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. (symbol: HCWB) is a clinical-stage biopharmaceutical company dedicated to discovering and developing innovative immunotherapies. The company's primary focus is on extending the health span by addressing chronic, low-grade inflammation and its link to age-related diseases. Leveraging its extensive expertise in immunology, HCW Biologics is at the forefront of biopharmaceutical advancements.
HCW Biologics has pioneered the TOBI discovery platform, a novel Tissue factor-based fusion discovery platform. This groundbreaking approach facilitates the design of category-defining immunotherapeutic drugs. The company has identified two key product candidates: HCW9218 and HCW9302.
HCW9218 is a bifunctional immunotherapeutic designed to neutralize transforming growth factor-β (TGF-β) and stimulate immune cells, potentially offering transformative benefits in the treatment of cancer and other diseases. Currently, HCW9218 is under investigation in a Company-sponsored Phase 1b/2 clinical trial for advanced pancreatic cancer, conducted at the National Cancer Institute (NCI). The study is expected to conclude in the first half of 2024, with no dose-limiting toxicity observed so far.
HCW9302 is another promising candidate designed to activate and expand regulatory T cells, which play a crucial role in deactivating inflammasomes. This mechanism could be pivotal in addressing chronic inflammation and related diseases.
In recent news, HCW Biologics has been granted methods of use claims for administering HCW9218 to treat cancer, emphasizing the potential of this candidate to kill or reduce the number of senescent cells in patients with cancer.
Under the leadership of Dr. Hing C. Wong, Founder and CEO, the company is committed to advancing its clinical development and intellectual property programs. Future milestones include the continuation of clinical trials and further validation of their preliminary human data readout, which has shown promising results in line with preclinical animal studies.
For more information, you can contact Rebecca Byam, CFO of HCW Biologics Inc., at rebeccabyam@hcwbiologics.com.
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.
HCW Biologics (NASDAQ: HCWB) reported Q2 2024 financial results and business highlights. Key points include:
1. Settlement of a two-year arbitration, retaining ownership of the TOBI™ platform and molecules.
2. Launch of a multi-faceted financing plan, including an equity offering and out-licensing program.
3. Q2 2024 revenues of $618,854, slightly down from $622,807 in Q2 2023.
4. R&D expenses increased 26% to $2.0 million in Q2 2024.
5. Net loss widened to $15.3 million in Q2 2024, up from $4.3 million in Q2 2023.
6. Legal expenses surged to $10.4 million in Q2 2024 due to the Altor/NantCell matter.
7. The company faces Nasdaq compliance issues and substantial doubt about its ability to continue as a going concern without additional funding.
HCW Biologics reported its Q1 2024 financial results and business highlights. The company completed enrollment in two clinical trials for HCW9218 in solid tumors and is preparing for Phase 2 trials in ovarian and pancreatic cancers. Revenues increased to $1.1 million from $41,883 in Q1 2023, primarily from licensed molecule sales to Wugen. R&D expenses decreased by 6% to $2.1 million, while G&A expenses surged by 94% to $6.0 million due to legal costs. The net loss rose to $7.5 million from $5.1 million in Q1 2023. The company raised $6.1 million and plans to secure up to $10 million in bridge financing. However, there is substantial doubt about its ability to continue as a going concern without additional funding.
FAQ
What is the current stock price of HCW Biologics (HCWB)?
What is the market cap of HCW Biologics (HCWB)?
What does HCW Biologics Inc. specialize in?
What is the TOBI discovery platform?
What are the key product candidates of HCW Biologics?
What is the focus of HCW9218?
What is the current status of the HCW9218 clinical trial?
Who is leading the HCW9218 clinical trial?
What recent achievements has HCW Biologics announced?
How can I contact HCW Biologics for more information?
Who is the CEO of HCW Biologics Inc.?
What future plans does HCW Biologics have?
