WHWK — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-06

• The U.S. Food and Drug Administration (“FDA”) cleared our investigational new drug (“IND”) applications for HWK-007, for the treatment of solid tumors, including non-small cell lung cancer (“NSCLC”) and ovarian cancer, and HWK-016, for

• On December 19, 2024, we entered into the License Agreement with WuXi Biologics for exclusive rights to certain patents and know-how pertaining to WuXi Biologics’ preclinical ADC Therapies leveraging Hangzhou DAC linker-payload technology targeting each of MUC16, PTK7 and SEZ6. Under the License Agr…

• PIPE Financing. On May 13, 2026, we entered into a securities purchase agreement for a private investment in public equity financing (the "2026 PIPE Financing") with certain investors (the "2026 PIPE Investors") for the sale of (i) 4,330,866 shares of our common stock, par value $0.0001 per share, a…

• Pipeline Expansion. In May 2026, we entered into a new option agreement with Hangzhou DAC for access to CPT113, their core linker-payload technology, for use in up to five additional ADC programs. Per the terms of the option agreement, we will select targets and source antibodies, while retaining gl…

• In addition, in June 2026, we entered into a global collaboration with Biocytogen to develop bispecific antibody-drug conjugates ("BsADC"). Biocytogen will provide access to up to five bispecific antibodies using its proprietary RenLite® platform, and we will evaluate these in combination with our A…

Text removed vs the prior filing · source: 10-Q · 2026-05-07

• We submitted investigational new drug (“IND”) applications with the U.S. Food and Drug Administration (“FDA”) for HWK-007, for the treatment of solid tumors, including non-small cell lung cancer (“NSCLC”) and ovarian cancer, and HWK-016, for the treatment of cancers of female origin, in the fourth q…

• On December 19, 2024, we entered into the License Agreement with WuXi Biologics for exclusive rights to certain patents and know-how pertaining to WuXi Biologics’ preclinical ADC Therapies leveraging Hangzhou DAC linker-payload technology targeting each of MUC16, PTK7 and SEZ6. Under the License Agr…

• payment of $38.0 million on April 16, 2025, in each case, for the rights and licenses granted to us by WuXi Biologics. In accordance with the License Agreement, WuXi Biologics is eligible to receive from us (a) up to an aggregate of $265.0 million upon the achievement of certain development mileston…

• HWK-007 Development. In the first quarter of 2026, we initiated our Phase 1 trial for HWK-007 and the trial is now actively recruiting. The clinical trial is initially evaluating activity in lung and ovarian cancers, two PTK7-expressing tumor types with established precedent data, as well as endomet…

• HWK-016 Development. In the first quarter of 2026, the IND for HWK-016, our MUC16-targeted ADC Therapy, was cleared by the FDA. A Phase 1 trial is now actively recruiting and is initially evaluating activity in two high MUC16-expressing gynecologic cancers, ovarian and endometrial. We expect data re…

Text added vs the prior filing · source: 10-Q · 2026-08-06

• Our business is subject to the risks associated with doing business in China. For example, the BIOSECURE Act recently signed into law as part of the 2026 National Defense Authorization Act, among other things, restricts federal government contracts, grants, and loans from being issued to companies t…

• We are a clinical-stage biopharmaceutical company with a limited operating history upon which you can evaluate our business and prospects. We had a single product, FYARRO, approved for commercial sale by the FDA in November 2021

• our companion diagnostic development plans or we may not be able to compete effectively upon approval, which could adversely impact our ability to generate revenue from the sale of our approved products and our business operations.

• Breakthrough Therapy designation is for a product candidate that is intended, alone or in combination with one or more other drugs or biologics, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the product candidate may demonstrate substant…

• Even if orphan drug designation is granted, we may not be able to obtain or maintain orphan drug exclusivity for that product candidate. We may not be the first to obtain regulatory approval of any product candidate for which we have obtained orphan drug designation for the orphan-designated indicat…

Text removed vs the prior filing · source: 10-Q · 2026-05-07

• Our business is subject to the risks associated with doing business in China.

• We are a clinical-stage biopharmaceutical company with a limited operating history upon which you can evaluate our business and prospects. We had a single product, FYARRO, approved for commercial sale by the FDA in November 2021 and launched commercially in the United States for treatment of advance…

• foreseeable future. Our ability to generate future revenue and achieve profitability depends significantly on our ability, or any current or future collaborator’s ability, to achieve several objectives, including, but not limited to:

• delays in regulatory approval. We may be required to conduct additional studies to support a broader claim. Also, to the extent other approved diagnostics are able to broaden their labeling claims to include our approved drug products, we may be forced to abandon our companion diagnostic development…

• Breakthrough Therapy designation is for a product candidate that is intended, alone or in combination with one or more other drugs or biologics, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the product candidate may demonstrate substant…