Aptose Biosciences Inc. (“Aptose” or the “Company”) is a clinical-stage biotechnology company committed to discovering and developing personalized therapies addressing unmet medical needs in oncology. The Company’s executive office is located in San Diego, California and its corporate office is located in Toronto, Canada.

 

Aptose has clinical-stage programs and a program that is discovery-stage and partnered with another company. (“CG-), Aptose’s mutation-agnostic FMS-like tyrosine kinase ( / Bruton’s tyrosine kinase (BTK) inhibitor, is currently enrolling patients in a Phase multicenter, open label, dose-escalation study with expansions to assess the safety, tolerability, PK, and preliminary efficacy of CG- in patients with chronic lymphocytic leukemia (CLL/SLL) or non-Hodgkin lymphomas (NHL). Aptose plans to seek allowance from the FDA to move into patient populations that include relapsed or refractory acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) in a separate Phase trial. APTO- Aptose’s program, is a small molecule MYC inhibitor and is currently enrolling patients in a Phase clinical trial for the treatment of patients with R/R blood cancers, including AML and high-risk Myelodysplastic Syndrome.

 

We are advancing -in-class targeted agents to treat life-threatening cancers that, in most cases, are elective for patients and require immediate treatment.  However, COVID- has caused global economic and social disruptions that could adversely affect our ongoing and planned research and development of our clinical-stage programs including but limited to drug manufacturing campaigns, clinical trial activities including enrollment of patients in our ongoing and planned clinical trials, collection and analysis of patient data and eventually, and the reporting of results from our trials. 

 

Since our inception, we have financed our operations and technology acquisitions primarily from equity financing, proceeds from the exercise of warrants and stock options, and interest income on funds held for future investment. Our uses of cash for operating activities have primarily consisted of salaries and wages for our employees, facility and facility-related costs for our offices and laboratories, fees paid in connection with preclinical and clinical studies, drug manufacturing costs, laboratory supplies and materials, and professional fees.

 

We do expect to generate positive cash flow from operations for the foreseeable future due to the early stage of our clinical trials. It is expected that negative cash flow will continue until such time, if ever, that we receive regulatory approval to commercialize any of our products under development and/or royalty or milestone revenue from any such products exceeds expenses.

 

We believe that our cash, cash equivalents and investments on hand at will be sufficient to finance our operations for at least months from the issuance date of these financial statements.  We have based these estimates on assumptions and plans which change and which could impact the magnitude and/or timing of operating expenses and our cash runway. These estimates include the rate of enrolment and timing and release of the results of our clinical trials, and our reliance on our manufacturers.

 

We expect that we will need to raise additional capital or incur indebtedness to continue to fund our operations in the future. Our ability to raise additional funds could be affected by adverse market conditions, the status of our product pipeline and various other factors and we be unable to raise capital when needed, or on terms favorable to us, and COVID- negatively affect our ability to raise additional capital. If necessary funds are available, we have to delay, reduce the scope of, or eliminate some of our development programs, potentially delaying the time to market for any of our product candidates.