Seed Innov Regulatory News (SEED)

24 January 2024

SEED Innovations Limited

("SEED" or the "Company")

Investee Company Update: Avextra AG

SEED Innovations Ltd, the AIM-quoted company investment company providing shareholders with exposure to early-stage health, wellness and medical cannabis companies to which, in normal circumstances, they have limited access to, is pleased to note the announcement released by its portfolio company, Avextra AG ('Avextra'), a German-based, European vertically integrated medical cannabis company.

SEED remains a holder of 2,242 shares in Avextra representing approximately 3% of Avextra on a fully diluted basis.

The following extract from the announcement is set out without material changes or adjustments and the announcement in full can be accessed from the following link:

https://www.globenewswire.com/news-release/2024/01/23/2813771/0/en/German-Pain-Association-DGS-and-Pharmaceutical-Company-Avextra-Join-Forces-to-Launch-Their-New-Study-OCEAN.html

Start of Avextra AG announcement:

23 January 2024

German Pain Association (DGS) and Pharmaceutical Company Avextra

Join Forces to Launch Their New Study OCEAN

Highlights

· Avextra, the German pharmaceutical company focused on Cannabis-Based Medicines (CBM) and the German Pain Association (DGS), the leading physicians' society dedicated to chronic pain therapy, jointly announces their collaboration to support patients suffering from Chemotherapy-induced neuropathic pain (CINP).

· CINP causes persistent pain and numbness symptoms in 60-80% of oncology patients undergoing cancer treatments, significantly impacting their quality of life.

· For the next 18 months the two organisations aim to investigate the efficacy and safety of Avextra's THC/CBD full-spectrum extract in approximately 400 CINP patients in over 20 DGS centres throughout Germany in a real-world environment.

· OCEAN marks the next project in Avextra's Alliance for Evidence-based Cannabis Medicine dedicated to conducting studies within the framework of exclusive partnerships using diverse galenic forms to address indications with significant unmet patient need.

BENSHEIM, Germany, Jan. 23, 2024 (GLOBE NEWSWIRE) -- Avextra AG ("Avextra" or the "Company"), a leading European vertically-integrated manufacturer and developer of pharmaceutical cannabis-based medicines (CBMs) located in Germany, is proud to announce a joint study with the German Pain Association (DGS) focused on Chemotherapy-induced neuropathic pain (CINP). The study which is being conducted under the name of OCEAN is the next initiative as part of Avextra's Alliance for Evidence-based Cannabis Medicine. Initial studies indicate that cannabis-based medicine (CBMs) could be a promising indication for neuropathic pain conditions, including CINP. However, as is often the case in the field of cannabis medicine, reliable evidence is lacking for this vulnerable patient population. Avextra is proud to collaborate with the German Pain Association (DGS) on their OCEAN study and address the research gap.

CINP is an independent pain disorder resulting from the toxic peripheral nerve damage caused by chemotherapy agents in the course of the treatment. The real-world study aims to investigate whether a full-spectrum cannabinoid extract could be a suitable therapeutic addition to alleviate the symptom burden of chemotherapy patients.

OCEAN is a prospective 12-week parallel group observational study utilising Avextra's own balanced 10:10 (THC:CBD) Cannabis extract conducted under real-world conditions with 400 adults suffering from CINP. OCEAN will evaluate a number of factors including pain intensity, pain-related impairments, sleep quality and the phenotypes of neuropathic pain. Upon completion, the study results will contribute to a more precise understanding of the treatment requirements for the patients affected, offering valuable insights to inform the design of a future Phase III clinical trial.

"OCEAN is a unique and promising opportunity to gain valuable patient data aimed to improve the quality of life for CINP patients. We are delighted to partner with the DGS to collect real-world evidence in Germany throughout this study. This initiative is an important part of our Alliance for Evidence-Based Cannabis Medicine, with a significant goal of developing cannabis-based medicines tailored to address specific indications, ultimately providing symptom relief to a broader patient population," explains Dr. Bernhard Babel, CEO of Avextra.

The OCEAN study is now underway. "Our association has gathered valuable experience in treating chronic pain patients with cannabis-based medicines. Together with Avextra, we aim to investigate the efficacy and safety of a THC/CBD full-spectrum extract 10mg/10mg in comparison to a non-cannabis-based comparative therapy amongst the large patient population suffering from neuropathy as a result of chemotherapy. This prospective, 12-week parallel group study is designed as a non-interventional approach," states DGS President, Dr. med. Dipl. Lic. Psych. Johannes Horlemann. "There is a large unmet need for neuropathic pain therapy amongst patients after undergoing chemotherapy. Because success of the chemotherapy is often the main focus, patients often do not address their pain symptoms in subsequent physician consultations. Standard medications for neuropathic pain provide little or no relief. A study is therefore essential to determine how pain and the accompanying symptoms can be improved by a THC-CBD full-spectrum extract. We are looking forward to the results," summarises Dr. med. Dipl. Lic. Psych. Johannes Horlemann.

Avextra is focused on creating cannabis-based medicines "CBMs" that will gather the necessary evidence to support the use of unregistered CBMs and expedite the development of Registered Cannabis-based Medicines. The Company is committed to transparency, and as such, the trials and study results will be shared with the scientific community and regulatory authorities, contributing to the collective knowledge of cannabinoid-based therapies. The company is dedicated to working in collaboration with the medical community, regulators, and other stakeholders to drive evidence-based innovation forward.

End of Avextra AG announcement:

-Ends-

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Notes

Seed Innovations Ltd

SEED Innovations is an AIM quoted investment company focused primarily on disruptive high growth life sciences and technology businesses particularly within the medical cannabis arena. The Company's strategy is to identify early-stage opportunities that have an upcoming investment catalyst and grow its portfolio in terms of value whilst limiting the number of investee companies to a level where relevant time can be devoted to each.

About Avextra AG

Avextra is one of Europe's leading vertically integrated suppliers of high-quality cannabis-based medicines. Founded in 2019 and based out of Germany, the company focuses on the production of precisely formulated cannabis-based medicines. Avextra controls the entire value chain - from cultivation in Portugal to EU-GMP certified extraction and manufacturing in Germany. Avextra operates across continental Europe through an expansive distribution network of multiple channels and assets strategically developed for these key markets.