Ad hoc announcement pursuant to Art. 53 LR
- Funding to enable immediate initiation of the COPILOT study, the first of two Phase 3 ColiFin® studies; first-patient-in expected in June 2023
- Commitment structured as a mix of secured debt and subordinated debt mandatorily converting into equity
ALLSCHWIL, Switzerland, April 18, 2023 (GLOBE NEWSWIRE) — Spexis AG (SIX: SPEX), a clinical-stage biopharmaceutical company focused on rare diseases and oncology, today announced that the company has finalized a capital commitment from SPRIM Global Investments (SGI) totaling USD 4.5 million in the form of secured, interest-bearing debt with partial warrant coverage and subordinated debt mandatorily converting into equity. Proceeds from the capital commitment will enable the initiation of the Phase 3 COPILOT study, the first part of the registrational clinical studies planned for ColiFin®. The COPILOT study, which will enroll 38 patients and evaluate and confirm the use of once or twice daily dosing for COPA, the second part of the planned pivotal efficacy and safety Phase 3 study of ColiFin®, has study start-up activities ongoing, and is expected to enroll its first patient in June 2023.
“Building upon our recently announced clinical trial partnership, we are pleased to receive this capital commitment from SGI, which will allow us to expeditiously proceed with the initiation of our ColiFin® Phase 3 development program,” said Jeff Wager, M.D., Chairman & CEO of Spexis. “The COPILOT study, which we now are on track to achieve first-patient-in by June, will be a critical trial to determine the potential for a once daily dosing regimen for ColiFin®, which would offer a significantly lower treatment burden to cystic fibrosis patients in need. With site activations and study start-up activities ongoing, we look forward to efficiently deploying this capital to execute our COPILOT study and in parallel continue our efforts to secure the balance of financing to cover the remaining costs of the COPA trial.”
In February, Spexis announced the execution of non-binding term sheets describing a clinical trial partnership with SGI. The partnership, which includes a debt facility, is expected to provide Spexis with up to half of the total ColiFin® Phase 3 clinical development costs, which includes both the COPILOT and COPA trials. The clinical development of ColiFin® is supported by FDA Orphan Drug, Qualified Infectious Disease Product (QIDP) and Fast Track Designations.
In addition, and as part of an ongoing strategic realignment, two members of Spexis’ executive committee will be transitioning out of the company. Stephan Wehselau, currently Chief Operating Officer, will be leaving Spexis by the end of June. Juergen Froehlich, MD, Chief Medical Officer, will be transitioning from his role to that of an external consultant effective immediately, but will retain an oversight and advisory role during COPILOT’s implementation.
Spexis (SIX: SPEX) is a clinical-stage biopharmaceutical company based in Allschwil, Switzerland, focused on rare diseases and oncology. For further information please visit: www.spexisbio.com.
About SPRIM Global Investments (SGI)
SPRIM Global Investments (SGI) is a leading health sciences venture capital firm with deep industry expertise and decades of operating experience across 17 countries. SGI invests in biotechnology, digital health and R&D service companies to commercialize the newest technologies and accelerate innovations that are the future of health around the world. For more information, visit: www.sprim.net.
For further information please contact:
Chief Financial Officer
+41 61 567 1600
Dr. Stephan Feldhaus
Feldhaus & Partner
+41 79 865 9256
Europe: +49 89 210 2280
Dr. Brigitte Keller/Laurie Doyle
Europe: +49 89 210 2280, U.S.: +1 339 832 0752
Ph. +1 858 525 2047
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.