Core Viewpoint - Nektar Therapeutics has announced the pricing of an upsized public offering of $400 million, which includes common stock and pre-funded warrants, aimed at supporting its clinical development and general corporate purposes [1][2] Group 1: Offering Details - Nektar is offering 6,603,449 shares of common stock at a price of $58.00 per share and 293,103 pre-funded warrants at a price of $57.9999 each, leading to expected gross proceeds of approximately $400 million before expenses [1] - The underwriters have a 30-day option to purchase an additional 1,034,482 shares at the public offering price [1] - The offering is expected to close on February 13, 2026, subject to customary conditions [1] Group 2: Use of Proceeds - The net proceeds from the offering will be used for general corporate purposes, including research and development, clinical development (notably Phase 3 trials for rezpegaldesleukin), and manufacturing costs [1] Group 3: Company Overview - Nektar Therapeutics is a clinical-stage biotechnology company focused on developing innovative treatments for autoimmune and chronic inflammatory diseases [1] - The lead product candidate, rezpegaldesleukin, is being evaluated in multiple clinical trials for conditions such as atopic dermatitis, alopecia areata, and Type 1 diabetes mellitus [1] - Nektar's pipeline includes additional candidates like NKTR-0165, NKTR-0166, and NKTR-422, as well as NKTR-255, which is designed to enhance the immune system's ability to combat cancer [1]

Table of Contents As filed with the Securities and Exchange Commission on February 11, 2026 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 HCW BIOLOGICS INC. (Exact name of Registrant as specified in its charter) Delaware 2834 82-5024477 (State or Other Jurisdiction of Incorporation or Organization) Primary Standard Industrial Classification Code Number 2929 N Commerce Parkway Miramar, FL 33025 (9 ...

Summary of enGene Therapeutics Conference Call Company Overview - **Company**: enGene Therapeutics (NasdaqCM: ENGN) - **Industry**: Non-muscle invasive bladder cancer (NMIBC) therapeutics - **Lead Product Candidate**: Detalimogene Key Points Product Value Proposition - Detalimogene is designed to meet the needs of both academic and community urologists, focusing on efficacy, tolerability, ease of use, and economic fit within practice flow [3][4] - The product has a competitive efficacy profile and a best-in-class tolerability profile, with low treatment discontinuation and interruptions [4][12] Market Dynamics - Over 80% of NMIBC patients are managed in community settings, highlighting the importance of products that cater to busy practices [5] - Community urologists prioritize agents that are effective, well-tolerated, and easy to use, making detalimogene a suitable option [5] Competitive Landscape - Recent innovations in the NMIBC space include J&J's INLEXZO and TAR-200, which are seen as important for building the prevalent patient population [6][8] - Detalimogene's low cost of goods provides flexibility in pricing, which is crucial in a competitive market [8][31] Clinical Study Updates - The LEGEND study has fully enrolled 125 patients, exceeding the initial target of 100 [11] - Interim data shows a 6-month complete response rate of 62%, aligning with other agents in the market [11][16] - The tolerability profile is highlighted as a significant advantage, with adverse events (AEs) at 44%, compared to 60%-80% for other agents [12] Regulatory Interactions - enGene has received special regulatory guidance from the FDA, allowing for a single study approval with 100 patients, and has been granted RMAT designation [19][20] - The company is on track for a regulatory filing in the second half of the year, with a strong dialogue with the FDA [20] Future Opportunities - enGene is exploring additional patient cohorts, including BCG naive and BCG exposed patients, which could lead to label expansions [26] - There is interest in expanding the use of detalimogene to intermediate risk and muscle-invasive bladder cancer (MIBC) patients [27] Commercialization Strategy - The U.S. commercialization strategy involves building an internal team, with plans for 40-60 sales representatives [29] - enGene is conducting market research to identify key physicians and prepare for a successful launch [29] Pricing Strategy - The pricing strategy will be influenced by the new benchmark set by TAR-200, with enGene's low-cost manufacturing allowing for competitive pricing flexibility [30][32] - The goal is to price the product attractively for practices while reflecting the value provided [32] Additional Insights - The company is focused on ensuring a successful launch and is preparing for potential challenges in the regulatory and manufacturing processes [24] - The unique non-viral approach of detalimogene is seen as a competitive advantage in the market [23]

