Endocarditis, Bacterial

Nodenza Venture Partners invests in Trellis Bioscience Lead product TRL1068 targets biofilm, estimated to cause 60-70% of antibiotic resistant infections New York, October 22, 2024 – Nodenza Venture Partners (“Nodenza”), today announces its investment in Trellis Bioscience (“Trellis”), a clinical-stage company focused on discovering and developing native human monoclonal antibodies to treat and prevent drug-resistant, life-threatening infectious diseases. Trellis has developed a patented, proprietary technology (CellSpot) to clone genes of rare fully-human therapeutic monoclonal antibodies (mAbs) from memory B-cells of the blood of individual human donors. CellSpot has identified a high-affinity, broad-spectrum native human antibody, TRL1068, which targets and disrupts bacterial biofilm, a physiological factor promoting drug resistance in most clinically relevant multi-drug-resistant bacteria species, both gram positive and gram negative. TRL1068 is being developed for the treatment of chronic prosthetic joint infection (“PJI”), a chronic infection which requires, as standard of the care, the surgical removal of the prostheses with an estimated cost to the US health system of more than $10bn a year. In addition to PJI, it is estimated that biofilm is the cause of 60-70% of antibiotic resistant infections. TRL1068 has been granted Fast Track and QIDP designations and orphan drug designation for PJI and infective endocarditis by the U.S. Food and Drug Administration (FDA). Chronic PJI always forms biofilms on the prosthesis, thereby shielding the bacteria from eradication by antibiotics, being the reason for PJI to be a difficult-to-treat disease. As biofilm cannot be removed by antibiotics or any other non-invasive treatment, the current standard treatment of chronic PJI is a complex two-stage surgical procedure consisting of removal and replacement of the infected prosthesis. This costly and invasive two-stage process substantially and adversely affects quality of life, with increased immobility and morbidity in addition to decreased 5-year survival rates in patients with PJI when compared with non-infected patients that receive a prosthetic joint replacement. In a clinical proof-of-concept trial, published in a peer-reviewed article in the prestigious AAC Journal, TRL1068 has demonstrated the ability to disrupt the bacterial biofilm barrier to antibiotic access, allowing antibiotics to be efficacious without surgical intervention: In 25% of TRL1068-treated patients, biofilm was removed below the limit of detection after only 7 days of treatment, a finding that has never been observed in this patient population.64% of chronic PJI patients treated with an infusion of a single dose of TRL1068 and standard antibiotics had a bacterial biofilm burden below 100 CFU/mL sonication fluid after only 7 days of treatment. Although the sample size is small (n=11), a favourable comparison to historical data where only 15% of PJI patients are below that mark, suggesting that a treatment period 8 times longer, as planned in a Phase 2 study, will be highly efficacious.TRL1068 was well-tolerated across all three dose groups with no drug-related adverse events.The results of this initial exploratory study have provided strong evidence of efficacy across a diverse set of bacterial species, safety, and pharmacokinetic data to guide the design of a pivotal clinical study of TRL1068 for PJI with the goal to treat the infection without the need for a complex replacement surgery. Ross Morton, Managing Partner of Nodenza Venture Partners, said: “Antibiotic resistance is a significant and growing global threat, with insufficient investment to identify urgently needed new approaches. Trellis stands out with its truly novel and innovative approach to address antibiotic resistance. Through the application of its unique CellSpot technology, Trellis has the potential to be at the forefront of innovation in this critical field. CellSpot and TRL1068 align perfectly with Nodenza Venture Partners’ strategy of identifying and investing in disruptive technologies and therapies with the potential to deliver exceptional benefits to patients. We believe that Trellis has the potential to generate a multi-fold return on for Nodenza.” Stefan Ryser, Ph.D, President & CEO of Trellis Bioscience, commented: “Nodenza’s deep expertise of the pharmaceutical and biotech industry, and their recognition of the novelty of biofilm disruption, makes it an ideal investment partner for Trellis Bioscience as we prepare to advance TRL1068 rapidly through the clinic. The positive data generated to date give us confidence in the potential for a successful clinical study that may result in early FDA marketing authorisation given the five times higher mortality of the