Core Insights - ImmunityBio, Inc. (IBRX) shares surged 41.9% following the European Commission's conditional marketing authorization for Anktiva in combination with Bacillus Calmette-Guérin (BCG) for treating BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS) [1][5] Regulatory Approval - Anktiva plus BCG is the first immunotherapy authorized in Europe for the NMIBC indication, now cleared in 33 countries across four regulatory jurisdictions, including the US, EU, UK, and Saudi Arabia [2] - The approval was anticipated as the European Medicines Agency's advisory committee had previously recommended marketing authorization for this combination therapy [3] Clinical Efficacy - The approval is supported by the phase II/III QUILT-3.032 study, which showed a 71% complete response rate among 100 adults with BCG-unresponsive NMIBC CIS [6] - Among responders, 66% maintained a complete response at 12 months and 42% at 24 months, with a median duration of complete response of six months [6] Safety Profile - Most treatment-related adverse events reported in the QUILT-3.032 study were mild to moderate, with common adverse reactions including dysuria, hematuria, and urinary tract infections [7] Market Context - Bladder cancer is a significant health issue in the EU, with about three-quarters of diagnoses being NMIBC, and treatment options for BCG-unresponsive cases have been limited [8] - The broader availability of BCG in Europe, with approximately six approved strains, supports combination treatment approaches [9] Ongoing Requirements - ImmunityBio is required to submit long-term follow-up results from ongoing studies to confirm Anktiva's safety and effectiveness, with the authorization subject to annual renewal [4][5]

Core Insights - ImmunityBio (IBRX) shares surged 41.9% to close at $8.54, reversing a previous 7.1% loss over the past four weeks, supported by high trading volume [1][2] Company Developments - The significant share price increase was driven by the European Commission granting conditional approval for ImmunityBio's Anktiva plus BCG therapy for treating BCG-unresponsive non-muscle invasive bladder cancer, expanding its market presence to 33 countries [2] - This approval marks the first immunotherapy authorized in Europe for this specific indication, enhancing the company's growth prospects [2] Financial Expectations - ImmunityBio is projected to report a quarterly loss of $0.08 per share, reflecting a year-over-year increase of 46.7%, with expected revenues of $37.1 million, up 391.4% from the previous year [3] - The consensus EPS estimate for the upcoming quarter has been revised 6.3% higher in the last 30 days, indicating a positive trend that typically correlates with stock price appreciation [4] Industry Context - ImmunityBio operates within the Zacks Medical - Biomedical and Genetics industry, where Mirum Pharmaceuticals, another company in the sector, has seen a 2.2% increase in its stock price, closing at $105.1, with an 11.9% return over the past month [4] - Mirum Pharmaceuticals has a consensus EPS estimate that has changed by +50.9% over the past month, indicating a significant year-over-year change of +104.1% [5]

Group 1 - ImmunityBio Inc. (NASDAQ:IBRX) is recognized as one of the 13 stocks with the highest upside potential, particularly following the initiation of a Phase 2 clinical trial for a novel combination immunotherapy targeting indolent B-cell non-Hodgkin lymphoma (iNHL) [1] - The company amended a $505 million convertible promissory note with Nant Capital LLC, allowing for the conversion of outstanding principal into shares of ImmunityBio's common stock before the note's maturity date [2] - H.C. Wainwright raised its price target for ImmunityBio from $8 to $10 while maintaining a Buy rating, noting the company's strong financial position with liquid assets exceeding short-term obligations and a current ratio of 5.77 [3] Group 2 - ImmunityBio is a clinical-stage immunotherapy company focused on developing next-generation therapies aimed at combating cancers and infectious diseases [4]

Core Viewpoint - ImmunityBio's stock surged 41.86% following the European Commission's conditional marketing authorization for its immunotherapy Anktiva to treat bladder cancer, indicating strong market interest and potential for growth in sales [1][3]. Company Summary - ImmunityBio develops immunotherapies and vaccines for cancers and infectious diseases, with Anktiva being its flagship product [1]. - The company went public in 2015 and has seen its stock price decline by 75% since then, despite recent gains [1]. - Anktiva is now authorized for use in over 30 new countries, which is expected to accelerate sales growth [3]. - The company reported a 700% increase in Anktiva sales in 2025 and has received additional approvals from the Saudi Food and Drug Authority [7]. Market Performance - ImmunityBio's stock closed at $8.54 with a trading volume of 78.5 million shares, significantly above its three-month average of 28.2 million shares [1]. - The S&P 500 and Nasdaq Composite also saw gains, with increases of 0.53% and 0.78% respectively on the same day [2]. Investment Considerations - Despite the promising developments with Anktiva, ImmunityBio remains a volatile stock, heavily reliant on positive news regarding its main immunotherapy [4]. - Analysts from The Motley Fool Stock Advisor have not included ImmunityBio in their list of top investment recommendations, suggesting caution for potential investors [5].