Core Insights - Cancer has become the most lucrative area for the pharmaceutical industry, with global cancer drug sales exceeding $200 billion in 2024, making it the largest revenue category in biopharma [1] - Despite high sales, many profitable cancer drugs do not significantly extend patients' lives, with fewer than half of the 176 cancer drugs approved since 2000 showing clear improvement in overall survival [2][9] - The oncology market continues to grow due to regulatory changes that allow drugs to be approved based on surrogate endpoints like progression-free survival, which do not necessarily correlate with improved patient outcomes [7][8] Industry Trends - The immunotherapy revolution that began in 2011 has plateaued, with response rates for single-agent checkpoint inhibitors in melanoma ranging from 33% to 42%, and five-year survival rates peaking at 41% [4][5] - Combination therapies have increased response rates to around 60%, but they also come with severe toxicity rates exceeding 50%, impacting patients' quality of life [6] - The current system rewards speed and volume in drug approvals, leading to a disconnect between drug costs and actual patient benefits [10] Economic Pressures - Many leading checkpoint inhibitors are set to lose patent protection in the next two years, which may reduce financial incentives for further development [11] - The economic model of immunotherapy is facing challenges as extracting incremental benefits from aging assets becomes increasingly difficult [11] Emerging Solutions - New precision oncology approaches, such as Sona Nanotech's targeted hyperthermia therapy, aim to make tumors more recognizable to the immune system by releasing tumor antigens through localized treatment [13] - Sona's recent first-in-human study showed promising results, with eight out of ten melanoma patients responding to therapy and minimal toxicity observed [15] - The focus is shifting towards achieving maximum tumor response with minimal treatment-related toxicity, indicating a potential reset in oncology treatment paradigms [17]

Industry Overview - The global oncology market is undergoing rapid transformation due to increasing cancer incidence, demographic changes, and scientific advancements, with an estimated 2.1 million new cancer diagnoses and over 626,000 cancer-related deaths expected in the U.S. in 2026 [2] - Lifestyle-related risk factors and demographic shifts are contributing to a rise in cancer prevalence, leading to sustained growth in oncology healthcare spending [2] Innovation in Cancer Treatment - Advances in immunotherapies, targeted medicines, and personalized vaccines are reshaping cancer treatment, moving beyond traditional chemotherapy and radiation [3] - Immune-based approaches, such as checkpoint inhibitors and CAR-T therapies, utilize the immune system to target tumors, while targeted therapies focus on specific molecular and genetic disease drivers [3] - Technologies like genomic sequencing and AI are enhancing biomarker discovery and patient stratification, leading to earlier diagnoses and improved survival rates across various cancer types [4] Pharmaceutical Investment - Major pharmaceutical companies, including Novartis, AstraZeneca, and Pfizer, are investing heavily in oncology pipelines, developing new therapies such as antibody-drug conjugates and next-generation immuno-oncology treatments [5] - Smaller biotech firms are also crucial in driving innovation through partnerships, licensing deals, and acquisitions [5] Market Resilience - The oncology sector is viewed as one of the most resilient and attractive segments of the global healthcare market for long-term investors, supported by ongoing innovation and favorable reimbursement trends [6] Company Highlights - **ImmunityBio**: Its lead drug, Anktiva, approved in April 2024, generated $113 million in preliminary sales in 2025, with a 750% increase in volumes. The drug is under review in the EU and is being evaluated for expanded use in various cancers [8][9] - **Arcus Biosciences**: Developing casdatifan, a potential best-in-class HIF-2a inhibitor for treating clear cell renal cell carcinoma, with a market opportunity of over $5 billion. Multiple data readouts are expected in 2026 [10] - **Allogene Therapeutics**: Focused on genetically engineered T-cell therapies, with lead candidate cema-cel in a pivotal phase II study for large B-cell lymphoma. Another candidate, ALLO-316, shows early anti-tumor activity in advanced renal cell carcinoma [12][13]

Core Insights - AIM ImmunoTech Inc. reported positive data from the ongoing Phase 2 clinical study of Ampligen combined with AstraZeneca's Imfinzi for treating metastatic pancreatic cancer, showing median survival of 19.7 months compared to 8.6 months with standard care [1][2] - The study aims to assess the clinical benefit rate, overall survival, progression-free survival, immune monitoring, and quality of life for patients [2][3] Group 1: Clinical Study Details - The DURIPANC study is an exploratory, open-label trial expected to enroll up to 25 subjects, with 18 patients already enrolled [3] - The study has shown promising results in progression-free survival and overall survival, with no significant toxicity reported, indicating a favorable safety profile [3][4] - The combination therapy appears to enhance the body's immune response, suggesting a coordinated activation of both innate and adaptive immune systems [5] Group 2: Market Potential and Intellectual Property - AIM holds a U.S. patent for Ampligen as an oncology treatment in combination with anti-PD-L1 therapies, extending protection until August 9, 2039 [7] - The company has received orphan drug designations in pancreatic cancer from both the U.S. and EU, providing market exclusivity post-commercial approval [7][8] - AIM believes that advancing Ampligen to Phase 3 clinical trials could present significant financial opportunities for the company and its shareholders [5][8]

