FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 HCW BIOLOGICS INC. Table of Contents As filed with the Securities and Exchange Commission on January 9, 2026 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 (Exact name of Registrant as specified in its charter) (State or Other Jurisdiction of Incorporation or Organization) Delaware 2834 82-5024477 Primary Standard Industrial Classification Code Number 2929 N Commerce Parkway Miramar, FL 33025 (954 ...

SAN DIEGO, Jan. 09, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today provided additional context regarding its previously announced proposal to change the Company’s jurisdiction of incorporation from Alberta, Canada, to the State of Nevada in the United States. The Company believes it is important to clearly communicate the strategic and operational reasons underlying this proposal as Oncolyt ...

Core Viewpoint - PDS Biotechnology Corporation has submitted an amended protocol for its Phase 3 VERSATILE-003 trial, aiming for accelerated approval of its immunotherapy PDS0101 by changing the primary endpoint to progression-free survival (PFS) [1][2][3] Group 1: Clinical Trial Updates - The amendment to the VERSATILE-003 trial allows for an earlier evaluation of PFS with significant statistical power, which could support accelerated approval [1][2] - Median overall survival (mOS) remains the primary endpoint for full approval as originally recommended by the FDA [1] - The submission follows a constructive Type C meeting with the FDA in December 2025, discussing the accelerated approval pathway for PDS0101 in HPV16-positive recurrent and/or metastatic head and neck cancer [2] Group 2: Company Insights - PDS Biotechnology is focused on transforming how the immune system targets and kills cancers, with a pivotal clinical trial for advanced HPV16-positive head and neck squamous cell cancers [4] - The lead investigational targeted immunotherapy, PDS0101 (Versamune HPV), is being developed in combination with a standard-of-care immune checkpoint inhibitor and a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate [4] - The company expresses confidence in the potential to accelerate regulatory submission based on discussions with the FDA [3]

Core Viewpoint - Tiziana Life Sciences is set to present its lead candidate, intranasal foralumab, at the 9th Annual Neuroscience Innovation Forum, highlighting its potential in treating neurodegenerative conditions [1][3][4]. Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies using alternative drug delivery technologies, particularly intranasal administration [7]. - The company’s lead candidate, intranasal foralumab, is the only fully human anti-CD3 monoclonal antibody currently in clinical development, showing a favorable safety profile and clinical response in patients [6][7]. Product Details - Foralumab is designed to modulate the immune system and reduce microglial activation in neurodegenerative conditions, specifically targeting non-active secondary progressive multiple sclerosis (na-SPMS) [3][5]. - In an open-label intermediate sized Expanded Access Program, 14 patients with na-SPMS have been dosed, with all showing either improvement or stability of disease within 6 months [5]. Event Participation - CEO Ivor Elrifi will deliver a corporate presentation at the Neuroscience Innovation Forum, which is a key industry event featuring discussions on advancements in therapeutics and neurotechnology [1][3][4]. - Members of Tiziana's senior management team will also be available for one-on-one meetings with investors and stakeholders during the forum [2].

Core Insights - IM1240, a tri-specific antibody from Purple Biotech's CAPTN-3 platform, has shown improved safety in a toxicology study, allowing doses up to 300-fold higher than a non-capped comparator with significantly reduced immune-related toxicity [1][2][3] - The pharmacokinetic profile of IM1240 indicates increased systemic exposure and a prolonged circulating half-life, supporting its therapeutic potential [1][3] - Purple Biotech plans to submit for regulatory approval for first-in-human clinical trials in the second half of 2026 [1] Study Results - The toxicology study demonstrated that IM1240's proprietary capping technology significantly reduced immune-related toxicity, including minimal cytokine release, compared to a non-capped comparator [2][3] - Hematologic findings in the study aligned with expected pharmacodynamic effects on immune activation, showcasing a favorable safety and tolerability profile [3] - The capping design of IM1240 allowed for a significant reduction in immune-related effects, maintaining modest cytokine release even at high doses [3] Pharmacokinetics - IM1240 exhibited a favorable pharmacokinetic profile characterized by dose-dependent increases in systemic exposure, as indicated by AUC and Cmax [3] - The findings support the dose-exposure relationship and provide proof of concept for the capping design and albumin incorporation contributing to IM1240's favorable pharmacokinetic profile [3] CAPTN-3 Platform Overview - The CAPTN-3 platform consists of capped tri-specific antibodies that target tumor-associated antigens while engaging T cells and NK cells, significantly expanding the therapeutic window compared to conventional T-cell engagers [4][5] - IM1240 targets the 5T4 antigen, while another candidate, IM1305, targets TROP2 and is currently in preclinical development [4][5] Company Background - Purple Biotech Ltd. is a clinical-stage oncology company focused on developing first-in-class therapies to overcome tumor immune evasion and drug resistance [5] - The company's pipeline includes additional clinical-stage assets, such as CM24 and NT219, which are in various stages of clinical trials [5]

