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HCW Biologics Receives Patent Allowance for HCW9302 in Treating Alopecia Areata
HCW Biologics announced receipt of a Notice of Allowance from the U.S. Patent and Trademark Office for claims directed to use of HCW9302 to treat alopecia areata. Together with four other recently issued patents with claims for broad compositions, nucleic acids encoding for HCW9302 and the vectors comprising these, and method of treating other autoimmune diseases, the underlying U.S. patent estate has been further strengthened for the protection of the company's intellectual property related to further development and potential commercialization of HCW9302, a best-in-class IL-2-based immunotherapeutic for the treatment of autoimmune diseases. The company continues to extend protection of its broad rights for treatments for all indications with respect to HCW9302 built on the foundation of its worldwide, perpetual, fully paid-up, royalty-free, exclusive license rights for this compound. The Phase 1 dose-escalating clinical study evaluating HCW9302 as monotherapy in patients with alopecia areata is on track for completion in Q4 2026, and continues to be well tolerated with no dose-limiting toxicities. A preliminary readout of the first two dose cohorts is encouraging, with patients diagnosed with alopecia areata showing positive response after a single dose of monotherapy at the 3 micrograms/kg dose level.
Selling Stockholders Plan to Sell 1.24M Shares of Common Stock
This filing relates to the offer and sale from time to time by the selling stockholders of up to 1.24M shares of common stock. The company is not selling any shares under this prospectus and will not receive any of the proceeds from the sale of shares by the selling stockholders.
HCW Biologics Completes $1.6M Private Placement
HCW Biologics announced the pricing of its $1.6M private placement offering with a group of investors, including officers, directors and an existing stockholder of the company. Pursuant to a securities purchase agreement entered into with the Investors, the company agreed to issue and sell an aggregate of 618,682 units, with each Unit consisting of (i) one share of the company's common stock, or, in lieu thereof, one pre-funded warrant to purchase one share of Common Stock, and (ii) the right to receive one common stock purchase warrant to purchase one share of Common Stock upon, and subject to, stockholder approval of the issuance thereof. In connection with the Offering, the company will issue 218,682 shares of Common Stock and 400,000 Pre-Funded Warrants. Subject to stockholder approval, which the company is obligated to seek pursuant to the terms of the Purchase Agreement, the Investors will also be entitled to receive Common Warrants to purchase up to an aggregate of 618,682 shares of Common Stock. The combined purchase price for each Unit consisting of one share of Common Stock and the right to receive one Common Warrant upon, and subject to, stockholder approval of the issuance thereof, was $2.585 per Unit. The combined purchase price for a Pre-Funded Warrant and the right to receive one Common Warrant upon, and subject to, stockholder approval of the issuance thereof, was $2.5849 per Unit. The Pre-Funded Warrants have an exercise price of $0.0001 per share of Common Stock, are exercisable immediately and will not expire until exercised in full. The Common Warrants will have an exercise price of $2.585 per share and will expire on the five and one half year anniversary of their issuance.
HCW Biologics to Execute 1-for-6 Reverse Split to Comply with Nasdaq Rules
HCW Biologics reported that the Nasdaq Hearings Panel of Nasdaq found that the company regained compliance with Listing Rule 5550, the "Bid Price Rule," per the terms set forth in the Panel's decision letter dated May 29 as amended, and is subject to a mandatory monitoring period through June 17, 2027. To ensure long-term compliance with the bid price rule, the company will effect a reverse stock split at a one-for-six ratio on June 30.
HCW Biologics Releases Preliminary Data for HCW9302 Clinical Trial
HCW Biologics announced a preliminary human data readout for the first two dose cohorts from its dose-escalating Phase 1 clinical trial of HCW9302, an IL-2 based fusion immunotherapeutic, in patients with alopecia areata. In the second dose cohort, comprised of patients who received a single subcutaneous dose of HCW9302 monotherapy of three micrograms/kg body weight, all three participants showed preliminary indications of improvement in Severity of Alopecia Tool scores. These three participants, all with mild alopecia, showed a greater than or equal to 25% reduction in SALT scores compared to baseline at four and/or nine weeks after dosing. Treatment of patients in the third dose cohort is underway and evaluation of correlative study endpoints is ongoing. All patients, including the first dose cohort at one microgram/kg body weight and the second dose cohort at three micrograms/kg body weight, received a single subcutaneous dose of HCW9302 monotherapy. There were no reported incidences of capillary leak or cytokine release syndromes associated with high dose intravenous IL-2 therapy. Additionally, HCW9302 treatment did not increase blood eosinophil counts, another serious side effect commonly associated with IL-2 therapy. All reported HCW9302 treatment emergent adverse events were mild in severity and self-limiting and resolved without medical intervention. The most common side effect was temporary injection-site reaction. These preliminary findings support the company's belief that HCW9302 has the potential to activate and expand regulatory T, or Treg, cells in patients, reducing inflammation, while minimizing the risk of broad immunosuppression or unwanted side effects caused by the activation of immune effector cells. For alopecia areata, the company believes that HCW9302 can suppress the hair-follicle killing activities of the auto-reactive immune cells by activating and expanding Treg cells.
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