Aptose Q2 2024 Results Released

Aptose Biosciences Inc., a clinical-stage precision oncology company, has announced its financial results for the quarter ending June 30, 2024, and provided several corporate updates.

Dr. William G. Rice, Chairman, President, and CEO of Aptose, expressed satisfaction with the FDA's approval to proceed with their triplet protocol involving tuspetinib, venetoclax, and azacitidine (TUS+VEN+AZA) at a 40 mg dose of tuspetinib. This approval is significant for Aptose, as the combination is intended for newly diagnosed acute myeloid leukemia (AML) patients who are unfit for chemotherapy. The triplet therapy aims to improve outcomes for these patients who are in desperate need of better frontline treatment options.

Key corporate highlights during the quarter include the readiness of the TUS+VEN+AZA triplet study. This phase 1/2 study will test tuspetinib in combination with standard doses of azacitidine and venetoclax for newly diagnosed AML patients who have not received prior chemotherapy (VEN-naïve, FLT3i-naïve, and HMA-naïve). The trial is expected to show positive results due to the anticipated responsiveness of this patient group to the regimen.

Additionally, Aptose submitted an abstract on July 31, 2024, for the upcoming 2025 Annual Meeting of the American Society of Hematology (ASH). The abstract discusses the safety and efficacy results supporting the TUS+VEN+AZA triplet combination as frontline therapy for newly diagnosed AML patients who cannot undergo intensive chemotherapy. This submission highlights the potential of tuspetinib as a frontline treatment option that is not dependent on FLT3 mutation status, differentiating it from other therapies.

However, the company also faced challenges, as indicated by a deficiency letter from the Nasdaq Listing Qualifications Department on July 19, 2024. The letter noted that Aptose’s common shares had closed below the minimum required bid price of $1.00 per share for 30 consecutive business days. Although this does not immediately affect the company’s Nasdaq listing, Aptose has until January 10, 2025, to regain compliance by achieving a closing bid price of $1.00 or more for ten consecutive business days. Failure to meet this requirement may result in a second compliance period.

On the financial front, Aptose reported a net loss of $7.3 million for the three months ending June 30, 2024, a reduction from the $14.1 million net loss in the same period in 2023. For the six months ending June 30, 2024, the net loss was $16.9 million, down from $27.8 million in the same period of the previous year. The decrease in net loss is attributed to reduced research and development expenses, particularly in the tuspetinib program, and lower general and administrative costs.

The company's total cash, cash equivalents, and short-term investments stood at $8.3 million as of June 30, 2024. Aptose expects these funds, along with available capital, to support its operations through August 2024.

In terms of research and development expenses, the three-month period ending June 30, 2024, saw a decrease to $4.4 million from $10.6 million in the same period in 2023. This reduction is primarily due to decreased activity in the tuspetinib program, including the completion of a healthy volunteer study in 2023, and lower costs associated with the luxeptinib program and APTO-253, which has been discontinued.

Looking ahead, Aptose has several planned milestones, including the initiation of the frontline therapy triplet pilot dose for newly diagnosed AML in the second half of 2024, with early data expected by the ASH 2024 meeting. They aim to complete the triplet pilot with data on complete remission and minimal residual disease by the European Hematology Association (EHA) 2025 meeting, and plan to initiate a phase 2/3 pivotal program in the second half of 2025.

Aptose Biosciences remains committed to developing precision medicines for unmet medical needs in oncology, focusing on hematologic malignancies. Their lead compound, tuspetinib, continues to show promise in both monotherapy and combination settings for AML patients.