Aptose Biosciences Inc (APTO)

[kojak007]

Hi tartia. I sent you a message on the tcon board: Hi Tartia,
I have no idea how this is possible. I guess its dead now. What do you think?

[dcaf7]

20% probability of success
Published 03/27/2024, 05:28 PM
On Wednesday, Jones Trading adjusted its outlook on Aptose Biosciences (NASDAQ:APTO), lowering the price target to $5 from the previous $12, while maintaining a Buy rating on the company's stock. The adjustment comes as Aptose Biosciences shifts its development focus towards a new drug combination for treating Acute Myeloid Leukemia (AML).

The firm highlighted that Aptose's immediate strategy will concentrate on a triplet combination therapy involving tuspetinib, venetoclax, and HMA for first-line AML treatment. A pilot study for this combination is slated to begin in the summer, with initial findings expected to be presented at the American Society of Hematology (ASH) conference.

Meanwhile, the development for relapsed/refractory AML has been paused to improve strategic positioning, with data to be shared at the European Hematology Association (EHA) 2024 conference.

Jones Trading noted that if Aptose demonstrates clear clinical benefits in the first-line setting, it may lead to enhanced business development opportunities as compared to the relapsed/refractory AML setting. Still, the firm also pointed out that a capital overhang is a significant pressure point for both the stock and its clinical development progress.

The company's current cash position stands at $18.6 million, which is expected to fund operations through August 2024. Jones Trading has updated its financial model to reflect the new strategic direction towards first-line AML treatment, estimating unadjusted peak sales of approximately $250 million, assuming a 20% probability of success and a 40% market penetration among patients unfit for intensive chemotherapy.

In light of these developments and other minor changes across the model, Jones Trading reiterated its Buy rating but reduced the price target for Aptose Biosciences to $5. The firm believes that despite the lowered target, the company's stock remains a positive investment opportunity.
https://www.investing.com/news/company-news/aptose-biosciences-target-cut-maintains-buy-rating-on-new-drug-development-93CH-3355850

[Zeppo]

Asking ourselves the obvious question, is APTO any closer to commercialization of product? My answer is NO, and I imagine yet another reverse split will be on the horizon in a year. Dilutions will take the stock below $1.00 again without any announcements of a stand-alone Phase 3 test anywhere......IMHO.

[dcaf7]

Not sure that increase in plasma concentration from 1 uM to 2-3 uM will help much. They don't report responses in 11 new AML patients they studied. Most disappointing is that they stopped developing Tus/Ven doublet as potentially registrational combination. They have good data with Flt3mut patients and now instead of working in this direction, they offer you to focus on triple combination project for which they don't have any preliminary data. A lousy strategy and Rice is a lousy leader.

[Tartiaboy]

I was very happy to see that Lux is still alive. I don't think Aptose has the resources to develop it at this time. It's a shame. They really squandered this opportunity. In any event it is news that will keep my interest in Aptose alive. I haven't listened to the cc yet. They still have a huge $ problem and I think Hanmi is calling the shots.

[dcaf7]

Here is what Bejar said at ASH in December, “Brisk patient enrollment in our APTIVATE trial has led to a fast-growing database that includes many more patients at various stages of treatment. We look forward to reporting our next set of data in the first quarter of 2024.” I think, it should happen at earing call. Last chance to impress investors?

[Monksdream]

APTO under $2

[Zardiw]

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[Tartiaboy]

I still hold a speculative position in TCON. I am expecting binary news before EOM. Out of 46 pts. they had 4 responses by BICR and 7 by Investigator review. It is right on the edge of meeting the target. If met I see $1+ immediately, it not perhaps 10 cents immediately. If you want to discuss, let's do so on the Ihub TCON board.

I am watching a painful demise here for APTO.

[kojak007]

Hi Tartia,
Are you still in TCON? I was thinking maybe they can actually indeed reach the 11.25% by BICR. Since beginning of 2023 thy are dosing with the double dose at 600. More data from that group could actually turn the needle. What do you think?
Greetings

[Monksdream]

APTO new 52 week lo

[Tartiaboy]

Unfortunately, I believe we have already seen a Hanmi takeover. They are just interested in TUS.

[spiderman3600]

I think our only hope is a Hamni takeover.

