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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of
1934
Date of Report (Date of earliest event reported): January 13, 2025
APTOSE BIOSCIENCES INC.
(Exact name of registrant as specified in its charter)
Canada |
001-32001 |
98-1136802 |
(State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
66 Wellington Street West, Suite 5300
TD Bank Tower, Box 48
Toronto, Ontario M5K 1E6
Canada
(Address of Principal Executive Offices) (Zip Code)
(310) 849-8060
(Registrant's telephone number, including area code)
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy
the filing obligation of the registrant under any of the following provisions:
☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
☐ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
Common Shares, no par value |
APTO |
The Nasdaq Stock Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule
405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2
of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use
the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a)
of the Exchange Act. ☐
Item 9.01. Financial Statements and Exhibits.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Aptose Biosciences Inc. |
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Date: January 13, 2025 |
By: |
/s/ William G. Rice, Ph.D. |
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William G. Rice, Ph.D. |
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President and Chief Executive Officer |
Exhibit 99.1
Aptose Precision oncology company developing oral targeted agents to treat hematologic malignancies Corporate Presentation January 2025 Tuspetinib in Frontline Triple Drug Therapy to Treat Newly Diagnosed AML 1 NASDAQ: APTO TSX: APS
AML (Acute Myeloid Leukemia) • Highly aggressive and deadly cancer of the bone marrow and blood Current Standard of Care Therapy • VEN+AZA (Venetoclax + Azacitidine) two drug therapy • Too few patients achieve responses • Survival too short | median Overall Survival <15mos • VEN drug resistance emerges Critical Medical Need • Improved Therapy to get More Newly Diagnosed AML Patients into Deep and Sustained Responses that Extend Survival Adding a 3rd Agent to VEN +AZA • Boost Effectiveness of VEN+AZA standard of care • Improve safety | broad activity | avoid resistance Tuspetinib (TUS) Lead Clinical Asset TUS is an Ideal 3 rd Agent to Add to VEN+AZA • TUS: Boosts efficacy when combined with VEN or AZA • TUS : Favorable safety when combined with VEN or AZA • TUS : Broad activity across diverse AML genetic subgroups • TUS: Minimize risk of drug resistance when combined with VEN TUS+VEN+AZA Triplet Drug Combination • Being developed to treat Newly Diagnosed AML • Expect high CR rates and durability of response • Expect to treat FLT3 - mutated and FLT3 - wildtyp e AML • TUS+VEN+AZA triplet dosing of patients is ongoing TUS Commercial Potential Critical to Business Model • $1Bn+ market potential to treat Newly Diagnosed AML AML : Acute Myeloid Leukemia ; TUS : Tuspetinib ; VEN : Venetoclax ; AZA : Azacitidine ; HMA : Hypomethylating agent ; SOC : Standard of Care ; CR : Complete Remission ; mOS : median overall survival 2
