Aptose Reports Year End 2024 Results and Corporate Highlights

Tuspetinib Triple Drug Frontline Therapy Advancing in TUSCANY Clinical Trial

Results to Date Highlight TUS Potential as an Ideal Third Drug to Include in AML Triplet Therapy

Aptose Signs Debt Conversion Agreement with Hanmi

SAN DIEGO and TORONTO, March 28, 2025 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing a tuspetinib (TUS)-based triple drug frontline therapy to treat patients with newly diagnosed acute myeloid leukemia $(AML.UK)$, today announced financial results for the year ended December 31, 2024, and provided a corporate update.

"During 2024 and into 2025, we continue to advance our lead investigational drug tuspetinib in combination with venetoclax $(VEN.AU)$ and azacitidine $(AZA.SI)$ for frontline treatment of newly diagnosed acute myeloid leukemia $(AML.AU)$," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer of Aptose. "Tuspetinib brings favorable safety and broad activity across AML genetic subtypes to the TUS+VEN+AZA triplet therapy, which already has achieved complete remissions (CRs) in difficult-to-treat and underserved TP53-mutated/CK AML and FLT3-wildtype AML patients in our ongoing TUSCANY trial. We look forward to sharing more data as the trial evolves."

Key Corporate Highlights

   -- Tuspetinib Phase 1/2 TUSCANY Trial Well Under Way with Responses Noted - 
      Tuspetinib based TUS+VEN+AZA triplet therapy is being advanced in the 
      TUSCANY Phase 1/2 trial with the goal of creating an improved frontline 
      therapy for newly diagnosed AML patients that is active across diverse 
      AML populations (mutation agnostic triplet frontline therapy), including 
      FLT3-wildtype AML. This activity differentiates TUS from other drugs in 
      development. In January 2025, Aptose announced initiation of dosing in 
      the first TUSCANY trial cohort with the starting dose of 40 mg TUS in 
      combination with standard-of-care doses of VEN+AZA. At 40 mg TUS, the 
      triplet therapy achieved complete remissions (CRs) in difficult-to-treat 
      TP53-muated AML and FLT3-wildtype AML patients, including a measurable 
      residual disease $(MRD.AU)$ negative remission (press release here). In 
      February 2025, amid the promising early results and favorable safety from 
      patients treated at the 40 mg dose level, the Cohort Safety Review 
      Committee (CSRC) monitoring the TUSCANY trial approved escalating to 80 
      mg TUS in the triplet therapy (press release here). Subjects have now 
      begun treatment at the 80 mg TUS dose level of the triplet therapy and 
      further recruitment is under way. No significant safety concerns have 
      been reported to date, including no prolonged myelosuppression of 
      subjects in remission. This TUS+VEN+AZA triplet therapy study in newly 
      diagnosed AML was supported with robust safety and efficacy data from the 
      TUS single agent dose escalation study and the TUS+VEN doublet APTIVATE 
      study in relapsed or refractory (R/R) AML, both of which were completed 
      during 2024 after treating more than 170 patients. 
 
   -- Financing Activity -- During 2024, Aptose completed several financings 
      for a total of approximately $37 million to support the TUS-based 
      TUS+VEN+HMA triplet therapy development for AML. This included a $10 
      million loan Facility Agreement with Hanmi Pharmaceutical Co. Ltd. 
      ("Hanmi"). Subsequently in March 2025, Hanmi and Aptose executed a Debt 
      Conversion Agreement to convert a portion of the debt into equity, 
      subject to Hanmi owning no more than 19.99% of the issued and outstanding 
      common shares of Aptose. Therefore, an amount of $1.5 million has been 
      converted into 409,063 common shares as of this date. Beyond the $10 
      million, Aptose and Hanmi are negotiating a new tuspetinib co-development 
      collaboration agreement intended to provide additional funding to 
      accelerate clinical development of tuspetinib. Aptose licensed tuspetinib 
      from Hanmi Pharmaceutical in November 2021. 
 
   -- Aptose Signs CRADA with NCI -- In December, Aptose announced that it 
      entered into a Cooperative Research and Development Agreement ("CRADA") 
      with the National Cancer Institute $(NCI)$, part of the National Institutes 
      of Health (press release here). Under the CRADA, the NCI and Aptose will 
      collaborate on the clinical development of TUS, an inhibitor of key 
      signaling kinases involved in myeloid malignancies, in the NCI Cancer 
      Therapy Evaluation Program (CTEP) sponsored myeloMATCH trials employing 
      combinations of targeted therapy for the treatment of molecularly defined 
      AML and myelodysplastic syndromes (MDS) populations. These trials will be 
      conducted by NCI's National Clinical Trials Network (NCTN), with the 
      participation of the NCI Community Oncology Research Program (NCORP) in 
      the U.S. and Canada. 
 