PJI standard of care surgery versus an aseptic prostheses replacement as well as the lack of new mechanisms to tackle the specific challenges of prosthetic joint infection. Nodenza has also recognized the enormous potential of TRL1068 beyond PJI as it addresses the broader global threat of antibiotic resistance.” Contacts: Nodenza Venture Partners Ross Morton, Managing Partnerinfo@nodenza.com Mo Advisory PRmo@mopradvisory.comMo Noonan / Jonathan Birt Notes to Editors About Nodenza Venture PartnersNodenza Venture Partners provides financial and operational support to early-stage and pre-commercial biotech and medtech companies and products designed to bring exceptional patient benefit. Our bi-modal investment strategy combines early-stage opportunities – advancing new treatment modalities through active IND to phase 2 - with pre-commercial targets supporting their transition from scientific to commercial companies delivering strong upside potential. Established by a team of experienced life sciences entrepreneurs, founders and leaders, our approach leverages Nodenza’s extensive expertise in the creation and growth of new companies, as well as late-stage product development and launch. For more information visit us at https://www.nodenza.com Trellis BioscienceTrellis Bioscience is a clinical-stage company focused on discovering and developing native human monoclonal antibodies to treat and prevent drug-resistant, life-threatening infectious diseases. Antibodies are the immune system's most potent natural weapon against disease. Trellis's innovative proprietary technology CellSpot™ overcomes technical obstacles that have long hindered exploiting the full human antibody repertoire. This ideal source of drugs focuses on the selection of elite antibodies that bind highly conserved target epitopes with high affinity. To learn more, visit trellisbio.com. Attachment Nodenza Trellis Investment Final

Continuous commitment to create a global leader in phage therapies to treat severe and resistant bacterial infections Ambitious development strategy on track with clear objectives set for the Prosthetic Joint Infections (PJI) strategic program Clinical readout expected before end of year 2024, including Updated Compassionate real life clinical data and PhagoDAIR pilot studyImminent Filing of Investigational New Drug Application (IND) in US and Clinical Trial Application (CTA) in Europe for GLORIA, the first global GLORIA Phase II study for the treatment of Staphylococcus aureus infections of PJI, with the aim of approval by the US and European regulatory agencies expected in Q4 2024Launch of the 1st global GLORIA Phase II study in Prosthetic Joint Infections (PJI) expected in Q1 2025 Cash and cash equivalents of €1.5 million as of June 30, 2024, not including the €6.8 million net proceeds from the capital increase, which was settled in early July 2024 Lyon (France), September 25, 2024 at 5:45 pm CEST – PHAXIAM Therapeutics (Euronext: PHXM), a biopharmaceutical company developing innovative treatments for severe and resistant bacterial infections, today provides a business and financial update for the first half of 2024. “Since the beginning of 2024, all PHAXIAM teams have been very committed and focused on the submission of the GLORIA Phase II study protocol to the American and European authorities and on the preparation of the launch of this study, expected in the first quarter of 2025. With the IND (U.S.) and CTA (EU) about to be very shortly filed, the most important catalyst of our development strategy is in reach. In addition, clinical data from PhagoDAIR, our pilot study, are expected in late 2024, as planned.“ stated Thibaut du Fayet, Chief Executive Officer of PHAXIAM. BUSINESS HIGHLIGHTS Phage therapy strategy focused on high-value indications PHAXIAM has refocused its clinical development on programs targeting patients with severe resistant infections of high medical needs, associated with high mortality and budget impact. Significant progress has been achieved over the year 2024 to accelerate PHAXIAM’s strategy deployment on key therapeutic programs, particularly with its lead program targeting Prosthetic Joint Infections caused by Staphylococcus aureus (S. aureus). Clinical and regulatory strategy in S. aureus program on track With its lead S. aureus program, PHAXIAM pursues the ambition to propose a therapeutic solution to patients who failed traditional antimicrobial treatments in complex mono-bacterial S. aureus infections in several high-value indications. Prosthetic Joint Infections (PJI): toward the first global Phase II study, enabling a potential Early Access Pathway Leveraging on promising activity signals from real-life compassionate treatments, with more than 120 patients already treated (data to September 2024), PHAXIAM