Balixafortide

Spexis announces closing of sale of preclinical antibiotics program to Basilea Spexis AG / Key word(s): Miscellaneous 08-Feb-2024 / 07:15 CET/CEST Release of an ad hoc announcement pursuant to Art. 53 LR The issuer is solely responsible for the content of this announcement. Ad hoc announcement pursuant to Art. 53 LR Allschwil, Switzerland, February 8, 2024 Spexis announces closing of sale of preclinical antibiotics program to Basilea Basilea to pay up to CHF 2 million for a preclinical program with novel antibiotics targeting Gram-negative bacteria, including multidrug-resistant strains Transaction is part of Spexis’ efforts to partner or divest non-core programs and assets as the company works through its moratorium status Transaction was subject to certain closing conditions, which now have been met and which will commence payments from Basilea to Spexis Spexis AG (SIX: SPEX), a clinical-stage biopharmaceutical company focused on macrocycle therapeutics for rare diseases and oncology, today announced that it has closed its asset purchase agreement with Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN) wherein Basilea has now formally become the owner of a preclinical program of antibiotics developed by Spexis from a novel class targeting Gram-negative bacteria, including multidrug-resistant strains.1 The transaction was subject to the approval by the Western District Court of the Canton Basel-Landschaft, which has now been obtained. As part of the completed transaction, Basilea has acquired all program compounds, including intellectual property, and is paying Spexis up to a total of CHF 2 million, which consists of an upfront payment which was now received at closing, a payment related to the near-term transfer of the assets to Basilea, which is expected by the end of February and a potential final milestone payment related to the availability of near-term external funding for the further development of the program. In addition, Basilea has assumed the rights and obligations of Spexis related to the program, including potential low single-digit percentage royalties on sales, under licensing agreements. The assets sold to Basilea are macrocyclic antibiotics developed within Spexis’ Outer Membrane Protein Targeting Antibiotics (OMPTA) program which selectively disrupt the lipopolysaccharide transport bridge, an essential structure in Gram-negative bacteria. This results in a loss of the integrity of the outer cell membrane, intracellular accumulation of lipopolysaccharides and killing of the bacteria. Activity has been shown in vitro and in vivo against Enterobacteriaceae such as E. coli and K. pneumoniae, including strains resistant to beta-lactams and colistin, an antibiotic regarded as last-resort therapy. The program was funded in part by CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator)2, a global non-profit partnership dedicated to supporting early-stage antibacterial research and development to address the rising threat of drug-resistant bacteria. Jeff Wager, MD, Chairman & CEO of Spexis, said: “We are very pleased to have finalized this transaction with Basilea as it underscores the power of our macrocycle platform as a drug discovery platform and its potential to generate products that can address significant unmet medical needs. From a corporate strategy perspective, this transaction is part of Spexis’ efforts to partner or divest non-core programs and assets as the company works towards exiting its moratorium status and will generate funds and streamline focus which we can utilize towards advancing our core programs in rare disease and oncology. ” About multidrug-resistant Gram-negative bacteria Infections by multidrug-resistant Gram-negative bacteria (GNB) are a major challenge for healthcare professionals. Due to an additional outer cell membrane compared to Gram-positive bacteria, it is more difficult for antibiotics to get into the cell. In addition, this outer membrane carries lipopolysaccharides/endotoxins which induce inflammation and play an important amplifying role in the pathogenesis of infections by GNB and are therefore considered an important virulence factor. Moreover, GNB can acquire resistance to several classes of antibiotics such as carbapenems, fluoroquinolones, tetracyclines and earlier-generation cephalosporins, making infections with GNBs particularly difficult to treat. In 2017, the World Health Organization published a list of 12 classes of priority bacterial pathogens that pose the greatest threat to human health, of which nine classes are Gram-negative.3 About Spexis Spexis (SIX: SPEX) is a clinical-stage biopharmaceutical company based in Allschwil, Switzerland, focused on macrocycle therapeutics for rare diseases and oncology. For further information please visit: www.spexisbio.com. About Spexis’ Macrocycle Platforms Spexis possesses what we regard as some of the most distinct, highly diverse and very well characterized macrocycle libraries in the world, together with deep data on same, developed over the course of more than 25 years of research and development and significant investment. These include PEMFinder™, which is comprised of peptidomimetic macrocycles, and MACROFinder™, which are small molecule macrocycles. Each have distinct applications depending on the targets in question, which can be both extracelluar and intracellular targets. In addition to generating the specific OMPTA candidates described in this press release, these platforms have generated multiple other drug candidates in the Spexis pipeline, including murepavidin, balixafortide, lonodelestat and others. For further information please contact: For Investors: Stephen Jasper Managing Director Gilmartin Group stephen@gilmartinir.com For Media: Dr. Stephan Feldhaus Feldhaus & Partner +41 79 865 9256 feldhaus@feldhaus-partner.ch 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. This press release can be downloaded from www.spexisbio.com References M. Schuster, E. Brabet, K. K. Oi et al. Peptidomimetic antibiotics disrupt the lipopolysaccharide transport bridge of drug-resistant Enterobacteriaceae. Science Advances 2023 (9), eadg3683 Research reported in this press release is supported by CARB-X. CARB-X’s funding for this project is provided in part with federal funds from the US Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority under agreement number 75A50122C00028; and by awards from Wellcome (WT224842), and Germany’s Federal Ministry of Education and Research (BMBF). The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of CARB-X or any of its funders. https://www-who-int.libproxy1.nus.edu.sg/news/item/27-02-2017-who-publishes-list-of-bacteria-for-which-new-antibiotics-are-urgently-needed (Accessed: January 11th, 2024) End of Inside Information Language:EnglishCompany:Spexis AGHegenheimermattweg 1254123 AllschwilSwitzerlandPhone:+41 61 567 1600Fax:+41 61 567 1601E-mail:info@spexisbio.comInternet:www.spexisbio.comISIN:CH0106213793Valor:SPEXListed:SIX Swiss ExchangeEQS News ID:1832895 End of AnnouncementEQS News Service Spexis AG / Key word(s): Miscellaneous 08-Feb-2024 / 07:15 CET/CEST Release of an ad hoc announcement pursuant to Art. 53 LR The issuer is solely responsible for the content of this announcement. Ad hoc announcement pursuant to Art. 53 LR Allschwil, Switzerland, February 8, 2024 Spexis announces closing of sale of preclinical antibiotics program to Basilea Basilea to pay up to CHF 2 million for a preclinical program with novel antibiotics targeting Gram-negative bacteria, including multidrug-resistant strains Transaction is part of Spexis’ efforts to partner or divest non-core