Core Viewpoint - Innate Pharma SA has released its total number of shares outstanding and voting rights as of December 31, 2025, in compliance with French regulatory requirements [1]. Group 1 - The total number of shares outstanding for Innate Pharma SA is 93,719,323 ordinary shares [1]. - The announcement is made in accordance with article L. 233-8 II of the French "Code de Commerce" and article 223-16 of the French stock-market authorities (Autorité des Marchés Financiers, or "AMF") General Regulation [1].

Core Viewpoint - Coherus Oncology has introduced its investigational anti-CCR8 monoclonal antibody, tagmokitug, which shows high selectivity and efficacy in targeting CCR8+ T regulatory cells in solid tumors, indicating its potential as an anticancer treatment [1][3][4]. Group 1: Scientific Evidence and Mechanism - The publication in Molecular Cancer Therapeutics highlights tagmokitug's picomolar binding affinity and its ability to selectively eliminate CCR8+ T regulatory cells without off-target binding [1][3]. - Preclinical and clinical studies demonstrate that tagmokitug induces significant tumor regression in mouse models, especially when combined with anti-PD-1 antibody treatment [4]. - The first-in-human clinical study confirms that tagmokitug leads to selective reductions in CCR8+ Tregs in cancer patients, establishing proof of mechanism [5]. Group 2: Clinical Development and Pipeline - Tagmokitug is currently undergoing Phase 1b/2a clinical trials in combination with the PD-1 inhibitor toripalimab and chemotherapy for patients with various solid tumors [6][8]. - Coherus Oncology's pipeline includes multiple antibody immunotherapy candidates aimed at enhancing immune responses to improve cancer treatment outcomes [8]. Group 3: Company Overview - Coherus Oncology is a commercial-stage innovative oncology company with an approved PD-1 inhibitor, LOQTORZI®, and a promising pipeline targeting various cancers [7]. - The company's strategy focuses on growing sales of LOQTORZI in nasopharyngeal carcinoma and advancing new indications in combination with its pipeline candidates [7].

Group 1 - Corvus Pharmaceuticals is set to announce results from cohort 4 of its Phase 1 clinical trial for soquelitinib in patients with moderate to severe atopic dermatitis in the second half of January 2026 [1] - The company has canceled all previously planned conference attendances, including a presentation at the J.P. Morgan 2026 Healthcare Conference scheduled for January 12th [1] - Soquelitinib is an investigational oral small molecule drug that selectively inhibits ITK and is currently in a registration Phase 3 clinical trial for relapsed/refractory PTCL [2] Group 2 - Corvus Pharmaceuticals is pioneering ITK inhibition as a new approach to immunotherapy for various immune diseases and cancer [2] - The company is focused on developing innovative treatments and has a lead product candidate, soquelitinib, which is also in a Phase 1 clinical trial for atopic dermatitis [2]