is preparing the initiation of the 1st global (EU/US) Phase II POC study (GLORIA) for PJI patients (Hip or Knee prosthesis) having an open-surgery debridement (DAIR) in combination with antibiotics. As planned, PHAXIAM aims to: deliver PhagoDAIR pilot study preliminary data at the end of 2024, and the study’s complementary data in 2025,accelerate the transitioning of PJI clinical development effort into the ambitious global Phase II proof-of-concept study (GLORIA) to be launched in Q1 2025. GLORIA is PHAXIAM’s most important asset, having the highest priority. This multicentric, randomized, comparative Phase II proof-of-concept study, is expected to enroll 100 patients in Europe and the US. PHAXIAM is about to file the Investigational New Drug Application (IND) and the Clinical Trial Application (CTA) to US and European regulatory agencies respectively. The formal approval of the study is expected in Q4 2024, in view of starting patient enrollment in Q1 2025. Upon a successful completion of GLORIA Phase II study anticipated in Q3 2026, PHAXIAM may be eligible to an Early Access Pathway, paving the way for a pre-commercialization in Europe as soon as H2 2027. Endocarditis Infections (EI): patients’ enrolment ongoing in five French sites This Phase I PK study enrolls patients with resistant S. aureus infections in the cardiac chambers and valves. First clinical results are now expected around mid-2025. If positive, these results could allow PHAXIAM to: accelerate a clinical development in this indication; and use the intravenous (IV) administration for other indications requiring this administration route. Clinical study in complex mono-bacterial Escherichia coli (E. coli) infections, validated and ready for enrolment The objective of this E. coli program, including a Phase I PK study validated by the French Health Authority (ANSM), is to propose a therapeutic solution to patients having failed traditional antimicrobial treatment in complex mono-bacterial E. coli infections in the urinary tract. Confirmed valuable real-life clinical benefit data from compassionate treatments with more patients coming from European countries To date, PHAXIAM has treated more than 120 patients under compassionate treatment status, most of them suffering from hip or knee PJI. The vast majority is located in France but more and more compassionate patients, stemming from other European countries, are treated in their country with PHAXIAM phages: Sweden, Switzerland, Latvia, Romania and United Kingdom. Data from the first 77 patients evaluated so far show promising results with infection control at 3 months (clinical endpoint) reaching approximately 80%, considered as a significant improvement over standard of care (SoC) in this hard-to-treat patient population with severe resistant infections, often undergoing 2nd or 3rd line SoC antibiotic treatment. Early 2025, PHAXIAM is planning to file for another AAC (Autorisation d’Accès Compassionnel – early access program), in order to bring a new compassionate treatment to PJI patients associated with Pseudomonas aeruginosa (P. aeruginosa) resistance, complementing the first obtained AAC, associated with S. aureus resistance. Complementary Investigator-sponsored trials (IST) In addition to PHAXIAM’s sponsored clinical studies, two other investigator-sponsored trials, in which PHAXIAM is highly involved, are the opportunity to deliver additional clinical POC data in other high-value indications: Phase II study (60 patients) in Diabetic Foot Ulcer (DFU): this clinical study, sponsored by Nîmes Hospital, targets DFU infections due to mono-bacterial S. aureus infection; this study is ready for First-Patient-In, expected before the end of this year.Phase II study (180 patients) in complex Respiratory Tract Infections (cUTI): this clinical study, sponsored by La Pitié Salpêtrière Hospital in Paris, targets nosocomial pulmonary infections due to P. aeruginosa, including patients with ventilator-associated pneumopathies (VAP), a growing concern in hospital environments. The filing of this study is planned in France (ANSM) in Q1 2025. H1 2024 FINANCIAL RESULTS Key financial figures for the first half of 2024 compared with the same period of the previous year aresummarized below. As a reminder, PHAXIAM’s consolidated financial statements in IFRS standards for H1 2023 include ex-Pherecydes financial results as of the date of the merger, i.e. June 23, 2023. Consequently, PHAXIAM’s P&L information for the first 6 months of 2023 are mostly related to ex-Erytech activities only, while PHAXIAM’s consolidated balance sheet as of June 30, 2023, includes the financial positions of both merged companies. The full Financial Statements of PHAXIAM Therapeutics as of June 30, 2024 has been filed with the AMF on Wednesday, September 25, 