Potential to Be the First Targeted Fast-Acting Therapy for GBS, Setting a New Standard of Care BLA Submission with U.S./European Data from FORWARD Trial Planned in 2026 BRISBANE, Calif., Jan. 08, 2026 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company advancing the next generation platform of targeted immunotherapies aimed at neuroinflammatory diseases that impact nearly 10 million people worldwide, today announced it has submitted a Marketing Authorization Application (MAA) to t ...

Core Viewpoint - MAIA Biotechnology, Inc. has announced a private placement of 603,769 shares of common stock at a price of $1.22 per share, along with warrants for additional shares, aimed at raising approximately $736,600 to fund clinical trials and working capital [1][2]. Group 1: Private Placement Details - The private placement involves the sale of 603,769 shares at $1.22 each, with each share accompanied by a warrant to purchase one additional share at an exercise price of $1.52 [1]. - The warrants will be exercisable six months after issuance and will have a term of three years [1]. - The expected gross proceeds from the offering are approximately $736,600, before expenses [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized to fund Step 1 of Part C of the Phase II trial THIO-101 and for general working capital [2]. Group 3: Company Overview - MAIA Biotechnology is focused on developing targeted immunotherapies for cancer, with its lead program being ateganosine (THIO), aimed at treating NSCLC patients with telomerase-positive cancer cells [5].

Core Viewpoint - Calidi Biotherapeutics is undergoing significant transformation in leadership, focus, and financial management, aiming to advance its innovative oncology therapies, particularly the RedTail platform, which shows promise in delivering genetic medicines to metastatic cancer sites [1][3][7]. Company Developments - The appointment of Eric Poma as CEO in April 2025 marks a new leadership direction, with a focus on advancing therapeutic approaches in oncology [2]. - Dr. Guy Travis Clifton has been appointed as Chief Medical Officer, enhancing the company's expertise in clinical program advancement and regulatory strategy [2]. R&D Pipeline Progress - The RedTail platform is highlighted as a key focus, utilizing an engineered enveloped virus for systemic delivery of genetic medicines to metastatic cancer sites, representing over a decade of research [3][9]. - Recent preclinical data indicates that RedTail demonstrates potent tumor-selective targeting and improved anti-tumor immune modulation, differentiating it in the oncology market [4]. Strategic Partnerships - The company is actively seeking partnerships with leading biopharmaceutical firms to accelerate the development and commercialization of therapies, which could enhance market reach and shareholder value [4]. Future Milestones - The roadmap for the next 18 months includes completing IND-enabling studies for the lead candidate CLD-401, with an IND filing anticipated by the end of 2026 [5]. - An IND for the SuperNova virotherapy (CLD-201) was opened in April 2025, with Phase I trials expected to start by the end of 2025 [6]. Financial Management - As of Q1 2025, the company reported approximately $10.6 million in cash, with efforts to reduce costs and lower the burn rate while retiring most of its debt [7].