3 Q4 2024 ASH Key Milestones Achieved and Planned Q1 Q2 Q3 Q4 2025 Q1 Q2 Q3 Q4 2026 First Report of Response & Safety Data in 1L AML from Ph 1 Triplet Second Report of Response & Safety Data in 1L AML from Ph 1 Triplet Third Report of Response , Safety & Early Durability Data in 1L AML from Ph 1 Triplet Preparation for Ph 2/3 Triplet Pivotal Fourth Report of Response, Safety & Durability from Ph 1 Triplet 3 Response, Safety , & Durability Data from Ph 1 Triplet Data from Initiation of Triplet Ph 2/3 Pivotal Trial Phase 1/2 TUS+VEN+AZA Triplet Frontline Therapy for Newly Diagnosed AML $10M Advance from Hanmi Hanmi - Aptose Collaboration Planned $8M Financing Signed NCI CRADA Dosed 1 st Cohort of 1L Triplet Trial Tuspetinib Publication Tuspetinib Clinical Data at ASH Favorable Decision from Nasdaq Panel Data Sharing for Potential Pharma Partnership as Activity and Durability Data are Collected ASH ASH EHA EHA
4 Recent Milestones and Press Releases 4 Aug 30, 2024: Aptose Receives $10 Million Through a Facility Agreement with Hanmi; Negotiating Future Aptose - Hanmi TUS Collaboration Agreement to Jointly Develop Tuspetinib Nov 20, 2024: Initiation of TUSCANY Phase 1/2 Study for Newly Diagnosed AML Patients to Receive Tuspetinib - based Triplet Therapy Nov 25, 2024: Closing of $8 Million Public Offering Dec. 3, 2024: Signing CRADA with National Cancer Institute to Develop Tuspetinib for AML and MDS in Newly Launched MyeloMATCH Precision Medicine Trials Dec. 9, 2024: Clinical Data Featured in Poster Presentation at the 2024 ASH Annual Meeting Support Tuspetinib Triple Drug Therapy for Newly Diagnosed AML Dec. 12, 2024: Aptose Announces Publication of Preclinical Data in AACR Journal Demonstrating Tuspetinib’s Unique Mechanism of Action and Synthetic Lethality on AML Cells When Combined with Venetoclax Dec. 19, 2024: Aptose Announces Positive Decision by Nasdaq Hearings Panel Jan. 9, 2024: First AML Patients Dosed with Tuspetinib Triplet Frontline Therapy in TUSCANY Trial
5 5
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8 Tuspetinib Kinase Inhibition Profile – Unique Target Profile Suppresses key oncogenic signaling pathways Avoids targets that compromise safety 8 10nM Test Concentration >90% >75 - 89% >50 - 74% >25 - 49% PDGFR β HPK1 TRKC TRKB JAK2 JAK1 FLT1 MLK2 FGFR 3/4 FLT4 MLK3 MLK1 LOK PKCg LRRK2 ABL RET PDGFRb YES LCK SRC EPHA7 MUT - KIT PKCb CK2a2 PKCd DRK1b CLK2 PKN1 ARK5 LYN DDR1 STK39 Tie2 FLT3 IGF1R MUSK SYK TRKA FDFR2 ROS IC 50 <10nM RSK2 Activity Mutation Status Kinase Assay Methodology 0.58 WT FLT3 Binding Affinity (K D , nM) 0.37 ITD 0.29 D835Y 0.4 D835H 0.48 ITD/D835V 1.3 ITD/F691L 1.1 WT FLT3 Inhibition of Kinase Enzyme Activity (IC 50 , nM) 1.8 ITD 1.0 D835Y 2.9 WT SYK 2.8 JAK - 1 JAK 6.3 JAK - 2 9.9 JAK - 2 (V617F) > 500 WT c - KIT 3.6 D816H 3.5 D816V 9.7 RSK - 2 RSK Once - daily, oral tablet
9 9 TUS Targets Known VEN - Resistance Mechanisms and May Minimize Drug Resistance FLT3 KIT MCL - 1 PI3K/AKT RAS/ MAPK SYK JAK/STAT TUS Tuspetinib: • Suppresses oncogenic signaling directly • Promotes cancer cell death signaling indirectly
10 10 Newly Diagnosed AML Intensive Chemotherapy (7+3) Low Intensity Therapy (VEN + AZA) AML Patient Journey | Frontline (1L) Therapy | Standard - of - Care (SOC) Palliative Care Hospice 5 - year survival <10% for age >70 1 ; Most survive <1 year Patients “Unfit” for High Dose Chemotherapy Patients “Fit” for High Dose Chemotherapy • Need an Improved Frontline Therapy • Drives More Newly Diagnosed AML Patients into Complete Responses (CR) • Keeps the Patients in Complete Responses (CR) Longer and Extends Survival Cytarabine + anthracycline IV for 7d+3d, resp. Only 30 - 50% patients “Fit” ; Many relapse 3 5 - year survival rate Age 2 65 - 70% Children < 14 52% Ages 15 to 34 37% Ages 35 to 54 20% Ages 55 to 64 9% Ages 65 to 74 CR/CRi = 66%, mOS = 14.7 months; <25% alive at 3 - years 4 Mutated FLT3, RAS, TP53 have poorer responses/outcomes 1 Pei, Cancer Discos 2020); DiNardo, Blood 2020); ( Maiti et al., Haematologica 