PA protein

Ad hoc announcement pursuant to Art. 53 LR Study start-up activities nearly complete for COPILOT, the first part of the Phase 3 ColiFin® program, including regulatory and ethics committee approvals of trial sites Enrollment of Phase 1 trial of inhaled murepavadin in healthy volunteers continues with top-line results expected by year-end 2022 Analysis of balixafortide PK/safety clinical trial in renally impaired subjects completed; results expected to be announced this fall Good progress in earlier-stage pipeline derived from macrocycle platform Variety of partnering and funding options continue to be vigorously explored Cash and cash equivalents of CHF 7.0 million as of June 30, 2022 expected to finance operations through January 2023 Renewal of the IRIS equity-linked financing facility for up to CHF 15m completed, which may extend cash runway as needed to achieve additional corporate partnering and financing milestones Conference call scheduled for today, Tuesday, September 6, 2022, at 8 AM EDT / 2 PM CET ALLSCHWIL, Switzerland, Sept. 06, 2022 (GLOBE NEWSWIRE) -- Spexis AG (SIX: SPEX), a clinical-stage biopharmaceutical company focused on rare diseases and oncology, today announced its financial results for the first half of 2022 and provided a strategic business update. “Despite the ongoing very challenging financial markets, we continue to make steady progress with Spexis,” said Jeff Wager, M.D., Chairman & CEO of Spexis. “Our two cystic fibrosis programs are proceeding as smoothly and as quickly as possible given market conditions, with inhaled murepavadin expected to generate top-line results by the end of 2022 and ColiFin® to begin Phase 3 testing in the first half of 2023, assuming sufficient funding.” He continued: “In addition, we continue to vigorously pursue a variety of financing, corporate partnering and strategic transaction possibilities to advance our portfolio and our macrocycle platform as a leader in this space.” 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®: The Company continues to focus its resources on its lead program ColiFin®, which is being developed for the treatment of chronic lung infections in cystic fibrosis (CF) patients. While the introduction of CFTR modulators in recent years has improved and extended the lives of CF patients, progressive lung function decline due to chronic lung infections remains a major problem and is projected to rise as patients live longer, further increasing the need for safe and effective therapies. ColiFin® is believed to also have strong therapeutic potential in non-CF bronchiectasis (nCFBE) and chronic obstructive pulmonary disease (COPD). A significant number of these patients suffer from chronic Pseudomonas aeruginosa (PA) lung infections, representing far larger markets than that of CF. Spexis has worldwide rights to ColiFin® ex-Europe and is focused on developing the product first for the U.S. market. Spexis is preparing a Phase 3 program in adult and adolescent CF patients with moderate to severe lung function impairment and chronic PA lung infection. The Phase 3 program includes the COPILOT safety and tolerability pilot clinical trial. Its objective is to evaluate and confirm the use of once or twice daily dosing for COPA, the planned single efficacy and safety Phase 3 trial. 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. Prior to starting the COPILOT pilot trial or COPA Phase 3 trial with ColiFin®, Spexis needs to secure additional funding but is continuing to advance clinical trial readiness through a variety of internal and externally contracted clinical operations activities. In addition, as reported in July, the Company had originally planned to engage clinical trial sites in Ukraine and Russia. In view of the ongoing Ukraine war, the trial was expanded to sites in other countries. The process of site initiation is proceeding well, and the COPILOT trial is now planned to start in H1 of 2023, and aims to provide dosing data for COPA, which is now expected to initiate in H2 2023. Balixafortide, discovered from Spexis’ macrocycle platform, is a potent, specific and highly selective inhibitor of CXCR4, which plays a role in a number of tumor types as well as non-oncology indications. As reported in the Company’s July 28, 2022 update, Spexis is analyzing existing clinical and preclinical data with balixafortide to help determine the appropriate path forward for this program, including potential new indications, and recently