Axial Spondyloarthritis

BIMZELX® (bimekizumab) is the first and only treatment approved by Health Canada for eligible patients with active psoriatic arthritis (PsA) or axial spondyloarthritis (axSpA) that directly and selectively inhibits two key inflammatory proteins, IL-17A and IL-17F.1 Health Canada's approval is supported by Phase III clinical trial data which found BIMZELX provided significant improvement across key disease severity indicators.2,3,4 The approval of BIMZELX for adults with active PsA or axSpA demonstrates UCB's ongoing commitment to advancing science in immuno-dermatology and rheumatological conditions, addressing unmet patient needs and improving clinical outcomes. OAKVILLE, ON, March 14, 2024 /CNW/ - Today, UCB Canada Inc. is pleased to announce that BIMZELX® (bimekizumab injection) has received authorization from Health Canada for two new indications. On February 23, 2024, BIMZELX was approved for the treatment of adults with active psoriatic arthritis (PsA) and on March 11, 2024, the therapy also received approval for the treatment of adults with axial spondyloarthritis (axSpA). BIMZELX is a monoclonal antibody belonging to a group of medicines called interleukin (IL) inhibitors. Monoclonal antibodies are proteins that recognize and bind specifically to certain proteins in the body. This medicine works by reducing the activity of two proteins called IL-17A and IL-17F, which are present at increased levels in diseases such as PsA and axSpA.1 BIMZELX is also the first and only biologic that directly inhibits both IL-17A and IL-17F to be approved in Canada. "We are delighted with the approval of BIMZELX in Canada for both psoriatic arthritis and axial spondyloarthritis, and its first marketing authorization for these new indications in North America," said Lionel Houle, Head of Immunology, UCB Canada. "This follows our first product approval in moderate to severe plaque psoriasis. Our sights are set on innovative scientific solutions that can raise the standard of care in the lives of patients. We are proud to bring this new treatment option to people living with these illnesses in Canada, and believe that BIMZELX has the potential to help many patients living with the painful and debilitating symptoms of both conditions." Both Health Canada approvals are based on Phase III data which supports BIMZELX's role as an innovative treatment option for patients with PsA and axSpA, including non-radiographic axSpA (nr-axSpA) and ankylosing spondylitis (AS, also known as radiographic axSpA (r-axSpA)).2,3,4 "Psoriatic arthritis is an inflammatory arthritis which affect people with psoriasis. It leads to pain and swelling in the joints, and often results in joint damage, deformities and reduced quality of life and function," explained Dr. Dafna Gladman, Professor of Medicine, University of Toronto and Senior Scientist, Schroeder Arthritis Institute, Krembil Research Institute. "While there are already approved medications for psoriatic arthritis, they do not work for all patients. Bimekizumab is a novel biologic medication which works very well for both psoriasis and psoriatic arthritis. It is exciting for both patients and health care providers that this medication is now added to the current treatment of psoriatic arthritis." "Axial spondyloarthritis is a chronic, painful, inflammatory disease involving the axial skeleton, which significantly impacts patients' mobility, function, and quality of life," said Dr. Proton Rahman, Distinguished Professor, Memorial University and Chief of Rheumatology, Newfoundland and Labrador Health Services. "Primary results from the two Phase 3 studies, BE MOBILE 1 and 2, have convincingly demonstrated that bimekizumab, a novel monoclonal antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A, results in rapid improvement in axial spondyloarthritis symptoms. Bimekizumab marks a significant breakthrough in the management of axial spondyloarthritis and provides hope and relief for many living with this debilitating disease." BIMZLEX was previously approved for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.1 About Psoriatic Arthritis Psoriatic arthritis (PsA) is both an autoimmune disease and a form of inflammatory arthritis. The immune systems of people with PsA attack the joints, in addition to the skin. It is estimated that 0.2 per cent of adults in Canada have PsA, but the exact numbers are unknown. PsA can develop at any age and up to a third (approximately 30 per cent) of people with psoriasis will develop PsA in their lifetime.5 About Axial Spondyloarthritis Axial spondyloarthritis (axSpA) is a chronic, progressive, painful form of inflammatory arthritis that causes significant and long-lasting pain in the lower back, buttocks and hips.6 axSpA can occur at any age, but typically begins between ages 20 and 40.7 Estimates suggest as many as one per cent of the Canadian adult population lives with a form of axSpA known as ankylosing spondylitis (AS).8 BIMZELX Clinical