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PARIS, FRANCE / ACCESSWIRE / January 4, 2023 / Pharnext SA (FR001400BV89:ALPHA) (the "Company"), an advanced late-clinical stage biopharmaceutical company developing novel therapeutics for neurodegenerative diseases with high unmet medical need, today announces the appointment of Scott Johnson as VP, Head of Quality. This appointment further strengthens the Company's Senior Leadership Team (SLT) at the start of this important year, notably with the anticipated topline results of the pivotal Phase III clinical study of the drug candidate PXT3003, the PREMIER trial, in development for Charcot-Marie-Tooth disease type 1A (CMT1A). More than 15 years' experience in Quality and Compliance in Healthcare Scott has more than 15 years of experience in quality management and compliance within the healthcare sector. He joins from Oyster Point Pharma, where he was Head of Quality Assurance. There, he established and implemented a comprehensive quality management system and oversaw all quality-related functions during the submission of an NDA application and successful launch of Oyster Point's first commercial product. Prior to Oyster, Scott served as Director, Quality Assurance at Lupin Pharmaceuticals where he had overall responsibility for quality and compliance. He has also held roles at Johnson & Johnson and Warner Chilcott. Scott has a BA in Organizational Management from the Eastern University, St. David's, PA and previously served in the United States Navy. At Pharnext, Scott will continue to develop and maintain the Company's Quality strategy and ensure its operational execution. He will oversee the Quality activities in the areas of Manufacturing (Good Manufacturing Practices), Laboratory (Good Laboratory Practices) and Clinical (Good Clinical Practices) to ensure compliance with regulatory requirements. Scott will also be responsible for promoting a quality mindset across the Company and working with cross-departmental leadership to ensure the delivery of high-quality products and services. A renewed and enriched SLT With this new appointment, Pharnext strategically completes its SLT, which is now composed of experts in their field, namely: Hugo Brugière, MSc, Chairman and Chief Executive Officer since December 2022, is a serial entrepreneur with more than twenty companies to his credit, he has specialized in stock market and restructuring/turnarounds of listed companies. Burkhard Blank, MD, Chief Medical Officer since January 2022, has over 25 years of experience in global drug development, medical and regulatory affairs, and pharmacovigilance. Rob Quinn, PhD, Chief Financial Officer since September 2022, has raised more than €200 million in financing to date in his career. Xavier Paoli, MSc, Chief Operating Officer since April 2014, has almost 20 years of experience in drug commercialization, notably for diseases with high unmet medical need without acceptable therapeutic solutions. Antoine Gravelle, General Counsel since July 2022, has over 15 years of legal experience in the pharmaceutical and biotech sector, notably at Sanofi, Cellectis and OSE Immunotherapeutics. Raj Thota, MSc, Chief Manufacturing Officer and Head of CMC since August 2021, has over 28 years of experience. Throughout his career, Raj has successfully led the development, optimization and launch of Xtampza® ER Capsules, Vimovo® Tablets, Osmolex® CR Tablets and Entocort® ER Capsules, and many more complex and patentable clinical stage molecules. Melissa Israel, BSc, VP, Clinical Operations since December 2020, has over 30 years of clinical research experience as a results-driven clinical operations leader at Gan & Lee Pharmaceuticals, Johnson & Johnson Consumer, Pfizer Consumer Healthcare, Pfizer, Inc. and Rhône-Poulenc Rorer (now Sanofi). Abhijit Pangu, MPharm, Head of Regulatory Affairs since October 2021, has over 20 years of pharmaceutical industry experience in navigating drug development with global regulatory authorities. Hugo Brugière, Chairman and Chief Executive Officer of Pharnext, commented: "I look forward to working with Scott and am delighted to welcome him to the Pharnext Senior Leadership Team. His experience in quality assurance through the supply chain will be invaluable to Pharnextas we continue to progress our lead candidate PXT3003 in the pivotal Phase III PREMIER trial to treat Charcot-Marie-Tooth disease type 1A." On his appointment as VP, Head of Quality, Scott Johnson commented: "I am thrilled to join Pharnext at such an important time. Pharnext is moving closer to its goal of bringing a much-needed treatment option to patients with CMT1A and I am excited to be part of this important journey." About Pharnext Pharnext is an advanced clinical-stage biopharmaceutical company developing novel therapeutics for neurodegenerative diseases that currently lack curative and/or disease-modifying treatments. Pharnext has two lead products in clinical development. PXT3003 completed an international Phase III trial with positive topline results for the treatment of Charcot-Marie-Tooth disease type 1A (‘CMT1A') and benefits from orphan drug status in Europe