published data demonstrating synergistic efficacy in combination with docetaxel in metastatic prostate cancer. These data and others in development will inform future decisions on the program. In addition, this fall, the Company expects to report the results of its recently completed safety/PK study of balixafortide in human subjects with renal impairment. This clinical trial was initiated pursuant to interactions with the FDA as a condition to potentially include such patients in any future labeling claim. The Company also expects to share additional data and more details on its development plan for balixafortide later in 2022. Inhaled murepavadin (iMPV), a novel inhaled therapeutic specifically targeting PA and discovered from Spexis’ macrocycle platform, is currently in a Phase 1 study in healthy volunteers to evaluate safety and tolerability of single and multiple ascending doses (SAD/MAD). The study is ongoing and top-line data are expected by the end of this year. Potential indications that could be eventually targeted with iMPV include CF, nCFBE and COPD in patients with chronic PA infection. OMPTA is another class of products derived from application of its macrocycle platform. Spexis was previously awarded funding from CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator), a global non-profit partnership accelerating antibacterial products to address drug-resistant bacteria. This funding is to support the development of thanatin derivatives belonging to Spexis’ novel Outer Membrane Protein Targeting Antibiotic (OMPTA) class of therapeutics to potentially treat life-threatening infections caused by difficult-to-treat Gram-negative bacteria. This work is almost entirely funded by CARB-X, continues to move forward as planned, and was recently presented at the Gordon Research Conference New Antibacterial Discovery and Development event. Macrocycle platform Macrocycles are a proven chemical class of pharmaceutical therapeutics occupying the chemical space between small molecules and biologics. With a unique conformational balance of flexibility and rigidity, macrocycles can act on both extracellular and intracellular targets that are not easily accessible by other chemical classes. Indeed, since 2014, some 19 distinct macrocycle compounds have been approved by various drug regulatory authorities worldwide, involving a wide range of diseases and indications. More recently, with the emergence of the field of molecular glues and protein-protein interactions/degraders, macrocycles are increasingly recognized as possessing significant potential to target unique molecular targets and be combined with complementary technologies. Spexis possesses two distinct, highly diverse and very well characterized macrocycle libraries, together with deep data on same: PEMfinder®, which is comprised of peptidomimetic macrocycles, and MACROfinder®, which are small molecule macrocycles. Each library has distinct applications depending on the targets in question. In addition, Spexis has several pre-clinical leads for various indications which have already been considerably characterized. Spexis is looking to partner either these pre-clinical leads or the entire platform itself, potentially in combination with complementary technologies. Financial results In the first half of 2022, total loss was CHF 10.0 million, primarily driven by R&D expenses related to preparation of the ColiFin® Phase 3 program and other operating expenses. Total cash position was CHF 7.0 million (cash and cash equivalents) as of June 30, 2022, which is expected to finance operations through January 2023. On July 28, 2022, Spexis announced that it had renewed an equity-linked financing arrangement with the French company IRIS. The remaining CHF 13.6 million of the original agreement was replaced with a new equity-linked financing agreement which may raise, as needed, a gross amount of up to CHF 15.0 million over the period of two years. Key figures1 CHF million Income Statement 30.06.2022 30.06.2021 Total revenue 0.0 0.0 Research and development expenses -6.8 -0.3 Other operating expenses -2.8 -0.7 Net loss for the period -10.0 -1.0 Balance Sheet 30.06.2022 31.12.20213 Cash and cash equivalents 7.0 14.4 Total assets 40.0 50.0 Total equity 26.6 30.2 Average net cash burn2 1.3 0.2 Number of FTEs 27 28 Equity ratio in % 67 61 1) based on the consolidated IFRS financial statements 2) represents the average monthly cash used in operating and investing activities 3) Restated