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Hyloris Pharmaceuticals SA

Regulatory Filings Aug 1, 2024

3959_iss_2024-08-01_05b55038-68e2-4bcf-acb9-87244cfbc1cc.pdf

Regulatory Filings

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Hyloris Announces New Communication Policy

Liège, Belgium – 1 August 2024 – 9.00PM CET – Regulated Information - Hyloris Pharmaceuticals SA (Euronext Brussels: HYL) ("Hyloris" or the "Company")), a specialty biopharma company committed to addressing unmet medical needs through reinventing existing medications, today announces that, in response to recent events, its Board of Directors has approved a new communication policy (the "Communication Policy").

The Communication Policy applies to communications that include information concerning the business activities of the Company or any subsidiary of the Company, whether its business strategy, financial position (including future profits or losses or valuation), management (including its track record), assets, liabilities, investment strategy, investment and product portfolio, investment and product pipeline, cash flows, expenditures or prospects (including any periodic information or inside information to be disclosed by the Company), taking into account the sensitivity and/or confidentiality of such information.

The Communication Policy will be effective immediately and must be complied with by all directors, officers and employees of the group.

The main principles of the Communication Policy are as follows:

  • All press releases on behalf of the Company and other written communications should be submitted in advance to the Board of Directors for review. The Board may (i) decide that the communication may be released, (ii) require that the communication be amended before release, or (iii) decide that the communication may not be released;
  • Any oral communications (e.g. interviews with the press, participation in conferences, or presentations on behalf of the Company) should be consistent with the information that is already publicly available prior to the entering into effect of the Communications Policy or that has been approved since following a pre-release review by the Board; and
  • All communications on behalf of the Company should be made exclusively by or at the written instruction of the Chair of the Board or the co-CEOs, acting jointly, through such means as appropriate taking into account the Company's past practice. In case of oral communications about regulated information, the Chair of the Board (or, in his absence, the Chair of the Audit Committee) must be present when the Communication is made

About Hyloris Pharmaceuticals

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 18 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:

Stefan Yee Chairman of the Board Email: [email protected] +32 (0) 497 37 80 65

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 forwardlooking 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.

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