On May 10,2018 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ:APTO) (TSX:APS), a clinical-stage company developing highly differentiated therapeutics that target the underlying mechanisms of cancer, reported financial results for the three months ended March 31, 2018 and reported on corporate developments (Press release, Aptose Biosciences, MAY 10, 2018, View Source;p=RssLanding&cat=news&id=2348536 [SID1234526465]). Unless specified otherwise, all amounts are in US dollars.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The net loss for the quarter ended March 31, 2018 was $6.8 million ($0.23 per share) compared with $3.3 million ($0.19 per share) in the quarter ended March 31, 2017 and total cash used in operating activities was $4.1 million compared with $2.7 million in the quarter ended March 31, 2018. Total cash and cash equivalents and investments as of March 31, 2018 were $16.2 million (which, based on current operations, provide the Company with sufficient resources to fund research and development and operations into Q2 2019). In the quarter ended March 31, 2018, Aptose raised $8.9 million from the Common Shares Purchase Agreement with Aspire Capital and subsequent to March 31, we raised a further $6.1 million with Aspire Capital under this same agreement.
"CG-806, our highly potent non-covalent pan-FLT3/pan-BTK inhibitor, continues on track with IND-enabling studies," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer. "In parallel, new preclinical data on CG-806 presented at AACR (Free AACR Whitepaper) demonstrate its breadth and potency of activity against patient-derived AML and CLL cells and superiority to other kinase inhibitors. For our clinical-stage compound APTO-253, we made notable progress in manufacturing and qualification studies required to return the new drug product to the clinic. We also presented new mechanistic data for APTO-253 at AACR (Free AACR Whitepaper), demonstrating heightened sensitivity of BRCA1 or BRCA2 mutated cancer cells to APTO-253 and opening the door to genetically-defined solid tumor indications for the molecule."
Corporate Highlights
CG-806 preclinical data presented at AACR (Free AACR Whitepaper) – At the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Conference held in April, researchers from Oregon Health & Science University (OHSU) Knight Cancer Institute and Aptose presented preclinical data demonstrating that CG-806, a highly potent pan-FLT3/pan-BTK inhibitor, kills malignant cells in samples freshly collected from patients with various hematologic malignancies and demonstrates superiority to other kinase inhibitors. CG-806 was shown to have greater potency against a broader set of AML samples relative to other FLT3 inhibitors, including midostaurin, gilteritinib, quizartinib, sorafenib, crenolanib, and dovitinib. Separately, CG-806 was also shown to have greater potency and range of activity than ibrutinib on patient-derived CLL samples.
An additional study presented by Aptose explored the potency of CG-806 in hematologic malignancies relative to other FLT3 or BTK inhibitors commercialized or in development. CG-806 induced apoptosis through inhibition of key multiple signaling pathways that were specific to each sample of AML or B-cell cancer cells. CG-806 was also superior to other FLT3 inhibitors against FLT3-wild type (WT) AML cells, as well as AML cells housing various mutant forms of FLT3. Collectively, the data demonstrated the ability of CG-806 to target all WT and mutant forms of FLT3 and BTK and to inhibit multiple signaling pathways, producing killing of diverse subtypes of hematologic malignancies driven by different genomic aberrations.
New mechanistic data on APTO-253 presented at AACR (Free AACR Whitepaper) – Also at AACR (Free AACR Whitepaper), the Aptose research team presented data showing that APTO-253 stabilizes a G-quadruplex DNA structure in the MYC gene promoter, leading to suppression of MYC expression and induction of programmed cell death in AML cells. The action of APTO-253 on separate G-quadruplexes induces the DNA damage response in cancer cells and exhibits synthetic lethality comparable to olaparib – an FDA-approved targeted therapy that acts against cancers in people with hereditary BRCA1 or BRCA1 mutations, including some ovarian, breast and prostate cancers – albeit through a different mechanism. Unlike other drugs for which loss of this DNA repair function results in hypersensitivity, APTO-253 does not produce myelosuppression, even at the maximum tolerated dose. These findings open the window to how APTO-253 might be used clinically to treat certain solid tumor patients with tumors harboring deficiencies in DNA repair.
Completed manufacture of APTO-253 cGMP clinical supply – The Company completed the manufacture of the cGMP clinical supply that will be required for the potential return of APTO-253 to the clinic, and the new clinical supply has completed and passed stability, sterility, mock infusion, animal bridging and blood compatibility studies. Aptose plans to submit these findings to the FDA during the 2nd Quarter of 2018 to seek release of the CMC-related clinical hold and allow return of APTO-253 to dosing in the open Phase 1b trial in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
CG-806 pre-IND progress – Aptose successfully manufactured CG-806 drug substance and formulated drug product, and then performed animal dose range finding preclinical studies in rodents and dogs, and successfully dosed up to 1000 mg/kg/day, the maximum feasible dose. The Company is currently manufacturing a drug batch that will be used for IND-enabling GLP animal toxicology studies that are planned to begin during the 2nd quarter of 2018.
Appointment of New Board Member – In April, Aptose announced the appointment of Caroline M. Loewy to its Board of Directors. Ms. Loewy is an accomplished and respected executive leader with more than 25 years of experience in accelerating biotechnology product development and growth. She currently provides strategic advisory services to life science companies on a variety of high-impact matters including funding strategies, product pipeline evaluation, and assessing business development opportunities. Prior, she held numerous executive roles, including that of Chief Financial Officer at several public and private biopharmaceutical companies, and senior biotechnology research analyst at Morgan Stanley and Prudential Securities. Aptose’s Board of Directors now includes seven members with extensive biotechnology and pharmaceutical experience.
Early Exercise of Option for CG-806 License – In May, Aptose exercised its option under the 2016 Option Agreement to exclusively license CG-806 from CrystalGenomics, Inc. With the early exercise of the option, Aptose owns global rights to develop and commercialize CG-806 for all indications outside of Korea and China – the Licensed Territory. The exercise triggered a payment of $2.0 million to CrystalGenomics, and CrystalGenomics is eligible for regulatory and sales milestone payments, as well as royalties on product sales in the Licensed Territory.
New Base Shelf Prospectus Filing and New At-The-Market Facility – As previously announced in February, Aptose filed a new Base Shelf Prospectus in Canada, and a registration statement with the SEC, which allows the Company to offer up to $100,000,000 of common shares, warrants to purchase common shares or units comprised of one or more of these securities, for a period of 25 months. This provides Aptose with flexibility to raise capital to fund operations, R&D and potential upcoming clinical trials. Subsequently in March, Aptose entered into a new At-The-Market (ATM) Facility to replace the ATM Facility that expired in December 2017.