as a result of measurement period adjustments, refer to note 2.4 Business combinations of the half year report 2022, and correction of the presentation of Additional paid-in capital and Accumulated deficit, please refer to note 2.3 of the half year report 2022 The half year report 2022 is available for download on our website: Spexis H1 2022 financial results and business update call on September 6, 2022 at 14:00 CET/8:00 AM EDT Management will provide a business and financial update, followed by a Q&A session. To access the earnings call, please use the following details: France: Germany: Italy: Switzerland United Kingdom United States +33 (0)1 70 730 3 39 +49 (0)69 22222 5197 +39 02 0063 8217 +41 (0)44 580 7279 +44 (0)330 165 4012 +1 646-828-8073 Event Title: Spexis H1 2022 Financial Results and Business Update Confirmation code: 7688870 The presentation will also be available via webcast: Link for participants of the conference call (only slides, no audio, no delay): no-audio After the call, the presentation will be available via the above link. For further information please contact: For Investors: Hernan Levett Chief Financial Officer Spexis AG. +41 61 567 16 00 IR@spexisbio.com For Media: Dr. Stephan Feldhaus Feldhaus & Partner +41 79 865 92 56 feldhaus@feldhaus-partner.ch Raimund Gabriel MC Services spexis@mc-services.eu Europe: +49 89 210 228 0 Dr. Brigitte Keller/Laurie Doyle MC Services spexis@mc-services.eu Europe: +49 89 210 228 0 U.S.: +1 339 832 0752 About Spexis Spexis (SIX: SPEX) is a clinical-stage biopharmaceutical company based in Allschwil, Switzerland, focused on rare diseases and oncology. For further information please visit: . 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.

Ad hoc announcement pursuant to Art. 53 LRCash position to finance operations extended into January 2023Resources focused on advancing lead program, Phase 3 ColiFin®Assessment of balixafortide development options continues; balixafortide PK/safety clinical trial in renally impaired subjects completed; results expected to be reported this fallProgress in earlier-stage pipeline derived from macrocycle platformVariety of partnering and funding options being vigorously exploredCompany renews equity-linked financing with IRIS for up to CHF 15 millionConference call scheduled for today, Thursday, July 28, 2022, at 8 AM EDT / 2 PM CET ALLSCHWIL, Switzerland, July 28, 2022 (GLOBE NEWSWIRE) -- Spexis AG (SIX: SPEX), a clinical-stage biopharmaceutical company focused on rare diseases and oncology, today provides a business update, including development programs’ progress and its efforts to secure funding for these projects. Financial update and fundraising The Company has carefully evaluated its portfolio and is further focusing its resources and prioritizing programs. Through this effort, Spexis believes it will be able to extend its current cash position to finance operations into January 2023. This cash reach does not take into account the equity-linked financing the Company has just renewed with IRIS, the Paris-based equity-linked financing provider. Spexis has extended this arrangement to raise a gross amount of up to CHF 15 million through 2024. IRIS will receive Spexis shares, which will be created from the Company's conditional capital, based on this interest-free mandatory convertible bonds program. It remains at the sole discretion of Spexis to suspend or terminate the staggered financing. The Company is also actively pursuing a variety of other avenues to secure funding. This includes partnering opportunities for various programs, including ColiFin®, balixafortide and other product candidates derived from the macrocycle platform; traditional equity via current and new potential investors; as well as alternative financing strategies. Jeff Wager, M.D., Chairman and CEO of Spexis AG, said: “Given the challenges in raising funds in this currently very difficult economic and geopolitical climate, it is imperative that we explore a wide variety of options to secure the funding we need to advance our programs as well as to prioritize our development work. With ColiFin® ready to start Phase 3 testing for the important U.S. market, along with the feedback we have received from the medical community about the significant unmet need for new safe and effective options to treat chronic lung infections in cystic fibrosis patients, we are allocating the majority of our resources to moving this important program ahead.” He continued: “In addition to ColiFin®, we have a broad pipeline that we believe offers numerous opportunities for further partnering. This includes balixafortide and other programs derived from our macrocycle platform, the latter which we think has strong potential in the exciting space of molecular glues and protein degradation. Encouraged by both our fundraising and partnering efforts, we look forward to updating the markets as we make progress in these areas.” 