Aptevo Therapeutics Inc SEC Filings

Aptevo Therapeutics entered a 50/50 strategic collaboration with Niowave to develop up to three radiopharmaceutical oncology programs combining Aptevo’s multispecific antibody platforms with Niowave’s radioisotopes, including Actinium-225. The partners will start with a proof-of-concept study using assets such as APVO455 and a Nectin-4–targeting approach.

To align interests, Niowave purchased 98,522 Aptevo common shares and warrants to buy 53,201 additional shares in a private placement for about $500,000 at a combined price of $5.075 per share. The warrants are exercisable at $8.00 per share until May 25, 2031, subject to a beneficial ownership cap of 4.99% or, at Niowave’s election, up to 9.99%. Niowave may also buy up to 97,373 more shares over time, capped so its stake does not exceed 19.99% of Aptevo’s common stock.

Aptevo Therapeutics reported another quarterly loss and raised doubt about its ability to continue as a going concern. For the three months ended March 31, 2026, the company recorded a net loss of $6.7 million, driven by research and development expenses of $3.9 million and general and administrative costs of $2.9 million.

Cash and cash equivalents fell to $14.5 million from $21.6 million at year-end, with $8.0 million used in operating activities in the quarter. Management states that recurring losses, negative operating cash flow, and limited cash resources create substantial doubt about Aptevo’s ability to continue as a going concern over the next year, and the company expects to rely on equity facilities and other financings to fund its oncology pipeline.

Aptevo Therapeutics reported a first-quarter 2026 business update centered on its lead AML drug candidate mipletamig, executive changes, and added financing capacity. In the RAINIER Phase 1b/2 trial in frontline acute myeloid leukemia with venetoclax plus azacitidine, 31 evaluable patients showed an 87% clinical benefit rate, with 81% achieving complete remission or complete remission with incomplete hematologic recovery and 65% achieving complete remission. No cytokine release syndrome has been observed in frontline patients, and 52% of remission patients reached measurable residual disease-negative status. The company completed a planned leadership transition, appointing Jeff Lamothe as CEO and Marvin White as Executive Chair. Aptevo ended March 31, 2026 with $14.5 million in cash and cash equivalents and has a new $60 million Standby Equity Purchase Agreement to support upcoming clinical and strategic milestones.

Aptevo Therapeutics reported new data from its RAINIER frontline acute myeloid leukemia (AML) trial of mipletamig combined with venetoclax and azacitidine. Among 31 evaluable patients, the regimen achieved an 87% clinical benefit rate and an 81% remission rate, with no cytokine release syndrome observed.

The complete remission rate was 65%, and 52% of remissions reached measurable residual disease–negative status, often linked to more durable responses. Outcomes compared favorably to the venetoclax plus azacitidine benchmark from the VIALE-A study. The Phase 1b dose-optimization stage has entered its final cohorts, with trial completion and Phase 2 dose selection expected this year.

Aptevo Therapeutics Inc. is a clinical-stage biotechnology company developing novel immunotherapies for cancer using its wholly owned ADAPTIR™ and ADAPTIR-FLEX™ protein platforms. These modular technologies are designed to create monospecific, bispecific and multi-specific antibodies that engage the immune system to selectively attack tumors.

The company’s lead blood cancer candidate, mipletamig (CD123xCD3), has shown clinical activity and a differentiated safety profile in acute myelogenous leukemia, including high remission rates and no cytokine release syndrome to date in a 28‑patient frontline combination set. A Phase 1b/2 RAINIER trial in frontline AML is ongoing, with completion expected in the second half of 2026.

Lead solid tumor candidate ALG.APV-527, partnered with Alligator Bioscience, targets 4‑1BB and 5T4 and produced stable disease in most evaluable Phase 1 patients without severe liver toxicity. Aptevo is also advancing six preclinical ADAPTIR/ADAPTIR-FLEX candidates, including dual and trispecific constructs aimed at difficult solid tumors and validated immune pathways such as PSMA, Nectin‑4, CD40, PD‑L1, 4‑1BB and OX40.

Aptevo Therapeutics Inc. reported 2025 financial results and updated progress on its lead immune-oncology programs. The company ended 2025 with $21.6 million in cash and cash equivalents, up from $8.7 million a year earlier, and expects current resources to fund operations into the fourth quarter of 2026.

Mipletamig in triplet combination for frontline acute myeloid leukemia showed an 86% clinical benefit rate, including 79% CR/CRi and 61% complete remission, with no cytokine release syndrome observed in frontline patients. Aptevo also expanded its CD3 portfolio to five molecules, including its first trispecific candidates for solid tumors.

For 2025, Aptevo recorded a net loss of $25.97 million and a net loss attributable to common stockholders of $27.54 million, reflecting a non-cash $1.57 million dividend tied to warrant repricing. An additional $60 million equity line facility, if fully utilized with current resources, is expected to support operations into 2029.

Aptevo Therapeutics Inc. reported new interim clinical data for its AML drug candidate mipletamig given with venetoclax and azacitidine in newly diagnosed patients who are elderly or unfit for intensive chemotherapy. Among 28 evaluable frontline patients, the combination showed an 86% clinical benefit rate (CR/CRi/PR) and no cases of cytokine release syndrome (CRS), a common and sometimes serious side effect for T cell–engaging therapies.

The company stated that 79% of patients achieved complete remission or complete remission with incomplete blood recovery, with 55% of these reaching measurable residual disease–negative status, which is typically linked to deeper, more durable responses. It also highlighted that 35% of patients with remissions carried the high‑risk TP53 mutation, yet still responded. Four treated patients have gone on to allogeneic stem cell transplant, a best‑case outcome in AML. These results come from the Phase 1b/2 RAINIER trial and an earlier dose‑expansion study and support mipletamig’s potential role as an add‑on to current frontline AML standard‑of‑care regimens.

Aptevo Therapeutics reported the results of a special shareholder meeting where three proposals were considered. An amendment to the company’s Amended and Restated Certificate of Incorporation to make technical and administrative changes did not receive sufficient support, with 273,162 votes for and 61,044 against.

Shareholders approved the issuance of more than 19.99% of Aptevo’s issued and outstanding common stock as of January 8, 2026 under a Standby Equity Purchase Agreement with YA II PN, Ltd., known as Yorkville, as required by Nasdaq Listing Rules 5635(d) and 5635(b). They also approved authorization to adjourn the special meeting if necessary.

Aptevo Therapeutics Inc. is the subject of an amended ownership report showing that Point72 and Steven A. Cohen no longer own its common stock. In this Schedule 13G/A (Amendment No. 1), Point72 Asset Management, Point72 Capital Advisors Inc., and Mr. Cohen each report beneficial ownership of 0 Shares of Aptevo common stock and 0% of the class as of the close of business on December 31, 2025. They also certify that any securities referenced were not acquired or held for the purpose of changing or influencing control of Aptevo Therapeutics.