[Zeppo]

This is what happens after reverse splits when there is no perceived improvement to the business plan........let alone revenues

[Monksdream]

APTO new 52 week low

[Tartiaboy]

I have been rotating from APTO primarily into VINC over the past month. Also holding VSTM and ONCT.

[dcaf7]

Some thoughts on Rice.
Rice has an interesting career. “He served as Head of the Laboratory of Antiviral Drug Mechanisms and Manager of the HIV Clinical Interface Laboratory for the National Cancer Institute (NCI), National Institutes of Health from 1992 to 1998. In this position, Dr. Rice directed the activities of several projects targeting new ways to treat HIV and other infectious diseases. From 1989 to 1992, he was professor of Pediatric Hematology and Oncology at Emory University School of Medicine, where he built a program to identify new molecular structures as antiviral targets”. So, he was in hematology/oncology, but it was not related to oncology. Then, from Aug 1998 to Aug 2003 he worked as a CEO of Achillion Pharmaceuticals, an anti-infective pharmaceutical company. Under his leadership no drug was approved. From 2003 to 2013 he served as a CEO of Cylene Pharmaceuticals. The company was working on oral CK2 protein kinase inhibitor, CX-4945, in patients with advanced solid tumors, or multiple myeloma. This drug is still in clinical trials, not even close to FDA approval. Their second drug was Quarfloxin, a selective binder for MYC GQ structure. Is it related to APTO-253? Anyway, later quarfloxin was discarded due to its poor bioavailability. Isn’t it a familiar theme? And from 2013 to the present, Rice has been a CEO of Lorus/Aptose Biosciences. The result of his work as a leader of Aptose is two failed drugs, APTO-253 and Luxeptinib. Point is that during his very long career in biotech industry as a CEO, Rice was not able to bring any drug to the market. I hope Tuspetinib is his last chance.

[dcaf7]

Would you like to share your greener pastures?

[Tartiaboy]

Hello All. I have not posted here in a while but have continued to follow the discussions. As always, thank you Decaf for the information you share.

After serious deliberation I decided it was time to begin liquidating my APTO shares. I have been selling for the past month. There is no ONE reason. It is a cumulation of factors. I feel that Rice has lost his credibility and APTO will struggle for the foreseeable future. I will continue to monitor and may buy back shares at a later date.
On to greener pasteurs.

[spiderman3600]

Thanks decaf. Sounds like a good backup plan.

[dcaf7]

In recently posted Hanmi 2024 1Q IR presentation, you can see Tuspetinib data on slide 18. Nothing new there but you have an impression that it is their own data. If Aptose needs a partner to start triplet in 1st line patients, Hanmi would be the best candidate.
https://www.hanmipharm.com/file/admin/ir/1707107587558.pdf

[Wolverine3]

I agree and yes I still own shares (unfortunately).

[spiderman3600]

Hamni seems to have confidence in the drug. They can’t do any worse. Do you still own any shares? tia

[Wolverine3]

No, it is not a solid backup plan. This company is a disaster, totally mismanged rersources and did not execute on the drugs they have or had.

[spiderman3600]

Thanks decaf. Sounds like a solid backup plan. Hanmi definitely has the resources to finish the job.

[dcaf7]

It looks like Aptose can replace their curent employees with Koreans and Hanmi will pay them salary, bonuses etc. Is it a kind of takeover? Let's start from Rice.

[dcaf7]

From latest 8-K. Very interesting. What is a Hanmi's purpose?
"Hanmi will have the right to designate for employment one or more individuals that are legally able to work in the United States or Canada (each, an “Hanmi Nominee”) to a position or positions within Aptose in applicable areas based on each Hanmi Nominee’s skills, education and experience. The parties agreed that the Hanmi Nominee shall be subject to Aptose’s usual employment rules, practices, policies, evaluation procedures, as amended from time to time and Aptose shall retain the right, in its sole discretion, to terminate such Hanmi Nominee’s appointment with Aptose for violations of Aptose’s employment rules, practices, policies and procedures. The parties also agreed that the Hanmi Nominee shall be entitled to salary, bonus, vacation, incentive payments and bonuses, expenses, allowances and any applicable benefits in amounts and to the extent consistent with employees of Aptose serving or having recently served in a similar capacity with Aptose with such amounts to be reimbursed to Aptose by Hanmi. In the event that a visa or other permit is required to be obtained to permit the Hanmi Nominee to work in the United States or Canada the parties agreed that Aptose would use its commercially reasonable efforts to assist the Hanmi Nominee with obtaining such visa or permit. The parties agreed that upon the nomination of the Hanmi Nominee that the parties would enter into a separate service agreement to outline the specific terms and conditions of the Hanmi Nominee’s appointment".