2021); (Mannis et al., Leukemia Research 2023); Bewersforf et al., Leukemia Research 2022; 122: 106942 2 NIH; Yale Medicine; American Cancer Society; NIH; Healthline; DiNardo, Erba, Freeman et al., Lancet, 2023 3 Kantarjian , Blood Canc J 2021 4 DiNardo, NEJM 2020; Pei, Cancer Discos 2020; DiNardo, Blood 2020; Maiti , Haematologica 2021; Mannis, Leukemia Research 2023; Bewersforf , Leukemia Research 2022 CR : Complete Remission ; CRi : Complete Remission with incomplete hematologic recovery; CRc : composite Complete Remission ; OS : Overall Survival Annual new cases in U.S. ≈ 21,000 | Majority patients age >65 Annual deaths in U.S. ≈ 11,200 | 5 - yr survival for age >65 ≈ 9% Ref. 2 Complete Response HSCT Therapeutic Failure Survival: Weeks to Few Months Relapse Survival: Weeks to Few Months Therapeutic Failure Survival: Weeks to Few Months
11 Solution: TUS as Superior 3 rd Agent Proof that Triplet Therapy Works ‒ Gilteritinib (Gilt) added to VEN+AZA boosts CR rate to 90% So, What’s the Problem: Gilt proves “Triplet Therapy” works, but has Limitations ‒ Gilt active in 30% of patients (harbor FLT3 mutation) ‒ Gilt not active in 70% of patients (no FLT3 mutation) ‒ Gilt adds excessive toxicities to the VEN+AZA backbone New Treatment Paradigm with Triple Drug Therapy for Newly Diagnosed AML Adding a Targeted Agent to the VEN+AZA Backbone Therapy TUS has a cleaner safety profile TUS has broader activity TUS is active in Gilt - failure patients TUS can avoid drug resistance 1 Short et al. J Clin Oncol. 2024 Jan 26:JCO2301911. Epub ahead of print. PMID: 38277619. 11 Tuspetinib Triplet (TUS + VEN + AZA) into Newly Diagnosed AML to Improve Patient Response and Survival Outcomes CONFIDENTIAL
12 Completed TUS Single Agent and TUS+VEN Doublet to Prepare for Triplet in 1L Therapy Treated AML Patients Who Failed Prior Therapies (R/R) with TUS and TUS+VEN 12 Cohort 1: 20 mg QD 2 Cohort 2: 40 mg QD 17 Cohort 3: 80 mg QD 20 Cohort 4: 120 mg QD 32 Cohort 5: 160 mg QD 16 Cohort 6: 200 mg QD 4 TUS Single Agent Dose Escalation and Exploration 1 Total n=93 Doses with CR & no DLT TUS+VEN Doublet Study Extensive Dose Exploration: Total N = 79 (TUS 80mg or 40mg + VEN 400mg ) Cycle 1 Treatment Plan : Day 1 Day 15 (BM blasts <5% or aplastic) Day 28 (up to Day 42) TUS 80 mg or 40 mg daily VEN 400 mg daily VEN held Cycle 1 extended if needed to allow for count recovery VEN held if BM blasts <5% or aplastic Day 1 Day 15 (BM blasts ≥ 5%) Day 28 (up to Day 56) Cycle 1 extended if needed to allow for count recovery TUS Single Agent √ Thorough Dose Exploration √ Demonstrated Responses √ Demonstrated Safety √ Orphan Drug Designation √ Fast Track Status TUS+VEN √ Characterize Safety of TUS+VEN √ Characterize PK of TUS and VEN Findings from TUS Single Agent Study & TUS+VEN Doublet Study TUS 80 mg or 40 mg daily VEN 400 mg daily
13 13 TUS and TUS+VEN Safe and Well Tolerated in Highly Treatment Experienced R/R AML TUS+VEN Doublet TUS Single Agent Related to TUS/VEN, n(%) (n=79) Adverse Events Treatment Emergent AEs Related to VEN Treatment Emergent AEs Related to TUS Treatment Emergent AEs Treatment Related AEs Treatment Emergent AEs 37 (46.8%) 40 (50.6%) 77 (97.5%) 29 (31.2%) 89 (95.7%) Any Most Frequent AEs ≥10% 3 (3.8%) 2 (2.5%) 19 (24.1%) 0 (0%) 32 (34.4%) Pneumonia 10 (12.7%) 14 (17.7%) 21 (26.6%) 9 (9.7%) 20 (21.5%) Nausea 1 (1.3%) 1 (1.3%) 10 (12.7%) 0 (0%) 19 (20.4%) Pyrexia 4 (5.1%) 5 (6.3%) 15 (19.0%) 9 (9.7%) 18 (19.4%) Diarrhoea 3 (3.8%) 3 (3.8%) 12 (15.2%) 2 (2.2%) 13 (14.0%) Alanine aminotransferase increased 1 (1.3%) 2 (2.5%) 11 (13.9%) 0 (0%) 13 (14.0%) Hypokalaemia 0 (0%) 0 (0%) 4 (5.1%) 0 (0%) 12 (12.9%) Epistaxis 4 (5.1%) 4 (5.1%) 11 (13.9%) 2 (2.2%) 11 (11.8%) Decreased appetite 4 (5.1%) 3 (3.8%) 21 (26.6%) 1 (1.1%) 11 (11.8%) Febrile neutropenia 1 (1.3%) 1 (1.3%) 4 (5.1%) 0 (0%) 11 (11.8%) Hypomagnesaemia 1 (1.3%) 1 (1.3%) 4 (5.1%) 0 (0%) 10 (10.8%) Abdominal pain 0 (0%) 0 (0%) 6 (7.6%) 2 (2.2%) 10 (10.8%) Constipation 0 (0%) 0 (0%) 8 (10.1%) 0 (0%) 10 (10.8%) Dyspnoea 6 (7.6%) 7 (8.9%) 16 (20.3%) 2 (2.2%) 10 (10.8%) Fatigue 0 (0%) 0 (0%) 7 (8.9%) 1 (1.1%) 10 (10.8%) Headache 3 (3.8%) 3 (3.8%) 10 (12.7%) 0 (0%) 7 (7.5%) Anaemia 2 (2.5%) 2 (2.5%) 11 (13.9%) 1 (1.1%) 4 (4.3%) Aspartate aminotransferase increased 0 (0%) 0 (0%) 10 (12.7%) 0 (0%) 8 (8.6%) Cough 3 (3.8%) 4 (5.1%) 10 (12.7%) 1 (1.1%) 5 (5.4%) Platelet count decreased 7 (8.9%) 6 (7.6%) 10 (12.7%) 2 (2.2%) 4 (4.3%) White blood cell count decreased 0 (0%) 1 (1.3%) 8 (10.1%) 0 (0%) 4 (4.3%) Leukocytosis 5 (6.3%) 6 (7.6%) 8 (10.1%) 2 (2.2%) 5 (5.4%) Neutrophil count decreased 4 (5.1%) 3 (3.8%) 8 (10.1%) 2 (2.2%) 7 (7.5%) Vomiting 22 (27.8%) 22 (27.8%) 68 (86.1%) 9 (9.7%) 67 (72.0%) Grade ≥ 3 AEs (≥10%) 3 (3.8%) 2 (2.5%) 17 (21.5%) 0 (0%) 27 (29.0%) Pneumonia 3 (3.8%) 2 (2.5%) 20 (25.3%) 1 (1.1%) 11 (11.8%) Febrile neutropenia 2 (2.5%) 2 (2.5%) 9 (11.4%) 0 (0%) 6 (6.5%) Anaemia 3 (3.8%) 4 (5.1%) 10 (12.7%) 0 (0%) 4 (4.3%) Platelet count decreased 5 (6.3%) 6 (7.6%) 8 (10.1%) 2 (2.2%) 5 (5.4%) Neutrophil count decreased SAEs 10 (12.7%) 0 (0%) 10 (12.7%) 1 (1.1%) 12 (12.9%) Leading to treatment termination 0 (0%) 0 (0%) 18 (22.8%) 0 (0%) 17 (18.3%) Leading to death Data Cut 05 Nov 2024 • No drug - related myelosuppression in remission • No treatment related QTc prolongation or CPK elevations • No drug - related discontinuations or deaths • No drug - related non - hematologic SAEs • No differentiation syndrome TUS Single Agent Study Excellent Safety and Tolerability • No new or unexpected safety signals with TUS+VEN • No drug related AE of QTc prolongation • No differentiation syndrome observed • No drug related deaths TUS+VEN Doublet Study Excellent Safety and Tolerability
14 14 TUS Single Agent Treatment Bone Marrow Leukemic Blasts │Percent Change from Baseline Blast Reductions Demonstrate Activity Across 4 Dose Levels Activity in Patients Who Failed Prior - VEN and Prior - FLT3i Note: Blast percent change was calculated as 100 X (the lowest post - baseline bone marrow blast - baseline bone marrow blast)/bas eline bone marrow blast. Patients with blast percent change >=100% are shown as 100%. Only patients who reported both baseline and any p ost - baseline bone marrow blast results are included in the figure. Black triangle indicates patients who received prior Ven before starting Tuspetinib . Red triangle indicates prior FLT3i. * Black asterisk indicates patients who administered hydoxyurea within 7 days prior to the lowest marrow blast value Data cut Nov 05, 2024 TUS and TUS+VEN : Bone Marrow Blast Reductions and Responses in R/R AML Patients Prior - VEN Prior FLT3i TUS Initial Dose Level TUS+VEN Dose Level TUS - VEN Doublet Treatment Bone Marrow Leukemic Blasts │Percent Change from Baseline Blast Reductions in VEN - Naïve and Prior - VEN R/R AML Blast Reduction in R/R AML Who Failed Prior - VEN and Prior - FLT3i Prior - VEN Prior FLT3i * *