programs and assets as the company works through its moratorium status Transaction was subject to certain closing conditions, which now have been met and which will commence payments from Basilea to Spexis Spexis AG (SIX: SPEX), a clinical-stage biopharmaceutical company focused on macrocycle therapeutics for rare diseases and oncology, today announced that it has closed its asset purchase agreement with Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN) wherein Basilea has now formally become the owner of a preclinical program of antibiotics developed by Spexis from a novel class targeting Gram-negative bacteria, including multidrug-resistant strains.1 The transaction was subject to the approval by the Western District Court of the Canton Basel-Landschaft, which has now been obtained. As part of the completed transaction, Basilea has acquired all program compounds, including intellectual property, and is paying Spexis up to a total of CHF 2 million, which consists of an upfront payment which was now received at closing, a payment related to the near-term transfer of the assets to Basilea, which is expected by the end of February and a potential final milestone payment related to the availability of near-term external funding for the further development of the program. In addition, Basilea has assumed the rights and obligations of Spexis related to the program, including potential low single-digit percentage royalties on sales, under licensing agreements. The assets sold to Basilea are macrocyclic antibiotics developed within Spexis’ Outer Membrane Protein Targeting Antibiotics (OMPTA) program which selectively disrupt the lipopolysaccharide transport bridge, an essential structure in Gram-negative bacteria. This results in a loss of the integrity of the outer cell membrane, intracellular accumulation of lipopolysaccharides and killing of the bacteria. Activity has been shown in vitro and in vivo against Enterobacteriaceae such as E. coli and K. pneumoniae, including strains resistant to beta-lactams and colistin, an antibiotic regarded as last-resort therapy. The program was funded in part by CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator)2, a global non-profit partnership dedicated to supporting early-stage antibacterial research and development to address the rising threat of drug-resistant bacteria. Jeff Wager, MD, Chairman & CEO of Spexis, said: “We are very pleased to have finalized this transaction with Basilea as it underscores the power of our macrocycle platform as a drug discovery platform and its potential to generate products that can address significant unmet medical needs. From a corporate strategy perspective, this transaction is part of Spexis’ efforts to partner or divest non-core programs and assets as the company works towards exiting its moratorium status and will generate funds and streamline focus which we can utilize towards advancing our core programs in rare disease and oncology. ” About multidrug-resistant Gram-negative bacteria Infections by multidrug-resistant Gram-negative bacteria (GNB) are a major challenge for healthcare professionals. Due to an additional outer cell membrane compared to Gram-positive bacteria, it is more difficult for antibiotics to get into the cell. In addition, this outer membrane carries lipopolysaccharides/endotoxins which induce inflammation and play an important amplifying role in the pathogenesis of infections by GNB and are therefore considered an important virulence factor. Moreover, GNB can acquire resistance to several classes of antibiotics such as carbapenems, fluoroquinolones, tetracyclines and earlier-generation cephalosporins, making infections with GNBs particularly difficult to treat. In 2017, the World Health Organization published a list of 12 classes of priority bacterial pathogens that pose the greatest threat to human health, of which nine classes are Gram-negative.3 About Spexis Spexis (SIX: SPEX) is a clinical-stage biopharmaceutical company based in Allschwil, Switzerland, focused on macrocycle therapeutics for rare diseases and oncology. For further information please visit: www.spexisbio.com. About Spexis’ Macrocycle Platforms Spexis possesses what we regard as some of the most distinct, highly diverse and very well characterized macrocycle libraries in the world, together with deep data on same, developed over the course of more than 25 years of research and development and significant investment. These include PEMFinder™, which is comprised of peptidomimetic macrocycles, and MACROFinder™, which are small molecule macrocycles. Each have distinct applications depending on the targets in question, which can be both extracelluar and intracellular targets. In addition to generating the specific OMPTA candidates described in this press release, these platforms have generated multiple other drug candidates in the Spexis pipeline, including murepavidin, balixafortide, lonodelestat and others. For further information please contact: For Investors: Stephen Jasper Managing Director Gilmartin Group stephen@gilmartinir.com For Media: Dr. Stephan Feldhaus Feldhaus & Partner +41 79 865 9256 feldhaus@feldhaus-partner.ch 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. This press release can be downloaded from www.spexisbio.com References M. Schuster, E. Brabet, K. K. Oi et al. Peptidomimetic antibiotics disrupt the lipopolysaccharide transport bridge of drug-resistant Enterobacteriaceae. Science Advances 2023 (9), eadg3683 Research reported in this press release is supported by CARB-X. CARB-X’s funding for this project is provided in part with federal funds from the US Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority under agreement number 75A50122C00028; and by awards from Wellcome (WT224842), and Germany’s Federal Ministry of Education and Research (BMBF). The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of CARB-X or any of its funders. https://www-who-int.libproxy1.nus.edu.sg/news/item/27-02-2017-who-publishes-list-of-bacteria-for-which-new-antibiotics-are-urgently-needed (Accessed: January 11th, 2024) End of Inside Information Spexis AG / Key word(s): Miscellaneous 08-Feb-2024 / 07:15 CET/CEST Release of an ad hoc announcement pursuant to Art. 53 LR The issuer is solely responsible for the content of this announcement. Ad hoc announcement pursuant to Art. 53 LR Allschwil, Switzerland, February 8, 2024 Spexis announces closing of sale of preclinical antibiotics program to Basilea Basilea to pay up to CHF 2 million for a preclinical program with novel antibiotics targeting Gram-negative bacteria, including multidrug-resistant strains Transaction is part of Spexis’ efforts to partner or divest non-core programs and assets as the company works through its moratorium status Transaction was subject to certain closing conditions, which now have been met and which will commence payments from Basilea to Spexis Spexis AG (SIX: SPEX), a clinical-stage biopharmaceutical company focused on macrocycle therapeutics for rare diseases and oncology, today announced that it has closed its asset purchase agreement with Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN) wherein Basilea has now formally become the owner of a preclinical program of antibiotics developed by Spexis from a novel class targeting Gram-negative bacteria, including multidrug-resistant strains.1 The transaction was subject to the approval by the Western District Court of the Canton Basel-Landschaft, which has now been obtained. As part of the completed transaction, Basilea has acquired all program compounds, including intellectual property, and is paying Spexis up to a total of