Spexis announces extension of moratorium, receipt of an additional payment related to the sale of a preclinical antibiotics program and reversion of the lonodelestat license from Santhera

Ad hoc announcement pursuant to Art. 53 LR

Allschwil, Switzerland, April 17, 2024

Spexis announces extension of moratorium, receipt of an additional payment related to the sale of a preclinical antibiotics program and reversion of the lonodelestat license from Santhera

• The Western District Court of the Canton Basel-Landschaft has granted Spexis’ request to extend its provisional moratorium by an additional 4 months.
• Spexis received the second of three potential payments as part of an asset purchase agreement announced on Jan 15, 2024 totaling CHF 2 million.
• Santhera Pharmaceuticals Holding AG (Pratteln, Switzerland) has terminated the license agreement relating to lonodelestat, Spexis’ inhaled neutrophil elastase inhibitor, as part of its portfolio review and announced focus on its lead asset vamorolone.
   

Spexis AG (SIX: SPEX), a clinical-stage biopharmaceutical company focused on macrocycle therapeutics for rare diseases and oncology, today announced that its request to extend its provisional moratorium has been granted for an additional four months by the Western District Court of the Canton Basel-Landschaft.  This request was made as part of Spexis’ efforts to partner or divest non-core programs and assets and raise additional capital in order to eventually emerge from moratorium.

In addition, Spexis sold all rights to a preclinical program of macrocycle antibiotics developed by Spexis from a novel class (outer membrane protein targeting antibiotics, or “OMPTAs”) targeting Gram-negative bacteria, including multidrug-resistant strains, under an asset purchase agreement to Basilea Pharmaceutica International Ltd, Allschwil. The transaction was first reported on 15 January 2024 and further reported on 8 February 2024 upon closing.  In the meantime, Basilea has made the second of three total potential payments to Spexis.  This payment related to the completion of transfer of the asset to Basilea.

Finally, Spexis announces that Santhera Pharmaceuticals Holding AG (Pratteln, Switzerland) has terminated the February 2018 agreement wherein Spexis (formerly Polyphor) out-licensed worldwide rights of lonodelestat, its novel, inhaled neutrophil elastase inhibitor, to Santhera.  Importantly, the decision to terminate the license was taken in light of Santhera’s portfolio prioritization, and not as a result of any safety or efficacy data having arisen from the Phase 1a or Phase 1b studies undertaken on lonodelestat during the term of the license.  All rights to lonodelestat and all data generated by Santhera on lonodelestat during the term of the license shall revert to Spexis during a brief transition period. 

Jeff Wager, MD, Chairman & CEO of Spexis, said: “These three events represent significant progress in the implementation of Spexis' moratorium plan, and we continue to pursue the goal of ultimately emerging from moratorium status.  In addition, the reversion of lonodelestat rights to Spexis also strengthens one of our core rare disease aereas – that of niche respiratory conditions – wherein Spexis already has significant assets and experience.  We thank Santhera for the progress they made with lonodelestat as a licensee, and based upon this progress, we plan to announce further, innovative development plans as soon as practicable.  We continue to have great confidence in the novelty of our macrocycle technology as a drug discovery platform to ultimately address significant unmet medical needs in rare disease and oncology.”

About Spexis

Spexis (SIX: SPEX) is a clinical-stage biopharmaceutical company based in Allschwil, Switzerland, 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.

About Lonodelestat

Lonodelestat is a highly potent and selective peptide inhibitor of human neutrophil elastase (hNE).  Neutrophil elastase is an enzyme associated with tissue inflammation, leading to degradation of the lung tissue in several acute and chronic pulmonary diseases.

In preclinical studies, lonodelestat was effective in animal models of neutrophil activation in lung tissue and of acute lung injury (ALI) [1, 2].  Currently available clinical data demonstrated that single and multiple doses (Phase 1b) of lonodelestat when administered by inhalation via an optimized eFlow® nebulizer (PARI Pharma GmbH) can lead to high drug concentrations within the lung, resulting in inhibition of hNE in sputum of patients, an enzyme associated with lung tissue inflammation [3]. The Phase 1b study further confirmed the tolerability of lonodelestat after treatment of up to four weeks in patients with CF. Lonodelestat may also show therapeutic benefit for a range of neutrophilic pulmonary diseases with high medical need such as non-CF bronchiectasis (NCFB), alpha-1 antitrypsin deficiency (AATD), chronic obstructive pulmonary disease (COPD), acute respiratory distress syndrome (ARDS) or primary ciliary dyskinesia (PCD), amongst many others. 

Lonodelestat currently has EU orphan drug designations (ODD) for the treatment of CF as well as for AATD and PCD in both EU and US.
Both Spexis and Santhera acknowledges the support of the Cystic Fibrosis Foundation (CFF) by providing funding for the conduct of the Phase 1a and 1b safety trials with lonodelestat.

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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

References

1. Sellier Kessler O et al. Effect of POL6014, a potent and selective inhaled neutrophil elastase inhibitor, in a rat model of lung neutrophil activation.  Am J Respir Crit Care Med 2018; 197: A2988
2. Lagente V et al. A novel protein epitope mimetic (PEM) neutrophil elastase (NE) inhibitor, POL6014, inhibits human NE-Induced acute lung injury in mice.  Am J Respir Crit Care Med 2009; 179: A5668
3. Barth P et al. Single dose escalation studies with inhaled POL6014, a potent novel selective reversible inhibitor of human neutrophil elastase, in healthy volunteers.  J Cyst Fibros 2020; 19: 299-304