Autoimmune Diseases

Sionna Therapeutics and Odyssey Therapeutics have joined Metsera and Maze in an attempt to go public via the still rocky IPO route. The biotechs, focused on cystic fibrosis and immunology respectively, filed for their initial public offerings on Friday evening. Sionna and Odyssey departed last week’s annual JP Morgan Healthcare Conference with plans for public life as $SION and $ODTX . They join the Nasdaq queue alongside obesity drug developer Metsera and kidney disease startup Maze , which has spun out other companies and formed joint ventures over the years. None of the IPO hopefuls have yet outlined the size of their planned debuts. If all four biotechs follow through with their plans, they’d create a buzzy start to 2025 compared to the relatively dry IPO market of the past few years. The new entrants Sionna and Odyssey are both well-funded, clinical-stage biotechs with experienced management teams, ticking most of the boxes that public market investors seek for drug development startups in the current IPO environment. Last year, Boston-based Sionna in-licensed three cystic fibrosis drug candidates from AbbVie, just months after disclosing a $182 million Series C that would take it through 2026, CEO Mike Cloonan told Endpoints News last July. Cloonan was a long-time Biogen executive and Sage Therapeutics operating chief before joining Sionna in spring 2021. New details on the AbbVie deal were revealed in Sionna’s S-1 paperwork, which was filed on 17 January. AbbVie got $5 million upfront and $8.6 million worth of common stock. The pharma giant could also get up to $360 million in development and commercial biobucks, plus up to $130 million in commercial and sales-based milestones, according to the S-1 filing . Sionna had $180 million in cash, equivalents and marketable securities at the end of September, according to the filing. The mid-stage biotech spent about $43 million on R&D in the first nine months of 2024, a $12 million jump over the same period the prior year, per the S-1. Sionna has raised about $330 million since its 2019 founding. RA Capital owns the largest chunk of the biotech at 29.2%. TPG Growth holds 17.4%, Atlas Venture owns 11.4% and OrbiMed maintains a 9.9% stake. OrbiMed is also one of the largest stakeholders in Odyssey. SR One is the biggest shareholder at 16.2% followed by OrbiMed (14.3%), Fidelity (6.7%) and Foresite Capital (6%), according to Odyssey’s S-1 filing . Odyssey is developing small molecule therapies for ulcerative colitis, Crohn’s disease, atopic dermatitis, systemic sclerosis and other indications. It’s also creating protein therapeutics for vitiligo, type 1 diabetes, systemic lupus erythematosus and asthma. The preclinical asthma program is part of the burgeoning TSLP arena. Gary Glick, a chemistry professor-turned-serial entrepreneur, leads Odyssey. The biotech startup formed in 2021 and quickly disclosed three successive megaround financings, most recently a $101 million Series C in December 2023. Glick is also a co-founder of Scorpion Therapeutics. During last week’s JPM, Eli Lilly said it would buy Scorpion for up to $2.5 billion . Odyssey spent $81 million on R&D in the first nine months of 2024, a $5 million decrease compared with the same period of 2023. The company had about $155 million in cash, equivalents and marketable securities at the end of September.