15 TUS+VEN+AZA Triplet in Newly Diagnosed AML Patients : TUSCANY Trial Ongoing 15 • FLT3 WT (70% of cases) Most Common AML ‒ Only combination being developed for the FLT3 WT population • FLT3 MUT (30% of cases) Intermediate - Risk AML ‒ Potential to increase CR rates and survival of the FLT3 MUT population • TP53 MUT , RAS/MAPK MUT High - Risk AML ‒ Broad activity across adverse genetic subgroups ‒ Groups with greatest unmet medical needs • Expect Safer and Broader therapy than other triplets Tuspetinib Frontline Triplet Opportunities Patient Populations │ Approx. 18 - 26 Pts Total │ 50% FLT3 - MUT │ <20% TP53+/CK Dose Characterization │ Demonstrate TUS is Highly Active and May Avoid SOC Dose Reductions Goals of Trial │ Safety, CR rate, MRD negativity and OS across AML subtypes (FLT3 MUT/WT , TP53 MUT , RAS MUT ) TUS+VEN+AZA Triplet Cycle 1 Treatment Plan
16 Q4 2024 ASH ASH EHA Triplet Frontline Therapy In Newly Diagnosed AML Timeline : Financings , Clinical Trials, and Milestones ASH EHA Q1 Q2 Q3 Q4 2025 Q1 Q2 Q3 Q4 2026 TUS+VEN+AZA Ph 1 Triplet Study Initiated 1L Triplet Dosing in Newly Diagnosed AML First Report of Response and Safety Data in 1L AML from Ph 1 Triplet Second Report of Response and Safety Data in 1L AML from Ph 1 Triplet Third Report of Response , Safety and Early Durability Data in 1L AML from Ph 1 Triplet Preparation for Ph 2/3 Triplet Pivotal Fourth Report of Response, Safety & Durability from Ph 1 Triplet 16 Response /Safety/Durability Data from Ph 1 Triplet Data from Initiation of Triplet Ph 2/3 Pivotal Trial Ph 2 Portion Start - up Preparation Ph 2/3 Pivotal Trial: TUS+VEN+HMA Triplet 1L Therapy for Newly Diagnosed AML Planned via Pharma Partnership Today Phase 1/2 TUS+VEN+AZA Triplet Frontline Therapy for Newly Diagnosed AML Follow patients for durability (mOS) Patient Accrual Q3 $10M Advance from Hanmi $8M Financing Hanmi - Aptose Planned Collaboration NCI CRADA Data Sharing for Potential Pharma Partnership as Activity and Durability Data are Collected
17 APTO Nasdaq Market Summary • Market Cap $14M • 52 - Week range $0.13 to $2.60 • Avg Volume 6.6 million shares Investment Thesis: Multiple Clinical Data Forthcoming and Hanmi Collaboration Derisks Investment 17 2024 Financing Activity • $10M Hanmi Advance (Debt) Aug. 2024 • $8M Financing Nov. 2024 • $4.4M HCW – Armistice June 2024 o Dec 2024 all remaining C/S sold Capital Structure • Common Shares O/S 60,181,183 • Warrants 37,886,491 o Strike price range $0.22 to $2.14 o Weighted average $0.76 • $10M Debt o Forgivable against upfront payment on Hanmi - Aptose Collaboration Value vs Opportunity: Recent BD Deals in AML Space Kura Oncology & Kyowa Kirin singed a $1.5B Global Collaboration to develop Ziftomenib Nov 2024
Investment Thesis Hanmi Collaboration Reduces Investment Risk • The Hanmi TUS collaboration (expected Q1/2025) will provide significant capital to fund the TUS Triplet Study • Hanmi's advance of $10M will be offset against the collaboration's upfront payment Proven Effectiveness of Frontline Triplet as Concept • Gilt triplet improves response rates (CR > 90%) • Gilt triplet improves the durability of responses • But, Gilt only applicable to FLT3 MUT and toxicities remain TUS Could Improve on Triplet Design • TUS has broad activity on both subtypes: • FLT3 MUT (30% of AML cases) • FLT3 WT (70% of AML cases) • KOLs support TUS as the ideal 3 rd agent for 1L triplet • Excellent safety profile • May minimize resistance to VEN (Venetoclax) 2024 Accomplishments √ Completed $10 million from Hanmi as Advance on Collaboration √ Completed $8 million S - 1 financing √ Executed validating NCI MyeloMATCH for tuspetinib in AML/MDS √ Initiated enrollment to TUS+VEN+AZA tri plet in newly diagnosed AML √ ASH: Reported CR/Safety from APTIVATE TUS and TUS+VEN trial √ ASH: Reported dosing accrual from TUS+VEN+AZA triplet trial 2025: 1H ‒ Hanmi/Aptose Collaboration expected Q1 - 2025 ‒ Enroll two dose cohorts in TUS+VEN+AZA triplet study ‒ Report CR/MRD/Safety data from TUS+VEN+AZA triplet study 2025: EHA ‒ Report maturing data readout from TUS+VEN+AZA triplet study 2025: ASH ‒ Select TUS dose for TUS+VEN+HMA triplet Ph 2/3 PIVOTAL trials ‒ Prepare for Ph 2 portion of Ph 2 / Ph 3 pivotal program Completed and 2025 Milestones 18
