Ad hoc announcement pursuant to Art. 53 LR

Allschwil, Switzerland, 8 July, 2024

PARI Pharma GmbH announces termination of ColiFin® license to EnBiotix, Inc.

Spexis AG (SIX: SPEX), a clinical-stage biopharmaceutical company focused on macrocycle therapeutics for rare diseases and oncology, today announced that PARI Pharma GmbH (“PARI”), the owner of ColiFin®, its combination drug-device inhaled colistin product, has terminated the license of ColiFin® to EnBiotix, Inc., the wholly-owned subsidiary to which ColiFin® was licensed in 2019.

PARI terminated the license pursuant to non-payment of a required license payment by Enbiotix, Inc. (“Enbiotix”) to PARI.  The shares and assets of Enbiotix and Spexis’ other wholly-owned subsidiary Spexis Australia Pty Ltd were both subject to a receivership which SPRIM implemented as part of its alleged default of certain conditions of loans extended to Spexis, which Spexis maintains it did not breach. 

As a result of this non-payment and resulting license termination, Spexis is continuing its negotiations with SPRIM regarding debt-restructuring while it weighs its further business and legal options aimed in the short term to obtain a definitive moratorium at the upcoming court hearing scheduled for 23 July 2024.  In parallel, Spexis will seek to re-in-license ColiFin® from PARI directly, subject to the Company completing a debt-restructuring with its creditors and obtaining sufficient additional financing, which the Company aims to raise in its ongoing and multi-pronged fundraising and strategic transaction campaign to ultimately exit from moratorium. There can be no assurance that such efforts will be successful.  

Jeff Wager, MD, Chairman & CEO of Spexis, said: “This license termination is obviously unfortunate in light of present moratorium circumstances, but we are committed as a Company to fully explore all avenues available to re-acquire rights to ColiFin®, continue debt-restructuring with our creditors in the framework of a definitive moratorium in the immediate term and ultimately exit from moratorium.  There is increasing interest in macrocycles, next-generation alternatives to antibody-drug-conjugates and also radio-pharmaceuticals, and these are all areas in which Spexis has proven assets and a unique product pipeline.  We will continue to vigorously market these assets and opportunities as part of its fundraising and transaction campaign to firstly, obtain a definitive moratorium and then, continue to seek to exit moratorium and ultimately, to deliver superior returns to shareholders.”

About Spexis

Spexis (SIX: SPEX) is a clinical-stage biopharmaceutical company based in Allschwil, Switzerland, currently in provisional moratorium focused on macrocycle therapeutics for rare diseases and oncology. For further information please visit: www.spexisbio.com.

About Spexis’ Macrocycle Platforms

Spexis possesses what we regard as some of the most distinct, highly diverse and very well characterized macrocycle libraries in the world, together with deep data on same, developed over the course of more than 25 years of research and development and significant investment.  These include PEMFinder™, which is comprised of peptidomimetic macrocycles, and MACROFinder™, which are small molecule macrocycles.  Each have distinct applications depending on the targets in question, which can be both extracelluar and intracellular targets.  In addition to generating the specific OMPTA candidates described in this press release, these platforms have generated multiple other drug candidates in the Spexis pipeline, including murepavidin, balixafortide, lonodelestat and others.

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Disclaimer

This press release contains forward-looking statements which are based on current assumptions and forecasts of Spexis management. Known and unknown risks, uncertainties, and other factors could lead to material differences between the forward-looking statements made here and the actual development, in particular Spexis’ results, financial situation, and performance. Readers are cautioned not to put undue reliance on forward-looking statements, which speak only of the date of this communication. Spexis disclaims any intention or obligation to update and revise any forward-looking statements, whether as a result of new information, future events or otherwise.

This press release can be downloaded from www.spexisbio.com