Core Insights - The FDA has granted Fast Track Designation to Oncolytics Biotech's pelareorep for treating KRAS-mutant MSS metastatic colorectal cancer, indicating its potential as an immunotherapeutic platform in gastrointestinal cancers [1][2][3] Clinical Data - Pelareorep-based therapy shows a 33% objective response rate (ORR), significantly higher than the approximately 10% ORR with standard-of-care (SOC) [2] - The median progression-free survival (PFS) for pelareorep is 16.6 months, compared to 5.7 months with SOC, and the median overall survival (OS) is 27 months, compared to 11.2 months with SOC [2] Market Potential - There are approximately 2 million new colorectal cancer cases globally each year, with a total addressable market of $3-5 billion for the second-line KRAS-mutant MSS mCRC subgroup [2] Future Plans - The company plans to initiate a controlled clinical study comparing SOC alone versus SOC plus pelareorep, with the first clinical site expected to be activated in March 2026 and interim data anticipated by year-end [1][2] Regulatory Benefits - Fast Track Designation allows for more frequent communication with the FDA, potentially leading to Accelerated Approval and Priority Review if criteria are met [3]

Core Insights - Aptevo Therapeutics is undergoing executive leadership transitions to support its strategic objectives and growth as it advances into 2026 and beyond [1][2] Leadership Transition - Effective April 1, 2026, Marvin White will retire as President and CEO, transitioning to Executive Chair to focus on strategic opportunities [2] - Jeff Lamothe, currently Chief Operating Officer, will become the new President and CEO and join the Board of Directors [2] - John E. Niederhuber, M.D., will move from Chairman of the Board to Lead Independent Director, ensuring continuity in leadership [2] Company Progress - Aptevo has reached a significant inflection point with a clinically proven platform, a growing body of patient data, and a strong financial position [3] - The company has established proof-of-concept for its proprietary technology and expanded its pipeline to include eight molecules, including two trispecific programs [3] - More than 100 patients have been treated with the CD123 x CD3 program, mipletamig, showing strong efficacy and a differentiated safety profile in acute myeloid leukemia [3] Financial Position - Aptevo has strengthened its financial position, establishing a cash runway into 2029, including a $60 million equity line of credit [4] - The company's accomplishments reflect disciplined execution across technology development, clinical advancement, pipeline expansion, and financial stewardship [4] Leadership Confidence - Marvin White expressed confidence in Jeff Lamothe's leadership, highlighting his instrumental role in the company's key advances [6][7] - Lamothe emphasized the importance of disciplined execution and advancing the pipeline to positively impact cancer patients [8] Future Outlook - The leadership structure is aligned to support both execution and long-term strategy, positioning Aptevo to continue progressing toward its objectives [9]

