Lilly Announces New Phase 3 Data on Investigational Alopecia Areata Treatment Olumiant®

Lilly to Present New Data on Olumiant at the 31st European Academy of Dermatology and Venereology (EADV) Congress in Vienna, Austria

Lilly Announces Positive Top-Line Phase 3 Data from Two Studies Evaluating Olumiant in Moderate-to-Severe Alopecia Areata

Eli Lilly and Company (NYSE: LLY) today announced positive top-line results from two Phase 3 studies evaluating the efficacy and safety of Olumiant® (baricitinib) in adults with moderate-to-severe alopecia areata (AA). The studies, known as BRAVE-AA1 and BRAVE-AA2, met their primary endpoints, demonstrating that Olumiant significantly improved scalp hair regrowth and overall disease severity compared to placebo at 36 weeks. The data will be presented in a late-breaking oral presentation at the 31st European Academy of Dermatology and Venereology (EADV) Congress in Vienna, Austria, on Saturday, September 17, 2023, by Christiana Drake, MD, PhD, Consultant Dermatologist at St John's Institute of Dermatology, London, UK. "These positive results from the BRAVE-AA1 and BRAVE-AA2 studies provide further evidence of the potential of Olumiant to help people with moderate-to-severe alopecia areata," said Lotus Mallbris, MD, Vice President of Immunology Development at Lilly. "We are excited to share these data with the dermatology community at EADV and look forward to continuing to work with regulatory authorities to bring Olumiant to patients as quickly as possible." In the BRAVE-AA1 study, 66.5% of patients treated with Olumiant achieved an Investigator's Global Assessment (IGA) score of 0 or 1 (complete or almost complete scalp hair regrowth) at week 36, compared to 35.4% of patients treated with placebo (p<0.001). In the BRAVE-AA2 study, 55.9% of patients treated with Olumiant achieved an IGA score of 0 or 1 at week 36, compared to 22.6% of patients treated with placebo (p<0.001). The safety profile of Olumiant in the BRAVE-AA1 and BRAVE-AA2 studies was consistent with the known safety profile of Olumiant in other indications. The most common adverse events reported in the studies were acne (13.4%), nausea (8.3%), and headache (7.3%). Olumiant is an oral, once-daily JAK inhibitor that is currently approved in the United States for the treatment of adults with moderately-to-severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more TNF inhibitors. Olumiant is also approved in the European Union for the treatment of adults with severe AA who have failed to respond to at least one topical treatment. Lilly is committed to developing innovative treatments for people with immune-mediated diseases, including AA. The company is also investigating Olumiant in other immune-mediated diseases, such as systemic lupus erythematosus (SLE) and lupus nephritis (LN).

**About Alopecia Areata** Alopecia areata (AA) is an autoimmune disease that causes hair loss. It can affect people of all ages, races, and genders. AA is thought to be caused by the immune system attacking the hair follicles, which leads to hair loss. There is no cure for AA, but there are treatments that can help to slow or stop hair loss and promote hair regrowth. **About Olumiant** Olumiant (baricitinib) is an oral, once-daily JAK inhibitor. JAK inhibitors are a class of drugs that block the activity of Janus kinases (JAKs), which are enzymes that are involved in the immune system. Olumiant is approved in the United States for the treatment of adults with moderately-to-severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more TNF inhibitors. Olumiant is also approved in the European Union for the treatment of adults with severe AA who have failed to respond to at least one topical treatment. **About Lilly** Lilly is a global healthcare company that unites caring with discovery to create medicines that make life better for people around the world. We've been pioneering for nearly 150 years, so as we look ahead, we're putting our focus on what we can do next to help address some of the world's most urgent public health challenges. **Forward-Looking Statements** This press release contains forward-looking statements about Olumiant (baricitinib) as a potential treatment for alopecia areata (AA). It reflects Lilly's current beliefs, but actual results may differ from those described in the forward-looking statements as a result of various important factors, including, without limitation, the following: the results of clinical trials, actions of regulatory agencies, and changes in the healthcare environment. For further discussion of these and other risks and uncertainties, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.