Immunic Inc (NASDAQ:IMUX) has highlighted clinical and operational progress achieved during the second quarter, which ended June 30, 2024, and the subsequent period.
The biotechnology firm has welcomed experienced multiple sclerosis drug commercialization executive Jason Tardio as its chief operating officer and president and appointed senior pharmaceutical executive Simona Skerjanec to its board of directors.
“Jason's proven experience in launching and commercializing multiple sclerosis (MS) drugs for major biotechnology and pharmaceutical companies, including Novartis and Biogen, as well as his extensive partnering experience, will be invaluable, especially as we move closer to the potential commercialization of our late-stage clinical asset, vidofludimus calcium (IMU-838), an orally available nuclear receptor related 1 (Nurr1) activator,” Immunic CEO Dr Daniel Vitt said in a statement.
“We also welcomed Simona Skerjanec to our Board of Directors, who most recently served as the Senior Vice President, Global Head Neuroscience and Rare Diseases at Roche, where she had a successful track record achieving double-digit sales growth, including with Ocrevus (ocrelizumab), one of the most successful medicines for MS.”
Immunic also said its ongoing twin Phase 2 ENSURE trials in relapsing MS and Phase 2 CALLIPER trial in progressive MS remain on track.
Topline data is expected from the CALLIPER trial in April next year. The first ENSURE trial is expected to be completed in the second quarter of 2026 and the second ENSURE trial in the second half of 2026.
Dr Vitt told investors that the company plans to porivde detail on its MS development program at its next MS R&D Day in New York in September.
“The event will feature two renowned industry experts alongside Immunic's management team to discuss the unique profile of vidofludimus calcium and its potential to become a groundbreaking treatment of choice for both relapsing MS and progressive MS patients,” he said.
“We believe that vidofludimus calcium could elevate today's standard of care by providing a holistic solution for the full range of MS patients, given that it is designed to selectively manage all components of smoldering MS with its neuroprotective, anti-inflammatory and antiviral effects."
Further, Dr Vitt said during Q2 the company also continued to prepare for Phase 2 clinical testing of its second clinical program IMU-856, an orally available, systemically acting small molecule modulator targeting Sirtuin 6.
“We are exploring potential financing, licensing or partnering opportunities to fund the next clinical development steps for this program,” Dr Vitt said. “We believe that IMU-856 represents a potentially groundbreaking therapeutic approach for treating gastrointestinal disorders by restoring a healthy gut through the renewal of the bowel wall.”
During the quarter, the company invested $18.3 million in research and development, compared to $21.2 million in the year-ago quarter.
Immunic’s net loss was $21.4 million or $0.21 per share, down from a loss of $24 million or $0.54 per share in Q2 2023.
Shareholders welcomed the company’s update, sending shares 8.6% higher at US$1.27 before Thursday’s opening bell.