Hanxbio 2026 Interim: R&D Costs Down 16.6%, Loss Narrows Slightly as Pipeline Advances

Bulletin Express09-21

Hanx Biopharmaceuticals (Wuhan) Co., Ltd. (Hanxbio) released its 2026 interim report, detailing pipeline progress and a modestly improved bottom line for the six months ended 30 June 2026.

Revenue is not yet generated; performance is driven by other income, R&D investment and financing activities.

Key Operational Highlights • Core asset HX009, a bifunctional PD-1/SIRPα antibody, completed Phase Ib/II EBV+ NHL study in 2025 and is preparing a pivotal Phase II trial for EBV+ DLBCL pending CDE agreement. Phase Ib data in first-line acral and mucosal melanoma remain encouraging, though study completion shifted to early 2027 due to enrollment pace. • Phase I studies continue for first-in-class OX40-ADC HX111 (lymphoma and solid tumors) and bispecific CTLA-4/SIRPα antibody HX044 (monotherapy and PD-1 combo). • IND-enabling work proceeds for BsAb-ADC HX116; pre-IND engagement with the U.S. FDA has begun.

Financial Performance (RMB) • Other income and gains surged 421.0% year-on-year to 27.61 million, driven mainly by a fair-value gain on contingent consideration from a 2019 asset disposal. • Research and development expense fell 16.6% to 26.10 million as spending on HX009 dropped 38%. • Administrative expense rose 17.1% to 27.91 million, reflecting higher labour costs. • Finance costs declined 81.8% to 1.04 million after IPO-related redeemable-liability interest ceased in December 2025. • Net loss attributable to shareholders narrowed slightly to 36.88 million (total loss 33.24 million) versus 36.44 million a year earlier. Loss per share was RMB0.27.

Balance Sheet & Liquidity • Cash and cash equivalents stood at 500.29 million, down 18.6% from year-end 2025. • Current ratio improved to 18.6x (assets 610.51 million; liabilities 32.85 million). • Total borrowings were 66.80 million (all RMB-denominated, fixed-rate, long-term). • Gearing ratio decreased to 19.3% from 20.0%.

Capital Management • Hanxbio repurchased 1.70 million H-shares on the Hong Kong Stock Exchange for HK$48.10 million during the period, holding the shares in treasury for potential incentive plans or cancellation. • No interim dividend was declared.

IPO Proceeds Utilisation • Net proceeds from the December 2025 IPO totalled HK$531.30 million; HK$67.32 million (12.7%) has been deployed, primarily to pipeline R&D (HX009, HX301, HX044 and early-stage programs). HK$463.98 million remains allocated for ongoing trials, commercial preparation and working capital through 2030.

Commercialisation Timeline (Core Product HX009) • EBV+ DLBCL: pivotal Phase II start targeted for 1H 2027; BLA submission envisaged in 2029. • Acral/mucosal melanoma: Phase Ib/II completion expected early 2027; pivotal Phase III to follow subject to data readiness, with BLA after trial completion. • Biliary tract cancer: Phase IIa read-out projected Q3 2027; Phase III initiation thereafter.

Governance Updates • Ms. Xiao Jieyu became executive director, CFO and board secretary on 8 February 2026; Dr. Zhang Qiongguang joined the audit committee. • All directors confirmed compliance with the Model Code; the company met all Corporate Governance Code provisions.

Outlook Hanxbio enters the second half with a strengthened cash position, lower R&D burn rate and clear regulatory milestones for its bifunctional antibody and ADC portfolio. Management plans to initiate pivotal trials for HX009 while advancing first-in-class candidates HX111 and HX044 through early-stage development, supported by remaining IPO funds and ongoing cost discipline.

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