APVO — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-14

• Continued to advance the Phase 1b/2 RAINIER trial evaluating mipletamig in combination with venetoclax and azacitidine in frontline AML, with ongoing dose optimization activities supporting selection of a recommended Phase 2 dose.

• Appointed Mary J. Janatpour, Ph.D., as Senior Vice President and Chief Scientific Officer to lead research and preclinical development and support advancement of the Company’s oncology pipeline.

• Received a $1.5 million research grant from the Andy Hill Cancer Research Endowment (CARE) Fund to support IND-enabling activities for APVO451, the Company’s nectin-4-targeted trispecific immunotherapy candidate for solid tumors.

• Entered into a 50/50 collaboration with Niowave to develop up to three radiopharmaceutical oncology programs; in connection with the collaboration, Niowave made an equity investment in the Company at closing.

• Comparison of the three and six months ended June 30, 2026 and 2025

Text removed vs the prior filing · source: 10-Q · 2026-05-13

• RAINIER trial on track for completion and Phase 2 dose selection by year end.

• Mipletamig continues to generate strong data in frontline acute myeloid leukemia (AML) in combination with venetoclax + azacitidine. Across 31 evaluable patients (includes data through RAINIER Cohort 5, plus 4 patients from the previously completed dose expansion trial), the data has demonstrated co…

• 87% clinical benefit rate* demonstrates broad anti-leukemia activity and blast reduction across response categories

• 81% CR or CRi (remission), compared to 66.4% in the Phase 3 VIALE-A trial**

• 65% achieved CR (complete remission), compared to 37% in the Phase 3 VIALE-A trial**

Text added vs the prior filing · source: 10-Q · 2026-08-14

• business opportunities. A failure to raise the additional funding or to effectively implement cost reductions would harm our business, results of operations and future prospects.

• In addition, we are subject to certain contractual restrictions on our ability to raise capital. Under the Securities Purchase Agreement and the Warrant Inducement Letters, we agreed that from the date of such agreements until 3 months after the later of (i) the Stockholder Approval Date and (ii) th…

• Our future capital requirements will depend on many factors, including:

• Recent regulatory developments may affect our ability to access capital markets. In May 2026, the Securities and Exchange Commission proposed amendments to the registered offering framework that, if adopted, would expand eligibility to use Form S‑3 and eliminate the limitations currently applicable …

• Various macroeconomic factors and political events have in the past and could adversely affect in the future our business and the results of our operations and financial condition, including changes in inflation, interest rates and overall economic conditions and uncertainties such as those resultin…

Text removed vs the prior filing · source: 10-Q · 2026-05-13

• Various macroeconomic factors and political events have in the past and could adversely affect in the future our business and the results of our operations and financial condition, including changes in inflation, interest rates and overall economic conditions and uncertainties such as those resultin…

• products, which may lead to unpredictable economic consequences including inflation or trade wars. For example, inflation has negatively impacted the Company by increasing our labor costs through higher wages and operating costs. Supply chain constraints have led to higher inflation, which if sustai…

• Our operating results are difficult to predict and will likely fluctuate from quarter to quarter and year to year, as a result of a variety of factors, including:

• the level and timing of any milestone payments with respect to sales of IXINITY by Medexus;

• the extent of any payments received from collaboration arrangements and development funding as well as the achievement of development and clinical milestones under collaboration and license agreements that we may enter into from time to time and that may vary significantly from quarter to quarter; a…