MORE AWARDS FOR HEMERA INNOVATION

2025 closes with prestigious recognition for Hemera, further strengthening its visibility in the Italian scientific and entrepreneurial landscape. Cristiana Vignoli, CEO of Hemera, received the BFactor 2025 Award as part of the fifth edition of the prize promoted by the Marisa Bellisario Foundation, under the High Patronage of the European Parliament, the Italian Chamber of Deputies, the Presidency of the Council of Ministers, and relevant Ministries.

The award honors female entrepreneurs who, with vision, courage, and innovation, contribute to sustainable development and the progress of the country, recognizing initiatives with high social, economic, and scientific impact. The recognition of Cristiana Vignoli highlights the importance of her leadership and strategic vision in guiding Hemera and the development of REMaST®, the advanced cellular therapy for spinal cord regeneration.

Following the award, the CEO shared her experience and entrepreneurial vision in prominent interviews: on December 4, she appeared on the Tutto il bello che c’è segment of TG2, and on December 15, her story was featured in the Sole 24 Ore insert Donne, Economia e Potere.

These achievements underscore the impact of Hemera’s research and innovation, reinforcing the foundation for the company’s future growth.

ADVANCES IN PRECLINICAL RESEARCH AND TRANSLATIONAL DEVELOPMENT TOWARD CLINICAL PHASE

Between September and December 2025, Hemera’s Research & Development team, in collaboration with the Therapy Development team, completed the final review of data and the main scientific manuscript on the REMaST® therapy.

The article on the therapeutic efficacy of REMaST in treating spinal cord injuries has been accepted for publication in Immunity Cell Press, one of the leading international journals in immunology and neuroscience, with an Impact Factor of 26.3 (2025). The online publication is scheduled for January 26, with inclusion in the February print issue. This milestone represents a major recognition of the robustness of Hemera’s preclinical data and the innovative approach of the REMaST® platform, validated through a rigorous international peer-review process.

A second article, detailing the development and validation of the severe contusion-compression spinal cord injury preclinical model, has been accepted and published in STAR Protocols and is currently available online (PMID: 41456281).

In November, Prof. Ilaria Decimo presented data on REMaST® efficacy at the European Neurotrauma Summit 2025 (Lund, Sweden), attracting strong interest from the scientific community and initiating new international collaborations, with potential extensions of the technology to traumatic brain injuries.

New collaborations were also established with the Mario Negri Institute and the Carlo Besta Neurological Institute in Milan to preclinically validate REMaST®’s mechanisms of action in additional central nervous system pathologies, supporting the expansion of Hemera’s product pipeline.

Finally, interactions with Wings for Life, an international foundation leading research funding for spinal cord injuries, intensified through participation in joint grants, further strengthening Hemera’s scientific and strategic positioning in the global SCI research landscape.

ADVANCES IN REMAST® PRODUCT DEVELOPMENT AND TECHNOLOGY TRANSFER TOWARD THE CLINIC

During the last quarter, Hemera’s Product Development team continued efforts to consolidate and enhance the REMaST® therapy, with a focus on intellectual property, regulatory positioning, and expanding potential therapeutic applications.

On the IP front, the team responded to several international patent office reviews, providing new supporting data, including for the Russian patent application, further strengthening global protection of the product.

In the scientific and training sphere, Dr. Giulia Pronto, a PhD student co-funded by Hemera, successfully defended her doctoral thesis on REMaST®, receiving top marks and full commendation from the committee. This milestone further validates the scientific robustness of the product and the company’s internal know-how.

In parallel, and in collaboration with the R&D team, strategic contacts were established with the Traumatic Brain Injury group at the Mario Negri Institute, led by Dr. Elisa Zanier. These discussions have initiated preliminary in vitro studies to assess REMaST® efficacy in new neurological indications, laying the groundwork for potential pipeline expansion beyond spinal cord injuries.

Finally, with the support of technical partner ProPharma, preparations for a second Scientific Advice request to the EMA have begun, focusing on product safety and manufacturing procedures, reinforcing the regulatory pathway in anticipation of the upcoming clinical transition.

STRATEGIC PROGRESS: IP CONSOLIDATION AND REGULATORY ADVANCEMENT

During the last quarter, Hemera has intensified its efforts to consolidate and exploit its intellectual property and regulatory positioning. The R&D team has prepared the documentation for patent filing in the United States, building on patents already granted in Europe and Israel and pending in 13 additional countries, with accelerated procedures in strategic markets including the USA, Singapore, and Canada.

In parallel, a detailed regulatory strategy has been outlined to leverage the Orphan Drug Designation, engage early with EMA through Scientific Advice on preclinical results, the REMaST® product, and the interventional clinical protocol, and optimize access to accelerated pathways. A preliminary pricing and market access framework is also being developed, taking into account emerging HTA regulations, to support a first-in-the-market approach and maximize the commercial potential of REMaST®.

CONSOLIDATING GOVERNANCE FOR STRATEGIC GROWTH

In the last three months of 2025, Hemera has strengthened its strategic and operational capabilities to support the transition toward clinical development. Michela Pantaleoni has joined the core team and the Board of Directors as Pricing & Market Access Expert, bringing critical expertise to guide market entry and commercialization strategy.

Key roles in Clinical Development and Regulatory Affairs have been identified and assigned to two professionals whose identities remain confidential for privacy reasons, but they are expected to join the team soon, further reinforcing Hemera’s operational readiness.

Additionally, Cristiana Vignoli has been appointed Sole Director of Proemera, a special-purpose vehicle holding part of Hemera’s share capital and supporting the company since its inception. This appointment strengthens the strategic link between the two organizations and ensures continuity of vision and guidance in Hemera’s development. In her new role, Cristiana Vignoli will continue to promote investments in research and innovation, supporting the growth of Hemera and its projects.

These steps consolidate governance and provide a robust foundation for Hemera’s expansion in the biotechnology and regenerative medicine landscape at this critical stage of its journey.

ONGOING FUNDRAISING AND STRATEGIC COLLABORATIONS TO ADVANCE HEMERA

In December 2025, Hemera completed a capital increase, bringing the total funds raised since the company’s founding to €3 million, thereby consolidating the financial foundation for the development of the REMaST® platform. At the same time, the reporting for the Brevetti+ funded project was successfully completed, fulfilling all planned activities.

The team continues to actively drive fundraising efforts, constantly expanding the investor network and keeping stakeholders informed about scientific progress, recognitions, and key milestones achieved by the REMaST® platform. In addition to seeking venture capital investments, Hemera is actively pursuing grants and public funding to support the development of clinical and preclinical programs, including collaborations with leading research institutions and industrial partners.