and the United States. An international pivotal Phase III study of PXT3003 in CMT1A, the PREMIER trial, is currently ongoing. PXT864 has generated encouraging Phase II results in Alzheimer's disease and will be advanced through partnerships. Both of Pharnext's lead assets originated from the Pleotherapy™ R&D approach. Pharnext draws the attention of investors to the financial and other risk factors detailed in its financial reports. More information can be found at . Pharnext is listed on the Euronext Growth Stock Exchange in Paris (ISIN code: FR001400BV89). Contacts Media Relations (International) Consilium Strategic Communications Mary-Jane Elliott Sukaina Virji Alexandra Harrison pharnext@consilium-comms.com Financial Communication (Europe) ACTUS finance & communication Jérôme Fabreguettes Leib pharnext@actus.fr +33 (0)1 53 67 36 78 Media Relations (France) Ulysse Communication Bruno Arabian barabian@ulysse-communication.com +33 (0)6 87 88 47 26 +33 (0)1 81 70 96 30 SOURCE: Pharnext View source version on accesswire.com:

Increase in the funding commitment of Néovacs to cover cash requirements through the topline results of the pivotal Phase III clinical study of the drug candidate PXT3003, the PREMIER trial, in development in Charcot-Marie-Tooth Disease Type1A (CMT1A) Appointment of Hugo Brugière as Chairman and CEO Creation of an ad hoc committee dedicated to the search for a strategic industrial partner to develop the Company's assets and potential PARIS, FRANCE / ACCESSWIRE / December 28, 2022 / Pharnext SA (FR001400BV89 - ALPHA) (the "Company"), an advanced late-clinical stage biopharmaceutical company developing novel therapeutics for neurodegenerative diseases with high unmet medical need, today announces a series of decisions that have been made to secure the next steps in its development with the support of Néovacs (FR00140077X1 - ALNEV), a French biotech company focused on therapeutic vaccines targeting the treatment of autoimmune diseases and support for promising BioTech and MedTech companies, following the financing and strategic support agreement announced by Pharnext on October 3rd, 2022[1]. Increase in the funding commitment of Néovacs In order to meet Pharnext's financial needs through the first results of the pivotal Phase III clinical study of the drug candidate, PXT3003, which is in development for CMT1A, and to cover the potential 12-month liquidity risk, Néovacs has committed to increasing its financial support up to an additional €2 million per month until the end of 2023. This extension complements the financing agreement signed in October 2022 with Néovacs, for a net amount of €20.7 million, via the issuance of several tranches of simple bonds with warrants. Under the terms of the agreement, Néovacs could become a reference shareholder of Pharnext as of January 1, 2024. This new financing agreement is a partial or total complement to the OCEANE-BSA financing granted by Global Tech Opportunities 13 ("GTO 13"). As a reminder, Pharnext SA and GTO 13 entered into an Agreement for the issuance of and subscription to warrants giving access to notes convertible into new and/or existing shares with share subscription warrants attached ("Bons d'émission d'obligations convertibles ou echangeables en actions nouvelles et/ou existantes avec bons de souscription d'actions attachés") dated June 4, 2021. According to this agreement, as subsequently amended and described in the press release published on October 3rd, 2022, GTO 13 has undertaken to subscribe in cash for tranches of OCEANE-BSAs for a net amount of €2 million per month, starting in December 2022 and ending in December 2023 inclusive (i.e. thirteen tranches for a maximum total of €26 million). The subscription undertaking for each tranche is subject to certain conditions (including, in addition to certain customary conditions, Pharnext's market capitalization not dropping below €2 million over a period of ten days preceding the payment of each tranche and GTO 13's holding of Pharnext securities being below 400% of the market capitalization as a result of the payment of the tranche). The GTO 13 Investment Committee did not approve the disbursement of the 12th tranche of €2 million, planned for the end of December 2022, noting that the agreed conditions precedent had not been met. However, Néovacs, through the trust managing its financing contract with Pharnext, has agreed to subscribe to the €1 million tranche scheduled for late December. In this context, Néovacs has committed to compensate for the non-drawing of the 12th tranche with a cash injection of up to €2 million by the end of January. This contribution will be made in the form of a current-account contribution of associates, the terms of which have yet to be defined according to actual needs for the month of January, and which are currently being studied. Pharnext expects to re-engage the financing agreement with GTO 13 once the conditions precedent would be met again. In parallel, Pharnext and GTO 13 have initiated discussions with a view to amicably terminating their previous agreements in the event of the signature of an agreement with a strategic