costs of completion for that specific manufacturing batch. The value of the revenue recognised with regards to the manufacturing batches which remain in progress at period end is £40.4 million. If the assessed percentage of completion was 10 percentage points higher or lower, revenue recognised in the period would have been £4.2 million higher or £5.0 million lower. Revenue recognition: Percentage of completion of fixed price process development revenuesAs it satisfies its performance obligations, the Group recognises revenue and the related contract asset with regards to fixed price process development work packages. Revenues are recognised on a percentage of completion basis and as such require estimation in terms of the assessment of the correct percentage of completion for that specific process development work package. The value of the revenue recognised with regards to the work packages which remain in progress at year end is £18.9 million. If the assessed percentage of completion was 10 percentage points higher or lower, revenue recognised in the period would have been £2.7 million higher or £2.9 million lower. Revenue recognition: Provision for out of specification manufacturing batchesManufacturing of clinical/commercial product for clients is recognised on a percentage of completion basis over time as the processes are carried out. Progress is determined based on the achievement of verifiable stages of the process. As the Group has now been manufacturing product across a number of years and also in a commercial capacity, the Group has assessed the need to include an estimate of bioprocessed product for which revenue has previously been recognised and which may be reversed should the product go out of specification during the remaining period over which the product is bioprocessed. In calculating this estimate the Group has looked at historical rates of out of specification batches across the last three years and has applied the percentage of out of specification batches to total batches produced across the assessed period to the revenue recognised on batches which have not yet completed the manufacturing process at period end. The Group makes specific provisions for product batches where it is considered that the average overall historical failure rate does not adequately cover the perceived risk of revenue recognised on those specific batches having to be subsequently reversed. This estimate, based on the historical average percentage as well as certain specific provisions, may be significantly higher or lower depending on the number of manufacturing batches actually going out of specification in future. The estimate will increase or decrease based on the number of manufacturing batches undertaken, the percentage of completion of those manufacturing batches and the number of batches which go out of specification over the assessment period. If three additional batches failed during the year, this would lead to a material variance on the estimate. Consequently, manufacturing revenue of £1.3 million (31 December 2023: £1.1 million) has not been recognised during the year ended 31 December 2024 with the corresponding credit to contract liabilities. This revenue will be recognised as the batches complete manufacturing. Fair value assumptions on acquisition of OXB FranceThe estimations for the fair value of the Plant, Property and Equipment has been made using a Depreciated Replacement Cost. This cost has then been adjusted for economic obsolescence to determine the fair value adjustments to the opening acquisition balance sheet,. Impairment assessment of OXB US Cash Generating Unit (CGU)OXB US has been identified as a CGU (cash generating unit) of the business. Since the last impairment assessment performed, an impairment trigger was identified in the CGU as it did not fully deliver its annual budget and accordingly, a full impairment assessment has been performed as at 31 December 2024. The recoverable amount of the CGU is deemed to be the higher of its fair value less cost of disposal, or value in use. The Group has determined that the recoverable amount of the CGU is the fair value less costs of disposal (FVLCOD) of the OXB US CGU as it expects this value to be higher than the value in use. The valuation is considered to be level 3 in the fair value hierarchy due to unobservable inputs used in the valuation. Management's approach and the key assumptions used to determine the CGU’s FVLCOD were as follows: The Group assessed the FVLCOD of the OXB US CGU through a discounted cash flow calculation to approximate the fair value a buyer would be willing to pay for the CGU. The discounted cash flow calculation calculates the present value of the CGU taking into consideration the forecasted cash flows based on the Board approved long term forecast, as well as the calculation of the terminal value at the end of the cash flow period. Management has prepared the FVLCOD calculation based on an approved forecast of 10 years. Management have assessed this to be 10 years followed by the calculation of the terminal value. Sensitivity calculation: Key estimation uncertainty inputs which directly impact the FVLCOD of the CGU are assessed to be: Revenue growth rates including the ability of the CGU to acquire new clients and increase revenues from existing clients. Average growth rates of 24% over the period as assessed to be the expected growth rates for a start-up CDMO entity over the initial growth period after which growth rates are brought down to more inflationary levels. Revenues include revenues with respect to the LentiVector® platform for which the know how transfer was completed in 2024.Discount rate – the discount rate may be impacted by economic and market factors, as well as changes to the risk free rate of return which impacts debt borrowing rates. Should the discount rate calculated by management be adjusted, this may impact the FVLCOD of the CGU. The discount rate used of 12.3% has been calculated based on the current risk free rate, the NASDAQ biotechnology Index’s expected rate of return and the Group’s cost of debt.Operational expenditure and capital expenditure – the cash flows of OXB US are based on the management approved forecasts.These forecasts may change in future or the actual results vary.Long term inflation rates in the United States which are used to approximate the long term growth rate into perpetuity for the terminal value.Expected volatility of cash flows – should the expected volatility of OXB US cash flows vary, this may impact the FVLCOD of the CGU. Sensitivities to the FVLCOD model outcome 31-Dec-24Higher/ LongerLower/Shorter £'ms£'msForecast revenues 10% higher or lower43.2(43.5)Operational expenditure 10% higher or lower(19.8)19.8Capital expenditure 10% higher or lower(1.5)1.5Long term inflation rates 2% higher or lower20.6(13.1)Discount rate 3% higher or lower(17.5)33.3Long Term Growth Rate 2% higher or lower19.4(12.6) Based on the valuation of the CGU through a discounted cash flow calculation, the Group has assessed that no further impairment of OXB US is required in 2024 (2023: £99.3 million ($126.4 million)). Amortisation of intangibles assets (developed technology)The estimated useful life of developed technology acquired by the Group is 15 years as the Group expects the technology to generate cash flows for a total of 15 years. The estimate of 15 years is based on management’s experience of the time period over which the technology acquired as part of the acquisition of OXB US will become fully obsolete. Over time as the platform technology is improved, parts of the technology will become obsolete as they are superseded by new technology until after 15 years the original technology is expected to have been fully replaced by newer/improved technology. The effective date of the impairment of OXB US was 31 December 2023, therefore the amortisation charge in 2023 is pre impairment. If the estimated useful life of the assets had been 10 years, the estimated amortisation for the year ended 31 December 2024 would be £0.7 million higher (2023: £3.6 million); whilst, if the estimated useful life of the assets had been 20 years, the estimated amortisation for the year ended 31 December 2024 would be £0.8 million lower (2023: £1.8 million lower). 3. TaxationThe Group claims research and development tax credits under the UK Government's Research and Development Expenditure Credit (RDEC) Scheme for large companies. 20242023Current tax£'000£'000Corporation tax(1,809)(1,487)Total(1,809)(1,487)Adjustments in respect of prior periods: France corporation tax research and development credit219-United Kingdom corporation tax research and development credit246(58)Current tax(1,344)(1,545) Deferred tax Deferred tax relating to the origination of timing differences-5,910Deferred tax-5,910Taxation (charge)/ credit(1,344)4,365 UK income taxThe amount of £1.8 million (2023: £1.5 million) included as part of the taxation (charge)/credit within the Statement of Comprehensive income for the year ended 31 December 2024 comprises the corporation tax payable on the amount claimed as a Large Company Tax Credit (RDEC) within research and development expenses in the Statement of Comprehensive Income. The United Kingdom corporation tax research and development (RDEC) credit which is included in research and development expenses, is paid in arrears once tax returns have been filed and agreed. The tax credit recognised in the financial statements but not yet received is included in trade and other receivables in the Statement of Financial Position. The adjustment of current tax in respect of the prior year is £246,000. The adjustment in 2023 was £58,000 which related to the corporation tax credit on a lower than anticipated RDEC tax receipt. During 2024, the Group recognised £nil (2023: £nil) of current tax relating to tax relief obtained on exercise of share options directly within equity. At 31 December 2024, the Group had UK tax losses, with no expiry date, to be carried forward of approximately £118.3 million (2023: £127.6 million). 