2024, and is available on the company’s website. In thousands of euros H1 2024(6 months)H1 2023(6 months)Revenues ——Other income 1,093278Operating income 1,093278Research and development (6,406)(3,431)General and administrative (5,345)(9,245)Operating expenses (11,751)(12,676)Operating income (loss) (10,658)(12,398)Financial income 175331Financial expenses (132)(342)Financial income (loss) 43(11)Income tax (20)203Net loss (10,635)(12,201) Operating expenses of €11.7 million in the first half of 2024 were 7% lower (i.e. a €0.9 million reduction) than in the same period of the previous year. This decrease was driven by the 42% reduction of G&A expenses, including €3.4 million of non-recurring merger cost and €0.5 million of additional savings following Nasdaq delisting.This cost-cutting program was accelerated in the third quarter of 2024 to be in place as part of the 2025 budget. PHAXIAM’s operational R&D expenses in the first half of 2024 increased by €1.4 million (+41%) mostly on S. aureus development program, not included in the previous year's comparison. In addition, an impairment charge of €1.5 million on the endocarditis IP (EnDoCom) has been recorded. Net loss for the first half of 2024 was €10.6 million, compared with a net loss of €12.2 million for the same period of 2023. As of June 30, 2024, PHAXIAM had cash and cash equivalents totaling €1.5 million, compared with €10.5 million as of December 31, 2023. The €9 million decrease in cash position during the first half of 2024 was the result of a €8.2 million net cash utilization in operating activities including ~ €1 million in severance costs, €0.5 million in investing activities and €0.5 million used in financing activities, mostly related to lease reimbursement. On July 1, 2024, with the settlement & delivery of the €7.8 million capital increase, PHAXIAM's cash position increased by a net €6.8 million, after payment of capital increase costs. The Company believes that its current cash position can fund its existing programs and expected operating expenses into March 2025. The Company is studying all options to extend its financial visibility: cost reduction program, obtaining non-dilutive financing at the national and European level, search for strategic and institutional investors, etc. MANAGEMENT TEAM EVOLUTION Eric Soyer, former CFO / COO, is leaving PHAXIAM to pursue other interests. Frédéric Mathat succeeds him and will lead the Company’s Finance department as CFO.After a first robust experience in accounting and consolidation of listed companies (8 years at Nexity, the real estate branch of Vivendi, then 7 years at Sequana), Frédéric had been financial director of the Canson group for 11 years. He joined the pharmaceutical industry in 2017 to lead Erytech's finance department alongside Eric Soyer, until the merger with Pherecydes, in which he was instrumental and committed all along the process that led to the creation of PHAXIAM. Thibaut du Fayet, Chief Executive Officer of PHAXIAM, commented: “I would like to warmly thank Eric Soyer for his dedication during these 8 years spent at Erytech where he performed several fundraisings on Nasdaq and Euronext public markets, then at PHAXIAM where he was very instrumental in the success of the merger, as his contribution has been essential in designing PHAXIAM’s strategy; I wish him all the best for the near future. I am also delighted to welcome Frédéric as Chief Finance Officer. His extensive expertise and proven track record in finance add great value to our team.” KEY NEWSFLOW AND MILESTONES EXPECTED OVER THE NEXT 12 MONTHS Phase II IST in Diabetic Foot Ulcer (DFU) First-Patient-In expected in Q4 2024PhagoDAIR pilot study clinical readout expected before end of year 2024GLORIA global Phase II IND and CTA validation expected in Q4 2024GLORIA global Phase II First-Patient-In expected in Q1 2025Endocarditis Phase I PK study first readout expected around mid-2025 FIRST HALF 2024 WEBINAR DETAILS PHAXIAM management will hold a webinar today, Wednesday, September 25, 2024, at 6:00 pm CEST on the business highlights and financial results for the first half of 2024. Thibaut du Fayet, (CEO) and Frédéric Mathat (CFO), will deliver a brief presentation in French, followed by a Q&A session. The webinar, held in French, is accessible via this registering link. The replay of the webinar will be available on the Company's website in the following days. About PHAXIAM Therapeutics PHAXIAM is a biopharmaceutical company developing innovative treatments for resistant bacterial infections, which are responsible for many serious infections. The company is building on an innovative approach based on the use of phages, natural bacterial-killing viruses. PHAXIAM is developing a portfolio of phages targeting 3 of the most resistant and dangerous