CHF 2 million, which consists of an upfront payment which was now received at closing, a payment related to the near-term transfer of the assets to Basilea, which is expected by the end of February and a potential final milestone payment related to the availability of near-term external funding for the further development of the program. In addition, Basilea has assumed the rights and obligations of Spexis related to the program, including potential low single-digit percentage royalties on sales, under licensing agreements. The assets sold to Basilea are macrocyclic antibiotics developed within Spexis’ Outer Membrane Protein Targeting Antibiotics (OMPTA) program which selectively disrupt the lipopolysaccharide transport bridge, an essential structure in Gram-negative bacteria. This results in a loss of the integrity of the outer cell membrane, intracellular accumulation of lipopolysaccharides and killing of the bacteria. Activity has been shown in vitro and in vivo against Enterobacteriaceae such as E. coli and K. pneumoniae, including strains resistant to beta-lactams and colistin, an antibiotic regarded as last-resort therapy. The program was funded in part by CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator)2, a global non-profit partnership dedicated to supporting early-stage antibacterial research and development to address the rising threat of drug-resistant bacteria. Jeff Wager, MD, Chairman & CEO of Spexis, said: “We are very pleased to have finalized this transaction with Basilea as it underscores the power of our macrocycle platform as a drug discovery platform and its potential to generate products that can address significant unmet medical needs. From a corporate strategy perspective, this transaction is part of Spexis’ efforts to partner or divest non-core programs and assets as the company works towards exiting its moratorium status and will generate funds and streamline focus which we can utilize towards advancing our core programs in rare disease and oncology. ” About multidrug-resistant Gram-negative bacteria Infections by multidrug-resistant Gram-negative bacteria (GNB) are a major challenge for healthcare professionals. Due to an additional outer cell membrane compared to Gram-positive bacteria, it is more difficult for antibiotics to get into the cell. In addition, this outer membrane carries lipopolysaccharides/endotoxins which induce inflammation and play an important amplifying role in the pathogenesis of infections by GNB and are therefore considered an important virulence factor. Moreover, GNB can acquire resistance to several classes of antibiotics such as carbapenems, fluoroquinolones, tetracyclines and earlier-generation cephalosporins, making infections with GNBs particularly difficult to treat. In 2017, the World Health Organization published a list of 12 classes of priority bacterial pathogens that pose the greatest threat to human health, of which nine classes are Gram-negative.3 About Spexis Spexis (SIX: SPEX) is a clinical-stage biopharmaceutical company based in Allschwil, Switzerland, focused on macrocycle therapeutics for rare diseases and oncology. For further information please visit: www.spexisbio.com. About Spexis’ Macrocycle Platforms Spexis possesses what we regard as some of the most distinct, highly diverse and very well characterized macrocycle libraries in the world, together with deep data on same, developed over the course of more than 25 years of research and development and significant investment. These include PEMFinder™, which is comprised of peptidomimetic macrocycles, and MACROFinder™, which are small molecule macrocycles. Each have distinct applications depending on the targets in question, which can be both extracelluar and intracellular targets. In addition to generating the specific OMPTA candidates described in this press release, these platforms have generated multiple other drug candidates in the Spexis pipeline, including murepavidin, balixafortide, lonodelestat and others. For further information please contact: For Investors: Stephen Jasper Managing Director Gilmartin Group stephen@gilmartinir.com For Media: Dr. Stephan Feldhaus Feldhaus & Partner +41 79 865 9256 feldhaus@feldhaus-partner.ch 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. This press release can be downloaded from www.spexisbio.com References M. Schuster, E. Brabet, K. K. Oi et al. Peptidomimetic antibiotics disrupt the lipopolysaccharide transport bridge of drug-resistant Enterobacteriaceae. Science Advances 2023 (9), eadg3683 Research reported in this press release is supported by CARB-X. CARB-X’s funding for this project is provided in part with federal funds from the US Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority under agreement number 75A50122C00028; and by awards from Wellcome (WT224842), and Germany’s Federal Ministry of Education and Research (BMBF). The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of CARB-X or any of its funders. https://www-who-int.libproxy1.nus.edu.sg/news/item/27-02-2017-who-publishes-list-of-bacteria-for-which-new-antibiotics-are-urgently-needed (Accessed: January 11th, 2024) End of Inside Information Spexis AG / Key word(s): Miscellaneous 08-Feb-2024 / 07:15 CET/CEST Release of an ad hoc announcement pursuant to Art. 53 LR The issuer is solely responsible for the content of this announcement. Ad hoc announcement pursuant to Art. 53 LR Allschwil, Switzerland, February 8, 2024 Spexis announces closing of sale of preclinical antibiotics program to Basilea Basilea to pay up to CHF 2 million for a preclinical program with novel antibiotics targeting Gram-negative bacteria, including multidrug-resistant strains Transaction is part of Spexis’ efforts to partner or divest non-core programs and assets as the company works through its moratorium status Transaction was subject to certain closing conditions, which now have been met and which will commence payments from Basilea to Spexis Spexis AG (SIX: SPEX), a clinical-stage biopharmaceutical company focused on macrocycle therapeutics for rare diseases and oncology, today announced that it has closed its asset purchase agreement with Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN) wherein Basilea has now formally become the owner of a preclinical program of antibiotics developed by Spexis from a novel class targeting Gram-negative bacteria, including multidrug-resistant strains.1 The transaction was subject to the approval by the Western District Court of the Canton Basel-Landschaft, which has now been obtained. As part of the completed transaction, Basilea has acquired all program compounds, including intellectual property, and is paying Spexis up to a total of CHF 2 million, which consists of an upfront payment which was now received at closing, a payment related to the near-term transfer of the assets to Basilea, which is expected by the end of February and a potential final milestone payment related to the availability of near-term external funding for the further development of the program. In addition, Basilea has assumed the rights and obligations of Spexis related to the program, including potential low single-digit percentage royalties on sales, under licensing agreements. The assets sold to Basilea are macrocyclic antibiotics developed within Spexis’ Outer Membrane Protein Targeting Antibiotics (OMPTA) program which selectively disrupt the lipopolysaccharide transport bridge, an essential structure in Gram-negative bacteria. This results in a loss of the integrity of the outer cell membrane, intracellular accumulation of lipopolysaccharides and killing of the bacteria. Activity has been