industrial partner (see below). Appointment of Hugo Brugière as Chairman and Chief Executive Officer To underscore Néovacs' strong commitment, the Board of Directors of Pharnext has unanimously decided to appoint Hugo Brugière as Chairman and Chief Executive Officer to replace Joshua Schafer, who remains a Director of the Company. Hugo is a graduate of the Saint-Cyr Special Military School and Sciences Po Paris. A serial entrepreneur with more than twenty companies to his credit, he has specialized for several years in stock market and restructuring/turnarounds with listed companies. Notably, he is an executive of Boostheat, Cybergun, Néovacs and Verney-Carron, all of which are listed on Euronext in Paris, and of the investment funds HBR Investment Group and Dionae Investment. Hugo Brugière will ensure the continuity of the development of the Company and PXT3003, which is currently in development in a pivotal Phase III clinical study in patients with CMT1A, the PREMIER trial, with results expected in Q4 2023. He will focus on optimizing the operational structure and investments in order to control cash flow and related financing needs. Search for a strategic industrial partner This increased support from Néovacs is intended to allow Pharnext to begin a search for a strategic industrial partner at a time when the Board of Directors considers that the Company has reached a sufficient degree of maturity to develop its assets and commercial potential. Indeed, if the topline results of the current study are positive, they will form the basis of a marketing authorization application for the treatment of CMT1A with the FDA in the United States and the EMA in Europe. This valuation could be done in the context of a capital transaction that could eventually lead to a takeover of the Company. Pharnext currently favors an agreement with a player in the pharmaceutical industry. In order to optimize this search, Pharnext's Board of Directors have decided to form an ad hoc committee, consisting of Joshua Schafer, Director, James Kuo, Director, Rob Quinn, CFO and Xavier Paoli, COO. Joshua has led successful M&A transactions in excess of $16 billion. James has raised several rounds of financing as Managing Director and led HealthCare Ventures, a $378 million venture capital fund. Rob has raised over €200 million in financing to date and Xavier will bring his knowledge of PXT3003 after working 9 years at the Company. In this context, Pharnext plans to have an independent financial analysis performed by a recognized research firm in order to determine the intrinsic value and the target price. Pharnext will inform the market of any progress in respect of its financial communication obligations and of any confidentiality agreements signed with potential partners. Hugo Bruguière, Chairman and Chief Executive Officer of Pharnext, declared: "In my opinion, for the time being, Pharnext is one of the French biotech companies with the greatest potential. It was unbelievable that the Company would find itself in difficulty and that is why Néovacs decided to support it. It is now time for Pharnext to turn the page on convertible bond financing and to find a leading industrial partner which will allow us to potentially obtain marketing authorization for our treatment, PXT3003 in CMT1A, and to launch its commercialization as soon as possible. I am convinced that Pharnext is now on the right track." About Pharnext Pharnext is an advanced clinical-stage biopharmaceutical company developing novel therapeutics for neurodegenerative diseases that currently lack curative and/or disease-modifying treatments. Pharnext has two lead products in clinical development. PXT3003 completed an international Phase III trial with positive topline results for the treatment of Charcot-Marie-Tooth disease type 1A (‘CMT1A') and benefits from orphan drug status in Europe and the United States. An international pivotal Phase III study of PXT3003 in CMT1A, the PREMIER trial, is currently ongoing. PXT864 has generated encouraging Phase II results in Alzheimer's disease and will be advanced through partnerships. Both of Pharnext's lead assets originated from the Pleotherapy™ R&D approach. Pharnext draws the attention of investors to the financial and other risk factors detailed in its financial reports. More information can be found at . Pharnext is listed on the Euronext Growth Stock Exchange in Paris (ISIN code: FR001400BV89). Contacts Hugo Brugière Chairman and CEO contact@pharnext.com +33 (0)1 41 09 22 30 Media Relations (International) Consilium Strategic Communications Mary-Jane Elliott Sukaina Virji Alexandra Harrison pharnext@consilium-comms.com Financial Communication (Europe) Actifin Ghislaine Gasparetto ggasparetto@actifin.fr +33 (0)6 21 10 49 24 Media Relations (France) Ulysse Communication Bruno Arabian barabian@ulysse-communication.com +33 (0)6 87 88 47 26 +33 (0)1 81 70 96 30 [1]Pharnext executes a financing agreement with Néovacs for €20.7 million net to further develop PXT3003 for Charcot-Marie-Tooth disease type 1A Regulatory filing PDF > File: 2022.12.28_New deal Neovacs_EN SOURCE: Pharnext View source version on accesswire.com: