Ad hoc announcement pursuant Art. ALLSCHWIL (Switzerland), February 8, 2023 (GLOBE NEWSWIRE), -- Spexis AG (SIX) is a clinical-stage biopharmaceutical firm that focuses on rare diseases and oncology. Today, the Company announced that it has executed term sheets detailing a clinical trial partnership agreement with SPRIM Global Investments(SGI), a prominent venture capital firm in health sciences. SPRIM Global Investments has extensive industry experience and decades of operational experience across 17 countries. This partnership includes a debt facility that Spexis will use to pay half of the Phase3 clinical development costs of ColiFin (r). It also allows Spexis to initiate the Phase 3 COPILOT study. The first quarter of 2023 is expected to see Spexis' Phase 3. COPILOT will assess and confirm whether COPA is administered once daily or twice daily, in the planned Phase 3 pivotal safety and efficacy trial. The majority of this funding will be senior debt that is tied to funding the COPILOT/COPA studies. However, Spexis was also funded by SGI via interest-bearing convertible note financing of $500,000 with a term 2 years and partial warrant coverage. "The partnership we have with SGI will allow us to quickly advance ColiFin(r), into the next phase of development, particularly the impending initiation of our COPILOT research, which is expected in the second quarter," said Jeff Wager M.D. Chairman and CEO of Spexis. This collaboration will allow ColiFin(r),'s Phase 3 development to capitalize on significant clinical milestones. Thomas Fratacci (CFO at SGI) added that, "As part our commitment to tailoring financing options for the life sciences industry - especially in a climate depressed market capitalizations -- we developed our investment products in order to enable companies such as Spexis raise capital to continue clinical development and their priority programs." Final clinical trial agreements will be negotiated with selected CROs and associated funding agreements with SGI. The partnership's debt financing component is subject to negotiation. ColiFin(r), a treatment for chronic lung infections in patients with cystic fibrosis, is currently being developed. Spexis holds worldwide rights to ColiFin (r) ex-Europe, and is focusing on the U.S. market. Spexis received a 'Study May Proceed' letter from USA Food & Drug Administration (FDA) and will, upon securing sufficient funding, advance ColiFin (r) into a Phase III clinical program for adult and adolescent CF sufferers with moderate to severe lung function impairments and chronic Pseudomonas aeruginosa lung infection (PA). Two-thirds (or more) of CF chronic lung infections are caused by PA. This is the main cause of lung function decline, and death in CF patients. The Phase 3 program will include the COPILOT safety-tolerability pilot clinical study. This trial will enroll 38 patients to evaluate and confirm once- or twice-daily dosing for COPA. Phase 3 is a single pivotal safety and efficacy trial. Spexis (SIX, SPEX), a clinical-stage biopharmaceutical firm based in Allschwil Switzerland, focuses on oncology and rare diseases, is Spexis. SPRIM Global Investments is a global leader in health sciences venture capital. It has deep industry knowledge and extensive operating experience in 17 countries. SGI invests in digital health, biotechnology and R&D service businesses to accelerate innovation and commercialize the latest technologies. Contact:SPRIM Global Investments Pte. for more information. LtdDaniel MartinezVP Clinical Trials Financing+1
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Forward-looking statements in this press release are based upon current forecasts and assumptions of Spexis management. There are known and unknown risks and uncertainties that could cause material differences between forward-looking statements and actual developments, including Spexis' financial situation and performance. Forward-looking statements are only accurate as of the date of this communication. Readers should not place undue dependence on them. Spexis does not intend or have any obligation to revise or update any forward-looking statements as a result or new information.