New Risk • Apr 16
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended June 2023. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (42% average weekly change). Earnings have declined by 54% per year over the past 5 years. Market cap is less than US$10m (CHF4.32m market cap, or US$4.73m). Minor Risks Latest financial reports are more than 6 months old (reported June 2023 fiscal period end). Shareholders have been diluted in the past year (36% increase in shares outstanding). Revenue is less than US$5m (CHF1.2m revenue, or US$1.3m). New Risk • Mar 05
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: CHF8.73m (US$9.86m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (44% average weekly change). Earnings have declined by 54% per year over the past 5 years. Market cap is less than US$10m (CHF8.73m market cap, or US$9.86m). Minor Risks Shareholders have been diluted in the past year (19% increase in shares outstanding). Revenue is less than US$5m (CHF1.2m revenue, or US$1.3m). New Risk • Nov 08
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: CHF4.50m (US$5.02m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (28% average weekly change). Earnings are forecast to decline by an average of 52% per year for the foreseeable future. Market cap is less than US$10m (CHF4.50m market cap, or US$5.02m). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (CHF35m net loss in 2 years). Shareholders have been diluted in the past year (16% increase in shares outstanding). Revenue is less than US$5m (CHF1.2m revenue, or US$1.3m). Tillkännagivande • Sep 28
Spexis AG Announces Appointment of Gonçalo Bernardes as Acting Head of Chemical Biology Spexis AG announced that the company has appointed Gonçalo Bernardes, PhD, as acting Head of Chemical Biology. Dr. Bernardes is a leader in the fields of chemistry and oncology and currently a Full Professor at the University of Cambridge. He also leads a satellite lab at the Insituto Medicina Molecular in Lisbon. Multiple discoveries made in his lab have been translated into leading biopharmaceutical companies. Dr. Bernardes is a Full Professor of Chemical Biology and a Fellow of Trinity Hall College, Cambridge. He has co-founded companies using technology developed in his lab and has been awarded three European Research Council grants, as well as awards from the Royal Society of Chemistry, International Chemical Biology Society, European Federation of Medicinal Chemistry and The Blavatnik Family Foundation. Dr. Bernardes also serves as a Senior Fellow at Flagship Pioneering, the largest global venture incubator. He completed his Ph.D. at the University of Oxford, U.K., and his postdoctoral work at the Swiss Federal Institute of Technology (ETH) in Zürich. Tillkännagivande • Aug 15
Spexis AG announced that it has received $2.5 million in funding from SPRIM Ventures and other investors Spexis AG announced a private placement to issue secured, interest-bearing debt with partial warrant coverage from returning investor SPRIM Ventures and $1.5 million subordinated debt mandatorily converting into equity from institutional investors for the aggregate gross proceeds of $2.5 million on August 15, 2023. Tillkännagivande • Jun 27
Spexis AG, Annual General Meeting, Jun 26, 2023 Spexis AG, Annual General Meeting, Jun 26, 2023. Agenda: To approve the management report, the consolidated financial statements, and the annual financial statements for 2022; to consider re-election of the members of the Board of Directors, Jeffrey Wager, Kuno Sommer, Bernard Bollag, Daniel Hartmann, Robert Clarke, and Dennis Ausiello for a further year in office; to confirm Jeffrey Wager as Chairman of the Board of Directors; to elect Deloitte A.G. as auditors; and to consider other matters. Tillkännagivande • Jun 07
Spexis AG Announces the Publication of Preclinical Results from its Novel Class of Macrocyclic, Peptidomimetic Antibiotics Developed in Collaboration with the University of Zurich Spexis AG announced the publication of preclinical results from the company's novel class of macrocyclic, peptidomimetic antibiotics developed in collaboration with the University of Zurich, demonstrating potent in vitro and in vivo antimicrobial activity against multidrug resistant (MDR) and extensively drug resistant (XDR) Enterobacteriaceae. Antimicrobial resistance (AMR) has emerged as a significant threat for both patients and healthcare systems. According to the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO), bacterial AMR is associated with the deaths of approximately 5 million people worldwide each year. In the United States, more than 2.8 million antimicrobial-resistant infections occur each year, leading to over 35,000 deaths and an estimated USD 4.6 billion in healthcare costs. On a global scale, the WHO estimates the overall economic burden from the emergence of AMR, including impact on international trade and healthcare expenses, could cost the world economy USD 100 trillion by 2050. MDR, XDR, and carbapenem-resistant and colistin-resistant Enterobacteriaceae, specifically Klebsiella pneumoniae and Escherichia coli, have been identified by the WHO as priority one Gram-negative pathogens in the fight against AMR. Carbapenem-resistant Klebsiella pneumoniae strains exhibiting hypervirulence and resistance have been associated with overall mortality up to 84% according to the European Centre for Disease Prevention and Control (ECDC). The ECDC also projects that resistant Enterobacteriaceae