CROSSJECT News – January 2025

Today, we rely on an experienced manager accustomed to the context of smaller organizations and a Medical Director with extensive knowledge of our class of drugs. On the business development side, we are able to deal with both private and public stakeholders. Our U.S. team is, of course, supported by resources based in France, including regulatory, accounting, marketing, human resources, and supply chain functions.

Obtaining Emergency Use Authorization from the FDA will mark the starting point for ZEPIZURE®’s commercial deployment, enabling the release of initial batches for BARDA. It’s important to understand that even with BARDA’s support, the FDA is responsible for granting marketing authorization for a drug. Although streamlined, the process remains rigorous.

Regardless of the region, health authorities don’t register prototypes but commercial products. Practically speaking, we need to demonstrate the long-term stability of both our drug and production system. This requirement is based on the consistent production of 100% reliable batches. We expect to complete this process by early 2025, at which point the review timeline for our submission will depend entirely on the FDA. In fact, this means that for ZEPIZURE®, the era of clinical batch production is largely behind us, giving way to commercial batch production. Our factory in France is steadily ramping up its production capacity.

Additionally, as part of our American strategy, our latest capital increase attracted American investors, helping secure the final stretch while limiting financial risks. This also enhances the visibility and credibility of our U.S. commitment.

The “America First” strategy represents a collective project for CROSSJECT, and all our teams are dedicated to ensuring the success of our U.S. operations. While business is conducted in the U.S., production takes place in France! Moreover, the real-world learning from commercial production benefits all our products and markets.

Finally, I’d like to highlight the launch of CROSSJECT’s new website. Our status as a pharmaceutical laboratory and our ambitious commercial goals will now be more effectively supported by a modernized design and updated content. The content, of course, is accessible in both French and English.

Patrick ALEXANDRE, CEO and Founder of CROSSJECT

*Contract No. 75A50122C00031