INITIATION OF THE OBSERVATIONAL CLINICAL STUDY

The prospective observational clinical study is ready to begin, focusing on patients with traumatic and complete spinal cord injury in the acute phase. These patients will be observed for the following 12 months in their neurorehabilitation journey.

Authorized by the respective Ethics Committees, the study commences with patient recruitment at the first two facilities, the Grande Ospedale Metropolitano Niguarda in Milan and the Villa Beretta Center in Lecco. The initiation of the observational clinical study represents an important milestone in a complex process that has lasted many months, involving 30 experts from various disciplines, ranging from neurosurgery and neurorehabilitation to electrophysiology, biostatistics, and regulatory sciences.

The Niguarda Hospital in Milan is a center of excellence for the treatment and rehabilitation of spinal cord injuries. The Spinal Unit, directed by Dr. Michele Spinelli, is one of the leading Italian hubs for the rehabilitation and care of individuals with traumatic spinal pathologies, requiring specific rehabilitation programs. The medical team consists of physiatrists, urologists, neurologists, anesthesiologists, and benefits from the consultations of many other specialists. With 30 beds and approximately 120 annual admissions, the facility is a national reference point for individuals with spinal cord injuries from all over Italy.

The Villa Beretta Neurorehabilitation Center in Costa Masnaga (Lecco) is an excellent neurorehabilitation center, directed by Dr. Franco Molteni. It recently inaugurated the Rehabilitation Research Innovation Institute, a research and innovation institute dedicated to Rehabilitation Medicine, which combines and coordinates medicine, biology, neuropsychology, psychology, nutritional sciences, bioengineering, social sciences, and humanities in an interdisciplinary approach within a comprehensive vision of biological and social systems.

Hemera now enters the clinical phase with the aim of monitoring the physiological progression of the disease in patients for 12 months following trauma, acquiring a detailed understanding of the severe post-traumatic condition for the benefit of the entire clinical-scientific community in the treatment of spinal injuries, and collecting clinical data for the subsequent pharmacological intervention study, scheduled to commence in 2025.

ORPHAN DRUG DESIGNATION

The European Commission has granted REMaST the designation as an orphan drug. Orphan Drug Designation (ODD) is granted for rare diseases, for which no therapies are available on the market, and where a new drug candidate brings significant benefits to patients based on solid preclinical results. This represents a significant milestone in Hemera’s development journey and the REMaST therapy. The certification brings significant advantages in terms of accelerating the authorization process, access to high-profile consultations from the EMA, the opportunity to conduct drug trials in a limited patient cohort, facilitations for Marketing Authorization (MA), and guarantees market exclusivity.

“This recognition highlights the relevance of the results achieved so far by Hemera and strengthens the awareness of having created an advanced cellular therapy with high potential to treat patients who are still orphaned of care and provide them with a concrete perspective of autonomy” commented Cristiana Vignoli, CEO of the Company. It is a significant achievement that will allow for close dialogue with the European Medicines Agency, which will closely follow REMaST’s journey towards clinical trials and the market.

ITALIAN PATENT GRANT

The Italian Patent and Trademark Office has granted Hemera the Italian patent. Two years after the application was filed on March 18, 2021, the evaluation by the Italian Patent and Trademark Office has resulted in the long-awaited recognition for the REMaST cellular therapy. This is a significant milestone that represents a fundamental achievement for the Company. The process of international patent protection submission has already begun in 16 countries, including the USA, China, Brazil, Australia, and India. Hemera continues to develop and protect its scientific and technological know-how, investing in research and innovation with the goal of expanding its patent portfolio.