Patent application for the production and clinical use of REMAST macrophages

On March 18, a patent application entitled: “Method for obtaining regenerative macrophages educated by tumors and their use in regenerative medicine” was filed with the Italian Ministry for Economic Development. Evaluations are expected in the fourth quarter of 2021. In September 2021, an agreement for transferring ownership of the patent from the University of Verona to Hemera was signed.

Preclinical efficacy evaluation and identification of molecular mechanisms

In May 2021, experiments in the animal model made it possible to identify the main molecular mechanisms of the therapeutic effect of Hemera’s cell therapy. These results are very important for publication of research findings in high-impact scientific journals, for patent granting, and for cell therapy approval for use in humans. In June 2021, studies in experimental mouse models were completed which demonstrated the efficacy of Hemera’s macrophages in the treatment of severe spinal cord injury in a subacute phase.

Hemera becomes a spin-off of the University of Verona

On September 28, Hemera was accredited as a spin-off of the University of Verona. This allows us to use the laboratories, instrumentation, and staff of the University to carry out Hemera’s scientific project.

Constitution of the Regulatory & Advisory Board

In the second half of 2021, Hemera’s Regulatory & Advisory Board was established. The board includes:

• Dr. Franco Molteni, Director of the rehabilitation center “Villa Beretta”
• Dr. Marco Riva, neurosurgeon at Istituto Clinico Humanitas
• Dr. Mario Ricciardi, previously involved in EMA ODD evaluation
• Dr. Patrizia Cristofori, formerly at GSK R&D in UK

Acquisition of new scientific personnel

By the end of 2021, 1 lab manager, 2 biotech fellows and 1 PhD student in experimental medicine will join the scientific team.

Recognition of Small-Medium Enterprise (SME) qualification by EMA

Hemera has been recognized by the European Medicine Agency (EMA) as a Small-Medium Enterprise (SME): this allows Hemera to qualify, until October 31, 2023, for the administrative and financial assistance offered by the Regulatory Agency.

Co-optation of Board Members

On November 22, the Assembly of Members elected Ilaria Decimo as Managing Director with the role of Director of R&D and Cristiana Vignoli as Managing Director with the role of Chief Operating Officer.

Advisory Board plenary meeting

On December 13, the Advisory Board met at the LITA laboratory in Milan and discussed the following points:

• application dossier for Advanced Therapy classification by EMA;
• data supporting the Orphan Drug Designation by EMA;
• experimental protocols for laboratory tests;
• observational study protocol, patient inclusion/selection criteria, quality and efficacy endpoints, measurements, and instrumental investigations.

The University of Milan qualifies Hemera as an academic spin-off

On December 21, the Board of Directors of the University of Milan accredited Hemera as an academic spin-off. The Company has therefore obtained the recognition of spin-off status both by the University of Verona and by the University of Milan.

Aumenti di capitale

On November 17, the entry of the vehicle company Proemera into the shareholding structure of Hemera was formalized, with a capital increase of € 310,168.50. On December 29, the 3rd capital increase of the year was carried out, for additional € 360,000.