19 19 Aptose Disclosure This presentation does not, and is not intended to, constitute or form part of, and should not be construed as, an offer or i nvi tation for the sale or purchase of, or a solicitation of an offer to purchase, subscribe for or otherwise acquire, any securities, businesses and/or assets of any ent ity , nor shall it or any part of it be relied upon in connection with or act as any inducement to enter into any contract or commitment or investment decision whatsoever. This presentation contains forward - looking statements , which reflect APTOSE Biosciences Inc.’s (the “Company”) current expectations, estimates and projections regarding future events, including statements relating to our business strategy, our clinical development plans, our ability to obtain the substantial capital we require, our plans to secure strategic partnerships and to build our pipeline, our clinical trials and their projected timeli nes and milestones, the efficacy and toxicity of our product candidates, potential new intellectual property, our plans, objectives, expectations and intentions; and other st atements including words such as “anticipate”, “contemplate”, “continue”, “believe”, “plan”, “estimate”, “expect”, “intend”, “will”, “should”, “may”, and othe r s imilar expressions. Such statements constitute forward - looking statements within the meaning of securities laws. Although the Company believes that the views reflected in these forward - looking statements are reasonable, such statements invol ve significant risks and uncertainties, and undue reliance should not be placed on such statements. Certain material factors or assumptions are applie d i n making these forward - looking statements, and actual results may differ materially from those statements. Those factors and risks include, but are not limi ted to, our ability to raise the funds necessary to continue our operations, changing market conditions, the successful and timely completion of our clinical studie s i ncluding delays, the demonstration of safety and efficacy of our drug candidates, our ability to recruit patients, the establishment and maintenance of corporat e a lliances, the market potential of our product candidates, the impact of competitive products and pricing, new product development, changes in laws and regulations, un certainties related to the regulatory approval process and other risks detailed from time to time in the Company’s ongoing quarterly filings and annual rep orts. Forward - looking statements contained in this document represent views only as of the date hereof and are presented for the purpo se of assisting potential investors in understanding the Company’s business and may not be appropriate for other purposes. The Company does not undertake to upda te any forward - looking statements, whether written or oral, that may be made from time to time by or on its behalf, except as required under applica ble securities legislation. Investors should read the Company’s continuous disclosure documents available at EDGAR at www.sec.gov/edgar.shtml and SEDAR+ at www.sedarplus.com, especially the risk factors detailed therein.
Thank you 20
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Aptose Biosciences (NASDAQ:APTO)
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