shown in vitro and in vivo against Enterobacteriaceae such as E. coli and K. pneumoniae, including strains resistant to beta-lactams and colistin, an antibiotic regarded as last-resort therapy. The program was funded in part by CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator)2, a global non-profit partnership dedicated to supporting early-stage antibacterial research and development to address the rising threat of drug-resistant bacteria. Jeff Wager, MD, Chairman & CEO of Spexis, said: “We are very pleased to have finalized this transaction with Basilea as it underscores the power of our macrocycle platform as a drug discovery platform and its potential to generate products that can address significant unmet medical needs. From a corporate strategy perspective, this transaction is part of Spexis’ efforts to partner or divest non-core programs and assets as the company works towards exiting its moratorium status and will generate funds and streamline focus which we can utilize towards advancing our core programs in rare disease and oncology. ” About multidrug-resistant Gram-negative bacteria Infections by multidrug-resistant Gram-negative bacteria (GNB) are a major challenge for healthcare professionals. Due to an additional outer cell membrane compared to Gram-positive bacteria, it is more difficult for antibiotics to get into the cell. In addition, this outer membrane carries lipopolysaccharides/endotoxins which induce inflammation and play an important amplifying role in the pathogenesis of infections by GNB and are therefore considered an important virulence factor. Moreover, GNB can acquire resistance to several classes of antibiotics such as carbapenems, fluoroquinolones, tetracyclines and earlier-generation cephalosporins, making infections with GNBs particularly difficult to treat. In 2017, the World Health Organization published a list of 12 classes of priority bacterial pathogens that pose the greatest threat to human health, of which nine classes are Gram-negative.3 About Spexis Spexis (SIX: SPEX) is a clinical-stage biopharmaceutical company based in Allschwil, Switzerland, focused on macrocycle therapeutics for rare diseases and oncology. For further information please visit: www.spexisbio.com. About Spexis’ Macrocycle Platforms Spexis possesses what we regard as some of the most distinct, highly diverse and very well characterized macrocycle libraries in the world, together with deep data on same, developed over the course of more than 25 years of research and development and significant investment. These include PEMFinder™, which is comprised of peptidomimetic macrocycles, and MACROFinder™, which are small molecule macrocycles. Each have distinct applications depending on the targets in question, which can be both extracelluar and intracellular targets. In addition to generating the specific OMPTA candidates described in this press release, these platforms have generated multiple other drug candidates in the Spexis pipeline, including murepavidin, balixafortide, lonodelestat and others. For further information please contact: For Investors: Stephen Jasper Managing Director Gilmartin Group stephen@gilmartinir.com For Media: Dr. Stephan Feldhaus Feldhaus & Partner +41 79 865 9256 feldhaus@feldhaus-partner.ch 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. This press release can be downloaded from www.spexisbio.com References M. Schuster, E. Brabet, K. K. Oi et al. Peptidomimetic antibiotics disrupt the lipopolysaccharide transport bridge of drug-resistant Enterobacteriaceae. Science Advances 2023 (9), eadg3683 Research reported in this press release is supported by CARB-X. CARB-X’s funding for this project is provided in part with federal funds from the US Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority under agreement number 75A50122C00028; and by awards from Wellcome (WT224842), and Germany’s Federal Ministry of Education and Research (BMBF). The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of CARB-X or any of its funders. https://www-who-int.libproxy1.nus.edu.sg/news/item/27-02-2017-who-publishes-list-of-bacteria-for-which-new-antibiotics-are-urgently-needed (Accessed: January 11th, 2024) End of Inside Information Spexis AG / Key word(s): Miscellaneous 08-Feb-2024 / 07:15 CET/CEST Release of an ad hoc announcement pursuant to Art. 53 LR The issuer is solely responsible for the content of this announcement. Ad hoc announcement pursuant to Art. 53 LR Allschwil, Switzerland, February 8, 2024 Spexis announces closing of sale of preclinical antibiotics program to Basilea Basilea to pay up to CHF 2 million for a preclinical program with novel antibiotics targeting Gram-negative bacteria, including multidrug-resistant strains Transaction is part of Spexis’ efforts to partner or divest non-core programs and assets as the company works through its moratorium status Transaction was subject to certain closing conditions, which now have been met and which will commence payments from Basilea to Spexis Spexis AG (SIX: SPEX), a clinical-stage biopharmaceutical company focused on macrocycle therapeutics for rare diseases and oncology, today announced that it has closed its asset purchase agreement with Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN) wherein Basilea has now formally become the owner of a preclinical program of antibiotics developed by Spexis from a novel class targeting Gram-negative bacteria, including multidrug-resistant strains.1 The transaction was subject to the approval by the Western District Court of the Canton Basel-Landschaft, which has now been obtained. As part of the completed transaction, Basilea has acquired all program compounds, including intellectual property, and is paying Spexis up to a total of CHF 2 million, which consists of an upfront payment which was now received at closing, a payment related to the near-term transfer of the assets to Basilea, which is expected by the end of February and a potential final milestone payment related to the availability of near-term external funding for the further development of the program. In addition, Basilea has assumed the rights and obligations of Spexis related to the program, including potential low single-digit percentage royalties on sales, under licensing agreements. The assets sold to Basilea are macrocyclic antibiotics developed within Spexis’ Outer Membrane Protein Targeting Antibiotics (OMPTA) program which selectively disrupt the lipopolysaccharide transport bridge, an essential structure in Gram-negative bacteria. This results in a loss of the integrity of the outer cell membrane, intracellular accumulation of lipopolysaccharides and killing of the bacteria. Activity has been shown in vitro and in vivo against Enterobacteriaceae such as E. coli and K. pneumoniae, including strains resistant to beta-lactams and colistin, an antibiotic regarded as last-resort therapy. The program was funded in part by CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator)2, a global non-profit partnership dedicated to supporting early-stage antibacterial research and development to address the rising threat of drug-resistant bacteria. Jeff Wager, MD, Chairman & CEO of Spexis, said: “We are very pleased to have finalized this transaction with Basilea as it underscores the power of our macrocycle platform as a drug discovery platform and its potential to generate products that can address significant unmet medical needs. From a corporate strategy perspective, this transaction is part of Spexis’ efforts to partner or divest non-core programs and assets as the company works towards exiting its moratorium status and will generate