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HCW Biologics Granted Extension by the Nasdaq Hearings Panel to Regain Compliance with Continued Listing Requirements

MWN-AI** Summary

HCW Biologics Inc. (Nasdaq: HCWB), a clinical-stage biopharmaceutical company focused on developing immunotherapies to address age-related diseases associated with chronic inflammation, has received an extension from the Nasdaq Hearings Panel. Announced on March 3, 2025, following a hearing on February 13, the extension allows the company additional time to meet the Nasdaq continued listing requirements related to minimum bid price, market value of publicly held securities, and market value of listed securities.

The Panel granted HCW Biologics until April 25, 2025, to demonstrate compliance with the Bid Price Rule and until June 15, 2025, to satisfy all other exchange listing rules. Dr. Hing C. Wong, the company’s Founder and CEO, expressed satisfaction with the Panel's acceptance of their compliance plan and is optimistic about the execution of their strategy in the coming months.

The company's innovative approach focuses on treating inflammatory diseases and extending healthspan through novel immunotherapies. Their lead candidate, HCW9302, was developed using the TOBI™ platform, while a new platform, TRBC, enables the creation of a wide range of immunotherapeutics that target cancerous and infected cells. HCW Biologics has developed over 50 molecules within the TRBC platform, with several candidates currently undergoing preclinical evaluation.

The company aims to enhance the quality of life for patients battling chronic illnesses, including types of cancer and autoimmune diseases. Despite the challenges posed by Nasdaq compliance, HCW Biologics remains committed to advancing its therapies while maintaining transparency about the risks associated with forward-looking statements regarding its development plans and financial outlook.

MWN-AI** Analysis

HCW Biologics Inc. recently received a crucial extension from the Nasdaq Hearings Panel to regain compliance with its continued listing requirements. This extension represents a lifeline for investors and presents an intriguing opportunity amid the inherent risks associated with clinical-stage biopharmaceutical ventures.

The Panel's decision, stemming from a hearing held on February 13, 2025, requires HCW Biologics to comply with several key listing rules, including the minimum bid price and market valuations, with deadlines set for April 25 and June 15, 2025. Successful compliance can bolster investor confidence, potentially driving the stock's price upward and enhancing liquidity.

Dr. Hing C. Wong's optimistic outlook reflects the company's commitment to executing its compliance plan while advancing its proprietary immunotherapy technologies. The firm's focus on chronic inflammation and age-related diseases aligns well with increasing global health trends emphasizing longevity and quality of life improvements, which can position HCW Biologics favorably in a rapidly evolving biotech landscape.

However, investors should approach with caution. The company’s reliance on clinical trials and the speculative nature of biopharmaceutical development means that any setbacks in their drug pipeline could significantly impact stock performance. As of now, HCW Biologics has an extensive pipeline, including over 50 molecules developed using its TRBC platform, positioning it advantageously against competitors.

For prospective investors, this moment could signal a buying opportunity, particularly if the company successfully meets its Nasdaq listing requirements and continues to advance its therapeutic candidates. In the coming months, monitoring the company's progress and developments will be essential. Balancing potential upside against the challenges of a biopharmaceutical market remains critical, making this stock suited for risk-tolerant investors looking to tap into a promising yet volatile sector.

**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.

Source: GlobeNewswire

MIRAMAR, Fla., March 06, 2025 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company” or “HCW Biologics”) (Nasdaq: HCWB), a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen healthspan by disrupting the link between inflammation and age-related diseases, today reported that, on March 3, 2025, the Nasdaq Hearings Panel (the “Panel”) of The Nasdaq Stock Market LLC (“Nasdaq” or the “Exchange”) granted the Company an extension in which to regain compliance with all continued listing rules of The Nasdaq Capital Market.

The Panel’s determination follows a hearing on February 13, 2025, at which the Panel considered the Company’s plan to regain compliance with Listing Rules 5450(a)(1), 5450(b)(2)(A) and 5450(b)(2&3)(C), the minimum bid price (“Bid Price”), the market value of publicly held securities (“MVPHS”) and the market value of listed securities (“MVLS”) rules, respectively. As a result of the extension, the Panel granted the Company’s request for continued listing on the Exchange, provided that the Company demonstrates compliance with the Bid Price Rule by April 25, 2025, and all other Exchange continued listing rules by June 15, 2025.

Dr. Hing C. Wong, the Company’s Founder and CEO, stated “We are pleased that the Nasdaq Panel has accepted our plan and look forward to executing the strategy over the coming months as we also continue to make advancements in our proprietary platform technologies to develop immunotherapies for oncology and other senescent-cell-associated diseases.”