4. Basic and diluted profit/(loss) per ordinary shareThe basic loss per share of (41.75)p (2023: (163.11)p) has been calculated by dividing the loss for the period by the weighted average number of shares in issue during the year ended 31 December 2024 being 103,458,254 (2023: 96,555,347). As the Group incurred a loss in both the current and prior year, there is no difference between the basic loss per ordinary share and the diluted loss per ordinary share for the reporting period, as the impact of potential dilutive instruments is anti-dilutive. 5. Finance CostsFinance costs of £11.1 million (2023: £9.3 million) consists of loan interest (£4.5 million), foreign exchange gains relating to loans (£0.6 million) and lease liability interest recognised in accordance with IFRS 16 (Leases) (£5.3 million) offset by interest received on bank balances of £3.2 million.6. Intangibles GoodwillDeveloped technologyPatentsTotal £’000£’000£’000£’000Cost At 1 January 2024628105,8891,811108,328Additions-28937Effects of movements in exchange rates81,567-1,575At 31 December 2024636107,4841,820109,940 Amortisation and impairment At 1 January 202462874,9141,80577,347Charge for the period-2,34122,343Effects of movements in exchange rates81,023-1,031At 31 December 202463678,2781,80780,721 Net book amount at 31 December 2024-29,2061329,219 Intangible assets comprise Developed technology and Patents for intellectual property rights. The Developed Technology is being amortised over the period to February 2037. The Group has not capitalised any internally generated intangible assets. In 2024, an impairment indicator relating to the manufacturing and process development operation of the OXB US Cash generating unit (CGU) located at the Bedford, MA, US site was identified. The CGU was tested for impairment at 31 December 2024 which concluded no further impairment was required (2023: £62.6 million). Due to a tax deduction not being available on a portion of the developed technology intangible asset, there is a deferred tax liability of £2.1 million at 31 December 2024. £7.3 million was recognised at the acquisition date, reduced to £2.2 million after the December 2023 impairment, with the liability expected to unwind in line with the 15 year useful life of the developed technology intangible asset. 7. Property, plant and equipment Freehold propertyLeasehold improvementsOffice equipment and computersBio processing and laboratory equipmentRight-of-use assetsTotal £’000£’000£’000£’000£’000£’000Cost At 1 January 2024-61,06310,37154,96050,766177,160Additions at cost1,3331941,2244,7072607,718Additions through business combinations1,456-2056441,5453,850Reallocation between asset classes-(354)12342--Disposals-(11)(759)(996)(1,063)(2,829)Change of Estimate----(1,226)(1,226)Effects of movements in exchange rates(53)393(4)91210637At 31 December 20242,73661,28511,04959,74850,492185,310 Depreciation & Impairment At 1 January 2024-33,9018,18234,98224,403101,468Charge for the period3647,2018698,4833,16720,084Reallocation between asset classes-(958)782176--Impairment of assets-(8)--178170Effects of movements in exchange rates(7)34915185227769Disposals-(11)(739)(727)-(1,477)At 31 December 202435740,4749,10943,09927,975121,014 Net book value at 31 December 20242,37920,8111,94016,64922,51764,296 Leasehold improvements are capital improvements to buildings which the Group leases. Manufacturing and laboratory equipment is equipment purchased for the Group's laboratory and manufacturing processes and are generally movable from one facility to another. In 2024, an impairment indicator relating to the manufacturing and process development operation of the OXB US Cash generating unit (CGU) located at the Bedford, MA, US site was identified. The CGU was tested for impairment at 31 December 2024 which concluded no further impairment was required (2023: £36.7 million). 8. Inventories 20242023 £'000£'000Raw materials13,57312,872Total Inventory13,57312,872 Inventory constitutes raw materials held for commercial development and manufacturing purposes, all of which are expected to be recovered within the next 12 months.During the year, the Group wrote down £4.7 million (2023: £2.1 million) of inventory which is not expected to be used in production or sold onwards. 