bacteria, which together account for more than two-thirds of resistant hospital-acquired infections: Staphylococcus aureus, Escherichia coli and Pseudomonas aeruginosa. PHAXIAM is listed on the Euronext regulated market in Paris (ISIN code: FR0011471135, ticker: PHXM). PHAXIAM is part of the CAC Healthcare, CAC Pharma & Bio, CAC Mid & Small, CAC All Tradable, EnterNext PEA-PME 150 and Next Biotech indexes. For more information, please visit www.phaxiam.com Contacts PHAXIAMThibaut du FayetCEO+33 4 78 74 44 38 investors@phaxiam.com NewCap Mathilde Bohin / Dušan OrešanskýInvestor Relations Arthur Rouillé Media Relations+33 1 44 71 94 94 phaxiam@newcap.eu Forward-looking information This press release contains forward-looking statements, forecasts and estimates with respect to the clinical programs, development plans, business and regulatory strategy and anticipated future performance of PHAXIAM and of the market in which it operates. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will” and “continue” and similar expressions. All statements contained in this press release other than statements of historical facts are forward-looking statements. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond PHAXIAM's control. Therefore, actual results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Investor should carefully read the risk factors section of the Company which can be found in the Company’s regulatory filings with the French Autorité des Marchés Financiers (AMF), including in the Company’s 2023 Universal Registration Document (Document d’Enregistrement Universel) filed with the AMF on April 5, 2024 and future filings and reports by the Company. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. PHAXIAM disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any change in PHAXIAM’s expectations with regard thereto, or any change in events, conditions or circumstances on which any such statement, forecast or estimate is based, except to the extent required by law. Attachment PR_PHAXIAM_Q2-2024_BusinessFinancial_Update_EN

REDWOOD CITY, Calif.--( BUSINESS WIRE )-- Karius® , Inc. today announced it has been awarded a contract from the Division of Research, Innovation, and Ventures (DRIVe), under the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services. Valued over $600,000, the contract enables Karius to extend its current DNA pathogen detection capabilities to include RNA pathogen detection from a variety of human samples. “We are delighted to partner with BARDA DRIVe in developing highly scalable tests that can rapidly identify any type of pathogen anywhere in the body,” said Tim Blauwkamp, Chief Scientific Officer and co-founder of Karius. “Our agnostic test for DNA pathogens has already served over 60,000 hospitalized patients, and this new project brings our vision of rapid, comprehensive diagnostics for every patient one step closer.” This contract follows a $100M Series C announcement earlier in the year to expand its Karius Test® beyond the 400 U.S. hospitals currently using it and to support research into the broader applications of Karius’ metagenomics technology. Additionally, Karius announced that the Karius Test has been granted designation as a Breakthrough Device from The Center for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (FDA), for use in the diagnosis and management of immunocompromised patients with suspected lung infections including lower respiratory infection and pneumonia. To learn more about Karius visit kariusdx.com . To learn more about Karius’ contract with the Agnostic Diagnostics Program , please visit the BARDA website . This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number 75A50124C00023. About Karius Karius Inc., a global leader in liquid biopsy for infectious diseases, harnesses metagenomics sequencing, and artificial intelligence (AI) to help enhance the precision and speed of pathogen diagnosis. The Karius Test®, used in over 400 healthcare institutions–including 90+ transplant centers and 40+ children’s hospitals across the United States–identifies more than 1,000 pathogens, including viruses, bacteria, fungi, and parasites from a single blood draw typically within a day of sample receipt. A landmark study in the Journal of Clinical Microbiology found that the Karius Test detected 701 unique microbial taxa across a cohort of 15,000 patients, making it the largest study of its kind, demonstrating the capability of the Karius Test in pathogen identification for multiple applications including pneumonia, endocarditis, invasive fungal infections, and infectious causes of febrile neutropenia and fever of unknown origin. The Karius Test also has been incorporated into the diagnostics recommendations in the 2023 Duke-ISCVID Criteria for Infective Endocarditis .