Spexis and SPRIM Global Investments (SGI) Announce Plans for Clinical Trial Partnership to Fund up to Half of the Projected Phase 3 Clinical Development Costs of ColiFin®

Ad hoc announcement pursuant to Art. 53 LR

• SGI debt facility to provide Spexis up to half of the projected ColiFin^® Phase 3 development costs, including those involving both COPILOT and COPA
• SGI has invested in Spexis as part of the ColiFin^® P3 clinical trial partnership financing; additional investments from other investors expected in the near future
• SGI debt facility subject to a number of conditions, including negotiation of final agreements

ALLSCHWIL, Switzerland, Feb. 08, 2023 (GLOBE NEWSWIRE) -- Spexis AG (SIX: SPEX), a clinical-stage biopharmaceutical company focused on rare diseases and oncology, today announced that the Company has executed term sheets describing a clinical trial partnership with SPRIM Global Investments (SGI), a leading health sciences venture capital firm with deep industry expertise and decades of operating experience across 17 countries. The partnership, which includes a debt facility, is expected to provide Spexis with up to half of the Phase 3 clinical development costs of ColiFin^® and enable the initiation of Spexis’ Phase 3 COPILOT study, expected in the second quarter of 2023. COPILOT will evaluate and confirm the use of once versus twice daily dosing for COPA, the planned single pivotal efficacy and safety Phase 3 trial. While the majority of such funding is planned to be in the form of senior debt tied to the funding of the COPILOT and COPA studies, SGI has also invested in Spexis via an interest-bearing subordinated convertible note financing in an amount of $500,000, with a term of 2 years and partial warrant coverage. Spexis expects to secure additional investors in the near future.

“The planned partnership with SGI positions us well to rapidly advance ColiFin^® into the next stage of development – particularly the imminent initiation of our COPILOT study, expected in the second quarter,” said Jeff Wager, M.D., Chairman & CEO of Spexis. “This collaboration is expected to provide capitalization through significant clinical milestones in ColiFin^®’s Phase 3 development. As such, we are grateful for the support from SGI, both as debt funders for our clinical trials, as well as new investors in our fundraising, and are excited to work closely with them as we continue our mission to bring a novel treatment option to improve and extend the lives of cystic fibrosis patients.”

Thomas Fratacci, CFO of SGI, further commented, “As part of our commitment to tailoring financing solutions for the life science industry – particularly in a climate of depressed market capitalizations – we developed our investment products to enable companies like Spexis to raise capital in order to continue clinical development of their priority programs. What we’ve designed for Spexis is exactly such a product.”

The debt funding component of the partnership is subject to the negotiation of final clinical trial agreements with a selected CRO and related funding agreements with SGI. In addition, the initiation of the COPILOT and COPA trials will be subject to Spexis securing additional financing to cover the full cost of the Phase 3 trials.

ColiFin^® is being developed for the treatment of chronic lung infections in cystic fibrosis (CF) patients. Spexis has worldwide rights to ColiFin^® ex-Europe and is focused on developing the product first for the U.S. market. With a “Study may Proceed” letter from the United States Food & Drug Administration (FDA), Spexis will upon securing the necessary funding advance ColiFin^® into a Phase 3 clinical program in adult and adolescent CF patients with moderate to severe lung function impairment and chronic Pseudomonas aeruginosa (PA) lung infection. PA infection accounts for two-thirds of CF chronic lung infections and is the leading cause of lung function decline and mortality in CF patients. The Phase 3 program includes the COPILOT safety and tolerability pilot clinical trial which will enroll 38 patients and evaluate and confirm the use of once or twice daily dosing for COPA, the planned single pivotal efficacy and safety Phase 3 trial. The clinical development of ColiFin^® is supported by an FDA Orphan Drug Designation for treatment of respiratory infection in patients with cystic fibrosis, Qualified Infectious Disease Product (QIDP) Designation for ColiFin^® for the treatment of PA lung infections in CF patients, and Fast Track Designation.

About Spexis

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

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.