Lilly Eli & Co - LLY STOCK NEWS

Eli Lilly and Company released results from their national 'Urgent Conversations' survey, highlighting the challenges faced by people with ulcerative colitis (UC) in finding public restrooms. The survey of 1,800 U.S. adults, including 200 with moderately to severely active UC, found that 84% of UC patients struggle to find public restrooms, compared to 60% of the general population.

Key findings include:

• 63% of UC respondents need to use restrooms frequently when leaving home
• 81% of UC respondents take over 5 minutes to find a clean restroom
• 42% of UC respondents are more likely to have restroom emergencies
• 61% of UC respondents limit social outings due to restroom concerns

The Crohn's & Colitis Foundation has launched the 'We Can't Wait' mobile app to help locate public restrooms. Lilly's Omvoh® (mirikizumab-mrkz), approved in October 2023, showed promising results in treating UC symptoms and improving bowel urgency in clinical trials.

Eli Lilly and Company (NYSE: LLY) announced new data from the VIVID-1 Phase 3 study of mirikizumab for Crohn's disease. The study showed that more patients treated with mirikizumab achieved histologic response at Week 52 compared to ustekinumab, regardless of prior biologic experience. This is the first Phase 3 study to report histologic and combined histologic-endoscopic outcomes in Crohn's disease using a systematic assessment of five bowel segments.

Key findings include:

• 58.2% of mirikizumab patients achieved histologic response at Week 52 vs 48.8% for ustekinumab (p=0.0075)
• In patients with prior biologic failure, 56.5% on mirikizumab achieved histologic response at Week 52 vs 41.3% for ustekinumab (p=0.0064)
• Mirikizumab's safety profile was consistent with its known profile in ulcerative colitis

Lilly has submitted marketing authorization applications for mirikizumab in Crohn's disease globally and is conducting additional studies in pediatric and adult patients.

Eli Lilly and Company (NYSE: LLY) has announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development in Indiana's LEAP Research and Innovation District. This unique facility, set to open in late 2027, will combine research and manufacturing in a single location, allowing Lilly to innovate new production methods and scale up manufacturing of medicines for clinical trials.

The Medicine Foundry will focus on developing innovative solutions to optimize manufacturing processes, increase capacity for clinical trial medicines, and reduce costs and environmental impact. It will be capable of producing various molecular therapies, including small molecules, biologics, and nucleic acid therapies. The facility is expected to add 400 full-time jobs for highly skilled workers and will expand Lilly's total capital commitment in the United States to more than $23 billion since 2020.

Eli Lilly and Company (NYSE: LLY) announced new long-term results for EBGLYSS™ (lebrikizumab-lbkz) in treating moderate-to-severe atopic dermatitis. The data, from the ADjoin long-term extension study, will be presented at the European Academy of Dermatology and Venereology Congress.

Key findings include:

• Over 80% of adults and adolescents who responded to EBGLYSS at Week 16 maintained clear or almost-clear skin for up to three years with monthly maintenance dosing.
• 84% of patients on monthly dosing and 83% on bi-weekly dosing maintained clear or almost-clear skin (IGA 0,1) at three years.
• 87% of monthly dosing patients and 79% of bi-weekly dosing patients achieved or maintained at least 90% improvement in disease extent and severity (EASI-90) at three years.
• The safety profile remained consistent with previous studies, with no new safety signals observed.

EBGLYSS, an IL-13 inhibitor, was recently approved by the FDA and is also approved in the EU and Japan.

The Ministry of Health, Labour and Welfare Japan has approved Kisunla™ (donanemab-azbt) for the treatment of early symptomatic Alzheimer's disease (AD) in adults. This makes Japan the second major market to approve Kisunla, following its approval in the United States in July 2024. The treatment is designed for individuals with mild cognitive impairment and mild dementia stage of AD, with confirmed amyloid pathology.

Kisunla demonstrated significant results in the TRAILBLAZER-ALZ 2 Phase 3 study, showing a 35% slowing of decline in less advanced cases and 22% in the overall population. The drug reduced amyloid plaques by up to 84% after 18 months of treatment. Notably, 66% of patients achieved plaque clearance at one year, allowing them to complete treatment.

While Kisunla offers promising results, it can cause side effects such as amyloid-related imaging abnormalities (ARIA) and allergic reactions. The approval of Kisunla in Japan represents a critical step in providing treatment options for the growing number of AD patients in the country.

Eli Lilly's EBGLYSS™ (lebrikizumab-lbkz) has received FDA approval for treating moderate-to-severe atopic dermatitis in adults and children 12 years and older. This IL-13 inhibitor offers a new first-line biologic treatment for patients not well controlled with topical therapies. Key highlights:

- Significant skin clearance as early as 4 weeks and itch relief as early as 2 weeks
- Long-lasting efficacy through one year with monthly maintenance dosing
- 38% achieved clear/almost-clear skin at 16 weeks vs 12% with placebo
- 43% experienced itch relief at 16 weeks vs 12% with placebo
- Common side effects include eye inflammation and injection site reactions

EBGLYSS will be available in the U.S. in the coming weeks, with patient support programs planned.

Eli Lilly and Company (NYSE: LLY) announced a $1 billion expansion of its manufacturing site in Limerick, Ireland, dedicated to producing biologic active ingredients for Alzheimer's treatments. Additionally, Lilly unveiled a new $800 million facility in Kinsale, Ireland, operational since last year to meet the high demand for diabetes and obesity medications. This expansion is part of a larger $20 billion investment plan initiated since 2020.

The Limerick site will employ 450 highly skilled workers and utilize advanced technologies such as AI and machine learning. Production is expected to start in 2026, pending planning approval. The Kinsale facility integrates continuous manufacturing technology and recently won the 'Facility of the Year' Innovation award.

Lilly emphasizes sustainability, with the Limerick site designed to reduce energy, water, and waste, and the Kinsale site powered by the largest privately owned solar farm in Ireland.

Eli Lilly and Company (NYSE: LLY) announced detailed results from the QWINT-5 phase 3 trial evaluating once-weekly insulin efsitora alfa compared to once-daily insulin degludec in adults with type 1 diabetes. The study met its primary endpoint of non-inferior A1C reduction at week 26, with efsitora reducing A1C by 0.53% compared to 0.59% for insulin degludec. Key secondary endpoints showed similar time in range and rates of nocturnal hypoglycemic events between the two treatments.

However, efsitora showed higher rates of severe hypoglycemic events (0.14 vs 0.04 per patient-year) compared to insulin degludec, with 64% of these events occurring in the first 12 weeks of treatment. The results highlight the potential of efsitora to offer a once-weekly basal insulin option for type 1 diabetes patients, while also emphasizing the need for careful management of hypoglycemia risk.

Eli Lilly and Company (NYSE: LLY) has announced promising results from the QWINT-2 phase 3 trial of once-weekly insulin efsitora alfa compared to once-daily insulin degludec in adults with type 2 diabetes. The study, published in The New England Journal of Medicine and presented at EASD 2024, showed that efsitora met its primary endpoint of non-inferior A1C reduction. Key findings include:

- Efsitora reduced A1C by 1.34% vs. 1.26% for insulin degludec
- Participants achieved 45 minutes more time in range per day with efsitora
- No severe hypoglycemic events were reported with efsitora
- Efsitora demonstrated a safety profile similar to daily insulins

These results suggest efsitora could offer a convenient once-weekly option for type 2 diabetes patients, potentially improving treatment adherence while providing comparable outcomes to daily insulins.