HCW Biologics reports Q2 2026 results, alopecia data and going concern doubt

HCW Biologics reported financial results and business updates for the quarter ended June 30, 2026, on August 14, 2026. On June 16, 2026, the company announced preliminary human data from the first two cohorts of a dose-escalating Phase 1 study evaluating HCW9302, a fusion immunotherapeutic described as a potential best-in-class IL-2-based treatment for autoimmune diseases, as monotherapy in alopecia areata.¹

In the second dose cohort, all three participants who received a single subcutaneous dose of three micrograms/kg body weight showed preliminary indications of improvement in Severity of Alopecia Tool scores, with a 25% or greater reduction compared to baseline at four and/or nine weeks after dosing.¹ There were no reported incidences of capillary leak or cytokine release syndromes, and the treatment did not increase blood eosinophil count.¹ Treatment in the third dose cohort, at eight micrograms/kg, is underway with no dose-limiting toxicities reported.¹ The company said it remains on track for a full Phase 1 data readout in the fourth quarter of 2026.¹

For its T-cell engager program, the company requested a Type B pre-IND meeting with the FDA to discuss development and regulatory strategy for HCW11-018b, a tetravalent T-cell engager built on its TRBC platform.¹ The planned clinical trial is on track to begin in the first half of 2027, provided FDA authorization is secured.¹

On the corporate side, the company reacquired ex vivo rights to two commercial-ready molecules previously licensed to AlloTera Therapeutics on May 21, 2026, by terminating that license agreement.¹

Under a May 2026 securities purchase agreement, the company raised approximately $4.0 million in gross proceeds at closing through a private placement of common stock, pre-funded warrants and common warrants.¹ Under a July 2026 securities purchase agreement, it raised approximately $1.6 million at closing through a similar private placement.¹

As of June 30, 2026, the company said substantial doubt exists regarding its ability to continue as a going concern for at least 12 months from the issuance date of its audited financial statements, absent additional funding or financial support.¹ On June 30, 2026, the company effected a one-for-six reverse stock split.¹