- AMX0318 selected as development candidate after meeting key criteria, demonstrating a robust chemical stability profile, strong in vitro potency, evidence of in vivo efficacy and tolerability, high solubility, and a favorable pharmacokinetic profile consistent with a long-acting peptide
- IND-enabling studies expected to initiate in 2026 with an IND targeted for 2027, pending successful completion of IND-enabling studies
Gubra, founded in 2008 in Denmark and listed on NASDAQ Copenhagen, is a disease-agnostic techbio company specialized in peptide-based drug discovery and preclinical contract research services. Gubra's activities are focused on the early stages of drug development and are organized in two main business units - Biotech (D&P) and CRO services. The two business areas are highly synergistic and create a unique entity capable of generating a steady cash flow from the CRO business while investing in high-impact biotech R&D projects with significant value inflection potential through partnerships. Gubra has around 300 employees and had revenue of DKK 2.6 billion (around EUR 350 million) in the first 9 months of 2025. See www.gubra.dk for more information.
About Amylyx Pharmaceuticals
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, Amylyx' expectations regarding: the therapeutic potential for AMX0318, the expected timeline for the IND-enabling studies and IND submission for AMX0318, the payments and royalties to be received by Gubra, and the expected timeline for certain development, regulatory, and commercial milestones. Any forward-looking statements in this press release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of Amylyx' program development activities; Amylyx' ability to execute on its regulatory development plans and expectations regarding the timing of results from its planned data announcements and initiation of clinical studies; the risk that early-stage results may not reflect later-stage results; Amylyx' ability to fund operations, and the impact that global macroeconomic uncertainty, geopolitical instability, and public health events will have on Amylyx' operations, as well as the risks and uncertainties set forth in Amylyx' United States Securities and Exchange Commission (SEC) filings, including Amylyx' Annual Report on Form 10-K for the year ended December 31, 2024 and subsequent filings with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Amylyx undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
Gubra Media
+45 4188 9586
Kristian Borbos
kbo@gubra.dk
Emma Jappe Lange
ejl@gubra.dk
Amylyx Media
(857) 320-6191
Lindsey Allen
Investors@amylyx.com