Core Viewpoint - BriaCell Therapeutics Corp. and its subsidiary BriaPro Therapeutics Corp. have entered into a definitive purchase agreement for BriaPro to acquire BriaCell's exclusive license for the development and commercialization of Soluble CD80 (sCD80) as a biologic agent for cancer treatment [1][3]. Background - BriaCell secured the exclusive license for sCD80 from the University of Maryland, Baltimore County (UMBC) on August 2, 2022, which is based on technology developed by Dr. Suzanne Ostrand-Rosenberg [2]. - sCD80 has shown promise in animal models by halting tumor growth and potentially restoring anti-tumor immunity, with reported strong anti-tumor activity across multiple tumor types [2]. Transaction Details - BriaPro will gain worldwide rights to develop and commercialize sCD80, while UMBC retains certain rights, including a 2% royalty on commercialization and other development costs [3]. - BriaCell will provide up to $3 million to BriaPro for research and development, with fund usage subject to BriaCell's approval [4]. - As part of the transaction, BriaPro will issue 23,972,589 Common Shares to BriaCell, valued at approximately C$1.18 million, increasing BriaCell's ownership in BriaPro to about 78% post-transaction [5]. Shareholder Approval - The Purchase Agreement requires approval from a simple majority of disinterested shareholders of BriaPro, excluding votes from BriaCell due to its 10% stake [6]. - BriaPro plans to comply with formal valuation requirements under Multilateral Instrument 61-101, intending to obtain an independent third-party valuation to confirm fair market value [7][8]. Company Statements - The President and CEO of BriaCell and BriaPro emphasized the mission to develop effective cancer treatments, highlighting the potential of sCD80 as a transformational anti-cancer agent [9].

Core Viewpoint - BriaCell Therapeutics Corp. and its subsidiary BriaPro Therapeutics Corp. have entered into a definitive purchase agreement for BriaPro to acquire BriaCell's exclusive license for the development and commercialization of Soluble CD80 (sCD80) as a biologic agent for cancer treatment, which is expected to enhance cancer care through novel immunotherapies [1][3][9] Group 1: Transaction Details - BriaPro will gain worldwide rights to develop and commercialize sCD80, while the University of Maryland, Baltimore County (UMBC) retains rights to the inventions and patents, with BriaPro obligated to pay 2% royalties upon commercialization [3] - BriaCell will provide up to $3 million to BriaPro for research and development, with fund usage subject to BriaCell's approval [4] - As part of the transaction, BriaPro will issue 23,972,589 Common Shares to BriaCell, valued at approximately C$1.18 million, increasing BriaCell's ownership in BriaPro to about 78% post-transaction [5] Group 2: Approval and Valuation - The transaction requires approval from a simple majority of BriaPro's shareholders, excluding votes from BriaCell due to its 10% stake [6] - BriaPro plans to obtain a third-party valuation to ensure the transaction occurs at fair market value, despite a formal valuation not being legally required [8] Group 3: Background on sCD80 - The technology for sCD80 was developed by Dr. Suzanne Ostrand-Rosenberg and has shown promise in animal models by halting tumor growth and potentially restoring anti-tumor immunity [2] - Studies indicate that sCD80 may enhance the immune system's ability to recognize and destroy tumor cells, demonstrating strong anti-tumor activity across multiple tumor types [2]

Table of Contents As filed with the Securities and Exchange Commission on February 17, 2026 Registration No. 333-293396 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 AMENDMENT NO. 2 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 HCW BIOLOGICS INC. (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 (I.R.S. Employer Ident ...

