Hyloris Pharmaceuticals SA

Legal Proceedings Report • Sep 16, 2024

Press Release – Regulated information – Inside information

Arbitration Panel Issues Final Opinion in Dispute Between Hyloris Pharmaceuticals and AltaThera Pharmaceuticals

• AltaThera Damages Claims Rejected
• AltaThera Continues to Commercialize Sotalol IV in the U.S.

Liège, Belgium – 16th of September 2024 – 8 am CET - Regulated information – Inside Information - Hyloris Pharmaceuticals SA (Euronext Brussels: HYL), a specialty biopharma company committed to addressing unmet medical needs through reinventing existing medications, today announces an overall favorable outcome in its arbitration proceedings against AltaThera Pharmaceuticals LLC ("AltaThera").

In August 2022, AltaThera filed a lawsuit against Hyloris and its development partner centered around alleged misappropriation of trade secrets, improper inventorship, unjust enrichment, and breach of the licensing agreement governing the distribution of Sotalol IV, a cardiovascular drug licensed to AltaThera by Hyloris. AltaThera made significant claims for damages and rights specifically relating to Hyloris' intellectual property. Hyloris responded by initiating arbitration proceedings against AltaThera for breach of the same licensing agreement, including the failure of AltaThera to use commercially reasonable efforts in selling Sotalol IV and sought damages and termination of the licensing agreement.

The American Arbitration Association denied all AltaThera claims, except for a limited use of confidential information, and imposed no financial liabilities on Hyloris. This decision was an endorsement of Hyloris' position and a clear rejection of the damages claims. In addition, Hyloris' ownership of its intellectual property was confirmed. The arbitration panel confirmed termination of the license agreement as requested by AltaThera, confirming a perpetual survival of the Sotalol IV license allowing AltaThera to continue commercialization. Hyloris' claims were denied but Hyloris will continue to receive sales related royalties, as defined in the license agreement in accordance with the royalty structure already applied.

Hylorisis pleased that the damages claims from AltaThera have been rejected by the arbitration panel and remains dedicated to safeguarding its intellectual property rights while ensuring the continued development and growth of its portfolio and product candidates.

Hyloris is conducting a comprehensive analysis of the ruling and currently believes it to be final with no grounds for appeal.

The Company is entitled to offset a substantial part of its incurred expenses related to the arbitration proceedings against the future royalties that will be owed to its development partner that was part of the proceedings.

Press Release – Regulated information – Inside information

About Hyloris Pharmaceuticals SA

Hyloris is a specialty biopharma company focused on innovating, reinventing, and optimizing existing medications to address important healthcare needs and deliver relevant improvements for patients, healthcare professionals and payors.

The Company's development strategy primarily focuses on leveraging established regulatory pathways, such as the FDA's 505(b)2 pathway in the U.S or equivalent regulatory frameworks in other regions which are specifically designed for pharmaceuticals for which safety and efficacy of the molecule have already been established. This approach can reduce the clinical burden required for market entry, and significantly shorten the development timelines, leading to reduced costs and risks.

Hyloris has built a broad, patented portfolio of 19 reformulated and repurposed value-added medicines that have the potential to offer significant advantages over existing alternatives. Two products are currently in early phases of commercialization in collaboration with commercial partners: Sotalol IV for the treatment of atrial fibrillation, and Maxigesic® IV, a non-opioid post-operative pain treatment. In addition to its core strategic focus, the Company has 1 approved high barrier generic product launched in the U.S. and 2 high barrier generic products in development.

Hyloris is based in Liège, Belgium. For more information, visit www.hyloris.com and follow-us on LinkedIn.

For more information, contact Hyloris Pharmaceuticals:

Stijn Van Rompay, co-CEO stijn.vanrompay@hyloris.com +32 (0)4 346 02 07 Thomas Jacobsen, co-CEO Thomas.jacobsen@hyloris.com +32 (0)4 346 02 07

Disclaimer and forward-looking statements

Hyloris means "high yield, lower risk", which relates to the 505(b)(2) regulatory pathway for product approval on which the Company focuses, but in no way relates or applies to an investment in the Shares.

Certain statements in this press release are "forward-looking statements." These forward-looking statements can be identified using forward-looking terminology, including the words "believes", "estimates," "anticipates", "expects", "intends", "may", "will", "plans", "continue", "ongoing", "potential", "predict", "project", "target", "seek" or "should", and include statements the Company makes concerning the intended results of its strategy. These statements relate to future events or the Company's future financial performance and involve known and unknown risks, uncertainties, and other factors, many of which are beyond the Company's control, that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially different from those expressed or implied by any forward-looking statements. The Company undertakes no obligation to publicly update or revise forward-looking statements, except as may be required by law.