Aptevo Therapeutics Announces 1Q 2024 Financial Results and Business Update

Aptevo Therapeutics Inc., a clinical-stage biotechnology firm based in Seattle, WA, announced its financial results for the first quarter ending March 31, 2024, and provided updates on its business operations.

A significant highlight from the clinical developments includes a breast cancer patient who had previously undergone extensive treatment and enrolled in the ALG.APV-527 Phase 1 trial. This patient presented with progressive disease at the start but achieved stable disease status, maintaining it for over eleven months. The patient has been transitioned to a higher dose level without experiencing any new adverse events, suggesting a potential for increased clinical benefit. ALG.APV-527 is currently being tested on multiple solid tumor types in a trial that is over 50% enrolled, and the dosing for cohort 5 is ongoing.

Aptevo is also preparing to initiate a dose optimization trial for APVO436 in the second quarter of 2024. This upcoming Phase 1b/2 study will investigate APVO436 in combination with venetoclax and azacitidine for frontline acute myeloid leukemia (AML) in patients who have not previously been treated with venetoclax. This trial will be an open-label, multi-center, multi-cohort study aiming to assess the safety, tolerability, and efficacy of the combination therapy at various dose levels.

Marvin White, President & CEO of Aptevo, expressed enthusiasm about the progress in both clinical programs. He highlighted the exceptional case of the breast cancer patient in the ALG.APV-527 trial and the upcoming initiation of the APVO436 dose optimization trial for AML patients. White emphasized that these developments reflect the potential efficacy of Aptevo's bispecific solid tumor candidate and other proprietary molecules.

Financially, Aptevo reported a cash position of $10.3 million as of March 31, 2024, which increases to $14.3 million when including proceeds from an equity raise completed on April 10, 2024. Research and development expenses for the first quarter decreased to $3.8 million from $4.2 million in the same period of 2023, attributed to reduced spending on the APVO436 clinical trial and lower preclinical project and employee costs. However, this decrease was somewhat offset by higher costs associated with the ALG.APV-527 Phase 1 clinical trial.

General and administrative expenses also saw a reduction, dropping to $3.2 million from $3.6 million in the first quarter of the previous year, primarily due to lower employee and consulting expenses. The net loss for the quarter was $6.8 million, translating to $9.95 per share, compared to a net income of $2.8 million or $17.38 per share in the corresponding period of 2023.

Aptevo's lead proprietary drug, APVO436, targets AML and aims to recruit the patient's immune system to attack leukemic cells by engaging both leukemic and T cells through the CD123 antigen. This drug has received orphan drug designation and has shown a 91% clinical benefit rate in combination with venetoclax and azacitidine in venetoclax-naïve patients during the Phase 1b trial.

In summary, Aptevo Therapeutics is advancing its clinical trials for ALG.APV-527 and APVO436, showcasing promising preliminary data and gearing up for further significant trials in 2024. The company's current financial position and reduced operational costs reflect a strategic focus on optimizing its therapeutic candidates and sustaining its clinical programs.