9. Trade and other receivables 20242023Current£'000£'000Trade receivables23,2818,114Contract assets18,0485,228Other receivables7842,081Other tax receivable12,9144,962Prepayments3,9444,356 58,97124,741 Non-current trade and other receivables constitute other receivables of £4.9 million (2023: £4.3 million) which are deposits held in escrow as part of the Oxbox lease arrangements as well as security deposits held on the Group's Bedford, MA site lease. The fair value of trade and other receivables are the current book values. The Group has performed an impairment assessment under IFRS 9 and has concluded that the application of the expected credit loss model has had an immaterial impact on the level of impairment of receivables. Included in the Group's trade receivable balance are debtors with a carrying amount of £5.3 million (2023: £3.5 million) which were past due at the reporting date and of which £4.9 million (2023: £3.5 million) has been received after the reporting date. Contract assetsThe Group performed an impairment assessment under IFRS 9 and has concluded that the application of the expected credit loss model has had an immaterial impact on the level of impairment on contract assets. The Group has noted there has been no change in the time frame for a right to consideration to become unconditional and the performance obligation to be satisfied. 10. Trade and other payables 20242023 £'000£'000Trade payables9,6126,052Other taxation and social security1,5131,478Accruals15,04410,272Total Trade and other payables26,16917,802 11. Contract liabilities and deferred income Contract liabilities and deferred income arise when the Group has received payment for services in excess of the stage of completion which are expected to be released as the related performance obligations are satisfied over the period as described below: Years CurrentNon-CurrentTotalAt 31 December 2024 £'000£'000£'000Manufacturing services income 14,335614,341Process development income 6,158-6,158Procurement and storage services 3,121-3,121Licence fees and incentives 164460Contract Liabilities 23,630-23,680Grant 5621,0201,582Deferred Income 5621,0201,582 Contract liabilities and deferred income of £27.4 million are included in the statement of financial position at the end of 2023, £23.9 million has been recognised as revenue during the 2024 financial year. Included within manufacturing services contract liabilities is revenue of £1.3 million which has not been recognised during 2024 (2023: £1.1 million) relating to the estimate of out of specification batches. In 2024 all of the £1.1 million held in contract liabilities as an out of specification provision at 31 December 2023 was recognised as revenue. Deferred income relates to grant funding received from the UK Government for capital equipment purchased as part of the Oxbox manufacturing facility expansion. The income will be recognised over the period over which the purchased assets are depreciated. 12. Provisions 20242023 £'000£'000At 1 January8,4578,424New provision563772Unwinding of discount661528Change in estimate(1,105)(552)Derecognition-(715)At 31 December8,5768,457 Provisions are exclusively in respect of dilapidations. The dilapidations provisions relate to properties in Oxford and Wallingford, UK. They relate to anticipated costs of restoring the leasehold properties at the Corporate Office, Oxbox, Wallingford Warehouse, Windrush Court, Yarnton and Harrow House to their original condition at the end of the lease terms in 2025, 2033, 2037, 2037, 2024 and 2033 respectively. The future anticipated costs of restoring the properties is calculated by inflating the current expected restoration costs using the three year historic UK Consumer Price Inflation rate, up to the end of the lease term. The discount rate utilised for the purpose of determining the present value of the provision is 9.20% (2023: 7.69%) based on the risk free rate adjusted for inflation. The present value of the future anticipated costs of restoration is calculated by discounting the future expected value using the nominal rate of 9.20% (2023: 7.69%). The unwinding of this discount over time is included within finance costs. 13. Loans On 10 March 2022, the Group drew down an $85 million loan facility with Oaktree Capital Management, L.P. (Oaktree) to finance the acquisition of OXB US under a 1 year facility agreement maturing in 2023. Over the course of the loan term interest was payable quarterly with a nominal interest rate on the loan of 8.5%. On 7 October 2022, the loan facility was refinanced with Oaktree. Under the terms of such refinancing, the Company has partially repaid the outstanding amounts and amended the facility into a new senior secured four year term loan facility provided by Oaktree in a principal amount of $50 million. The term loan carries a variable interest rate, which is capped at 10.25% per annum and payable quarterly in cash, with up to 50% of the interest for the first twelve months payable in kind as additional loan principal, at the option of the Company. The interest rate is subject to downward adjustment following the satisfaction of certain commercial conditions. The Company has also secured the option, subject to the same commercial conditions as the amended facility and available for a three-year period, to draw down a further $25 million from Oaktree loan facility to fund certain permitted acquisitions. If the option were to be exercised, it would be assessed against meeting the substantial modification requirements under IFRS 9. The terms include financial covenants including holding a minimum of $20 million cash at all times, restrictions on the level of indebtedness the Group may enter into or distributions made by the Group. The Oaktree loan facility was secured by a pledge over substantially all of the Group's assets. 20242023 £'000£'000At 1 January38,53439,780Acquisitions through business combinations756-Interest accrued4,5154,570Interest paid(4,086)(4,136)Foreign exchange movement502(2,003)Amortised fees316323Loan repayment(466)-At 31 December40,07138,534 14. Put/ call option liability 20242023 £'000£'000At 1 January9,34838,182Revaluation(6,960)(28,834)At 31 December2,3889,348 On 10 March 2022, the Group recognised a put/ call option liability to acquire the remaining 20% of OXB US that it doesn't already own from Q32. The fair value of the put/ call option at the date of acquisition was assessed to be £39.0 million. In June 2024, the Group increased its ownership in OXB US by a further 10% to 90%. At 31 December 2024, the fair value of the put/ call option liability was £2.4 million (Dec 2023: £9.3m). The lower liability valuation was due to a decrease in the value at which the option is expected to be exercised as a result of lower forecasted revenues over the option period and due to the ownership change.15. Leases PropertyLaboratory EquipmentIT EquipmentMotor VehiclesTotal £'000£'000£'000£'000£'000Balance at 1 January 202426,363---26,363Acquisitions1,431-54601,545Reclassifications(55)55---Additions217--43260Disposals(1,057)-(4)(2)(1,063)Impairment of assets(178)---(178)Change in estimate(1,226)---(1,226)Depreciation charge for the period(3,093)(27)(14)(33)(3,167)Effects of movements in exchange rates(10)(3)(2)(2)(17)Balance at 31 December 202422,39225346622,517 16. Share capital and Share premium At 31 December 2024 and 31 December 2023 Oxford Biomedica had an issued share capital of 105,961,199 and 96,804,353 ordinary 50 pence shares respectively. 806,365 shares were created as a result of the exercise of options by employees during the period. 17. Cash flows from operating activities 20242023 £'000£'000Continuing operations Loss before tax(47,265)(188,527)Adjustment for: Depreciation20,08421,504Amortisation of intangible assets2,3437,206Impairment charge17999,285Loss on disposal of property, plant and equipment289197Loss/ (Gain) on sale and leaseback-(1,018)Net finance costs7,8904,353Charge in relation to employee share schemes1,6903,516Non-cash loss/(gains)(1,493)- Changes in working capital:1 (Increase)/Decrease in contract assets and trade and other receivables(33,338)28,793Increase/(Decrease) in trade and other payables2,893(18,125)(Decrease)/Increase in contract liabilities(6,048)7,034(Decrease)/Increase in provisions(83)2Decrease/(Increase) in inventory2,193(247)Net cash used in operations(50,666)(36,027) The movements in working capital attributable to subsidiary acquisition, are considered non-cash. Therefore, these movements have been excluded from the calculation of changes in working capital. 18. Non-controlling interest (“NCI”) The accounting policy selected and applied by the Group to calculate Non-controlling interest (NCI) was the holders' proportionate interest in the recognised amount of the identifiable net assets of the acquiree. The proportion of the identifiable net assets of the Non-controlling interest in OXB US on acquisition was determined to be £34.6 million. Goodwill of £0.6 million and acquisition of NCI without a change in control of £0.4 million was recognised. In June 2024, the Group acquired a further 10% of the equity of OXB US, bringing the residual NCI percentage to 10%. The following table summarises the information relating to the Group's subsidiary that has material NCI: 20242023 £'000£'000NCI percentage10%20% Non-current assets60,11350,282Current assets10,45111,813Non-current liabilities(20,594)(22,479)Current liabilities(15,560)(20,477)Net assets34,41019,139 Net assets attributable to NCI3,4413,828 Revenue3,29026,813 Loss(34,624)(133,361)Other comprehensive expense(384)(7,190)Total comprehensive expense(35,008)(140,551) Loss