have a high potential to cause outbreaks in healthcare and community settings with global dissemination a major concern. As antibiotic use increases, selective pressures on microbes increase, frequently leading to the development of resistance. Recent discovery of plasmid-mediated transferable colistin resistance genes have shown the ease with which resistance can spread in bacterial populations. These transferable genes are often transmitted with other resistance genes, leading to strains of multi-drug resistant bacteria. Data from a multinational prospective cohort study published in The Lancet showed that carbapenem resistance was associated with an increased length of hospital stays and increased probability of in-hospital mortality. Even countries with judicious antibiotic use have seen the prevalence of resistance doubling in the past 5 years according to a study in the British Medical Journal. Tillkännagivande • May 25
Spexis AG to Report Fiscal Year 2022 Results on May 30, 2023 Spexis AG announced that they will report fiscal year 2022 results on May 30, 2023 Tillkännagivande • Feb 09
Spexis AG announced that it has received $0.5 million in funding from SPRIM Ventures Spexis AG announced that it has received $500,000 in a round of funding on February 8, 2023. The transaction included participation from SPRIM Ventures. The company issued interest-bearing subordinated convertible note financing with a term of 2 years and partial warrant coverage. Tillkännagivande • Feb 08
Spexis and SPRIM Global Investments Announces Plans for Clinical Trial Partnership to Fund up to Half of the Projected Phase 3 Clinical Development Costs of ColiFin® Spexis AG 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 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. Tillkännagivande • Jan 09
Spexis AG Reports Solid Safety and Pharmacokinetics Results from First-In-Human Study with Inhaled Murepavadin, a Novel Macrocycle Compound Spexis AG announced the successful completion of the first-in-human clinical trial with novel class antibiotic murepavadin, delivered via the oral inhalation route (iMPV). iMPV is a macrocycle compound derived from Spexis’ proprietary platform and specifically targets the outer membrane of Pseudomonas aeruginosa (P. aeruginosa) including activity against highly resistant strains. P. aeruginosa is the key pathogen in cystic fibrosis (CF) lung infections. The study was supported by the European Innovative Medicines Initiative (IMI). This 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. A total of 39 subjects participated in the trial. In Part A of the trial, three single dose levels (12.5 mg, 25mg, and 50 mg of iMPV) were evaluated in four subjects per cohort. In Part B, single doses of 75 mg, 150 mg, and 300 mg were evaluated in nine subjects per cohort. The pharmacokinetics (PK) of iMPV were assessed in blood samples and in epithelial lining fluid (ELF) obtained by bronchoalveolar lavage. Analyses of the preliminary, blinded data from this study showed that iMPV was well tolerated at all dose levels, with all subjects completing the inhalation. No clinically relevant signs of irritation of the upper airways and no serious adverse events were reported. Serial pulmonary function tests were normal and did not show narrowing of the airways after administration of iMPV. Vital signs, ECGs and safety laboratory data were within the normal range. At the highest single dose tested, systemic bioavailability of MPV was lower than 5%, and peak plasma concentrations were observed at 1-2 hours post start of inhalation. In the ELF, the concentration of MPV at the 24-hour timepoint was still above the concentration that would inhibit the growth of 90% of P. aeruginosa isolates (MIC90) obtained from people with CF. These data indicate that iMPV leads to high inhibiting concentrations in the airways of the lung while systemic MPV levels remain substantially lower compared to the plasma level observed in previous clinical trials with intravenous administration of MPV. This observed favorable tolerability, safety and concentration profile of MPV after inhalation in the Phase 1 trial meets the company’s expectations and clears the way for further clinical trials of iMPV in people with CF or non-CF bronchiectasis. Tillkännagivande • Dec 13
Spexis Announces Promising Pre-Clinical Data with Balixafortide in Combination with Various Therapies on the Market for Treating B-Cell Lymphomas Spexis AG announced results from an in vitro study evaluating the effects of combining Spexis’ potent CXCR4 inhibitor balixafortide (BLX) with several conventional or targeted therapies on the market in B-cell lymphoma models. The research was conducted under the leadership of Prof. Francesco Bertoni at the renowned Institute of Oncology Research in Bellinzona, Switzerland. The study results demonstrated that the addition of either BLX or another CXCR4 inhibitor from the Spexis macrocycles platform, SPX5551, to conventional or targeted therapies, including the BCR-ABL tyrosine kinase inhibitor imatinib, the P13K inhibitor copanlisib and the BTK inhibitor ibrutinib, showed an increase in anti-proliferative activity, either additive or synergistic, across all tested B-cell lymphomas. These data suggest that the addition of balixafortide or SPX5551 has the potential to improve the effect of BCR inhibitors and may overcome resistance to BTK and PI3K inhibitors in the treatment of patients with certain types of B-cell lymphoma. The study was designed to assess whether the pharmacological inhibition of CXCR4 could increase the anti-tumor activity of various anti-lymphoma agents across different B-cell lymphoma cell lines, including some with secondary resistance to BTK and PI3K inhibitors. Anti-proliferative activity was measured by the MTT assay in cell lines derived from mantle cell lymphoma, chronic lymphocytic leukemia, and marginal zone lymphoma. The MTT assay is used to measure cellular metabolic activity as an indicator of cell viability, proliferation and cytotoxicity. Board Change • Nov 16
