Aptose Announces Q1 2024 Results

Aptose Biosciences Inc., a clinical-stage precision oncology company, announced significant progress and financial results for the first quarter ending March 31, 2024. The company is developing advanced oral targeted treatments for hematologic cancers, particularly acute myeloid leukemia (AML).

One of the key highlights is the advancement of Tuspetinib (TUS) to a triplet frontline (1L) therapy. This new treatment approach for newly diagnosed AML patients combines TUS with venetoclax (VEN) and hypomethylating agents (HMA). The addition of TUS aims to enhance response rates, prolong survival, improve quality of life, and address a broader range of AML genetic subpopulations while preventing resistance to VEN.

William G. Rice, Ph.D., Chairman, President, and CEO of Aptose, expressed optimism about this new development. He emphasized that TUS could be the solution to the limitations of the current VEN+HMA doublet therapy, which has low response rates and short survival periods in 1L therapy. Patients who fail VEN-containing treatments often have poor responses to subsequent salvage therapies, leading to a bleak prognosis. By integrating TUS with VEN and HMA, Aptose aims to overcome these challenges.

Tuspetinib, a once-daily oral agent targeting multiple kinases such as SYK, FLT3, mutated KIT, JAK1/2, and RSK2, has shown a favorable safety profile. It avoids many common toxicities, such as treatment-related QTc prolongation, CPK elevations, and differentiation syndrome. In the APTIVATE trial, TUS demonstrated significant activity across diverse AML genetic profiles, both as a single agent and in combination with VEN, in heavily pre-treated relapsed/refractory (R/R) AML patients.

The protocol for the TUS+VEN+HMA triplet therapy pilot study was submitted to the FDA in the first quarter and is now being activated at clinical sites. The study will enroll newly diagnosed AML patients who cannot undergo intensive induction chemotherapy due to age or comorbidities. Participants will be VEN-naïve, FLT3i-naïve, and HMA-naïve, a group known to be highly responsive to triplet regimens. The study aims to commence enrollment early next quarter, with initial data expected in the fourth quarter of this year.

Aptose will present a clinical poster at the European Hematology Association (EHA) 2024 Hybrid Congress in Madrid, Spain, showcasing the safety and efficacy of TUS monotherapy and the TUS+VEN doublet in the APTIVATE Phase 1/2 trial with R/R AML patients. This data supports the launch of the TUS+VEN+HMA triplet frontline therapy for newly diagnosed AML. Additionally, preclinical studies demonstrate TUS’s effectiveness against AML cells with NRAS-G12D mutations or resistance to VEN.

Financially, Aptose reported a net loss of $9.6 million ($0.73 per share) for the first quarter of 2024, compared to a net loss of $13.7 million ($2.22 per share) for the same period in 2023. The decrease in net loss is attributed to reduced research and development costs and lower general and administrative expenses. Total cash and equivalents as of March 31, 2024, were $9.3 million.

Despite these financial challenges, Aptose remains committed to advancing its pipeline of cancer therapeutics. The company expects that its current cash reserves will fund planned operations, including research and development, through August 2024. As of May 14, 2024, Aptose had 16,309,393 common shares outstanding.

In summary, Aptose Biosciences is making significant strides in developing its TUS+VEN+HMA triplet therapy for newly diagnosed AML patients. With promising clinical and preclinical data, the company is poised to address unmet medical needs in hematologic oncology, potentially improving patient outcomes and quality of life.