Core Insights - BioVaxys Technology Corp. has integrated the DPX™ platform into its operations, focusing on organic growth and innovative vaccine development that enhances immune response through a novel mechanism of action [1][5]. Company Developments - The company appointed Dr. James Tartaglia and Dr. Marianne Stanford to its Board and as Scientific Advisor, respectively, enhancing its scientific and business development expertise [2][3][4]. - Dr. Tartaglia has over 34 years of experience in vaccine R&D, having led vaccine development at Sanofi, while Dr. Stanford previously led the development of the DPX™ vaccine portfolio at IMV Inc [3][4]. Clinical Studies - BioVaxys reported positive results from a Phase 1 study of maveropepimut-S (MVP-S) in HR+/HER2- stage II-III breast cancer, showing a significant immune response and a decrease in Ki67 levels from a median of 24% to 6% post-treatment [7][8]. - The company plans to further evaluate MVP-S's systemic immunity and pursue a Phase II study to modify the tumor immune environment in high-risk HR+ breast cancer [9]. Collaborations and Licensing - BioVaxys entered a research agreement with Sona Nanotech to develop new cancer therapeutics combining the DPX platform with Sona's Targeted Hyperthermia Therapy™ [10]. - The company is exploring out-licensing opportunities for MVP-S, particularly for ovarian cancer, and is in discussions with a global pharma company [11][12]. Pipeline Expansion - BioVaxys is advancing its early-stage pipeline with multiple out-licensing opportunities and research collaborations, including a DPX formulation for rabies and a DPX-RSV vaccine that demonstrated antigen-specific immune responses in 93% of subjects [6][14]. - The company is also developing additional infectious disease programs, including DPX-rHA/DPX-FLU for influenza and DPX-rPA for anthrax, with promising preclinical results [15]. Revenue Generation - BioVaxys has revenue-generating licenses with Zoetis Inc. and SpayVac for Wildlife, Inc., focusing on vaccines in the animal health field, with ongoing progress towards commercialization [17][18]. - SpayVac has initiated the regulatory approval process for its immunocontraceptive vaccine targeting feral horses and deer populations, which is based on BioVaxys's technology [18][20]. Future Outlook - The company anticipates aggressive business development activity in 2026, aiming to advance ongoing out-licensing and research collaboration discussions, and to book its first royalty income [22].

Core Insights - IMUNON, Inc. is making significant progress towards a potential breakthrough in ovarian cancer treatment with its immunotherapy candidate IMNN-001, as evidenced by advancements in the Phase 3 OVATION 3 Study and promising data from the MRD study [1][2][3]. Group 1: Clinical Progress - The Phase 3 OVATION 3 Study is evaluating IMNN-001 in combination with standard chemotherapy for newly diagnosed advanced ovarian cancer, with strong enrollment interest from the medical community [2]. - In the Phase 2 OVATION 2 Study, IMNN-001 demonstrated a 13-month extension in median overall survival (OS) with a hazard ratio of 0.70, and in patients receiving PARP inhibitors, the median OS has not yet been reached, with many patients surpassing five years of follow-up [2]. - The ongoing MRD study shows encouraging preliminary results, including lower MRD positivity rates and higher complete response scores compared to the control arm [4]. Group 2: Immunotherapy Insights - IMNN-001 has shown a broad impact on the tumor microenvironment, leading to IL-12 production by macrophages, which enhances T cell cytotoxic functions [3][7]. - The treatment has resulted in a more inflamed tumor immune microenvironment, effectively converting "cold" tumors to "hot" tumors, thereby activating both innate and adaptive immune systems [7]. Group 3: Financial and Strategic Position - The company has maintained financial discipline throughout 2025, with significant cost reductions in cGMP-compliant manufacturing, positioning for high gross margins upon potential FDA approval [9]. - IMUNON is committed to funding the OVATION 3 trial, with an estimated budget of $30 million for the HRD+ subgroup focus, indicating a strategic approach to clinical development [9]. Group 4: Future Outlook - Looking ahead to 2026, IMUNON is poised for key milestones, including continued enrollment in OVATION 3 and potential early stopping for BLA filing in the HRD+ population [10]. - The company anticipates additional data presentations at major conferences and further insights from OVATION 2 tumor samples, reinforcing its commitment to advancing cancer care [10].