No independent directors Following the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 6 non-independent directors. Co-Founder and Director Dan Hartman was the last director to join the board, commencing their role in 2021. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model. Tillkännagivande • Sep 23
Spexis Announces Positive Renal Impairment Clinical Trial Results with Balixafortide Spexis AG announced the results of a Phase 1 clinical trial with balixafortide ("BLX"), a potent, specific and highly selective macrocycle inhibitor of CXCR4. This study was undertaken to investigate whether dosing of BLX needs to be adjusted in patients with renal impairment as part of any future market approval submission. 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 BLX. In this trial, BLX was shown to be safe and well tolerated in all subjects, with only transient and mild-to-moderate manageable hypersensitivity-like events known to occur during initial drug infusion with CXCR4 inhibitors that were independent of renal impairment grade. With increasing grades of renal impairment, BLX administration resulted in more and longer-persisting circulating white blood cell levels, including neutrophils. Previous clinical trials with BLX at lower doses had demonstrated the ability to stimulate stem cell mobilization in healthy volunteers and in patients with advanced hematologic malignancies. The data from this renal impairment trial indicate that BLX doses substantially higher than 5.5 mg/kg, the higher dose previously tested, can potentially be safely administered, stimulate higher levels of stem cell mobilization and 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. CXCR4 inhibition has been shown to be a viable approach to increase the yield of collecting stem cells from peripheral blood. Tillkännagivande • Jul 29
Spexis AG announced that it expects to receive CHF 15 million in funding from Iris Capital Management SAS Spexis AG announced that it has entered into an equity-linked financing arrangement and will raise CHF 15 million in a round of funding from Iris Capital Management SAS on July 28, 2022. The transaction is expected to close in 2024. The shares will be created from the company's conditional capital, based on this interest-free mandatory convertible bonds program. Tillkännagivande • Jul 07
Spexis' Cxcr4 Inhibitor Balixafortide Demonstrates Synergistic Efficacy in Combination with Docetaxel in Metastatic Prostate Cancer Preclinical Model SPEXIS AG announced that its CXCR4 inhibitor balixafortide demonstrated synergistic efficacy in combination with docetaxel compared to either drug alone in a metastatic prostate cancer preclinical model. Balixafortide is a potent and selective clinical-stage CXCR4 inhibitor. Spexis is currently evaluating various development opportunities for this program, including in hematological and solid tumors, as well as certain rare diseases beyond oncology. The preclinical study of metastatic prostate cancer combining balixafortide (20 mg/kg twice daily in mice, corresponding to a clinically relevant dose) and docetaxel (5 mg/kg once weekly) assessed tumor burden and tumor-induced bone degradation. Overall, results showed superior synergistic efficacy compared to either drug alone. For measuring tumor burden, PC3-luc tumor cells were assessed by bioluminescence imaging, while bone resorption was analyzed by tartrate-resistant acid phosphatase (TRAcP) serum levels. Animals that received treatment had lower TRAcP levels than the vehicle group (p = 0.01). The combination of balixafortide and docetaxel decreased the total tumor burden significantly (p = 0.009). In addition, tumor-induced bone degradation was assessed by radiography and biomarkers. Radiograph imaging of the tibia on the day of study end demonstrated that animals receiving a combination of balixafortide and docetaxel showed less overall bone degradation from PC3-luc tumor cells. Additional studies are in preparation to investigate the anti-metastatic mechanisms of action in more detail. The experiments were performed pursuant to a research collaboration with Professor Evan T. Keller from the University of Michigan. Board Change • Apr 27
No independent directors Following the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 6 non-independent directors. Co-Founder and Director Dan Hartman was the last director to join the board, commencing their role in 2021. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model. Tillkännagivande • Apr 01
Spexis AG, Annual General Meeting, Apr 26, 2022 Spexis AG, Annual General Meeting, Apr 26, 2022. Board Change • Jan 04
No independent directors Following the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 5 non-independent directors. Director Bob Clarke was the last director to join the board, commencing their role in 2020. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model. 