“A Phase II study evaluating tmAbA plus pembrolizumab in frontline will start soon.”

In context

“Roopal Thakkar (Executive Vice President, Research & Development; Chief Scientific Officer): Thank you, Jeffrey. I will begin with dermatology programs in immunology. RINVOQ was approved in Europe for the treatment of severe alopecia and non-segmental vitiligo. Applications are also under review in the U.S. with approval decisions anticipated later this year for vitiligo and early next year for alopecia areata. In hidradenitis suppurativa, we remain on track for 16-week data later this year from both RINVOQ and lutikizumab Phase III trials. In our early-stage dermatology pipeline, three programs were recently advanced into the clinic, including an IL-13/IL-31 receptor bispecific antibody for atopic dermatitis, an oral IL-23 receptor inhibitor for psoriasis, and a long-acting IL-1 alpha/beta bispecific antibody for hidradenitis suppurativa. Turning to gastroenterology, the U.S. application for SKYRIZI subcutaneous induction in Crohn's disease is under review with an approval decision expected later this fall. The subcutaneous regimen demonstrated very high levels of endoscopic response and clinical remission, with rates on both measures 25 points higher than placebo in the overall population and 45 points higher in patients who had not previously experienced advanced therapy. To our knowledge, these results in patients naive to advanced therapies are the highest reported for induction therapies in Crohn's disease, comparing very favorably to SKYRIZI IV and other approved agents. Full results from the study will be presented this fall, which will include additional important endpoints such as endoscopic remission. Start-up activities are underway for our Phase 2b combination trial in IBD. This multi-arm study will evaluate SKYRIZI plus a higher dose of our novel anti-alpha4beta7 antibody and an extended half-life TL1A antibody in both Crohn's disease and ulcerative colitis. Interim results for SKYRIZI plus the anti-alpha4beta7 in Crohn's disease demonstrated a doubling of endoscopic remission at week 24 compared to either monotherapy. This study is expected to complete this fall, and final results will be submitted for presentation at a future medical meeting. And lastly, in immunology, we announced the planned acquisition of Apogee Therapeutics, which adds a portfolio of long-acting biologics targeting atopic dermatitis, respiratory conditions, and other immune-mediated diseases. These novel assets are highly complementary to our immunology strategy and further strengthen an already robust pipeline. Moving to neuroscience, QLIPTA was approved in Europe for the acute treatment of migraine, expanding options for patients. In Parkinson's disease, an FDA approval decision is expected in the third quarter for tevapadon. Results from three Phase III trials demonstrated that this novel selective D1/D5 dopamine agonist has the potential to be a highly effective treatment for motor symptoms with low rates of dyskinesia, edema, sedation, and impulse control disorder. We look forward to bringing this innovation to patients later this year. In our early-stage neuroscience pipeline, multiple new trials were recently initiated, including a Phase II study for a novel toxin Trenibot in essential tremor and a Phase 1b study for a BBB-1.76 (a blood-brain-barrier crossing anti-pyroglutamate Aβ antibody) in Alzheimer's disease. In schizophrenia, the multi-ascending dose study for bretasilocin is nearing completion. The 100-milligram dose retained a safe and tolerable profile, and now 150 milligrams is being evaluated. Dose selection for both schizophrenia and psychosis programs is expected in the coming months, and we remain on track to begin Phase II studies in the fourth quarter. Moving to solid tumor programs, progress with tmAbA continues across a broad range of tumor types. In colorectal cancer, breakthrough therapy designation was granted for tmAbA in combination with bevacizumab in refractory metastatic CRC. This designation supports our Phase III strategy in an all-comer third-line plus setting, and the trial is now actively recruiting. In second-line CRC, data are expected later this year from a Phase II study evaluating tmAbA combinations versus chemotherapy. These results will help inform the development strategy for tmAbA in first- and second-line CRC as an irinotecan replacement. Early-stage results in ovarian and head and neck were presented at the recent ASCO meeting, demonstrating tmAbA's potential in both tumor types. In platinum-resistant ovarian cancer, tmAbA showed strong antitumor activity, particularly in c-Met selected patients where response rates reached as high as 80%. tmAbA also demonstrated a 50% response rate in clear cell carcinoma, a segment with high unmet need that typically does not respond well to cytotoxic therapy. Plans to advance tmAbA in ovarian cancer will be discussed with regulators over the coming months. In c-Met selected patients with advanced head and neck cancer, tmAbA demonstrated a 31% response rate and a median overall survival of 15.3 months, which compares favorably to standard of care. A Phase II study evaluating tmAbA plus pembrolizumab in frontline will start soon. And in pancreatic cancer, a Phase II study evaluating tmAbA with FOLFOX as a frontline combination therapy was recently initiated. Turning to hematologic oncology, progress continues with etansamig across lines of therapy in multiple myeloma. An interim analysis is planned in the third quarter for progression-free survival from the monotherapy ThirdLinePlus trial. If this interim analysis is positive, regulatory submission would occur later this year. A Phase III study evaluating etansamig in combination with pomalidomide in second-line plus patients, including those that were exposed or refractory to an anti-CD38 antibody, or who lost response to an anti-BCMA CAR T or ADC, will begin by year-end. Additionally, encouraging early-stage results for etansamig in relapsed/refractory light-chain amyloidosis were presented at the recent EHA Congress. At the 40-milligram dose, 100% of patients achieved hematologic complete response with a promising safety profile that included no CRS or ICANS. Based on these results, a Phase III trial in newly diagnosed patients is being planned. Also in hematology, DecNUPAS received FDA approval for blastic plasmacytoid dendritic cell neoplasm, an ultra-rare and aggressive blood cancer. As a new treatment alternative providing durable responses with a manageable safety profile and outpatient administration, DecNUPAS offers a meaningful benefit to patients with this rare cancer. Moving to aesthetics, our rapid-onset and short-duration toxin Bowie was approved in Europe and Canada for the temporary improvement in the appearance of glabellar lines. This marks an important milestone in aesthetic medicine. Bowie was developed to allow patients to temporarily preview the benefits of cosmetic toxins without worrying about long-lasting results. Clinicians and patients now have another option to tailor treatment to individual needs and goals. In summary, we are making meaningful progress with our pipeline and look forward to additional important data readouts, regulatory submissions, and approvals throughout the remainder of 2026. With that, I will turn the call over to Scott T. Reents.”