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®: The Company is further focusing its resources on lead program ColiFin®, which is being developed for the treatment of chronic lung infections in cystic fibrosis (CF) patients. While the introduction of CFTR modulators in recent years has improved and extended the lives of CF patients, progressive lung function decline due to chronic lung infections remains a major problem and is projected to rise as patients live longer, further increasing the need for safe and effective therapies. Spexis has worldwide rights to ColiFin® ex-Europe and is focused on developing the product first for the U.S. market. Spexis is moving forward with a Phase 3 program in adult and adolescent CF patients with moderate to severe lung function impairment and chronic Pseudomonas aeruginosa (PA) lung infections. The Phase 3 program includes the COPILOT pilot study to evaluate once daily versus twice daily dosing, and a single Phase 3 study, COPA. PA infections account for two-thirds of CF chronic lung infections and are the leading cause of lung function decline and mortality in CF patients. Prior to starting COPILOT or COPA, Spexis needs to secure additional funding, as discussed above. In addition, the Company had originally planned to use clinical trial sites in Ukraine and Russia; in view of the ongoing war, additional sites in other countries need to be brought on. Given this situation, the COPILOT study is now planned to start in H1 of 2023. The COPA Phase 3 trial will start once COPILOT is completed as this will determine if a once-daily or twice-daily regimen will be administered in the Phase 3 trial. With this, COPA is now expected to initiate in H2 2023. Balixafortide is a potent, specific and highly selective inhibitor of CXCR4, which plays a role in a number of tumor types as well as non-oncology indications. The Company is analyzing existing clinical and preclinical data with balixafortide to help determine the appropriate path forward for this program, including potential new indications, and has recently published data demonstrating synergistic efficacy in combination with docetaxel in metastatic prostate cancer.1 No definitive decisions have yet been made and several areas for further development are being explored. In the fall of 2022, the Company expects to report the results of its recently completed safety/PK (pharmacokinetics) study of balixafortide in human subjects with renal impairment. This clinical trial was initiated pursuant to interactions with the FDA as a condition to potentially include such patients in any future labeling claim. The Company also expects to share additional data and more details on its development plan for balixafortide later in 2022. Inhaled murepavadin (IMPV), a novel inhaled therapeutic specifically targeting PA and discovered from Spexis’ macrocycle technology platform, is currently in a Phase 1 study in healthy volunteers to evaluate safety and tolerability of single and multiple ascending doses (SAD/MAD). The study is ongoing, and data are expected by the end of this year. Potential indications that could be eventually targeted with IMPV include CF, non-CF bronchiectasis (nCFBE) and bronchiectasis associated with chronic obstructive pulmonary disease (COPD-BE). OMPTA: Spexis was previously awarded funding from CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator), a global non-profit partnership accelerating antibacterial products to address drug-resistant bacteria. This funding is to support the development of thanatin derivatives belonging to Spexis’ novel Outer Membrane Protein Targeting Antibiotic (OMPTA) class of therapeutics to potentially treat life-threatening infections caused by difficult-to-treat Gram-negative bacteria. This work is almost entirely funded by CARB-X and continues to move forward. Conference call today, July 28, 2022 at 8 AM EDT/2 PM CET As previously announced, a conference call will be held today. To participate, please use the following numbers: France:+33 (0)1 70 730 3 39Germany:+49 (0)69 22222 5197Italy:+39 0200638217Switzerland:+41 (0)44 580 7279United Kingdom+44 (0)330 165 4012United States+1 646-828-8075 Please dial in approximately 10 minutes prior to the start of the call. When asked, please provide the name of the event – “Spexis AG - Business and Strategy Update” – and the following confirmation code: 1507661. The presentation will also be available via webcast: For participants of the conference call: https://www.webcast-eqs.com/spexis20220728/ no-audio (audio via phone, presentation on the web browser)Live stream: https://www.webcast-eqs.com/spexis20220728 (audio and presentation on the web browser; for passive participants) A replay of the call will be available on the Company’s website in the Investor Relations – Calendar section here or via the above link. For further information please contact: For Investors:Hernan LevettChief Financial OfficerSpexis AG.+41 61 567 16 00IR@spexisbio.comRaimund GabrielMC Servicesspexis@mc-services.euPh: +49 89 210 228 0For Media:Dr. Stephan FeldhausFeldhaus & Partner+41 79 865 92 56feldhaus@feldhaus-partner.chDr. Brigitte Keller/Laurie DoyleMC Servicesspexis@mc-services.euEurope: +49 89 210 228 0U.S.: +1 339 832 0752 About SpexisSpexis (SIX: SPEX) is a clinical-stage biopharmaceutical company based in Allschwil, Switzerland, focused on rare diseases and oncology. For further information, please visit: www.spexisbio.com. DisclaimerThis 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. References__________________ 1 https://www.globenewswire.com/news-release/2022/07/07/2475531/0/en/Spexis-CXCR4-inhibitor-balixafortide-demonstrates-synergistic-efficacy-in-combination-with-docetaxel-in-a-metastatic-prostate-cancer-preclinical-model.html

The i:X device visualises fluorescence, enabling the point-of-care detection of wounds containing elevated levels of bacteria MolecuLight i:X® Receives FDA 510(k) Clearance for the Device’s Ability to Detect Wounds Likely to Contain Pseudomonas aeruginosa (PA) (Credit: CNW Group/MolecuLight) MolecuLight Inc., the leader in point-of-care fluorescence imaging for real-time detection of wounds containing elevated bacterial loads, announces that it has received FDA 510(k) clearance for the detection of wounds containing clinically significant levels (>104 CFU/g) of Pseudomonas aeruginosa (PA) for the previously cleared MolecuLight i:X imaging device.  The i:X device visualizes fluorescence, enabling the point-of-care detection of wounds containing elevated levels of bacteria. This new FDA clearance supports the ability of the i:X device to increase the clinician’s ability to detect the presence of Pseudomonas aeruginosa in wounds using the cyan fluorescence signal.  This augmented labeling is based on a detailed retrospective statistical analysis of over 350 patients. Pseudomonas aeruginosa (PA) is a common bacterial pathogen that precludes wound healing. PA is notorious for its intrinsic resistance to many antibiotics and its tendency to form biofilm matrices that evade antibiotics and other conventional treatment methods1. The presence of PA in wounds is associated with rapid deterioration and more severe wound outcomes 2,3. The MolecuLight i:X is the only imaging device that provides real-time information on whether a wound is likely to contain elevated levels of PA (>104 CFU/g). The i:X is becoming an essential tool for assisting in clinician decision-making regarding the assessment and treatment of wounds. “Bacterial removal is a critical component of wound care and wound healing. The ability of the MolecuLight i:X to detect and visualize wounds containing elevated bacterial burden while we are with the patient enables a proactive and objective approach to wound management”, says Dot Weir, RN, CWON, CWS, Clinician at Saratoga Hospital Center for Wound Healing and Hyperbaric Medicine, Saratoga Springs, New York and Co-Chair of SAWC, the Symposium on Advanced Wound Care. “Wounds harboring Pseudomonas often require unique treatments. This new FDA clearance recognizes the added benefit of the i:X in visualizing and differentiating Pseudomonas aeruginosa in wounds through the cyan fluorescence signal it produces on the images. This is especially important because detecting the presence of Pseudomonas aeruginosa at the point-of-care allows wound care professionals to act immediately to tailor our cleaning, debridement, antimicrobial strategy and treatments accordingly.” Source: Company Press Release