239 What Does It Mean-? AND WHY IS LUX NOT HAPPY?
Dr. William Rice
Thank you, Stoney, I’d like to welcome everyone to our call for the third quarter ended September 30, 2021. Today, I want to spotlight the actions we’ve taken during the past quarter and over the entire year to build value in Aptose. Our company focused on the effective treatment of hematologic malignancies and a company with expertise in kinase inhibitors, and with an expanded team to develop them.
This includes a look at our newest program, HM43239 or just 239, an oral once-daily myeloid kinome inhibitor that already has delivered multiple complete responses and a broad spectrum of AML patients. And for which just last week, we announced an exclusive global license agreement with the Hanmi Pharmaceutical Company.
We also will provide an update on luxeptinib or just Lux, our oral highly potent, non-covalent kinase inhibitor, with dual activity as a myeloid kinome inhibitor and a lymphoid kinome inhibitor. And we will address what this latest transaction with 239 means for Lux.
From an investment in catalyst thesis, 239 added a more advanced derisk asset with proven clinical activity to our portfolio, a molecule that dramatically increases the probability of success for our therapeutic pipeline. And we believe this deal increases significantly the overall value of Aptose by any rational measure.
239 is not a sudden revelation to us. As a matter of course, in our proactive business development efforts and our team focus, we continue to evaluate many compounds, even molecules at very early stages, as evidenced by our agreement with CrystalGenomics for Lux.
We developed a relationship with the Hanmi team some time ago and all the while we’ve been watching 239 and moving toward a partnership as a clinical validation data began to emerge over the past 12 months.
Indeed, 239 entered the clinic for the treatment of AML patients a year earlier than did our other kinase inhibitor Lux. And in that time, 239 has achieved multiple complete responses or CRs with a favorable safety profile. This is an effective and well tolerated drug that already has changed the lives of critically ill AML patients, harboring adverse mutation profiles that render them non-responsive to other drugs. So, 239 fits exactly into the type of agent that defines our goals at Aptose.
The timing of this deal was driven by the emerging clinical data with 239, as was illustrated in the ASH abstract released last week and the emerging competitiveness for this program. And I want to recognize Dr. Marango for orchestrating and negotiating the deal.
We’re thrilled to take the reigns for the development of this clinically proven agent as an addition to our evolving pipeline and to move rapidly through the next steps of development. As a complementary addition to Lux, 239 strengthens Aptoses ability to treat a wider spectrum of AML patients.
So how does this deal for 239 impact Lux? To be clear, 239 is an addition to our pipeline. It is not a replacement for Lux. Lux stands on its own merits and we intend to develop Lux to its full capacity. Lux is being tested in relapsed/refractory AML patients, where it already has achieved a complete response and in highly relapsed or refractory B-cell malignancy patients, where we have begun to see consistent signs of anti-tumor activity.
Some of you bluntly have asked, if we believe that Lux will be active in AML patients, then why did we in licensed 239? The short answer is, we want to own this therapeutic space and adding 239 to our pipeline, along with Lux is an important step toward that vision.
The longer answer is, it’s because AML represents a collection of many forms of acute leukemia and not one single disease, because AML is so mutationally diverse. No one agent can fully cover the range of all oncogenic drivers in all AML patients and we’re focused on treating the patients rather than merely treating a target. As we’ve said in the past, there’s room for many agents in the treatment of AML.
/ / / / /
Last week, we distributed the press release on the ASH abstracts that were accepted for presentation in December, which include an oral presentation on clinical results for agent 4239 and poster presentations on Lux and B-cell malignancies and an AML, as well as a poster on APTO-253 our MYC expression.
Because of submission cutoff dates, the Lux abstracts in particular were largely based on previously announced data. The actual posters will contain some incremental data and our plan corporate event will bring you up-to-date on our more recent data and all of our ongoing studies.....
Hummmmmmmmmmm>
Lets check the cash here-
First, a quick summary of the key terms of the licensing agreement for 239, for exclusive global rights to 239 for all indications, Hanmi will receive an upfront payment totaling $12.5 million, which will include $5 million in cash and the rest in Aptose shares.
Hanmi will also receive up to $407.5 million in future milestone payments, contingent upon the achievement of certain clinical, regulatory and sales milestones across several potential indications, as well as tiered royalties on net sales.
YIKES! >>>>
We ended the third quarter with approximately $95 million in cash, cash equivalents and investments. During the quarter, we utilized approximately $8.1 million in operating activities,
This is a tricky one.... I would say the prospects are VERY good for this 238 which they paid so much for...// Certainly in Dec we want to be around this idea as the abstract is presented...
This is one of the better $3 ideas.>