FDA Approvals & Rejections - Intellia Therapeutics has received FDA approval to resume its MAGNITUDE-2 Phase 3 trial for nexiguran ziclumeran (nex-z) targeting hereditary transthyretin amyloidosis with polyneuropathy, increasing target enrollment from 50 to 60 patients [2][4] - Outset Medical's next-generation Tablo Hemodialysis System has been granted FDA 510(k) clearance, making it the first dialysis device to meet enhanced cybersecurity standards, with shipping expected to begin in Q2 2026 [6][7] - OKYO Pharma has received positive feedback from the FDA for its Phase 2b/3 trial design for Urcosimod, a candidate for neuropathic corneal pain, with plans to start the trial in the first half of 2026 [8][9] - REGENXBIO has faced clinical holds on its RGX-111 and RGX-121 gene therapy programs due to a case of CNS tumor in a child treated with RGX-111, although no similar findings were reported in other patients [10][11] - Almirall has received NMPA approval for Seysara in China for treating moderate-to-severe acne vulgaris, expanding its dermatology portfolio in the region [12][13] Clinical Trials - Breakthroughs - Aprea Therapeutics reported early clinical activity for APR-1051 in endometrial cancer, achieving a 50% reduction in target lesion size in a patient with PPP2R1A-mutated uterine serous carcinoma [19][21] - Fractyl Health's Revita demonstrated positive results in weight maintenance after GLP-1 drug discontinuation, showing a 4.5% weight regain compared to 7.5% in the sham group [22][24] - Ascletis Pharma announced positive Phase 3 results for Denifanstat in moderate-to-severe acne vulgaris, focusing on long-term safety in a trial with 240 patients [25][26] - GRI Bio reported new gene expression data from its Phase 2a study of GRI-0621 in idiopathic pulmonary fibrosis, showing significant improvements in lung injury and fibrosis progression [27][28] - Cardiff Oncology announced encouraging results from its Phase 2 trial of Onvansertib in RAS-mutated metastatic colorectal cancer, with a well-tolerated regimen and plans to advance to a registrational program [31][32] - Genentech's CT-388 Phase 2 trial for obesity showed a significant placebo-adjusted weight loss of 22.5% at 48 weeks, with a high percentage of participants achieving significant weight loss [34][36] - Sarepta Therapeutics reported positive three-year results from its EMBARK study for ELEVIDYS in Duchenne muscular dystrophy, showing significant slowing of disease progression in treated patients [38][41] Deals - YD Bio Limited has signed a letter of intent to acquire Safe Save Medical for approximately $26.87 million, aiming to enhance its capabilities in advanced cellular therapeutics [14][15][17]

Financial Data and Key Metrics Changes - Total revenue for Q4 2025 was $3.9 billion, reflecting a 3% year-over-year increase, driven by higher collaboration revenue and strong sales growth of Dupixent, EYLEA HD, and Libtayo [40][41] - Diluted net income per share was $11.44, with net income of $1.2 billion [40] - Regeneron's share of collaboration profits from Sanofi grew 42% year-over-year, primarily due to Dupixent [41] Business Line Data and Key Metrics Changes - Global net product sales for Dupixent reached $4.9 billion in Q4 2025, a 32% increase year-over-year [7] - Libtayo's global net sales were $425 million in Q4 2025, up 13% year-over-year [37] - EYLEA HD net product sales in the U.S. were $506 million in Q4 2025, representing a 66% increase [9] Market Data and Key Metrics Changes - Dupixent is now approved in eight indications, with over 1.4 million patients on therapy globally, indicating significant market penetration potential [7] - EYLEA HD has become a growing proportion of Regeneron's total anti-VEGF franchise, contributing nearly half of total net sales [33] - Libtayo is recognized as the leading immunotherapy for advanced non-melanoma skin cancers, with strong demand growth across all approved indications [37] Company Strategy and Development Direction - Regeneron anticipates at least four FDA approvals in 2026, including three for new molecular entities and one for the EYLEA HD prefilled syringe [11] - The company plans to initiate 18 additional phase 3 studies, targeting approximately 35,000 patients over multiple years [13] - Regeneron aims to continue capital deployment for share repurchases, dividends, and complementary business development to drive long-term shareholder value [14] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about reaching an agreement with the U.S. government to reduce drug costs while ensuring access to innovative treatments [11] - The company highlighted the importance of its innovative pipeline, with multiple pivotal readouts and regulatory milestones expected in 2026 [30] - Management emphasized the competitive advantages of Dupixent, including its efficacy and safety profile compared to other immunomodulators [59] Other Important Information - Regeneron generated $4.1 billion in free cash flow in 2025 and returned $3.8 billion to shareholders, primarily through share repurchases [44][45] - The company initiated a quarterly dividend, providing additional flexibility to return capital to shareholders [45] Q&A Session Summary Question: Update on Libtayo plus fianlimab readouts - Management indicated that the best estimate for advanced melanoma readout is in the first half of the year, with adjuvant timing also expected in the same timeframe [52] Question: Dupixent IP and future potential - Management refrained from providing additional comments but acknowledged Sanofi's commentary on extending the IP runway [55] Question: Frontline metastatic melanoma data and hazard ratio - Management stated that the study is powered to achieve a primary endpoint similar to the current standard of care, with hopes for better outcomes [63] Question: Broader R&D strategy and focus areas - Management confirmed a commitment to a balanced approach across therapeutic areas, driven by genetics to identify new drug opportunities [70] Question: Development of a new version of Dupixent - Management discussed the potential of a "souped-up" version of Dupixent that may offer longer-lasting effects and other advantages, with plans to move it forward in clinical development [76]