funds and streamline focus which we can utilize towards advancing our core programs in rare disease and oncology. ” About multidrug-resistant Gram-negative bacteria Infections by multidrug-resistant Gram-negative bacteria (GNB) are a major challenge for healthcare professionals. Due to an additional outer cell membrane compared to Gram-positive bacteria, it is more difficult for antibiotics to get into the cell. In addition, this outer membrane carries lipopolysaccharides/endotoxins which induce inflammation and play an important amplifying role in the pathogenesis of infections by GNB and are therefore considered an important virulence factor. Moreover, GNB can acquire resistance to several classes of antibiotics such as carbapenems, fluoroquinolones, tetracyclines and earlier-generation cephalosporins, making infections with GNBs particularly difficult to treat. In 2017, the World Health Organization published a list of 12 classes of priority bacterial pathogens that pose the greatest threat to human health, of which nine classes are Gram-negative.3 About Spexis Spexis (SIX: SPEX) is a clinical-stage biopharmaceutical company based in Allschwil, Switzerland, focused on macrocycle therapeutics for rare diseases and oncology. For further information please visit: www.spexisbio.com. About Spexis’ Macrocycle Platforms Spexis possesses what we regard as some of the most distinct, highly diverse and very well characterized macrocycle libraries in the world, together with deep data on same, developed over the course of more than 25 years of research and development and significant investment. These include PEMFinder™, which is comprised of peptidomimetic macrocycles, and MACROFinder™, which are small molecule macrocycles. Each have distinct applications depending on the targets in question, which can be both extracelluar and intracellular targets. In addition to generating the specific OMPTA candidates described in this press release, these platforms have generated multiple other drug candidates in the Spexis pipeline, including murepavidin, balixafortide, lonodelestat and others. For further information please contact: For Investors: Stephen Jasper Managing Director Gilmartin Group stephen@gilmartinir.com For Media: Dr. Stephan Feldhaus Feldhaus & Partner +41 79 865 9256 feldhaus@feldhaus-partner.ch 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. This press release can be downloaded from www.spexisbio.com References M. Schuster, E. Brabet, K. K. Oi et al. Peptidomimetic antibiotics disrupt the lipopolysaccharide transport bridge of drug-resistant Enterobacteriaceae. Science Advances 2023 (9), eadg3683 Research reported in this press release is supported by CARB-X. CARB-X’s funding for this project is provided in part with federal funds from the US Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority under agreement number 75A50122C00028; and by awards from Wellcome (WT224842), and Germany’s Federal Ministry of Education and Research (BMBF). The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of CARB-X or any of its funders. https://www-who-int.libproxy1.nus.edu.sg/news/item/27-02-2017-who-publishes-list-of-bacteria-for-which-new-antibiotics-are-urgently-needed (Accessed: January 11th, 2024) End of Inside Information Spexis AG / Key word(s): Miscellaneous 08-Feb-2024 / 07:15 CET/CEST Release of an ad hoc announcement pursuant to Art. 53 LR The issuer is solely responsible for the content of this announcement. 08-Feb-2024 / 07:15 CET/CEST Ad hoc announcement pursuant to Art. 53 LR Allschwil, Switzerland, February 8, 2024 Spexis announces closing of sale of preclinical antibiotics program to Basilea Basilea to pay up to CHF 2 million for a preclinical program with novel antibiotics targeting Gram-negative bacteria, including multidrug-resistant strains Transaction is part of Spexis’ efforts to partner or divest non-core programs and assets as the company works through its moratorium status Transaction was subject to certain closing conditions, which now have been met and which will commence payments from Basilea to Spexis Spexis AG (SIX: SPEX), a clinical-stage biopharmaceutical company focused on macrocycle therapeutics for rare diseases and oncology, today announced that it has closed its asset purchase agreement with Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN) wherein Basilea has now formally become the owner of a preclinical program of antibiotics developed by Spexis from a novel class targeting Gram-negative bacteria, including multidrug-resistant strains.1 The transaction was subject to the approval by the Western District Court of the Canton Basel-Landschaft, which has now been obtained. As part of the completed transaction, Basilea has acquired all program compounds, including intellectual property, and is paying Spexis up to a total of CHF 2 million, which consists of an upfront payment which was now received at closing, a payment related to the near-term transfer of the assets to Basilea, which is expected by the end of February and a potential final milestone payment related to the availability of near-term external funding for the further development of the program. In addition, Basilea has assumed the rights and obligations of Spexis related to the program, including potential low single-digit percentage royalties on sales, under licensing agreements. The assets sold to Basilea are macrocyclic antibiotics developed within Spexis’ Outer Membrane Protein Targeting Antibiotics (OMPTA) program which selectively disrupt the lipopolysaccharide transport bridge, an essential structure in Gram-negative bacteria. This results in a loss of the integrity of the outer cell membrane, intracellular accumulation of lipopolysaccharides and killing of the bacteria. Activity has been shown in vitro and in vivo against Enterobacteriaceae such as E. coli and K. pneumoniae, including strains resistant to beta-lactams and colistin, an antibiotic regarded as last-resort therapy. The program was funded in part by CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator)2, a global non-profit partnership dedicated to supporting early-stage antibacterial research and development to address the rising threat of drug-resistant bacteria. Jeff Wager, MD, Chairman & CEO of Spexis, said: “We are very pleased to have finalized this transaction with Basilea as it underscores the power of our macrocycle platform as a drug discovery platform and its potential to generate products that can address significant unmet medical needs. From a corporate strategy perspective, this transaction is part of Spexis’ efforts to partner or divest non-core programs and assets as the company works towards exiting its moratorium status and will generate funds and streamline focus which we can utilize towards advancing our core programs in rare disease and oncology. ” About multidrug-resistant Gram-negative bacteria Infections by multidrug-resistant Gram-negative bacteria (GNB) are a major challenge for healthcare professionals. Due to an additional outer cell membrane compared to Gram-positive bacteria, it is more difficult for antibiotics to get into the cell. In addition, this outer membrane carries lipopolysaccharides/endotoxins which induce inflammation and play an important amplifying role in the pathogenesis of infections by GNB and are therefore considered an important virulence factor. Moreover, GNB can acquire resistance to several classes of antibiotics such as carbapenems, fluoroquinolones, tetracyclines and earlier-generation cephalosporins, making infections with GNBs particularly difficult to treat. In 2017, the World Health Organization published a