Core Insights - HCW Biologics has entered into an exclusive worldwide license agreement with WY Biotech for the development and commercialization of the proprietary molecule HCW11-006, valued at $7 million [1][2] - The Phase 1 clinical study for HCW11-006 is expected to begin in the first half of 2027, targeting solid tumors [3][4] - HCW Biologics retains a royalty-free option to reclaim rights for the Americas territory after the Phase 1 trial [4] Company Overview - HCW Biologics Inc. is a clinical-stage biopharmaceutical company focused on developing innovative immunotherapies targeting chronic inflammation and related diseases [6] - The company has developed over 50 molecules using its TRBC drug development platform, which aims to create immunotherapeutics for various diseases, including cancer and autoimmune disorders [6][7] Partnership and Financials - A new entity, Beijing Trimmune Biotech Co., Ltd., has been established to manage the development and commercialization of HCW11-006, backed by CITIC Medical Fund and TigerYeah Capital Fund [2][3] - Trimmune has initiated payment of $1.75 million as part of a $3.5 million upfront cash license fee to HCW Biologics, with additional milestone payments and royalties expected from future sales [3][4] Development Strategy - Trimmune plans to leverage the expertise of HCW Biologics and its own management team to advance the clinical development of HCW11-006, aiming to address significant unmet medical needs in the Chinese market [2][5] - The collaboration is expected to facilitate the exploration of business development opportunities with multinational corporations once key clinical data is generated [4][5]

Core Insights - Medicenna Therapeutics is advancing its clinical pipeline with promising data for MDNA11 and MDNA113, targeting various cancers and autoimmune diseases [2][3][21] Clinical Data and Trials - Updated clinical data from the ABILITY-1 trial shows MDNA11 achieving an objective response rate (ORR) of 36% in monotherapy and 43% when combined with pembrolizumab in patients treated as second or third-line therapy [4][5] - The ABILITY-1 study has expanded to include patients with non-small cell lung cancer (NSCLC) and secondary resistance to checkpoint therapy, addressing a significant unmet need in cancer treatment [4][6] - The NEO-CYT trial will evaluate MDNA11 in combination with nivolumab for high-risk melanoma, with patient enrollment expected to start in H1 2026 and interim data anticipated in H2 2026 [8][10] Product Development - MDNA113, a bifunctional anti-PD-1–IL-2 superkine, is progressing through IND-enabling studies, with plans to submit an IND in H2 2026 after demonstrating a favorable safety profile in non-human primates [3][14] - Bizaxofusp (formerly MDNA55) has shown a significant increase in median overall survival for recurrent glioblastoma patients, with a median overall survival of 13.6 months compared to the standard of care of 7 months [14] Financial Overview - As of December 31, 2025, Medicenna reported cash and cash equivalents of $10.6 million, expected to fund operations into Q3 2026 [16] - The company reported total operating costs of $5.6 million for the quarter, an increase from $5.1 million in the same period the previous year, primarily due to higher R&D expenditures [17][19] - The net loss for the quarter was $4.4 million, a decrease from $5.2 million in the prior year, attributed to an increase in the gain on the fair value of derivative warrant liability [18]

Core Insights - Medicenna Therapeutics is advancing its clinical pipeline with promising data for MDNA11 and MDNA113, aiming for significant milestones in 2026 [2][3] Clinical Data and Trials - The ABILITY-1 trial for MDNA11 shows an objective response rate (ORR) of 36% in monotherapy and 43% when combined with pembrolizumab, with a disease control rate (DCR) of 86% and 72% respectively [3][4] - A new expansion cohort in the ABILITY-1 study will treat patients with non-small cell lung cancer (NSCLC) and secondary resistance to checkpoint therapy [3][5] - The NEO-CYT trial will evaluate MDNA11 in combination with nivolumab for melanoma, with patient enrollment expected to start in H1 2026 and interim data anticipated in H2 2026 [7][9] Product Development - MDNA113, a bifunctional anti-PD-1–IL-2 superkine, is progressing through IND-enabling studies, with plans to submit an IND in H2 2026 [2][12] - Bizaxofusp (formerly MDNA55) has shown a median overall survival (mOS) of 13.6 months in a Phase 2b trial for recurrent glioblastoma, compared to the standard mOS of 7 months [12] Financial Overview - As of December 31, 2025, Medicenna reported cash and cash equivalents of $10.6 million, expected to fund operations into Q3 2026 [14] - The company reported total operating costs of $5.6 million for the quarter, an increase from $5.1 million in the same period the previous year, primarily due to higher R&D expenditures [15][17] - The net loss for the quarter was $4.4 million, a decrease from $5.2 million in the prior year, attributed to a gain on the fair value of derivative warrant liability [16]