View ValuationThis company listing is no longer activeThis company may still be operating, however this listing is no longer active. Find out why through their latest events.See Latest EventsSpexis 将来の成長Future 基準チェック /06現在、 Spexisの成長と収益を予測するのに十分なアナリストの調査がありません。主要情報n/a収益成長率n/aEPS成長率Biotechs 収益成長22.3%収益成長率n/a将来の株主資本利益率n/aアナリストカバレッジNone最終更新日n/a今後の成長に関する最新情報更新なしすべての更新を表示Recent updatesNew Risk • Apr 16New minor risk - Financial data availabilityThe 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 05New major risk - Market cap sizeThe 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 08New major risk - Market cap sizeThe 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).お知らせ • Nov 01+ 1 more updateSpexis AG Announces Executive Changes, Effective December 1, 2023Spexis AG announced that Hernan Levett, currently Chief Financial Officer, has decided to pursue a new career opportunity outside the company. He will continue to support the company as a strategic advisor on financial transactions and will depart the company effective December 1, 2023. Martin Jakobovic, currently Head of Finance, will succeed Hernan Levett as interim Chief Financial Officer joining the Executive Committee on December 1, 2023.お知らせ • Sep 28Spexis AG Announces Appointment of Gonçalo Bernardes as Acting Head of Chemical BiologySpexis 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.お知らせ • Aug 15Spexis AG announced that it has received $2.5 million in funding from SPRIM Ventures and other investorsSpexis 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.お知らせ • Jun 27Spexis AG, Annual General Meeting, Jun 26, 2023Spexis 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.お知らせ • Jun 07Spexis AG Announces the Publication of Preclinical Results from its Novel Class of Macrocyclic, Peptidomimetic Antibiotics Developed in Collaboration with the University of ZurichSpexis 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.お知らせ • May 25Spexis AG to Report Fiscal Year 2022 Results on May 30, 2023Spexis AG announced that they will report fiscal year 2022 results on May 30, 2023お知らせ • Feb 09Spexis AG announced that it has received $0.5 million in funding from SPRIM VenturesSpexis 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.お知らせ • Feb 08Spexis 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.お知らせ • Jan 09Spexis AG Reports Solid Safety and Pharmacokinetics Results from First-In-Human Study with Inhaled Murepavadin, a Novel Macrocycle CompoundSpexis 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.お知らせ • Dec 13Spexis Announces Promising Pre-Clinical Data with Balixafortide in Combination with Various Therapies on the Market for Treating B-Cell LymphomasSpexis 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 16No independent directorsFollowing 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.お知らせ • Sep 23Spexis Announces Positive Renal Impairment Clinical Trial Results with BalixafortideSpexis 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.お知らせ • Jul 29Spexis AG announced that it expects to receive CHF 15 million in funding from Iris Capital Management SASSpexis 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.お知らせ • Jul 07Spexis' Cxcr4 Inhibitor Balixafortide Demonstrates Synergistic Efficacy in Combination with Docetaxel in Metastatic Prostate Cancer Preclinical ModelSPEXIS 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 27No independent directorsFollowing 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.お知らせ • Apr 01Spexis AG, Annual General Meeting, Apr 26, 2022Spexis AG, Annual General Meeting, Apr 26, 2022.Board Change • Jan 04No independent directorsFollowing 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. このセクションでは通常、投資家が会社の利益創出能力を理解する一助となるよう、プロのアナリストのコンセンサス予想に基づく収益と利益の成長予測を提示する。しかし、Spexis は十分な過去のデータを提供しておらず、アナリストの予測もないため、過去のデータを外挿したり、アナリストの予測を使用しても、その将来の収益を確実に算出することはできません。 シンプリー・ウォール・ストリートがカバーする企業の97%は過去の財務データを持っているため、これはかなり稀な状況です。 業績と収益の成長予測BRSE:SPEX - アナリストの将来予測と過去の財務データ ( )CHF Millions日付収益収益フリー・キャッシュフロー営業活動によるキャッシュ平均アナリスト数12/31/20231-20-5-5N/A9/30/20231-16-7-7N/A6/30/20231-12-8-8N/A3/31/20231-16-10-10N/A12/31/20221-19-12-12N/A9/30/20221-20-10-10N/A6/30/20221-21-8-8N/A3/31/20220-16-5-5N/A12/31/20210-12-1-1N/A9/30/20210-7-1-1N/A6/30/20210-2-1-1N/A3/31/20210-2-1-1N/A12/31/20200-2-1-1N/A12/31/20190-2-1-1N/Aもっと見るアナリストによる今後の成長予測収入対貯蓄率: SPEXの予測収益成長が 貯蓄率 ( 0.4% ) を上回っているかどうかを判断するにはデータが不十分です。