Spexis provides business update and announces financial results for the full year 2022

Ad hoc announcement pursuant to Art. 53 LR

• USD 4.5 million capital commitment from SPRIM Global Investments to enable initiation of ColiFin® COPILOT study; first patient dosing expected in mid-2023
• Reported solid safety and pharmacokinetics results from first-in-human study of inhaled murepavadin
• Announced positive renal impairment clinical trial results with balixafortide

ALLSCHWIL, Switzerland, May 29, 2023 (GLOBE NEWSWIRE) — Spexis AG (SIX: SPEX), a clinical-stage biopharmaceutical company focused on rare diseases and oncology, today announced its financial results for the full year of 2022 and provided a strategic business update.

“With the recent closing of the capital commitment from SPRIM Global Investments, Spexis is well-positioned to execute on the clinical development of our Phase 3 ColiFin® program, beginning with the initiation of our COPILOT study expected in the middle of the year,” said Jeff Wager, M.D., Chairman & CEO of Spexis. “In addition to the progress made with our lead asset ColiFin®, we are highly encouraged by the accomplishments across our entire pipeline, including promising clinical results from both our balixafortide and inhaled murepavadin programs. Looking ahead to the rest of the year, we remain laser focused on driving each of these programs forward and will continue to diligently evaluate sources of capital to allow for the advancement of our pipeline through value creating milestones.”

Pipeline Status and Plans

The subsequent plans regarding further development of various programs in the Spexis’ pipeline are subject to the company raising additional funds and/or entering into partnering agreements.

Lead Program: ColiFin®

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 is advancing 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.

In April 2023, Spexis reported the closing of a capital commitment of USD 4.5 million from SPRIM Global Investments (SGI) to enable the initiation of the ColiFin® Phase 3 COPILOT study. COPILOT has study start-up activities ongoing and is expected to enroll its first patient in Q3 2023 with data expected in the first quarter of 2024. Additional financing will be required to continue the clinical development of ColiFin® into the COPA pivotal study.

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.

Balixafortide

Spexis announced positive results from the Phase 1 clinical trial of balixafortide (BLX) in patients with renal impairment in September 2022. The Phase 1 trial was designed to investigate the pharmacokinetics, safety and tolerability of BLX in subjects with mild (n=8), moderate (n=8), or severe (n=7) renal impairment compared to a control group (n=8) with normal renal function. Each person received a single 2-hour intravenous infusion at the previously studied clinical dose of 5.5 mg/kg of BLX. The data from this trial indicate that BLX doses substantially higher than 5.5 mg/kg, the highest dose previously tested, and can potentially be safely administered while stimulating higher levels of stem cell mobilization for longer durations well beyond 24 hours. Increase of functional stem cells, also called mobilization, is an important prerequisite to the collection and transplantation of bone marrow cells in patients with hematologic malignancies.

Inhaled murepavadin

In January 2023, Spexis reported promising safety and pharmacokinetics results from a first-in-human study with inhaled murepavadin (iMPV), a novel macrocycle compound. The proprietary compound was derived from the company’s macrocycle platform and targets the outer membrane of Pseudomonas aeruginosa (PA) including resistant strains present in cystic fibrosis infections. The Phase 1 trial was a single center, double blind, randomized placebo-controlled trial to investigate the safety, tolerability, and pharmacokinetics of single ascending doses of iMPV in healthy volunteers. At the highest single dose tested, systemic bioavailability of MPV was lower than 5%, and peak plasma concentrations were observed 1-2 hours post start of inhalation. Pharmakokinetic results showed the concentration of iMPV at the 24-hour timepoint was still above the concentration that would inhibit the growth of 90% of PA isolates (MIC90) obtained from people with CF. The data suggested that iMPV leads to concentrations in the airways of the lung sufficient to target PA, while remaining lower than intravenous administration. This favorable tolerability, safety, and concentration profile provides support for future clinical trials of iMPV in people with CF or non-CF bronchiectasis.

Spexis intends to advance iMPV into Phase 1b/2 studies in CF patients in 2023, with the potential to expand development efforts into moderate to severe non-CF bronchiectasis (“nCFBE”), a significant additional market opportunity.

Financial Results

In the full year of 2022, Spexis’ total loss was CHF 18.6 million, primarily driven by research and development (R&D) expenditures of CHF 12.7 million. R&D expenditures are expected to increase in 2023 as the company launches the Phase 3 trial for ColiFin®, beginning with the COPILOT study in mid-2023. Spexis’ cash position as of December 31, 2022 was CHF 1.8 million (cash and cash equivalents). In April, Spexis received a capital commitment of USD 4.5 million from SPRIM Global Investments, as part of a clinical trial partnership expected to provide up to half of the projected ColiFin® Phase 3 development costs, including those involving both COPILOT and COPA.

Key figures¹

CHF million

¹⁾ based on the consolidated IFRS financial statements
²⁾ represents the average monthly cash used in operating and investing activities

The annual report 2022 is available for download on our website: https://www.spexisbio.com/investor-relations/reporting/

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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.

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.