Aptose Biosciences(APTO) - 2024 Q1 - Quarterly Results

Corporate and Clinical Update Aptose is advancing its lead drug, Tuspetinib, into a frontline triplet therapy for newly diagnosed AML, with key milestones planned through 2025, while also addressing Nasdaq listing compliance Key Corporate Highlights Aptose has advanced its lead drug, Tuspetinib, into a frontline triplet therapy (TUS+VEN+HMA) for newly diagnosed Acute Myeloid Leukemia (AML), with the protocol submitted to the FDA and clinical sites being activated, supported by extensive data showing a favorable safety profile and broad activity, while also addressing Nasdaq listing compliance issues - The TUS+VEN+HMA triplet therapy protocol for newly diagnosed (ND) AML was submitted to the FDA in Q1 2024 and is now being activated at clinical sites[1][4] - The triplet therapy aims to improve upon the current VEN+HMA standard of care by increasing response rates and prolonging survival, particularly for patients who respond poorly to VEN-containing regimens[2] - Tuspetinib has demonstrated a favorable safety profile with no treatment-related QTc prolongation, differentiation syndrome, or drug-related deaths in prior trials[3] - Aptose regained compliance with a Nasdaq listing rule concerning a private placement after amending warrant terms with Hanmi Pharmaceutical[7] - The company received a second Nasdaq non-compliance notice for its stockholders' equity falling below the $2.5 million minimum as of December 31, 2023, but equity has since turned positive to $137,000 as of March 31, 2024[8] Upcoming Milestones Aptose has outlined a series of key milestones for its Tuspetinib triplet therapy program, starting with data presentation at EHA 2024, followed by the initiation and dose escalation of the pilot study in 2024, and culminating in the planned initiation of a pivotal Phase 2/3 program in the second half of 2025 Planned Milestones for Tuspetinib Triplet Program | Milestone | Expected Timing | | :--- | :--- | | TUS+VEN data presentation in R/R AML | EHA 2024 | | Triplet pilot dose initiation in ND AML | Summer 2024 | | Triplet pilot early data (CR/MRD/safety) | ASH 2024 | | Triplet pilot completion and dose selection | EHA 2025 | | Triplet Ph2/Ph3 pivotal program initiation | 2H 2025 | Financial Results for Q1 2024 Aptose reported a reduced net loss in Q1 2024 due to decreased operating expenses, with its financial position showing positive stockholders' equity and sufficient cash to fund operations through August 2024 Summary of Operations For the first quarter of 2024, Aptose reported a net loss of $9.6 million, or $0.73 per share, representing a significant reduction from the $13.7 million net loss, or $2.22 per share, in the same period of 2023, driven by decreased operating expenses Q1 2024 Statement of Operations Highlights (in thousands, except per share data) | Metric | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Research and development | $6,445 | $8,811 | | General and administrative | $3,315 | $5,285 | | Operating expenses | $9,760 | $14,096 | | Net loss | $(9,640) | $(13,676) | | Net Loss per share | $(0.73) | $(2.22) | - The decrease in net loss was primarily due to a $2.4 million reduction in R&D costs and a $2.0 million reduction in general and administrative costs compared to Q1 2023[13] Financial Position As of March 31, 2024, Aptose had $9.3 million in cash, cash equivalents, and short-term investments, with stockholders' equity turning positive to $0.14 million from a deficit of $2.9 million at the end of 2023, and management expects the current cash position to fund operations through August 2024 Balance Sheet Data (in thousands) | Metric | March 31, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | Cash, cash equivalents and short-term investments | $9,328 | $9,252 | | Working capital | $(318) | $(3,375) | | Total assets | $12,796 | $12,989 | | Stockholders' equity | $137 | $(2,901) | - The company projects its current cash and available capital are sufficient to fund planned operations through August 2024[14] Research and Development (R&D) Expenses Analysis R&D expenses for Q1 2024 decreased by $2.4 million to $6.4 million compared to the same period in 2023, primarily driven by lower program costs for Tuspetinib due to the near completion of APTIVATE trials and a significant decrease in costs for the Luxeptinib program as certain clinical activities concluded R&D Expenses Breakdown (in thousands) | Program | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Tuspetinib | $3,923 | $4,774 | | Luxeptinib | $208 | $1,289 | | Personnel related expenses | $1,954 | $2,078 | | Stock-based compensation | $328 | $652 | | Total R&D Expenses | $6,445 | $8,811 | - Tuspetinib program costs decreased due to the near completion of APTIVATE clinical trials and reduced manufacturing costs[17] - Luxeptinib program costs fell by approximately $1.1 million due to the conclusion of certain clinical trial and manufacturing activities[18] Corporate Information Aptose Biosciences is a clinical-stage biotechnology company focused on precision oncology, with its report containing forward-looking statements subject to inherent risks and uncertainties About Aptose Aptose Biosciences is a clinical-stage biotechnology company focused on developing precision oncology medicines, particularly for hematologic malignancies, with a pipeline featuring two oral kinase inhibitors: tuspetinib for AML and luxeptinib for other relapsed or refractory hematologic malignancies - Aptose is a clinical-stage biotech company developing precision medicines for unmet needs in oncology, with an initial focus on hematology[21] - The company's pipeline includes two oral kinase inhibitors: tuspetinib for AML and luxeptinib for relapsed or refractory hematologic malignancies[21] Forward-Looking Statements This press release includes forward-looking statements concerning the company's clinical development plans, the potential of its drug candidates, trial timelines, and its financial runway, which are subject to significant risks and uncertainties, and actual results may differ materially from expectations - The report contains forward-looking statements regarding clinical development plans, the potential of tuspetinib, clinical trial timelines, and the company's capital resources[22] - These statements are subject to risks and uncertainties, and the company does not assume any obligation to update them[23]