収益対市場: SPEXの収益がSwiss市場よりも速く成長すると予測されるかどうかを判断するにはデータが不十分です高成長収益: SPEXの収益が今後 3 年間で 大幅に 増加すると予想されるかどうかを判断するにはデータが不十分です。収益対市場: SPEXの収益がSwiss市場よりも速く成長すると予測されるかどうかを判断するにはデータが不十分です。高い収益成長: SPEXの収益が年間20%よりも速く成長すると予測されるかどうかを判断するにはデータが不十分です。一株当たり利益成長率予想将来の株主資本利益率将来のROE: SPEXの 自己資本利益率 が 3 年後に高くなると予測されるかどうかを判断するにはデータが不十分です成長企業の発掘7D1Y7D1Y7D1YPharmaceuticals-biotech 業界の高成長企業。View Past Performance企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2025/04/10 04:29終値2025/03/19 00:00収益2023/12/31年間収益2023/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレークこのレポートを生成するために使用した分析モデルの詳細は、当社の Github ページ でご覧いただけます。また、レポートの使い方に関する ガイド や YouTube の チュートリアル もご用意しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋Spexis AG 0 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。1 アナリスト機関Christian OrqueraFirst Berlin Equity Research GmbH
New Risk • Apr 16New minor risk - Financial data availabilityThe 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 05New major risk - Market cap sizeThe 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 08New major risk - Market cap sizeThe 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).
お知らせ • Nov 01+ 1 more updateSpexis AG Announces Executive Changes, Effective December 1, 2023Spexis AG announced that Hernan Levett, currently Chief Financial Officer, has decided to pursue a new career opportunity outside the company. He will continue to support the company as a strategic advisor on financial transactions and will depart the company effective December 1, 2023. Martin Jakobovic, currently Head of Finance, will succeed Hernan Levett as interim Chief Financial Officer joining the Executive Committee on December 1, 2023.
お知らせ • Sep 28Spexis AG Announces Appointment of Gonçalo Bernardes as Acting Head of Chemical BiologySpexis 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.
お知らせ • Aug 15Spexis AG announced that it has received $2.5 million in funding from SPRIM Ventures and other investorsSpexis 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.
お知らせ • Jun 27Spexis AG, Annual General Meeting, Jun 26, 2023Spexis 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.
お知らせ • Jun 07Spexis AG Announces the Publication of Preclinical Results from its Novel Class of Macrocyclic, Peptidomimetic Antibiotics Developed in Collaboration with the University of ZurichSpexis 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.
お知らせ • May 25Spexis AG to Report Fiscal Year 2022 Results on May 30, 2023Spexis AG announced that they will report fiscal year 2022 results on May 30, 2023
お知らせ • Feb 09Spexis AG announced that it has received $0.5 million in funding from SPRIM VenturesSpexis 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.
お知らせ • Feb 08Spexis 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.
お知らせ • Jan 09Spexis AG Reports Solid Safety and Pharmacokinetics Results from First-In-Human Study with Inhaled Murepavadin, a Novel Macrocycle CompoundSpexis 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.
お知らせ • Dec 13Spexis Announces Promising Pre-Clinical Data with Balixafortide in Combination with Various Therapies on the Market for Treating B-Cell LymphomasSpexis 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 16No independent directorsFollowing 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.
お知らせ • Sep 23Spexis Announces Positive Renal Impairment Clinical Trial Results with BalixafortideSpexis 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.
お知らせ • Jul 29Spexis AG announced that it expects to receive CHF 15 million in funding from Iris Capital Management SASSpexis 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.
お知らせ • Jul 07Spexis' Cxcr4 Inhibitor Balixafortide Demonstrates Synergistic Efficacy in Combination with Docetaxel in Metastatic Prostate Cancer Preclinical ModelSPEXIS 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 27No independent directorsFollowing 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.
お知らせ • Apr 01Spexis AG, Annual General Meeting, Apr 26, 2022Spexis AG, Annual General Meeting, Apr 26, 2022.
Board Change • Jan 04No independent directorsFollowing 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.