   -- Aptose Meets Nasdaq Minimum Bid Compliance -- Earlier this month, Aptose 
      announced that it received a written notification from the Listing 
      Qualifications Department of The Nasdaq Stock Market, LLC notifying the 
      Company that it is in compliance with Nasdaq's minimum bid price 
      requirement (press release here). On March 14, 2025, Nasdaq confirmed 
      that, for ten consecutive business days, the closing bid price of the 
      Company's common shares has been $1.00 per share or greater. Accordingly, 
      the Company has regained compliance with Listing Rule 5550(a)(2). 
      Separately, Aptose is not in compliance with the $2.5 million 
      shareholders equity requirement and is operating under an exception 
      granted by the Nasdaq Hearing Panel, which provides Aptose additional 
      time to regain compliance, although there is no assurance that the 
      Company will successfully achieve full compliance with the Nasdaq 
      shareholders equity requirement. 

Completed and Planned Value-Creating Milestones

2024 Accomplishments

   -- Completed $10 million loan from Hanmi as Advance on Collaboration 
 
   -- Completed $8 million S-1 financing 
 
   -- Executed CRADA with NCI MyeloMATCH for tuspetinib in AML/MDS 
 
   -- Initiated dosing of TUS+VEN+AZA triplet therapy in newly diagnosed AML 
      patients in TUSCANY trial 
 
   -- ASH: Reported CR/Safety from APTIVATE TUS and TUS+VEN trial 
 
   -- ASH: Reported dosing accrual from TUS+VEN+AZA triplet therapy trial 

2025: 1H

   -- Demonstrated safety and efficacy with 40mg TUS+VEN+AZA in triplet therapy 
      trial 
 
   -- Dosing 80mg TUS in TUS+VEN+AZA dose cohort in triplet therapy trial 
 
   -- Executed Debt Conversion agreement with Hanmi 
 
   -- Expect to report CR/MRD/Safety data from TUS+VEN+AZA triplet therapy 
      trial 
 
   -- Expect to execute Hanmi/Aptose Collaboration 
 
   -- EHA2025 Congress - Report maturing data readout from TUS+VEN+AZA triplet 
      therapy trial 

2025: 2H

   -- Select optimal TUS doses for TUS+VEN+HMA triplet therapy Ph 2/3 pivotal 
      trials 
 
   -- Prepare for Ph 2 portion of Ph 2 / Ph 3 pivotal program 
 
   -- American Society of Hematology $(ASH)$ Update 
 
                    FINANCIAL RESULTS OF OPERATIONS 
                        Aptose Biosciences Inc. 
                     Statements of Operations Data 
                              (unaudited) 
         ($ in thousands, except for share and per share data) 
 
                                                        Year ended 
                                                       December 31, 
                                                    2024        2023 
------------------------------------------------  ---------  ----------- 
Expenses: 
 
Research and development                          $ 15,103   $ 36,765 
General and administrative                          11,154     15,591 
                                                   -------    ------- 
Operating expenses                                  26,257     52,356 
Other income, net                                      827      1,149 
                                                   -------    ------- 
Net loss                                          $(25,430)  $(51,207) 
 
Net loss per share, basic and diluted             $ (36.38)  $(227.43) 
Weighted average number of common shares 
 outstanding used in computing net loss per 
 share, basic and diluted                          698,980    225,154 
                                                   -------    ------- 
 
 

Net loss for the year ended December 31, 2024 decreased by $25.8 million to $25.4 million, as compared to $51.2 million for the comparable period in 2023.

 
                         Aptose Biosciences Inc. 
                            Balance Sheet Data 
                               (unaudited) 
                             ($ in thousands) 
 
                                           December 31,     December 31, 
                                               2024             2023 
----------------------------------------  --------------  ---------------- 
Cash, cash equivalents and restricted 
 cash equivalents                          $      6,707    $      9,252 
 
Working capital                                   5,071          (3,375) 
Total assets                                     10,127          12,989 
Long-term liabilities                            10,211             621 
Accumulated deficit                            (540,967)       (515,537) 
 
Shareholders' deficit                            (4,543)         (2,901) 
 
 
   -- Total cash, cash equivalents and restricted cash equivalents as of 
      December 31, 2024, were $6.7 million. Based on current operations, the 
      Company expects that cash on hand and available capital provides the 
      Company with sufficient resources to fund planned Company operations 

      including research and development until April 2025. 
 
   -- As of March 21, 2025, we had 2,552,429 Common Shares issued and 
      outstanding. In addition, there were 39,219 Common Shares issuable upon 
      the exercise of outstanding stock options and there were 1,267,585 Common 
      Shares issuable upon the exercise of the outstanding warrants. 

RESEARCH AND DEVELOPMENT EXPENSES

The research and development expenses for the years ended December 31, 2024 and 2023 were as follows:

 
                                 Year ended 
                                December 31, 
(in thousands)                  2024     2023 
----------------------------  --------  ------- 
Program costs -- Tuspetinib   $ 9,606   $24,925 
Program costs -- Luxeptinib       422     3,510 
Program costs -- APTO-253         (19)       40 
Personnel related expenses      4,735     6,878 
Stock-based compensation          346     1,373 
Depreciation of equipment          13        39 
----------------------------   ------    ------ 
Total                         $15,103   $36,765 
----------------------------   ------    ------ 
 
 

Research and development expenses decreased by $21.7 million to $15.1 million for year ended December 31, 2024, as compared to $36.8 million for the comparable period in 2023. Changes to the components of our research and development expenses presented in the table above are primarily as a result of the following events:

   -- Program costs for tuspetinib were $9.6 million for the year ended 
      December 31, 2024, compared with $24.9 million for the comparable period 
      in 2023. The lower program costs for tuspetinib in the current year were 
      due to reduced activity in our APTIVATE clinical trial, reduced 
      manufacturing costs, and related expenses. In the comparable period in 
      2023, Tuspetinib program costs included the healthy volunteer study, 
      which was completed in the same year. 
 
   -- Program costs for luxeptinib decreased by approximately $3.1 million 
      primarily due to lower clinical trial and manufacturing activities. 
 
   -- Program costs for APTO-253 decreased by approximately $59 thousand. This 
      reduction was due to the Company's decision to discontinue further 
      development of APTO-253. 
 
   -- Personnel-related expenses decreased by $2.1M due to lower headcount 
      2024. 
 
   -- Stock-based compensation decreased by approximately $1.0 million in the 
      year ended December 31, 2024, primarily due to stock options granted with 
      lower grant date fair values when compared to the options granted in the 
      prior period, coupled with option forfeitures recorded in the current 
      year. 

About Aptose

Aptose Biosciences is a clinical-stage biotechnology company committed to developing precision medicines addressing unmet medical needs in oncology, with an initial focus on hematology. The Company's small molecule cancer therapeutics pipeline includes products designed to provide single agent efficacy and to enhance the efficacy of other anti-cancer therapies and regimens without overlapping toxicities. The Company's lead clinical-stage compound tuspetinib (TUS), is an oral kinase inhibitor that has demonstrated activity as a monotherapy and in combination therapy in patients with relapsed or refractory acute myeloid leukemia (AML) and is being developed as a frontline triplet therapy in newly diagnosed AML. For more information, please visit www.aptose.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of Canadian and U.S. securities laws, including, but not limited to, statements regarding the Company's clinical development plans, the clinical potential, anti-cancer activity, therapeutic potential and applications and safety profile of tuspetinib, clinical trials, the enrollment in clinical trials and the data therefrom, the submission of a compliance plan to Nasdaq and available options to regain compliance, upcoming milestones and presentation of additional data, financing activities, expectations regarding capital available to the Company to fund planned Company operations, maintenance of the Nasdaq and TSX listings, use of proceeds from financings, the conversion of debt into equity contemplated by the Debt Conversion Agreement entered into with Hanmi, the negotiation of a co-development collaboration agreement with Hanmi, the collaboration with the NCI for the clinical development of tuspetinib and statements relating to the Company's plans, objectives, expectations and intentions and other statements including words such as "continue", "expect", "intend", "will", "hope" "should", "would", "may", "potential" and other similar expressions. Such statements reflect our current views with respect to future events and are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by us, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies. Many factors could cause our actual results, performance or achievements to be materially different from any future results, performance or achievements described in this press release. Such factors could include, among others: our ability to obtain the capital required for research and operations; the inherent risks in early stage drug development including demonstrating efficacy; development time/cost and the regulatory approval process; the progress of our clinical trials; our ability to find and enter into agreements with potential partners; our ability to attract and retain key personnel; changing market and economic conditions; unexpected manufacturing defects, the evolving regulatory and political landscape and the funding of government programs and other risks detailed from time-to-time in our ongoing current reports, quarterly filings, annual information forms, annual reports and annual filings with Canadian securities regulators and the United States Securities and Exchange Commission.

Should one or more of these risks or uncertainties materialize, or should the assumptions set out in the section entitled "Risk Factors" in our filings with Canadian securities regulators and the United States Securities and Exchange Commission underlying those forward- looking statements prove incorrect, actual results may vary materially from those described herein. These forward-looking statements are made as of the date of this press release and we do not intend, and do not assume any obligation, to update these forward-looking statements, except as required by law. We cannot assure you that such statements will prove to be accurate as actual results and future events could differ materially from those anticipated in such statements. Investors are cautioned that forward-looking statements are not guarantees of future performance and accordingly investors are cautioned not to put undue reliance on forward-looking statements due to the inherent uncertainty therein.

For further information, please contact:

Aptose Biosciences Inc.

Susan Pietropaolo

Corporate Communications & Investor Relations

201-923-2049

spietropaolo@aptose.com

(END) Dow Jones Newswires

March 28, 2025 08:01 ET (12:01 GMT)