allocated to NCI(5,419)(26,672)Other comprehensive expense allocated to NCI(49)(1,438) Cash flows from operating activities(24,516)(15,105)Cash flows from investment activities(19,397)3,077Cash flow from financing activities (dividends to NCI: nil)45,469(3,717)Net increase in cash and cash equivalents1,556(15,745) 19. Contingent liabilities and capital commitments The Group has a letter of credit for £1.4 million (2023: £1.4 million) related to the deposit on the Patriots Park lease which is disclosed within Trade and other receivables in non-current assets. The Group had commitments of £1.1 million for capital expenditure for leasehold improvements and plant and equipment not provided for in the financial statements at 31 December 2024 (2023: £3.5 million). 20. Related party transactions TransactionsBalance outstanding 2024202320242023 £'000£'000£'000£'000Sales of goods and services Q32 (formerly Homology Medicines, Inc)14523,664-2,429 Purchase of services Q32 (formerly Homology Medicines, Inc)– rental income-387-17 Other Other: Q32 (formerly Homology Medicines, Inc)– rental income1,7431,074-258 21 Acquisition of subsidiaryOn 29 January 2024, the Group acquired 100% of the shares and voting interests in ABL Europe SAS (OXB France). As a result, the Group’s equity interest granted it control of OXB France. Included in the identifiable assets and liabilities acquired at the date of acquisition are inputs, production processes and an organised workforce. The Group has determined that together the acquired inputs and processes contribute to the ability to create revenue. The Group has concluded that the acquired inputs and processes constitute a business. a) Consideration transferred: On acquisition date the fair value of the shares in Oxford Biomedica plc was 180.6p, this represents the fair value of the consideration under IFRS 3. 3.149 million shares were issued giving a consideration of £5.7 million Consideration transferred:31 December 2024 £'000Fair value of shares in OXB issued to Institut Mérieux5,700Total consideration transferred5,700 b) Acquisition related expenses: The Group incurred acquisition related legal and due diligence expenses of £1.5 million which is included in Administrative expenses.c) Identifiable assets acquired and liabilities assumed: Identifiable assets acquired and liabilities assumed:Acquired net assetsFair value adjFair value of net assets £'000£'000£'000Property plant and equipment8,018(4,168)3,850Intangible assets832(832)-Long term receivables191-191Inventory2,894-2,894Cash and cash equivalents9,004-9,004Prepayments and accrued income2,145-2,145Trade and other receivables1,384-1,384Lease liabilities(1,548)-(1,548)Payroll and other taxes(2,568)-(2,568)Other liabilities(7,931)-(7,931)Total identifiable net assets acquired:12,421(5,000)7,421 d) Goodwill: The acquisition of OXB France increases access to EU-based clients and broadens the Group's international development, manufacturing and testing presence, whilst increasing its capacity in process and analytical development and early stage manufacturing. Conversely, the vendors have been able to dispose of a business that was not profitable for them. As a result of the mutual benefits of the transaction, the fair value of the net assets acquired is in excess of the fair value of the shares transferred as consideration which has created a negative goodwill.Negative goodwill arising from the acquisition has been recognised through the profit and loss in other operating income as follows GoodwillAcquired net assets £'000Consideration transferred5,700Fair value of identifiable assets7,421Negative goodwill(1,721) e) Impact of acquisition: During the year ended 31 December 2024, the acquisition has contributed £11.5 million revenue and pre-tax loss of £11.7 million. Had the acquisition taken place on 1 Jan 2024, then the revenue contributed in the period would have been £0.7 million more and a further £0.9 million loss.f) Acquired receivables: The fair value of trade and other receivables is £1.4 million and includes trade receivables with a fair value of £1.4 million. The gross contractual amount for trade receivables due is equal to the fair value. 