list of 12 classes of priority bacterial pathogens that pose the greatest threat to human health, of which nine classes are Gram-negative.3 About Spexis Spexis (SIX: SPEX) is a clinical-stage biopharmaceutical company based in Allschwil, Switzerland, focused on macrocycle therapeutics for rare diseases and oncology. For further information please visit: www.spexisbio.com. About Spexis’ Macrocycle Platforms Spexis possesses what we regard as some of the most distinct, highly diverse and very well characterized macrocycle libraries in the world, together with deep data on same, developed over the course of more than 25 years of research and development and significant investment. These include PEMFinder™, which is comprised of peptidomimetic macrocycles, and MACROFinder™, which are small molecule macrocycles. Each have distinct applications depending on the targets in question, which can be both extracelluar and intracellular targets. In addition to generating the specific OMPTA candidates described in this press release, these platforms have generated multiple other drug candidates in the Spexis pipeline, including murepavidin, balixafortide, lonodelestat and others. For further information please contact: For Investors: Stephen Jasper Managing Director Gilmartin Group stephen@gilmartinir.com For Media: Dr. Stephan Feldhaus Feldhaus & Partner +41 79 865 9256 feldhaus@feldhaus-partner.ch 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. This press release can be downloaded from www.spexisbio.com References M. Schuster, E. Brabet, K. K. Oi et al. Peptidomimetic antibiotics disrupt the lipopolysaccharide transport bridge of drug-resistant Enterobacteriaceae. Science Advances 2023 (9), eadg3683 Research reported in this press release is supported by CARB-X. CARB-X’s funding for this project is provided in part with federal funds from the US Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority under agreement number 75A50122C00028; and by awards from Wellcome (WT224842), and Germany’s Federal Ministry of Education and Research (BMBF). The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of CARB-X or any of its funders. https://www-who-int.libproxy1.nus.edu.sg/news/item/27-02-2017-who-publishes-list-of-bacteria-for-which-new-antibiotics-are-urgently-needed (Accessed: January 11th, 2024) Ad hoc announcement pursuant to Art. 53 LR Ad hoc announcement pursuant to Art. 53 LR Allschwil, Switzerland, February 8, 2024 Allschwil, Switzerland, February 8, 2024 Spexis announces closing of sale of preclinical antibiotics program to Basilea Spexis announces closing of sale of preclinical antibiotics program to Basilea Basilea to pay up to CHF 2 million for a preclinical program with novel antibiotics targeting Gram-negative bacteria, including multidrug-resistant strains Transaction is part of Spexis’ efforts to partner or divest non-core programs and assets as the company works through its moratorium status Transaction was subject to certain closing conditions, which now have been met and which will commence payments from Basilea to Spexis Basilea to pay up to CHF 2 million for a preclinical program with novel antibiotics targeting Gram-negative bacteria, including multidrug-resistant strains Basilea to pay up to CHF 2 million for a preclinical program with novel antibiotics targeting Gram-negative bacteria, including multidrug-resistant strains Transaction is part of Spexis’ efforts to partner or divest non-core programs and assets as the company works through its moratorium status Transaction is part of Spexis’ efforts to partner or divest non-core programs and assets as the company works through its moratorium status Transaction was subject to certain closing conditions, which now have been met and which will commence payments from Basilea to Spexis Transaction was subject to certain closing conditions, which now have been met and which will commence payments from Basilea to Spexis Spexis AG (SIX: SPEX), a clinical-stage biopharmaceutical company focused on macrocycle therapeutics for rare diseases and oncology, today announced that it has closed its asset purchase agreement with Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN) wherein Basilea has now formally become the owner of a preclinical program of antibiotics developed by Spexis from a novel class targeting Gram-negative bacteria, including multidrug-resistant strains.1 The transaction was subject to the approval by the Western District Court of the Canton Basel-Landschaft, which has now been obtained. 1 As part of the completed transaction, Basilea has acquired all program compounds, including intellectual property, and is paying Spexis up to a total of CHF 2 million, which consists of an upfront payment which was now received at closing, a payment related to the near-term transfer of the assets to Basilea, which is expected by the end of February and a potential final milestone payment related to the availability of near-term external funding for the further development of the program. In addition, Basilea has assumed the rights and obligations of Spexis related to the program, including potential low single-digit percentage royalties on sales, under licensing agreements. The assets sold to Basilea are macrocyclic antibiotics developed within Spexis’ Outer Membrane Protein Targeting Antibiotics (OMPTA) program which selectively disrupt the lipopolysaccharide transport bridge, an essential structure in Gram-negative bacteria. This results in a loss of the integrity of the outer cell membrane, intracellular accumulation of lipopolysaccharides and killing of the bacteria. Activity has been shown in vitro and in vivo against Enterobacteriaceae such as E. coli and K. pneumoniae, including strains resistant to beta-lactams and colistin, an antibiotic regarded as last-resort therapy. The program was funded in part by CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator)2, a global non-profit partnership dedicated to supporting early-stage antibacterial research and development to address the rising threat of drug-resistant bacteria. Jeff Wager, MD, Chairman & CEO of Spexis, said: “We are very pleased to have finalized this transaction with Basilea as it underscores the power of our macrocycle platform as a drug discovery platform and its potential to generate products that can address significant unmet medical needs. From a corporate strategy perspective, this transaction is part of Spexis’ efforts to partner or divest non-core programs and assets as the company works towards exiting its moratorium status and will generate funds and streamline focus which we can utilize towards advancing our core programs in rare disease and oncology. ” in vitro in vivo Enterobacteriaceae E. coli K. pneumoniae 2 About multidrug-resistant Gram-negative bacteria About multidrug-resistant Gram-negative bacteria Infections by multidrug-resistant Gram-negative bacteria (GNB) are a major challenge for healthcare professionals. Due to an additional outer cell membrane compared to Gram-positive bacteria, it is more difficult for antibiotics to get into the cell. In addition, this outer membrane carries lipopolysaccharides/endotoxins which induce inflammation and play an important amplifying role in the pathogenesis of infections by GNB and are therefore considered an important virulence factor. Moreover, GNB can acquire resistance to several classes of antibiotics such as carbapenems, fluoroquinolones, tetracyclines and earlier-generation cephalosporins, making infections with GNBs particularly difficult to treat. In 2017, the World Health Organization published a list of 12 classes of priority bacterial