Program Health Canada's approval of BIMZELX for the treatment of adults living with active PsA was based on two multicentre, randomized, double-blind, placebo-controlled studies: BE OPTIMAL: evaluated 852 patients not previously exposed to any biologic disease-modifying anti-rheumatic drug (bDMARD-naïve) for the treatment of psoriasis or PsA2 BE COMPLETE: evaluated 400 patients with an inadequate response or intolerance to treatment with one or two tumour necrosis factor alpha inhibitors (TNFi-IR) for either psoriasis or PsA3 According to the results of both trials, bimekizumab treatment demonstrated positive outcomes at Week 16 vs placebo. The safety pro bimekizumab was consistent with previous Phase III studies in patients with plaque psoriasis, and with IL-17A inhibitors. In BE OPTIMAL, the most frequent treatment-emergent adverse events (TEAEs) (3 per cent or more) for patients on bimekizumab up to Week 16 were nasopharyngitis, upper respiratory tract infection, headache, diarrhoea, oral candidiasis, pharyngitis and hypertension.2 In BE COMPLETE, the most frequent TEAEs (2 per cent or more) for patients on bimekizumab up to Week 16 were nasopharyngitis, oral candidiasis and upper respiratory tract infection.3 Health Canada's approval of BIMZELX for the treatment of axSpA was based on two multicentre, randomised, double-blind, placebo-controlled studies: BE MOBILE 1: evaluated 254 patients with non-radiographic axSpA (nr-axSpA) BE MOBILE 2: evaluated 332 patients with ankylosing spondylitis (AS, also known as radiographic axSpA (r-axSpA))4 In both trials, dual inhibition of IL-17A and IL-17F with bimekizumab resulted in improvements in efficacy outcomes vs placebo and was well tolerated in patients with nr-axSpA and r-axSpA. The most frequently reported TEAEs (3 per cent or more in any bimekizumab group in either trial) up to Week 16 were nasopharyngitis, upper respiratory tract infection, pharyngitis, diarrhoea, headache and oral candidiasis.4 More information about BIMZELX can be found by accessing the product monograph. About UCB Canada Inc. Inspired by patients and driven by science, UCB Canada Inc. is a biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe autoimmune and central nervous system diseases. For more information, please consult . About UCB UCB, Brussels, Belgium ( ) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 8,400 people in nearly 40 countries, the company generated revenue of €5.3 billion in 2020. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news. References SOURCE UCB Canada Inc.

Dose ordered and robust HiSCRs were rapidly demonstrated with about a third of patients achieving HiSCR100, or resolution of abscesses and nodules, by week 16 and through week 32 Deep and consistent HiSCR responses were observed for placebo patients switching to active treatment Marked reductions in draining tunnels and skin pain also contributed to clinically meaningful improvements in quality of life Potential for differentiation was demonstrated with both high clinical responses as well as a favorable safety profile consistent with the IL-17A class and previous izokibep experience LOS ANGELES, March 11, 2024 (GLOBE NEWSWIRE) -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today announced long-term data from a Phase 2b clinical trial of izokibep in hidradenitis suppurativa (HS). These data demonstrated no evidence of increased safety liability with longer-term treatment and increased duration of therapy was associated with further clinical improvements over time. Patients who switched from placebo to izokibep at week 16 achieved a similar speed and magnitude of response as those who began treatment with izokibep at baseline for HiSCRs, draining tunnels, skin pain and Dermatology Life Quality Index (DLQI). High orders of HiSCR were achieved with the majority of patients achieving HiSCR75 and about a third achieving HiSCR100 by week 16 and through 32 weeks. These results are from an open label extension with all subjects through week 32. Additional information can be found at ACELYRIN.com. Further data from this trial will be presented at future scientific meetings. “The magnitude and depth of responses for signs and symptoms of Hidradenitis Suppurativa in this long-term study are consistent with izokibep’s mechanism of action. These results are corroborated by the appreciable clinical responses observed in the placebo cross-over cohort, which demonstrate rapid, HiSCR response,” said Kim Papp, MD, PhD, President and Director of Research, Probity Medical Research, Inc. “We believe that these consistent and robust results in HS point to the future potential for izokibep to deliver differentiated clinical benefits for patients.” “It’s heartening to see the exciting results from this longer term follow up across all of the important manifestations of this debilitating disease, despite the initial primary endpoint of this study not meeting statistical significance,” said Shao-Lee Lin, MD, PhD, Founder and CEO of ACELYRIN. “Across indications, we have observed clinically meaningful and potentially differentiated benefit from izokibep. We have consistently seen responses in high order efficacy measures such as HiSCR100 in HS and ACR70 and PASI100 in PsA, that move patients toward disease resolution. This reinforces our enthusiasm for developing izokibep as an important potential new medicine for patients.” Izokibep was well-tolerated with a favorable safety profile consistent with previous experience and the IL-17A class. Potential for differentiation was demonstrated with higher clinical responses achieved earlier than reported by other IL-17A agents and the IL-17A&F agents without evidence to date for increased risk of infection, especially fungal or suicidal ideation and behavior, in a patient population predisposed to infection and clinical depression. “The pain and discomfort that people living with HS experience on a daily basis is extremely debilitating,” said Falk Bechara, MD, Clinical Professor in the Department of Dermatology at the Ruhr-University Bochum. “These data are impressive, showing izokibep dose ordered, fast speed of onset across endpoints. The consistency and magnitude of responses in resolution of abscesses and nodules, reduction in draining tunnels, and improvement in pain, impact overall quality of life and suggest that izokibep could be a significant therapeutic for HS, with a positive benefit risk in addressing an unmet need.” Topline data from an ongoing phase 3 trial in HS is expected by the end of 2024. A confirmatory phase 3 trial of approximately 400 patients is planned to address guidance on size of safety database given the FDA no longer considers moderate-to-severe HS an orphan disease. About the Phase 2b Hidradenitis Suppurativa clinical trialThe Phase 2b clinical trial (NCT05355805) is a global, multi center, randomized double-blind, placebo-controlled, trial evaluating the safety and efficacy of izokibep dosed 160 mg every week (QW) or every two weeks (Q2W) versus placebo. At week 16, patients who received placebo were randomized to either the weekly or every two week active treatment arm and all patients were assessed through week 32. The objective of the study was to determine the effect of izokibep versus placebo on various measures of clinical impact and determine the appropriate dose(s) for further clinical development in hidradenitis suppurativa. For more information about the Phase 2b HS clinical trial, please visit www.clinicaltrials.gov. About Hidradenitis SuppurativaHidradenitis Suppurativa (HS) is a chronic Inflammatory skin disease causing scarring, abscesses, malodor and pain. HS typically occurs in areas with high concentrations of sweat glands and is typically accompanied by pain, malodor, drainage, and disfigurement that contribute to disability and a devastating impact on quality of life. Patients with HS miss a greater number of days of work and have increased disability compared to the average population. In 2019, there were an estimated 317,000 HS patients in the U.S., of which 50-60% were moderate-to-severe HS patients. About IzokibepIzokibep is a small protein therapeutic designed to inhibit IL-17A with high potency through tight binding affinity, the potential for robust tissue penetration due to its small molecular size, about one-tenth the size of a monoclonal antibody, and an albumin binding domain that extends half-life. Clinical trial data supports the hypothesis that these unique characteristics of izokibep may provide clinically meaningful and differentiated benefits for patients, including resolution of key manifestations of disease. Izokibep is being evaluated in multiple late-stage trials in moderate-to-severe hidradenitis suppurativa (HS), psoriatic arthritis (PsA), and uveitis, with plans to initiate an additional Phase 3 program in axial spondyloarthritis (AxSpA). About ACELYRIN, INC.ACELYRIN, INC. (Nasdaq: SLRN) is a Los Angeles area-based late-stage clinical biopharma company – with additional operations in the San Francisco Bay area – focused on providing patients life-changing new treatment options by identifying, acquiring, and accelerating the development and commercialization of transformative medicines. For more information about ACELYRIN, visit us at www.acelyrin.com or follow us on LinkedIn and X. Forward Looking StatementsThis press release contains forward-looking statements including, but not limited to, statements related to the overall advancement of ACELYRIN’s programs and ability to accelerate the development and delivery of transformative medicines; anticipated development activities including the planned initiation of a clinical program in AxSpA; the therapeutic potential of ACELYRIN’s product candidates including its ability to offer clinically meaningful, differentiated benefits for patients that may include resolution of key manifestations of disease and limit safety liability; and other statements that are not historical fact. These forward-looking statements are based on ACELYRIN’s current plans, objectives and projections, and are inherently subject to risks and uncertainties that may cause ACELYRIN’s actual results to materially differ from those anticipated in such forward-looking statements. Such risks and uncertainties include, without limitation, those associated with the successful completion of development and regulatory activities with respect to ACELYRIN’s product candidates and other risks and uncertainties affecting ACELYRIN including those described from time to time under the caption “Risk Factors” and elsewhere in ACELYRIN’s current and future reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2023. Forward-looking statements contained in this press release are made as of this date, and ACELYRIN undertakes no duty to update such information except as required under applicable law. ACELYRIN, INC. Contact:investors@acelyrin.commedia@acelyrin.com

Late-breaking platform presentation showed that BIMZELX® (bimekizumab-bkzx) rapidly achieved and maintained high rates of clinical and health-related quality-of-life responses through four years; six out of ten patients achieved complete skin clearance at Year 4 Responder-analyses demonstrated that approximately nine out of ten patients treated with BIMZELX who achieved PASI90 at Week 16, and over seven out of ten patients who achieved complete skin clearance (PASI100) maintained their response to Year 4 Four-year safety data showed that treatment-emergent adverse events were consistent or decreased with longer BIMZELX exposure, with no new safety signals ATLANTA, March 9, 2024 /PRNewswire/ -- UCB, a global biopharmaceutical company, today announced that the first presentations of BIMZELX® (bimekizumab-bkzx) four-year efficacy and safety data in the treatment of adults with moderate-to-severe plaque psoriasis are being shared this week at the 2024 American Academy of Dermatology (AAD) Annual Meeting in San Diego, California, March 8–12. "We are proud to debut the BIMZELX® four-year psoriasis data at the world's largest dermatology meeting, showing that the majority of adult patients treated with BIMZELX achieved deep and durable clinical response through four years, with a consistent tolerability profile. These results, from the largest pool of Phase 3 data, closely follow the U.S. launch, and reinforce our belief that BIMZELX has the potential to transform the lives of people with moderate-to-severe plaque psoriasis," said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB. "Moderate-to-severe plaque psoriasis is a chronic condition with physical skin manifestations that can place a significant burden on a patient's health-related quality-of-life. Analysis shows that through four years of bimekizumab treatment, over six out of ten patients achieved and maintained complete skin clearance, a clinically meaningful endpoint and outcome for patients. These long-term data will be highly welcomed by the dermatology community since they provide important considerations for clinical practice," said Dr. Bruce Strober, Clinical Professor of Dermatology at Yale University, and Central Connecticut Dermatology, Connecticut, U.S. The late-breaking platform presentation shared BIMZELX pooled data from treatment initiation through four years, showing that high rates of clinical and health-related quality-of-life responses were rapidly achieved and were maintained in the long-term.¹ Responder-analyses showed that approximately nine out of ten patients treated with BIMZELX who achieved ≥90 percent improvement from baseline in the Psoriasis Area Severity Index (PASI90) and over seven out of ten patients who achieved complete skin clearance (PASI100) at Week 16 maintained their responses to Year 4.² Pooled analysis from five Phase 3/3b studies showed that BIMZELX demonstrated good tolerability and a consistent safety profile with no new safety findings identified up to four years in patients with moderate-to-severe plaque psoriasis.³ Highlights from the four-year BIMZELX data in moderate-to-severe plaque psoriasis presented at the 2024 AAD: Treatment initiation through four years: Data were pooled across the 52-week BE VIVID study, the 56-week BE READY and BE SURE studies and their open-label extension (OLE Week 144) BE BRIGHT.¹ Analyzed patients were randomized to BIMZELX 320 mg every four weeks (Q4W) to Week 16, then BIMZELX Q4W or Q8W until OLE entry.¹ Clinical and health-related quality of life (PASI90 and PASI100, body surface area [BSA] ≤1 percent and Dermatology Life Quality Index [DLQI]0/1) responses were assessed through to Year 4 (OLE Week 144).¹ Data are presented below for all patients who received BIMZELX continuously from baseline and entered the OLE (n=771):¹ 90.9 percent achieved PASI90 at Week 16, and 86.1 percent through to Year 4.1¥ 65.8 percent achieved PASI100 at Week 16, and 64.7 percent through to Year 4.1¥ 78.5 percent achieved BSA≤1 percent at Week 16, and 79.8 percent through to Year 4.1¥ 71.5 percent achieved DLQI0/1 at Week 16, and 78.7 percent through to Year 4.1 ¥ Responder analysis to Year 4: Patients who completed the BE VIVID, BE SURE, and BE READY Phase 3 studies could enter the BE BRIGHT OLE.² Analyzed patients were randomized to BIMZELX 320 mg Q4W to Week 16, then BIMZELX Q4W or Q8W until OLE entry, then BIMZELX Q4W or Q8W dependent on PASI response/prior dose.² Maintenance of PASI90 and PASI100 was assessed in Week 16 responders to Year 4 (OLE Week 144) and is presented below for all patients:² 87.7 percent who achieved PASI90 at Week 16 (n=693) maintained their response to Year 4.2¥ 73.3 percent who achieved PASI100 at Week 16 (n=503) maintained their response to Year 4.2¥ Safety and tolerability through four years: Data were pooled across the 52-week BE VIVID study, the 56-week BE READY and BE SURE studies, and the OLE studies BE BRIGHT and BE RADIANT.3 The total BIMZELX exposure was 6,324.3 patient-years (PY) across the studies (n=2,186).3 Exposure-adjusted incidence rates (EAIRs) of treatment-emergent adverse events (TEAEs) remained consistent or decreased with longer BIMZELX exposure. Overall, TEAEs occurred at an EAIR of 170.5/100 PY and serious TEAEs at 5.5/100 PY.3 The most common TEAEs were nasopharyngitis (12.7/100 PY), oral candidiasis (8.9/100 PY), and upper respiratory tract infections (5.7/100 PY). Oral candidiasis decreased from 18.9/100 PY at Year 1 to 5.4/100 PY at Year 4.3 Throughout, fewer TEAEs occurred with BIMZELX every 8 weeks (Q8W) (115.4/100 PY) vs. every 4 weeks (Q4W) (224.4/100 PY).3 ¥ Modified non-responder imputation analyses Notes to Editors: About BIMZELX (bimekizumab-bkzx) Bimekizumab is a humanized IgG1 monoclonal antibody that selectively binds to IL-17A, IL-17F and IL-17AF cytokines, blocking their interaction with the IL-17RA/IL-17RC receptor complex.4 Elevated levels of IL-17A and IL-17F are found in lesional psoriatic skin.4 BIMZELX is not approved in the U.S. for the treatment of psoriatic arthritis or axial spondyloarthritis and these are investigational indications only. Please see Important Safety Information below and full U.S. prescribing information at . BIMZELX U.S. IMPORTANT SAFETY INFORMATION4 Suicidal Ideation and Behavior BIMZELX® (bimekizumab-bkzx) may increase the risk of suicidal ideation and behavior (SI/B). A causal association between treatment with BIMZELX and increased risk of SI/B has not been established. Prescribers should weigh the potential risks and benefits before using BIMZELX in patients with a history of severe depression or SI/B. Advise monitoring for the emergence or worsening of depression, suicidal ideation, or other mood changes. If such changes occur, advise to promptly seek medical attention, refer to a mental health professional as appropriate, and re-evaluate the risks and benefits of continuing treatment. Infections BIMZELX may increase the risk of infections. Do not initiate treatment with BIMZELX in patients with any clinically important active infection until the infection resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing BIMZELX. Instruct patients to seek medical advice if signs or symptoms suggestive of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, monitor the patient closely and do not administer BIMZELX until the infection resolves. Tuberculosis Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with BIMZELX. Avoid the use of BIMZELX in patients with active TB infection. Initiate treatment of latent TB prior to administering BIMZELX. Consider anti-TB therapy prior to initiation of BIMZELX in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Closely monitor patients for signs and symptoms of active TB during and after treatment. Liver Biochemical Abnormalities Elevated serum transaminases were reported in clinical trials with BIMZELX. Test liver enzymes, alkaline phosphatase and bilirubin at baseline, periodically during treatment with BIMZELX and according to routine patient management. If treatment-related increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt BIMZELX until a diagnosis of liver injury is excluded. Permanently discontinue use of BIMZELX in patients with causally associated combined elevations of transaminases and bilirubin. Avoid use of BIMZELX in patients with acute liver disease or cirrhosis. Inflammatory Bowel Disease Cases of inflammatory bowel disease (IBD) have been reported in patients treated with IL-17 inhibitors, including BIMZELX. Avoid use of BIMZELX in patients with active IBD. During BIMZELX treatment, monitor patients for signs and symptoms of IBD and discontinue treatment if new onset or worsening of signs and symptoms occurs. Immunizations Prior to initiating therapy with BIMZELX, complete all age-appropriate vaccinations according to current immunization guidelines. Avoid the use of live vaccines in patients treated with BIMZELX. Most Common Adverse Reactions Most common adverse reactions (≥1 percent) are upper respiratory infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, Herpes Simplex Infections, acne, folliculitis, other Candida infections, and fatigue. For further information, contact UCB: Investor Relations Antje Witte T +32.2.559.94.14 email [email protected] U.S. Communications Erica Puntel T +1.770.970.8465 email [email protected] About UCB UCB, Brussels, Belgium () is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 9,000 people in approximately 40 countries, the company generated revenue of €5.3 billion in 2023. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCBUSA. Forward looking statements This press release may contain forward-looking statements including, without limitation, statements containing the words "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will", "continue" and similar expressions. These forward-looking statements are based on current plans, estimates and beliefs of management. All statements, other than statements of historical facts, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, arbitration, political, regulatory or clinical results or practices and other such estimates and results. By their nature, such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and assumptions which might cause the actual results, financial condition, performance or achievements of UCB, or industry results, to differ materially from those that may be expressed or implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms or within expected timing, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, product liability claims, challenges to patent protection for products or product candidates, competition from other products including biosimilars, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws, and hiring and retention of its employees. There is no guarantee that new product candidates will be discovered or identified in the pipeline, will progress to product approval or that new indications for existing products will be developed and approved. Movement from concept to commercial product is uncertain; preclinical results do not guarantee safety and efficacy of product candidates in humans. So far, the complexity of the human body cannot be reproduced in computer models, cell culture systems or animal models. The length of the timing to complete clinical trials and to get regulatory approval for product marketing has varied in the past and UCB expects similar unpredictability going forward. Products or potential products, which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences disputes between the partners or may prove to be not as safe, effective or commercially successful as UCB may have believed at the start of such partnership. UCB's efforts to acquire other products or companies and to integrate the operations of such acquired companies may not be as successful as UCB may have believed at the moment of acquisition. Also, UCB or others could discover safety, side effects or manufacturing problems with its products and/or devices after they are marketed. The discovery of significant problems with a product similar to one of UCB's products that implicate an entire class of products may have a material adverse effect on sales of the entire class of affected products. Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment, including pricing pressure, political and public scrutiny, customer and prescriber patterns or practices, and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement activities and outcomes. Finally, a breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of UCB's data and systems. Given these uncertainties, you should not place undue reliance on any of such forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labelling in any market, or at any particular time, nor can there be any guarantee that such products will be or will continue to be commercially successful in the future. UCB is providing this information, including forward-looking statements, only as of the date of this press release. UCB expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report or reflect any change in its forward-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations. Additionally, information contained in this document shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction. References 1. Strober B. 2024 AAD. Oral Presentation. 2. Blauvelt A, Foley P, Langley RG, et al. Bimekizumab 4-year maintenance of responses in Week 16 responders with moderate to severe plaque psoriasis: Results from the BE BRIGHT open label extension phase 3 trial. Abstract at the 2024 American Academy of Dermatology Annual Meeting, San Diego, CA, U.S., March 8–12, 2024. 3. Gordon KB, Thaçi D, Gooderham M, et al. Bimekizumab safety and tolerability in moderate to severe plaque psoriasis: Pooled analysis from up to 4 years of treatment in 5 phase 3/3b clinical trials. Abstract at the 2024 American Academy of Dermatology Annual Meeting, San Diego, CA, U.S., March 8–12, 2024. 4. BIMZELX [prescribing information]. Smyrna, GA: UCB, Inc. SOURCE UCB