22 Re-presentationIn 2024, the Group has pivoted to a pure-play CDMO and as a result, the classification of the expenditure types has been reviewed and represented in a more meaningful way. The costs previously disclosed as Bioprocessing and the element of Research and Development which related to Development services are now included as operating costs.Innovation costs relate to the internal development work undertaken on OXB platforms.Commercial costs relate to the teams engaged in business development activities.Administration expenses are those departments who support the operational teams across the Group. The table below shows the impact on 2023 of the changes made in the year. 2023 Re-presentedRe-presentation Impact2023 as previously reported £'000£'000£'000Revenue 89,539-89,539Cost of sales (49,812)-(49,812)Gross Profit 39,727-39,727Operating costs (86,163)86,163-Bioprocessing costs -(43,746)(43,746)Research and Development costs -(59,353)(59,353)Innovation costs (11,471)11,471-Commercial costs (3,911)3,911-Administration expenses (26,893)1,480(25,413)Impairment of assets (99,284)-(99,284)Other operating income 2,803-2,803Gain/loss on sale and leaseback 1,018-1,018Change in fair value of available for sale assets -7474Operating loss (184,174)-(184,174)Finance income 4,910-4,910Finance costs (9,263)-(9,263)Loss before tax (188,527)-(188,527)Taxation 4,365-4,365Loss for the period (184,162)-(184,162)Other comprehensive income Foreign currency translation differences (5,307)-(5,307)Other comprehensive income (5,307)-(5,307)Total comprehensive expense (189,469)-(189,469)

高管变更并购财报基因疗法

2025-03-24

·蒲公英Ouryao

乐城第一现场：从乐城定价看我国CGT双轨制发展

特约撰稿人 | 张长风博士来源 | 蒲公英Ouryao 2025年3月22日，第二届博鳌乐城干细胞大会在海南省琼海市召开，乐城管理局副局长廖敬乐在大会上公布了首批3款细胞治疗产品的收费定价，瞬间吸引了全行业的目光。笔者有幸入选大会学术委员会，并亲身参与了此次大会。在此，仅以个人角度记录所见所想，供同行参考。 01 对乐城干细胞产品“明码标价”的总体感受是什么？非常好！此次乐城管理局展示的并不光是3款细胞产品的价目表，而是一套完整的监管思路及配套的软硬件设施建设。这其中许多设计都令笔者耳目一新，大受震撼。另一方面，也正因如此，乐城的情况短时间内恐怕很难被我国其他地区所复制，因此也不会显著改变其他地区的细胞治疗行业生态。因为其他地区很难在短时间内建设配套的软硬件设施，而没有配套建设，光颁布一纸政策是不够的。具体原因在下文的问题5中会有进一步阐述。 02 我们公司的细胞产品也想在乐城备案收费，该怎么做呢？假设一家国内细胞治疗企业有一款细胞产品想去乐城备案，那么首先要满足2个先决条件：第一，细胞产品要已经进入注册临床2期、或者完成国家卫健委IIT备案（还有一条是境外已上市，不过我们假设的前提是国内企业，所以就没算这一条）。从难易程度上说，卫健委IIT备案比注册临床2期更容易。但卫健委备案开始的时间不长，所以目前符合临床2期这一条件的细胞治疗产品可能反而会更多。第二，在乐城当地找一家医院进行合作。乐城管理局要求合作的医院或科室达到三甲水平（这个“科室达到三甲水平”比较复杂，在此不展开说明）。不过要注意，这个要求是针对乐城当地的医院、而不是细胞治疗企业。所以对企业来说，重点在于如何在乐城找一家符合要求的医院，并且说服医院接受自己的产品。这里大概率会产生费用，因为企业要使用医院的科室和人员，医院不可能白给你用。满足上述2个条件后，由医院向乐城管理局提交转化应用申请。之后会进入审查环节，包括5天的形式审查，40天的技术评估，最终会在60天内给出结论。申请通过以后，就可以向海南省医保和卫健委申请价格备案，公示完成后就可以收费了。 03 细胞治疗产品的类型很多，乐城在这方面有要求吗？乐城管理局公布了两批《转化应用实施目录》，在第二批目录中列出了干细胞、外泌体、TIL、非基因编辑的免疫细胞等17个方向，有意向来乐城的企业参考这个目录即可。可以看到，在这17个方向中没有涵盖行业内比较热门的CAR-T、TCR-T等细胞产品。这是由于乐城的思路是“风险可控、循序渐进”，因此不会一开始就把所有种类的产品都纳进来。之后这个目录还会逐步更新。另外，还有一个很现实的非政策原因，在下文中的问题6中会展开说明。 04 其他很多城市也推出了细胞治疗的优惠政策，乐城的特色在哪里？从政策制定角度来说，乐城的一系列政策做得是挺不错的。目前乐城的先行先试政策由3个层级组成，就是作为政策骨架的《生物医学新技术促进规定》、作为实施细则的《转化应用实施办法》、以及作为具体操作指引的《项目申报指南》。正是有这三位一体的政策支持，才有如今3个干细胞项目“明码标价”的历史性突破。为了实现政策落地，光有一个提纲挈领的政策骨架、没有配套的实施细则是不够的。举个例子，单位领导宣布发放补贴每人500元，之后就得指定负责发放的部门，再说明哪些人符合条件、领取时要带什么材料等等，这个补贴才能最终发到员工手里。我国有些地区的细胞治疗优惠政策就碰到了这个问题。优惠政策在大方向上写了许多大力扶持的条款，看得大家心潮澎湃。但仔细一研究，没有明确负责落地的部门，或者负责部门并不具备执行能力，最终造成个“光打雷不下雨”的尴尬局面。就这一点，乐城就比国内很多地区做得要好。 05 你说耳目一新、大受震撼，就是因为乐城的政策写得好？让笔者震撼的并不是乐城的先行先试政策本身，也不是细胞产品的首次定价，而是其背后展示的乐城管理局监管思路以及软硬件设施建设。我国的细胞治疗监管，名义上叫做双轨制或者类双轨制，但实际上是有缺陷的。两个轨道中，按药品监管的轨道路径很清晰。国家药监局从2016年开始花了很大力气做法规建设，到如今这条路径从临床前一直走到上市后都没问题。但是，按医疗技术监管的路径一直是不完善的。虽然也有对应的政策以及IIT备案制度，但是有一个关键问题一直悬而未决：怎么样才能收费？所谓的双轨制，其本质是双轨收费制。只有双轨没有收费，那么这个制度就是不完整的。而按医疗技术监管的路径，一直都没有打通收费这个“最后一公里”。国家监管机构不是没看到这个状况。但问题是，该怎么办。“收费”两个字背后，有太多问题悬而未决。放开收费之后如何监管，制剂质量如何保证，患者权益如何保证，会不会再现2016年前的乱象，临床应用收费会不会冲击药品监管轨道，这两条轨道又该如何调和？如果这些问题都不能妥善处理的话，那么宁可不打通这最后一公里。而这次，乐城管理局提供了打通这“最后一公里”的新思路：技术先进性方面，组建包括130位专家的评审专家库，每个项目审评时都配备至少7个专家评审，覆盖基础科研、临床、生产制备、伦理等各个方面，以避免“同名不同效”的落后技术混入其中。信息透明性方面，建立监管服务信息化平台，对接海南的“三医联动一张网”系统，将细胞治疗临床应用所产生的生产、质控、临床用药、不良反应处理等信息都上传数据平台，从而实现全程实时监管以及回溯性监管。患者权益方面，落实患者知情，发展相关保险产品，建立不良事件救助基金，避免重蹈“魏则西事件”的覆辙。制剂质量方面，建立了由乐城管理局运营的公共检测平台，将检测放行环节纳入政府监管之下，杜绝细胞产品质量参差不齐的情况。持续监管方面，项目备案通过不代表万事大吉，备案后仍会实行定期检查、随机抽查、有因检查，每3~6个月进行一次评估，并定期清退疗效不确定、安全性不佳的项目。和药品轨道的融合方面，直接联通国家药监局和医保局，以真实世界研究的方式，让在乐城产生的临床数据可以并入药监轨道，为上市申请及医保纳入提供支持。这一套组合拳，招招打在要害上，一看就是个对药品监管很懂行的人做的。医疗技术轨道不放开，归根到底还是担心管不住，落入“一放就乱”的怪圈。按乐城目前的规划，看起来是可以管住的。再叠加上乐城“医疗先行先试区”的招牌以及在药械和特医食品方面的成功经验，那还有什么理由不能放开的呢？不过，乐城这套打法需要相当程度的软硬件基础设施配套，这可不是一朝一夕就可以建立起来的。别的不说，一个乐城就配备了包含多名院士在内的130位医药领域专家，琼海市市长是分子生物学背景的技术型官员，乐城管理局局长是从海南省药监局和医保局的领导岗位上调任的。就冲这个配置，国内其他地区就算想复制，怕也找不到那么多省药监局局长。 06 乐城这么好，就没有什么缺点吗？当然有。在干细胞大会之余，笔者也走访了乐城当地医院、康养机构以及琼海市内，得到的信息有正面的也有负面的。其中最突出的难题是，乐城（或者说琼海市）当地没有患者资源。换句话说，无论是谁、开展什么技术，在乐城接受细胞治疗的每一个受试者都必须从别的地方“进口”。这种情况恐怕是国内多数细胞治疗公司不擅长应对的，还会导致成本上升，通过备案收费所获得的营收就会下降，甚至出现“赔本赚吆喝”的情况。这也是CAR-T类技术未必适合乐城的原因。以CD19 CAR-T治疗白血病为例，要保证患者愿意、并且身体状况能支撑飞来乐城可不太容易。而乐城现有的行业生态是以康养为主、治疗为辅的，所以也不是特别兼容CAR-T这种针对急危重症的细胞疗法。因此，即使细胞产品在乐城可以收费，也不等于所有企业都可以盈利。真实情况还需要等待时间来检验。 07 其他感想此次干细胞大会的火爆程度出乎很多人的意料。大会设在乐城的永不落幕国际创新药械展，展厅可容纳1000人，是乐城当地最大的展厅之一。但慕名前来的参会者远远超过了容纳数量，也超过了上一届大会的参会人数，更超过了本届大会组织者的预期。当地甚至紧急安排专人以防出现混乱或者踩踏事件。会议当天预定9点开始，但8点就在门口排起了长龙，8点30分就开始限流，导致许多参会者只能在门口看大屏幕直播，进入会场的人很多也只能席地而坐。如此火爆的情况下，大家还是不辞辛劳地飞抵海南参加大会，是因为什么呢？难道是会议中有哪位天王巨星级别的讲者，才有如此强大的引流力量？当然不是。所有人都知道，乐城的政策动向才是重点。大家不光是来看科学家的，更是来听干细胞定价的。据说乐城管理局本身是准备做个政策宣讲会，但是担心没有关注度，所以才想借干细胞大会来提升行业影响力。没想到结果反而是干细胞大会“蹭”了乐城新政的热度，说来也是挺有意思的。我国的细胞治疗行业（尤其是干细胞行业）已经发展十余年了，一直受限于“最后一公里”没有打通的问题。乐城这边稍微开了一条小口子，整个行业就爆发出了如此大的热情，可见行业真的是憋苦了、憋坏了。 2025年我国迎来了首个干细胞产品上市的好消息，这也成为了干细胞商业化时代的起点。目前，我国医药行业已经充分认识到了细胞治疗产品的巨大潜力，越来越多的人才与资金也在不断注入到这个领域中来。对业内公司而言，对行业进展的了解可以帮助企业捋清行业发展方向，调整自身战略布局，并为自家产品制定清晰的开发计划。作者简介张长风博士上药生物治疗注册总监，深圳市“领航人才”，珠海市“珠海英才”，苏州市“姑苏人才”，南昌市“洪城人才”，宾大医学院中国校友学者联合会副秘书长。师从“CART之父”Carl June院士，深度参与Kymriah（全球首款CART）等产品在FDA的申报工作，回国后作为总负责人斩获国内首个基因敲除CART产品的IND批件，并数次与CDE、中检院等药政监管部门联合举办细胞治疗中美政策研讨会。张博士迄今已在Nature Medicine, Blood, JCI-insight等国际权威期刊发表多篇论文，并组织开展多项临床研究，治疗白血病、骨髓瘤等各类癌症患者400余人。声明：本文仅代表作者个人观点，不代表任何组织及本公众号立场，如有不当之处，敬请指正。如需转载，请注明作者及来源：蒲公英Ouryao。

细胞疗法临床2期临床1期免疫疗法ASH会议

100 项与 Tisagenlecleucel 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	Tisagenlecleucel	L01	DB13881

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
复发性 B 细胞急性淋巴细胞白血病	韩国	Novartis AG	2021-03-05
难治性 B 细胞急性淋巴细胞白血病	韩国	Novartis AG	2021-03-05
前体B细胞成淋巴细胞白血病淋巴瘤	瑞士	Novartis AG	2018-10-18
滤泡性淋巴瘤	加拿大	Novartis Pharmaceuticals Canada, Inc.	2018-09-05
急性淋巴细胞白血病	欧盟	Novartis Europharm Ltd.	2018-08-23
急性淋巴细胞白血病	冰岛	Novartis Europharm Ltd.	2018-08-23
急性淋巴细胞白血病	列支敦士登	Novartis Europharm Ltd.	2018-08-23
急性淋巴细胞白血病	挪威	Novartis Europharm Ltd.	2018-08-23
复发性弥漫性大B细胞淋巴瘤	欧盟	Novartis Europharm Ltd.	2018-08-23
复发性弥漫性大B细胞淋巴瘤	冰岛	Novartis Europharm Ltd.	2018-08-23
复发性弥漫性大B细胞淋巴瘤	列支敦士登	Novartis Europharm Ltd.	2018-08-23
复发性弥漫性大B细胞淋巴瘤	挪威	Novartis Europharm Ltd.	2018-08-23
难治性弥漫性大 B 细胞淋巴瘤	欧盟	Novartis Europharm Ltd.	2018-08-23
难治性弥漫性大 B 细胞淋巴瘤	冰岛	Novartis Europharm Ltd.	2018-08-23
难治性弥漫性大 B 细胞淋巴瘤	列支敦士登	Novartis Europharm Ltd.	2018-08-23
难治性弥漫性大 B 细胞淋巴瘤	挪威	Novartis Europharm Ltd.	2018-08-23
复发性滤泡性淋巴瘤	欧盟	Novartis Europharm Ltd.	2018-08-23
复发性滤泡性淋巴瘤	冰岛	Novartis Europharm Ltd.	2018-08-23
复发性滤泡性淋巴瘤	列支敦士登	Novartis Europharm Ltd.	2018-08-23
复发性滤泡性淋巴瘤	挪威	Novartis Europharm Ltd.	2018-08-23

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
侵袭性 B 细胞非霍奇金淋巴瘤	临床3期	美国	诺华（中国）生物医学研究有限公司	2019-05-07
侵袭性 B 细胞非霍奇金淋巴瘤	临床3期	美国	Novartis Pharma AG	2019-05-07
侵袭性 B 细胞非霍奇金淋巴瘤	临床3期	美国	Novartis Pharmaceuticals Corp.	2019-05-07
侵袭性 B 细胞非霍奇金淋巴瘤	临床3期	中国	Novartis Pharmaceuticals Corp.	2019-05-07
侵袭性 B 细胞非霍奇金淋巴瘤	临床3期	日本	Novartis Pharma AG	2019-05-07
侵袭性 B 细胞非霍奇金淋巴瘤	临床3期	日本	Novartis Pharmaceuticals Corp.	2019-05-07
侵袭性 B 细胞非霍奇金淋巴瘤	临床3期	日本	诺华（中国）生物医学研究有限公司	2019-05-07
侵袭性 B 细胞非霍奇金淋巴瘤	临床3期	澳大利亚	诺华（中国）生物医学研究有限公司	2019-05-07
侵袭性 B 细胞非霍奇金淋巴瘤	临床3期	澳大利亚	Novartis Pharma AG	2019-05-07
侵袭性 B 细胞非霍奇金淋巴瘤	临床3期	澳大利亚	Novartis Pharmaceuticals Corp.	2019-05-07

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ASH2024	N/A	滤泡性淋巴瘤	-	Tisagenlecleucel	廠鬱淵蓋觸鬱醖遞淵鹹(鹽築鑰壓繭廠鬱網鹹遞) = 62.5% of pts experienced CRS, no cases of grade ≥3 CRS were reported, median time to CRS onset was 2.0 days (range: 1.0-5.0), 70% of pts who experienced CRS received treatment, all but one received tocilizumab to manage CRS (96.4%), median time to ICANS onset was 5.0 days (range: 1.0-7.0) 鹹艱範糧廠繭獵繭製夢 (願鹽廠齋衊淵鏇餘夢鏇 ) 更多	-	2024-12-09
ASH2024 人工标引	N/A	弥漫性大B细胞淋巴瘤	484	Tisagenlecleucel	構蓋鑰鹹簾鏇選糧壓艱(壓鬱膚範鹽憲膚製齋選) = 壓選簾願齋艱艱顧簾願艱鬱醖範窪廠鏇壓鹹窪 (壓廠積簾鬱積衊築衊鏇 ) 更多	积极	2024-12-08
ASH2024	N/A	滤泡性淋巴瘤	-	Tisagenlecleucel	觸鏇觸積選構選積觸夢(鑰願襯範網願糧艱遞構) = 19 pts have died during the study: 8 due to progressive disease, 10 due to AEs (1 pt each; acute myeloid leukemia, bladder transitional cell carcinoma, cardiac arrest, CRS, encephalitis, gastrointestinal hemorrhage, infection, metastatic squamous cell carcinoma, pneumonia, sepsis), and 1 from euthanasia 齋衊顧膚遞齋廠夢積獵 (蓋鬱餘艱廠膚醖築鬱網 ) 更多	-	2024-12-08
ASH2024 人工标引	N/A	大B细胞淋巴瘤	-	Chimeric Antigen Receptor T-Cell Therapy (aged ≥80)	鹹製獵觸鬱廠蓋鏇憲築(鬱顧襯齋窪鹽壓憲糧膚) = 築餘鹽膚繭積鹹構鹽製獵齋夢夢艱糧簾選積築 (襯觸衊範鏇構衊衊願獵 ) 更多	积极	2024-12-07
ASH2024 人工标引	N/A	大B细胞淋巴瘤	-	Chimeric Antigen Receptor T-Cell Therapy (aged 65-79)	鹹製獵觸鬱廠蓋鏇憲築(鬱顧襯齋窪鹽壓憲糧膚) = 築醖襯選夢糧範築鹹鏇獵齋夢夢艱糧簾選積築 (襯觸衊範鏇構衊衊願獵 ) 更多	积极	2024-12-07
ESMO2024 人工标引	N/A	滤泡性淋巴瘤	113	Tisagenlecleucel (CTL019)	繭膚積築鏇襯範鑰鏇壓(製夢鏇憲鏇壓願構製襯) = 膚壓築鬱艱窪鏇齋範顧鹽範鑰齋積鬱艱製醖遞 (構廠艱網觸壓範觸艱艱 ) 更多	积极	2024-09-13
SOHO2024	N/A	复发性儿童急性淋巴细胞白血病	-	Tisagenlecleucel	蓋齋選壓襯網築餘餘齋(簾願壓醖齋選構願窪獵) = 獵襯簾遞廠網齋鬱鬱糧餘鬱範構製齋壓蓋壓選 (艱觸餘糧積膚鹽遞襯襯, 61 ~ 71) 更多	-	2024-09-04
ELIANA trial (ASCO2024)	N/A	复发性 B 细胞急性淋巴细胞白血病 \| 难治性 B 细胞急性淋巴细胞白血病 CD19	974	Tisagenlecleucel	窪築製壓築廠膚遞膚鹹(糧衊膚範願鑰製夢窪構) = 築廠製鏇顧壓衊壓醖醖糧鹹夢鏇範糧製壓膚鹽 (淵遞觸製衊壓遞糧鏇憲, 61 ~ 71) 更多	积极	2024-05-24
NCT03568461 (ELARA, EHA 12024 \| EHA 22024) 人工标引	临床2期	滤泡性淋巴瘤三线	97	Tisagenlecleucel infusion	顧襯艱構鏇選齋壓網製(淵齋夢鏇製顧淵繭餘壓) = 廠顧襯網壓鬱鏇淵觸淵廠繭膚鑰鹹壓鹽簾積淵 (鬱鬱襯壓網憲鏇窪鹹鹹, 77.5 ~ 92.4) 更多	积极	2024-05-14
CART-SIE (EHA2024) 人工标引	N/A	弥漫性大B细胞淋巴瘤 CD19	485	Axicabtagene Ciloleucel	積壓壓膚製襯構繭餘製(構選艱範淵窪遞衊齋獵) = 鏇夢糧積糧鏇繭淵積糧構鹹壓醖鹹製餘範獵獵 (範網糧顧鹹鹹壓積製繭 ) 更多	积极	2024-05-14
CART-SIE (EHA2024) 人工标引	N/A	弥漫性大B细胞淋巴瘤 CD19	485	Tisagenlecleucel	積壓壓膚製襯構繭餘製(構選艱範淵窪遞衊齋獵) = 餘鏇網夢遞觸廠憲淵廠構鹹壓醖鹹製餘範獵獵 (範網糧顧鹹鹹壓積製繭 ) 更多	积极	2024-05-14
NCT02445248 (ABCL-647 \| JULIET, CTgov)	临床2期	复发性弥漫性大B细胞淋巴瘤	115	tisagenlecleucel (Tisagenlecleucel - Main Cohort)	構願襯壓夢簾鏇積製選 = 衊構艱齋廠淵範鏇繭衊膚鏇壓願淵蓋窪觸網選 (鬱衊艱網廠網鹹顧鏇蓋, 製鹽鬱醖膚製齋窪遞襯 ~ 獵製鏇鹹遞夢淵衊廠顧) 更多	-	2024-04-18
NCT02445248 (ABCL-647 \| JULIET, CTgov)	临床2期	复发性弥漫性大B细胞淋巴瘤	115	tisagenlecleucel (Tisagenlecleucel - Cohort A)	鏇鏇膚艱壓廠鹹襯夢齋 = 獵餘積襯窪糧壓觸鏇顧願範鑰願齋衊窪簾鬱選 (壓齋鬱壓觸衊糧網壓鬱, 範選醖艱鏇鹹憲糧鹹觸 ~ 鬱遞遞醖觸糧襯網齋夢) 更多	-	2024-04-18