Aptevo Therapeutics(APVO) - 2025 Q3 - Quarterly Report

Clinical Development - Mipletamig reported an 89% remission rate among evaluable frontline AML patients, with 100% remission in Cohort 3 of the ongoing RAINIER trial[99]. - No cytokine release syndrome (CRS) observed among evaluable frontline patients to date, distinguishing it from other treatments[99]. - The ongoing Phase 1b trial for mipletamig was initiated in August 2024, with favorable results reported to date[91]. - The company has two clinical candidates and six preclinical candidates currently in development, focusing on novel immunotherapy for cancer treatment[91]. - The company has an obligation to make a $2.0 million milestone payment upon dosing the first patient in a Phase 2 clinical trial of mipletamig under the OMT License Agreement[124]. Financial Performance - Research and development expenses increased by $0.9 million to $4.0 million for the three months ended September 30, 2025, compared to $3.1 million for the same period in 2024[102]. - General and administrative expenses rose by $1.5 million to $3.6 million for the three months ended September 30, 2025, compared to $2.1 million for the same period in 2024[104]. - Net cash provided by financing activities was $32.7 million for the nine months ended September 30, 2025, compared to $8.9 million for the same period in 2024[109]. - Total research and development expenses for the nine months ended September 30, 2025, were $11.0 million, up from $10.5 million in the same period in 2024[102]. - For the nine months ended September 30, 2025, net cash used in operating activities was $20.4 million, indicating ongoing operational losses[117]. - The company anticipates significant operating losses for the next several years as it continues to develop its product candidates, requiring substantial additional funding[117]. Capital Raising and Agreements - The company raised $18.7 million net in the third quarter, extending cash runway into Q4 2026[99]. - The company entered into a Standby Equity Purchase Agreement (SEPA) with Yorkville, allowing the issuance of up to $25 million in common stock over 36 months, with $15 million raised from 8.3 million shares issued as of September 30, 2025[110]. - Under the At The Market Offering Agreement (ATM Agreement), the company raised $7.6 million from the issuance of 2.8 million shares at an average price of $2.74 per share for the nine months ended September 30, 2025[111]. - The company has no remaining availability under the ATM Agreement due to limitations, but has $10 million remaining under the SEPA[111][118]. - The company has 12,535,033 common warrants outstanding, which could yield up to $23.9 million in gross proceeds if exercised[115]. - The company received $9.6 million from XOMA for the sale of future deferred payments and potential milestones related to IXINITY, with an additional $5.8 million in milestone payments contingent on regulatory achievements[114]. Market and Operational Challenges - The company may face delays in clinical trials and partnerships due to macroeconomic factors, including inflation and potential impacts on partners' financial stability[120]. - The company has cash and cash equivalents of $21.1 million and an accumulated deficit of $269.2 million as of September 30, 2025[116].