pathogens that pose the greatest threat to human health, of which nine classes are Gram-negative.3 3 About Spexis About Spexis Spexis (SIX: SPEX) is a clinical-stage biopharmaceutical company based in Allschwil, Switzerland, focused on macrocycle therapeutics for rare diseases and oncology. For further information please visit: www.spexisbio.com. www.spexisbio.com About Spexis’ Macrocycle Platforms About Spexis’ Macrocycle Platforms Spexis possesses what we regard as some of the most distinct, highly diverse and very well characterized macrocycle libraries in the world, together with deep data on same, developed over the course of more than 25 years of research and development and significant investment. These include PEMFinder™, which is comprised of peptidomimetic macrocycles, and MACROFinder™, which are small molecule macrocycles. Each have distinct applications depending on the targets in question, which can be both extracelluar and intracellular targets. In addition to generating the specific OMPTA candidates described in this press release, these platforms have generated multiple other drug candidates in the Spexis pipeline, including murepavidin, balixafortide, lonodelestat and others. For further information please contact: For further information please contact: For further information please contact: For Investors: Stephen Jasper Managing Director Gilmartin Group stephen@gilmartinir.com For Media: Dr. Stephan Feldhaus Feldhaus & Partner +41 79 865 9256 feldhaus@feldhaus-partner.ch For Investors: Stephen Jasper Managing Director Gilmartin Group stephen@gilmartinir.com For Media: Dr. Stephan Feldhaus Feldhaus & Partner +41 79 865 9256 feldhaus@feldhaus-partner.ch For Investors: Stephen Jasper Managing Director Gilmartin Group stephen@gilmartinir.com For Media: Dr. Stephan Feldhaus Feldhaus & Partner +41 79 865 9256 feldhaus@feldhaus-partner.ch For Investors: Stephen Jasper Managing Director Gilmartin Group stephen@gilmartinir.com For Investors: For Investors: stephen@gilmartinir.com For Media: Dr. Stephan Feldhaus Feldhaus & Partner +41 79 865 9256 feldhaus@feldhaus-partner.ch For Media: For Media: feldhaus@feldhaus-partner.ch Disclaimer 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. This press release can be downloaded from www.spexisbio.com www.spexisbio.com References References M. Schuster, E. Brabet, K. K. Oi et al. Peptidomimetic antibiotics disrupt the lipopolysaccharide transport bridge of drug-resistant Enterobacteriaceae. Science Advances 2023 (9), eadg3683 Research reported in this press release is supported by CARB-X. CARB-X’s funding for this project is provided in part with federal funds from the US Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority under agreement number 75A50122C00028; and by awards from Wellcome (WT224842), and Germany’s Federal Ministry of Education and Research (BMBF). The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of CARB-X or any of its funders. https://www-who-int.libproxy1.nus.edu.sg/news/item/27-02-2017-who-publishes-list-of-bacteria-for-which-new-antibiotics-are-urgently-needed (Accessed: January 11th, 2024) M. Schuster, E. Brabet, K. K. Oi et al. Peptidomimetic antibiotics disrupt the lipopolysaccharide transport bridge of drug-resistant Enterobacteriaceae. Science Advances 2023 (9), eadg3683 Research reported in this press release is supported by CARB-X. CARB-X’s funding for this project is provided in part with federal funds from the US Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority under agreement number 75A50122C00028; and by awards from Wellcome (WT224842), and Germany’s Federal Ministry of Education and Research (BMBF). The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of CARB-X or any of its funders. https://www-who-int.libproxy1.nus.edu.sg/news/item/27-02-2017-who-publishes-list-of-bacteria-for-which-new-antibiotics-are-urgently-needed (Accessed: January 11th, 2024) Language:EnglishCompany:Spexis AGHegenheimermattweg 1254123 AllschwilSwitzerlandPhone:+41 61 567 1600Fax:+41 61 567 1601E-mail:info@spexisbio.comInternet:www.spexisbio.comISIN:CH0106213793Valor:SPEXListed:SIX Swiss ExchangeEQS News ID:1832895 Language:EnglishCompany:Spexis AGHegenheimermattweg 1254123 AllschwilSwitzerlandPhone:+41 61 567 1600Fax:+41 61 567 1601E-mail:info@spexisbio.comInternet:www.spexisbio.comISIN:CH0106213793Valor:SPEXListed:SIX Swiss ExchangeEQS News ID:1832895 Language:English Language: English Company:Spexis AG Company: Spexis AG Hegenheimermattweg 125 Hegenheimermattweg 125 4123 Allschwil 4123 Allschwil Switzerland Switzerland Phone:+41 61 567 1600 Phone: +41 61 567 1600 Fax:+41 61 567 1601 Fax: +41 61 567 1601 E-mail:info@spexisbio.com E-mail: info@spexisbio.com Internet:www.spexisbio.com Internet: www.spexisbio.com ISIN:CH0106213793 ISIN: CH0106213793 Valor:SPEX Valor: SPEX Listed:SIX Swiss Exchange Listed: SIX Swiss Exchange EQS News ID:1832895 EQS News ID: 1832895 End of AnnouncementEQS News Service End of AnnouncementEQS News Service End of AnnouncementEQS News Service End of Announcement EQS News Service

Ad hoc announcement pursuant to Art. 53 LR Balixafortide, a potent CXCR4 inhibitor, to be evaluated for the treatment of pancreatic ductal adenocarcinoma (PDAC)Spexis closed capital commitments totaling USD $7.5 million supporting Phase 3 ColiFin® program in cystic fibrosis (CF) infectionsCOPILOT study expected to initiate in fourth quarter 2023Appointed Gonçalo Bernardes, PhD, as acting Head of Chemical BiologyAnnounced strong safety and pharmacokinetics results from first-in-human study with inhaled murepavadin, a novel macrocycle compoundEngaged Maxim Group LLC as M&A advisor to evaluate strategic transactions of which Spexis would be the surviving companyBusiness update conference call to be held in October ALLSCHWIL, Switzerland, Sept. 28, 2023 (GLOBE NEWSWIRE) -- Spexis AG (SIX: SPEX), a clinical-stage biopharmaceutical company focused on macrocycle therapeutics for rare diseases and oncology, today announced its financial results for the first half of 2023 and provided a strategic business update. “Spexis remains on track to deliver on the potential of our robust pipeline with multiple clinical development milestones on the horizon,” said Jeff Wager, M.D., Chairman & CEO of Spexis. “We anticipate initiating our Phase 3 ColiFin® program beginning with the COPILOT study in the fourth quarter supported by our financial partner on this program, SPRIM Global Investments. In addition, we have completed our initial analysis of further indication development potential for balixafortide. Based on our analysis, we are excited to announce balixafortide’s new focus on the treatment of PDAC where patients have long faced bleak and limited treatment options. Balixafortide’s well-documented and encouraging selective antagonism of the CXCR4 chemokine receptor and the new preclinical research illustrating its potential in PDAC have encouraged the company to focus our resources on the clinical development of balixafortide in this indication. We look forward to providing additional updates as our novel macrocycle derived pipeline continues to advance.” Pipeline status and plans The plans outlined below regarding the further development of various programs are subject to Spexis raising additional funds and/or entering into partnering agreements. Lead Program, ColiFin®: Spexis is committed to progressing its lead program ColiFin®, which is currently being developed to treat chronic lung infections in cystic fibrosis patients, but which also has strong therapeutic potential in non-CF bronchiectasis (nCFBE) and chronic obstructive pulmonary disease (COPD), as these