GUANGZHOU, China, Jan. 17, 2025 /PRNewswire/ -- Guangzhou Fermion Technology Co., Ltd. and Simcere Pharmaceutical Group Limited (HKEX: 2096) have announced a partnership to develop a clinical-stage pain treatment asset, FZ002-037, targeting SSTR4. FZ002-037 is a highly selective oral small-molecule SSTR4 agonist developed by Fermion. Preclinical studies indicate that the drug primarily provides peripheral analgesia without central side effects or addiction risks, making it a promising option for patients requiring long-term pain management. It is the first domestically developed SSTR4 agonist in China and the second globally to reach the clinical stage. The drug has completed Phase I clinical trials in China, with Phase II studies for diabetic peripheral neuropathy set to begin soon. Potential applications extend to various chronic and acute pain conditions. Dr. Deco Deng, Founder of Fermion, stated: "We are delighted to partner with Simcere, a leading pharmaceutical company. As the first domestically developed and the world's second high-selectivity SSTR4 agonist to enter the clinical stage, FZ002-037 holds great promise. By leveraging Simcere's strong development and commercialization capabilities, we are confident in accelerating its progress to provide better treatment options for patients suffering from pain." Zhou Gaobo, Chief Investment Officer of Simcere, added: "Pain significantly affects patients' quality of life and remains a major unmet clinical need. Addressing these 'clinical pain points' has always been a core mission for Simcere. We look forward to collaborating with innovative partners like Fermion to deliver more effective and safer pain therapies to patients as quickly as possible." Under the agreement, Simcere will gain exclusive rights to develop and commercialize FZ002-037 in Greater China (Mainland China, Hong Kong, Macau, and Taiwan). Fermion will receive an upfront payment, milestone payments, and tiered royalties based on future sales. About Fermion Technology Fermion is a clinical-stage, AI-driven biotech company founded in 2019. The company focuses on developing differentiated best-in-class (BIC) and first-in-class (FIC) products in the central nervous system (CNS) and autoimmune fields. Leveraging its proprietary Drug Studio AI platform, Fermion prioritizes high target selectivity and tissue targeting to minimize off-target effects, ensure precise distribution in target tissues, and foster the development of innovative drugs with enhanced safety profiles. For more information, please visit: . About Simcere Pharmaceutical Simcere Pharmaceutical Group Limited (2096.HK) is a pharmaceutical company driven by innovative R&D, and houses a "State Key Laboratory of Neurology and Oncology Drug Development". Simcere is committed to "providing today's patients with medicines of the future" across the following core therapeutic areas: oncology, central nervous system, autoimmunity and anti-infection. Furthermore, Simcere is also actively expanding presence in disease areas with significant clinical needs in the future. Simcere's industry-leading capabilities and commitment to synergistic innovation have also enabled various strategic collaborations and are seen as the partner of choice by innovative biopharmaceutical companies, medical institutes, and research teams in China and globally. For more information, please visit: About FZ002-037 FZ002-037 is a Phase II-ready non-opioid pain treatment that acts as an oral SSTR4 agonist. It is the first SSTR4 agonist to enter clinical trials in China and the second globally. The drug demonstrates excellent selectivity, with a double-digit pM EC50 and strong efficacy in multiple chronic and acute pain models. Phase I studies revealed a favorable safety profile, with no reported CNS or gastrointestinal adverse events, and an attractive PK profile (potential once-daily dosing). These characteristics highlight its potential as a breakthrough therapeutic option to address the unmet need for effective, non-addictive pain relief. For more information, please visit: Investors and Media Contact: [email protected] SOURCE Guangzhou Fermion Technology Co., Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

CALGARY, Alberta, Jan. 17, 2025 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. ("XORTX" or the “Company”) (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU), a late stage clinical pharmaceutical company focused on developing innovative therapies to treat progressive kidney disease and gout, announces the Company has changed its auditor from Smythe LLP, Chartered Professional Accountants (“Former Auditor”) to Davidson & Company LLP, Chartered Professional Accountants, (“Successor Auditor”) effective January 16, 2025. XORTX’s board of directors accepted the resignation of the Former Auditor, as of January 16, 2025 and appointed the Successor Auditor as the new auditor of the Company effective January 16, 2025, and to hold office until the close of the Company's next annual general meeting of shareholders. There were no reservations in the Former Auditor's audit reports for any financial period during which the Former Auditor was the Company's auditor. There are no "reportable events" (as the term is defined in National Instrument 51-102 - Continuous Disclosure Obligations) between the Company and the Former Auditor. In accordance with National Instrument 51-102, the Notice of Change of Auditor, together with the required letters from the Former Auditor and the Successor Auditor, have been reviewed by the Company's audit committee and board of directors and have been filed on the Company’s SEDAR+ profile at www.sedarplus.ca. About XORTX Therapeutics Inc. XORTX is a pharmaceutical company with three clinically advanced products in development: 1) our lead, XRx-008 program for ADPKD; 2) our XRx-026 program for the treatment of allopurinol intolerant gout; and 3) our secondary program in XRx-101 for acute kidney and other acute organ injury associated with Coronavirus / COVID-19 infection. In addition, XRx-225 is a pre-clinical stage program for Type 2 Diabetic Nephropathy. XORTX is working to advance its clinical development stage products that target aberrant purine metabolism and xanthine oxidase to decrease or inhibit production of uric acid. At XORTX, we are dedicated to developing medications to improve the quality of life and health of kidney disease patients and individuals with gout. Additional information on XORTX is available at www.xortx.com. For more information, please contact: Allen Davidoff, CEO Nick Rigopulos, Director of Communicationsadavidoff@xortx.com or +1 403 455 7727nick@alpineequityadv.com or +1 617 901 0785 Neither the TSX Venture Exchange nor Nasdaq has approved or disapproved the contents of this news release. No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein.