Welcome to our dedicated page for Hcw Biologics news (Ticker: HCWB), a resource for investors and traders seeking the latest updates and insights on Hcw Biologics stock.
HCW Biologics Inc. (NASDAQ: HCWB) is a clinical-stage biopharmaceutical company pioneering immunotherapies that target chronic inflammation and age-related diseases. This news hub provides investors and industry observers with timely updates on the company’s innovative drug development programs, strategic collaborations, and scientific advancements.
Access authoritative information about HCWB’s proprietary TOBI discovery technology, clinical trial progress, and global partnerships. The curated news collection features earnings reports, regulatory milestones, and research breakthroughs related to their bifunctional immunotherapies and protein engineering platforms.
Key updates include developments in candidates like HCW9218 for immune cell modulation and partnership agreements with international biotech firms. All content undergoes rigorous verification to ensure compliance with financial disclosure standards.
Bookmark this page for consolidated access to HCW Biologics’ official announcements, analyst insights, and progress reports on their mission to extend healthspan through targeted immune system modulation. Visit regularly to stay informed about this innovative player in the immunotherapy space.
HCW Biologics (NASDAQ: HCWB) has announced a 1-for-40 reverse stock split effective April 11, 2025, aimed at regaining compliance with Nasdaq's minimum bid price requirement of $1.00 per share. The reverse split will reduce the company's outstanding shares from 44,934,120 to approximately 1,123,353, while maintaining the total authorized shares at 250,000,000.
The split will uniformly affect all stockholders without altering their percentage ownership, except for fractional shares which will be rounded up to one whole share. The company's common stock will continue trading under the symbol 'HCWB' with a new CUSIP number 40423R204. The split will proportionally adjust equity incentive plans, stock options, and warrants, including their exercise prices.
HCW Biologics (NASDAQ: HCWB) reported its Q4 and fiscal year 2024 results, highlighting significant developments in its immunotherapy pipeline. The company received FDA clearance to begin Phase 1 trials for HCW9302 in alopecia areata treatment. A notable licensing agreement with WY Biotech is expected to bring in $7.0 million in June 2025.
Financial highlights include raising $16.3 million in 2024 through various transactions. However, revenues decreased from $1.3 million in Q4 2023 to $394,000 in Q4 2024. The company's net loss increased from $25.0 million in 2023 to $30.0 million in 2024, largely due to legal expenses.
The company faces Nasdaq compliance challenges and must meet listing requirements by April-June 2025. Management acknowledges substantial doubt about continuing operations without additional funding, though financing activities are underway with Maxim Group as Placement Agent.
HCW Biologics (HCWB) has received an extension from the Nasdaq Hearings Panel to maintain its listing on The Nasdaq Capital Market. The Panel's decision, announced on March 3, 2025, follows a hearing on February 13, 2025, where the company presented its compliance plan.
The extension requires HCWB to meet specific criteria: achieve minimum bid price compliance by April 25, 2025, and satisfy all other Exchange listing requirements by June 15, 2025. These requirements include compliance with market value of publicly held securities (MVPHS) and market value of listed securities (MVLS) rules.
HCW Biologics (NASDAQ: HCWB) has received FDA clearance for its Investigational New Drug Application to begin a first-in-human Phase 1 dose escalation clinical trial for HCW9302, targeting moderate-to-severe alopecia areata. This autoimmune disease causes sudden hair loss and currently lacks curative FDA-approved treatments.
HCW9302 is an injectable IL-2 fusion protein complex developed using the Company's TOBI platform technology. It works by binding to IL-2αβγ receptors on regulatory T cells (Treg), activating and expanding them to suppress unwanted immune and inflammatory responses. The drug has shown efficacy in treating autoimmune diseases through subcutaneous injections in preclinical models.
The initial trial aims to establish a safe dose that effectively increases Treg cell activity. Upon success, the company plans to expand into Phase 2 studies for other autoimmune diseases and inflammatory conditions, including dermatological conditions, graft rejection, arthrosclerosis, diabetes, and neurodegenerative diseases.
HCW Biologics (NASDAQ: HCWB) announced that its Founder and CEO, Hing C. Wong, Ph.D., will participate as a panelist at the 2025 GenScript Biotech Global Forum during J.P. Morgan Week in San Francisco. The panel discussion, focusing on Cell and Gene Therapy (CGT) challenges in biomanufacturing and supply chain management, will take place on January 15, 2025.
The company has developed subcutaneous immunotherapeutics using its drug discovery platform, categorized into three classes: Multi-Functional Immune Cell Stimulators, Second-Generation Immune Checkpoint Inhibitors and Multi-Specific Targeting Fusions, and Enhanced Immune-Cell Engagers. Dr. Wong will discuss how combining CGTs with their proprietary molecules could reduce costs and improve clinical efficacy of engineered effector cells. He will also present why Immune-Cell Engagers could potentially challenge cell-based therapies for cancer, autoimmune diseases, and aging-related conditions.
HCW Biologics (NASDAQ: HCWB) received notice from Nasdaq Listing Qualifications Staff regarding its failure to maintain compliance with the minimum market value requirement of $50 million for continued listing on the Nasdaq Global Market. The company had previously been notified on June 20, 2024, and was given a 180-day compliance period ending December 16, 2024. Having failed to regain compliance, HCWB received a delisting notice on December 17, 2024.
The company plans to request a hearing before the Nasdaq Hearing Panel, which will temporarily stay any delisting action. The Panel has authority to grant up to 180 additional days for compliance. While HCWB is exploring options to regain compliance, there is no guarantee the Panel will grant an extension or that the company will meet requirements within any granted timeframe.
HCW Biologics (NASDAQ: HCWB) has announced a $6.9 million registered direct offering and concurrent private placement priced above market. The company will issue 6,717,000 shares of common stock (or pre-funded warrants) at a combined effective price of $1.03 per share. Additionally, unregistered warrants to purchase up to 6,717,000 shares will be issued with an exercise price of $1.03, exercisable immediately with a five-year expiration. The offering, managed by Maxim Group as sole placement agent, is expected to close around November 20, 2024.
HCW Biologics (NASDAQ: HCWB) has entered into a worldwide exclusive license agreement with WY Biotech for developing and commercializing one of HCWB's preclinical immunotherapeutic candidates. The deal includes a $7 million upfront payment, potential development milestone payments, and double-digit royalties on future sales. HCWB retains a royalty-free option to recapture development rights for the Americas after Phase 1 trials. WY Biotech will bear all development and commercialization costs. The licensed molecule, part of HCWB's Class I portfolio, has shown strong anti-tumor responses in preclinical studies without significant side effects.
HCW Biologics (NASDAQ: HCWB) reported Q3 2024 financial results with revenues of $426,423, down from $853,102 in Q3 2023. Net loss decreased to $3.9 million from $4.9 million year-over-year. The company expanded its product portfolio with new immunotherapeutic compounds and filed an IND application for HCW9302. Legal expenses decreased 54% to $1.0 million in Q3 2024, though nine-month legal expenses increased significantly to $15.8 million due to arbitration with ImmunityBio. The company faces going concern issues with $14.4 million in legal fee obligations and launched a multi-faceted financing plan to maintain Nasdaq listing compliance.
HCW Biologics (NASDAQ: HCWB) reported Q2 2024 financial results and business highlights. Key points include:
- Reached a settlement agreement resolving a two-year arbitration overhang
- Launched a multi-faceted financing plan, including equity offering and out-licensing program
- Q2 2024 revenues: $618,854; Net loss: $15.3 million
- R&D expenses increased 26% to $2.0 million in Q2 2024
- Legal expenses surged 629% to $10.4 million in Q2 2024
- Raised $8.0 million in 2024 through private placement and Secured Notes
- Received Nasdaq non-compliance notices for market value, bid price, and publicly held shares requirements
The company faces going concern issues and is working on a financing plan to address its financial situation.
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