patients also suffer from chronic Pseudomonas aeruginosa (PA) lung infections. ColiFin® has been approved in the EU as an inhaled therapeutic and holds Orphan Drug and QIDP designations in the U.S. The company has worldwide rights to ColiFin® ex-Europe and is preparing a Phase 3 program in CF patients which includes the COPILOT safety and tolerability trial, and the COPA efficacy trial. COPILOT is expected to initiate prior to the end of 2023. Capital commitments from SPRIM Global Investments (SGI) and additional institutional investors totaling USD $7.5 million to-date will enable the near-term initiation of COPILOT. The company’s clinical trial partnership with SGI, which includes debt facilities, is expected to provide Spexis with up to half of the Phase 3 clinical development costs of ColiFin®. Future milestones are contingent on securing additional capital and/or partnering agreements. Balixafortide: Today Spexis announced plans to pursue the clinical development of balixafortide, the Company’s potent and selective macrocyclic CXCR4 inhibitor, in PDAC, an aggressive form of pancreatic cancer with a poor survival rate. Balixafortide has been well-studied in clinical trials and has demonstrated a promising safety profile both as a monotherapy as well as in combination with other therapies. PDAC has been traditionally resistant to immunotherapy due to a combination of tumor microenvironment features unique to PDAC, but recent preclinical studies have shown the successful modulation of these factors using anti-CXCR4 antibodies, anti-programmed cell death protein 1 antibodies (anti-PD-1) and focal adhesion kinase inhibitors (FAKi). The combination of anti-CXCR4 antibodies, anti-PD-1 antibodies and FAKi led to a significantly decreased metastatic rates in a well-validated PDAC murine liver metastasis model. These results were subsequently validated substituting anti-CXCR4 antibodies for balixafortide. The synergistic effects of targeting PDAC with this regimen represents a unique opportunity for balixafortide to address the significant unmet need that has persisted in the fight against pancreatic cancer. PDAC accounts for more than 90% of pancreatic cancer diagnoses, and its poor survival rate is due to limited treatment options and the absence of an early diagnosis in many patients. The average 5-year survival rate is less than 10%, and pancreatic cancer represents an increasing and worrying proportion of cancer deaths. In 2023, the American Cancer Society projects over 50,000 patients will die of pancreatic cancer in the United States, the third-leading cause of cancer deaths. Despite a growing patient population, treatment options have remained limited, increasing the demand for novel therapeutics and approaches. Inhaled murepavadin (iMPV): Earlier in 2023, Spexis announced safety and pharmacokinetics results from the company’s first-in-human study with inhaled murepavadin, its novel macrocycle compound. Results indicated that iMPV was well tolerated at all dose levels and no serious adverse events were reported in the Phase 1 double-blind, randomized, placebo-controlled trial. iMPV was derived from Spexis’ macrocycle platform, validating its potential to generate clinically relevant therapeutics capable of drugging specific targets across a variety of rare diseases. The study was supported by the European Innovative Medicines Initiative (IMI), with iMPV successfully targeting the outer membrane of Pseudomonas aeruginosa, showing activity against highly resistant strains of bacteria. Spexis remains committed to addressing antibiotic resistance and progressing iMPV through the clinic. Macrocycle platform: Macrocycles remain a key differentiator at Spexis as this burgeoning area of drug discovery yields additional promise. The company’s leadership in the space represents an opportunity to yield novel therapeutics and the potential to combine macrocycles with a wide variety of complementary technologies, including, but not limited to, molecular glues and degraders. Spexis possesses two distinct, highly diverse and very well characterized macrocycle libraries, together with deep data on each: PEMfinder®, which is comprised of peptidomimetic macrocycles, and MACROfinder®, which are small molecule macrocycles. Each library has distinct applications depending on the targets involved, with several pre-clinical characterized leads for various indications having already been identified and characterized. As one example of the power of Spexis’ macrocycle platform, in June of this year, Spexis announced the publication of promising results for a novel class of macrocyclic, peptidomimetic antibiotics in Science Advances demonstrating potent in vitro and in vivo antimicrobial activity against MDR and XDR Enterobacteriaceae, including carbapenem-resistant and colistin-resistant strains. The novel antibiotics were developed by Spexis in close collaboration with Professor Oliver Zerbe’s group at the University of Zurich with substantial funding by Innosuisse and CARB-X. Corporate updates Spexis announced the appointment of Gonçalo Bernardes, Ph.D., as acting Head of Chemical Biology. Dr. Bernardes is a Full Professor of Chemical Biology and a Fellow of Trinity Hall College, Cambridge. He has co-founded companies using technologies 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. Multiple discoveries made in his lab have been translated into leading biopharmaceutical companies. At Spexis Dr. Bernardes will focus his efforts on the company’s leading and proprietary macrocycle platform to produce novel therapeutics for the treatment of cancer and rare diseases. The Company expects to announce specific programs already in development in collaboration with Prof. Bernardes in the coming weeks and months. Financial results In the first half of 2023, Spexis’ total loss was CHF 3.9 million, primarily driven by research and development (R&D) expenditures of CHF 2.7 million. The total cash position was CHF 0.9 million (cash and cash equivalents) as of June 30, 2023. In August, Spexis closed additional capital commitments from SPRIM Global Investments and institutional investors totaling USD $2.5 million supporting the Phase 3 ColiFin® program in cystic fibrosis (CF) infections. Key figures1 CHF million Income Statement 30.06.2023 30.06.2022Total revenue0.00.0Research and development expenses-2.7-6.8Other operating expenses2-1.6-2.8Net loss for the period-3.9-10.0 Balance Sheet30.06.202330.06.2022Cash and cash equivalents0.91.8Total assets29.730.0Total equity17.319.4Average net cash burn30.51.0Number of FTEs2028Equity ratio in %5865 1based on consolidated IFRS financial statements 2net of other income 3represents the average monthly cash used in operating and investing activities The half year report 2023 is available for download on our website: Reporting* – Spexis (spexisbio.com) Spexis business update call to take place in October Management will provide a business and financial update, followed by a Q&A session. The specific date and time of said update shall be announced shortly. About Spexis Spexis (SIX: SPEX) is a clinical-stage biopharmaceutical company based in Allschwil, Switzerland, focused on macrocycle therapeutics for rare diseases and oncology. For further information please visit: www.spexisbio.com. For further information please contact: For Investors: Hernan LevettChief Financial OfficerSpexis AG.+41 61 567 16 00IR@spexisbio.com Or Stephen Jasper Managing DirectorGilmartin Groupstephen@gilmartinir.com For Media: Dr. Stephan FeldhausFeldhaus & Partner+41 79 865 92 56feldhaus@feldhaus-partner.ch 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.