About HCW Biologics:
HCW Biologics Inc. (Nasdaq: HCWB) is a clinical-stage biopharmaceutical company developing proprietary immunotherapies to treat diseases promoted by chronic inflammation, especially age-related and senescence-associated diseases. The Company’s immunotherapeutics represent a new class of drug that it believes have the potential to fundamentally change the treatment of cancer and many other diseases and conditions that are promoted by chronic inflammation — and in doing so, improve patients’ quality of life and possibly extend longevity. Chronic inflammation, including inflammaging, is believed to be a significant contributing factor to the cause for senescence-associated diseases and conditions that diminish healthspan, including many types of cancer, autoimmune diseases, and neurodegenerative diseases, as well as indications that impact quality-of-life that are not life-threatening. The Company’s lead product candidate, HCW9302, was developed using the Company’s legacy TOBI™ (Tissue factOr-Based fusIon) platform. The Company has created another drug discovery technology, the TRBC platform, which is not based on Tissue Factor. The TRBC platform has the capability to construct immunotherapeutics that not only activate and target immune responses but are also equipped with receptors that specifically target cancerous or infected cells. This platform is such a versatile scaffold that it enables the creation of multiple classes of immunotherapeutic compounds: Class I: Multi-Functional Immune Cell Stimulators; Class II: Second-Generation Immune Checkpoint Inhibitors; Class III: Multi-Specific Targeting Fusions and Enhanced Immune Cell Engagers. These novel immunotherapeutics can be used to treat a wide range of disease indications, including oncology, autoimmune diseases, and improving quality of life conditions. The Company has constructed over 50 molecules using the TRBC platform, including HCW11-002, HCW11-018, and HCW11-027. Further preclinical evaluation studies are currently being conducted for these three and related molecules the Company has selected based on promising early data. The Company has two licensing programs in which it has licensed exclusive rights for some of its proprietary molecules. See the Company Pipeline at https://hcwbiologics.com/pipeline/

Forward-Looking Statements:
Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “expect,” “believe,” “will,” “may,” “should,” “estimate,” “project,” “outlook,” “forecast” or other similar words and include, the Company’s ability to improve or extend healthspan; to extend longevity; to develop new immunotherapeutic treatments for chronic inflammation and age-related diseases; to develop treatments with its drug discovery platforms; the Company’s ability to execute its compliance plan and regain compliance with Nasdaq continued listing requirements; and the Company’s ability to raise additional funds. Similarly, statements that describe the Company’s objectives, plans or goals are, or may be, forward-looking statements. Forward-looking statements are based only on the Company’s current beliefs, expectations, and assumptions. Forward-looking statements are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict and many of which are outside of the Company’s control. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. The Company’s actual results may differ materially from those indicated in the forward-looking statements. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties that are described in the section titled “Risk Factors” in the Annual Report on Form 10-K/A filed with the United States Securities and Exchange Commission (the “SEC”) on May 15, 2024, the latest Quarterly Report on Form 10-Q filed with the SEC on November 14, 2024, and in other filings filed from time to time with the SEC.

Company Contact:
Rebecca Byam
Chief Financial Officer
HCW Biologics Inc.
RebeccaByam@hcwbiologics.com


FAQ**

How does HCW Biologics Inc. (HCWB) plan to achieve compliance with the Nasdaq continued listing requirements by the specified deadlines, and what specific strategies are in place to improve its market valuation?
HCW Biologics Inc. (HCWB) aims to achieve Nasdaq compliance by enhancing operational efficiencies, optimizing capital structure, and advancing its clinical pipeline, while implementing strategic partnerships and marketing initiatives to bolster its market valuation.
What are the key milestones for HCW Biologics Inc. (HCWB) in the preclinical evaluation of its TRBC platform candidates, and how do these align with the company’s strategic goals moving forward?
Key milestones for HCW Biologics Inc. in the preclinical evaluation of its TRBC platform candidates include successful candidate selection, completion of toxicity studies, and progression to IND submission, all aligning with the company’s goal of advancing innovative therapies targeting critical unmet medical needs.
Considering the competitive landscape for immunotherapies, how does HCW Biologics Inc. (HCWB) differentiate its drug candidates, particularly HCW9302, in treating age-related diseases and chronic inflammation?
HCW Biologics Inc. (HCWB) differentiates its drug candidates, including HCW9302, by leveraging unique mechanisms of action that specifically target age-related diseases and chronic inflammation, coupled with innovative delivery methods to enhance efficacy and patient outcomes.
What is HCW Biologics Inc. (HCWB)'s approach to securing additional funding, and how does the company plan to utilize these funds to support its ongoing development and compliance efforts?
HCW Biologics Inc. plans to secure additional funding through strategic partnerships and grants, aiming to utilize the capital for advancing clinical development, ensuring regulatory compliance, and enhancing its operational capabilities for innovative therapies.

**MWN-AI FAQ is based on asking OpenAI questions about HCW Biologics Inc. (NASDAQ: HCWB).

HCW Biologics Inc.

NASDAQ: HCWB

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Biotechnology & Life Sciences
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