Announcement • Jun 16
HCW Biologics Reports Positive Preliminary Human Data for Phase 1 Clinical Trial of HCW9302 Monotherapy in Alopecia Areata HCW Biologics Inc. announced a positive 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 (3) micrograms/kg body weight, all three participants showed preliminary indications of improvement in Severity of Alopecia Tool (“SALT”) scores. These three participants, all with mild alopecia, showed a =25% reduction in SALT scores compared to baseline at four and/or nine weeks after dosing. Treatment of patients in the third dose cohort (i.e., eight (8) micrograms/kg body weight) is underway and evaluation of correlative study endpoints is ongoing. All patients, including the first dose cohort at one (1) microgram/kg body weight and the second dose cohort at three (3) 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 (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. The Phase 1 multi-center dose-escalation study (Clinicaltrials.gov: NCT07049328) of HCW9302 monotherapy is designed to treat up to 30 patients with alopecia areata. The primary objectives of the study are to evaluate the safety of HCW9302, injected as a single dose under the skin (subcutaneously), and to determine the recommended dose level to advance to later phase clinical studies. Secondary objectives include assessment of disease responses and the effects of HCW9302 on proliferation and function of immune cells, particularly Treg cells. Depending on the results of this study, multi-dose studies of HCW9302 monotherapy in expanded cohorts of patients with alopecia areata and in patients with other inflammatory dermatological conditions are expected to be initiated. There are two active clinical sites enrolling patients, The Ohio State University Wexner Medical Center, Columbus, Ohio, and the James A. Haley Veterans’ Hospital, Tampa, Florida. HCW9302 is the Company’s lead product candidate for its clinical program to develop treatments for autoimmune diseases and inflammatory conditions. HCW9302 is a subcutaneously injectable, first-in-kind IL-2 based fusion immunotherapeutic molecule constructed with a proprietary tissue factor scaffold. IL-2, the active component of HCW9302, is the cytokine in humans responsible for maintaining the proper numbers and functions of Treg cells in the body which control excessive inflammation caused by other immune cells, which is the etiology of autoimmune diseases. In pre-clinical studies, HCW9302 was found to bind with high affinity to the IL-2 receptor a chain (“IL-2Ra”) expressed on the surface of Treg cells, resulting in preferential stimulation of Treg proliferation and activation compared to CD4+ and CD8+ T cells and Natural Killer cells. This strong IL-2Ra bias highly differentiates HCW9302 from native recombinant IL-2 and other IL-2-based muteins and PEG conjugates, which typically exhibit reduced binding activity to IL-2 receptor components. As a result, HCW9302 treatment was found to induce Treg cell accumulation and activity and reduce pro-inflammatory and autoimmune responses in animal disease models, including alopecia and atherosclerosis. HCW9302 is comprised of all human-derived components and can be produced with a cost-effective streamline process similar to therapeutic monoclonal antibodies. Announcement • Jun 02
HCW Biologics Inc. Receives Notice from Listing Qualifications Staff of the Nasdaq As previously disclosed, on March 26, 2026, HCW Biologics Inc. received written notice from the Listing Qualifications Staff (the Staff) of the Nasdaq Stock Market LLC (Nasdaq) that for 30 consecutive business days, the Company's listed securities did not maintain a minimum bid price of $1 per share, in accordance with Nasdaq Listing Rule 5550(a)(2) (Bid Price Rule) for continued listing on The Nasdaq Capital Market (the Exchange). Due to the fact that the Company effected a 1-for-40 reverse stock split on April 11, 2025, the Company was not afforded a 180-calendar day period to demonstrate compliance. On May 29, 2026, the Nasdaq Hearings Panel (the Panel) granted the Company an extension in which to regain compliance with continued listing rules of the Exchange. The Panel's determination follows the Company's hearing on May 5, 2026, at which the Company presented, and the Panel considered, the Company's plan to regain compliance with the Bid Price Rule. The Panel granted the Company's request for continued listing on the Exchange, subject to, among other things, that on or before July 29, 2026, the Company must demonstrate compliance with the Bid Price Rule by exhibiting a bid price at or above $1 for twenty consecutive trading days. The Panel also noted that if the Company becomes deficient with the Bid Price Rule prior to September 22, 2026, the Company will be immediately delisted. Further, if the Company becomes non-compliant with any other listing rule prior to September 22, 2026, the Company will be allowed seven calendar days to advise the Panel on its plan to cure the listing deficiencies and the Panel will, at that time, determine whether to grant the Company an exception to cure the deficiency. The Panel also required that Company provide prompt notification of any significant events that occur during the exception period that may affect the Company's compliance with Nasdaq requirements. If the Company regains compliance and satisfies the terms of the exception, the Panel intends to impose a Discretionary Panel Monitor on the Company for an additional one-year period, pursuant to Listing Rule 5815(d)(4)(A). Reported Earnings • May 17
First quarter 2026 earnings released: EPS: US$0.37 (vs US$1.97 loss in 1Q 2025) First quarter 2026 results: EPS: US$0.37 (up from US$1.97 loss in 1Q 2025). Revenue: US$6.54m (up US$6.54m from 1Q 2025). Net income: US$1.98m (up US$4.18m from 1Q 2025). Profit margin: 30% (up from net loss in 1Q 2025). Revenue is expected to decline by 84% p.a. on average during the next 3 years, while revenues in the Biotechs industry in the US are expected to grow by 22%. 