[Zeppo]

Is anyone surprised? The company has a perpetual green light to nowhere.

[Monksdream]

APTO new 52 week low

[Wolverine3]

What a piece of crap company. Total loss!

[dcaf7]

On page 7 under Key findings: "We are seeking a collaboration partner to study TUS as part of a TUS/VEN/HMA triplet in 1L newly diagnosed AML patients unfit for chemotherapy with or without FLT3 mutations".

[spiderman3600]

How about a salary cut!?!?

[dcaf7]

"We expect to revise our current development as follows. Assuming the net proceeds from this offering and our existing cash, cash equivalents and short-term investments, a net proceeds from the concurrent private placement offering, a committed equity facility, and ATM we plan to, (i) complete our ongoing APTIVATE clinical trial studying TUS and TUS/VEN, (ii) pause enrollment in the LUX G3 study and (iii) evaluate other costs reductions in general and administrative expenses."
Not a word about registrational trial?

[Wolverine3]

Thanks

[dcaf7]

A short video with Akriti Jain, MD, describing Tuspetinib data. She is particularly excited about effect of Tusp in Flt3mut patients.
https://www.healio.com/news/hematology-oncology/20240118/video-promising-monotherapy-treatment-for-challenging-to-treat-aml

[dcaf7]

From 3rdQ earning call, "Extension into HR-MDS and CMML planned: 4Q2023". Will they announce it today or tomorrow?

[dcaf7]

December corporate presentation posted. Most important info is on slide 26, "$10M financing combined with the $4M 2nd tranche from Hanmi extends cash runway to the end of Q3/2024 and delivers data from TUS/VEN Doublet in AML by 2Q/2024". This slide shows that they are still planning to initiate an MDS trial in 2023. Good luck. They have three days left to accomplish it. And of course, a delay. Now TUS/VEN/HMA triplet pilot arm for 1L AML will start in 2ndQ24. In ESH presentation, it was end of 2023. Slide 5 shows CR rate for patients with prior-VEN failures demonstrated in other studies. In one study, it was 15%, almost same as for TUS/VEN combination in Flt3 WT patients. It is important, since they need to establish and negotiate with FDA a certain CR rate to beat in pivotal study.

[dcaf7]

I don't know. My guess is G3 formulation is not good enough. Otherwise they would deliver good news.

[Wolverine3]

I know LUX is dead, but do you know the reasoning? Is there a clinical hold or just just lack of efficacy?

[dcaf7]

Lux AML study is not recruiting.

[dcaf7]

Possibly, but the answer is nobody knows. Discussing a possibility of a single arm Tus/Ven study at ESH, Rice said that we need to search contemporary publications to establish what a control arm looks like. Merry Christmas to you too!

[nferna]

What about this S1, is that not ugly?

Expected to be ugly of course, but goes to show that all other avenues were a no go

[Wolverine3]

I will take it, thanks

[spiderman3600]

Thanks decaf! In your opinion, are these results better then anything else that’s available? tia. Merry Christmas!

[dcaf7]

You want something positive? Swimmer plot on slide 13 shows an additional CRi detected in last minute before presentation and not included in previous slides. It will increase a CRc rate to 10/36 or 28% in all Tus/Ven patients and to 4/19 or 22% in Flt3 WT Ven R/R patients. And they were able to send one patient to HSCT. Looks like Daver made these changes and Aptose didn't catch it.

[Wolverine3]

Ooh, once again put in my place. That is why we listen to the PHD’s on this board. I guess data is once again not good enough to draw a meaningful partnership.

[dcaf7]

Not so shiny to me. Almost the same data was presented at ESH. And as I can see in ESH presentation, CRc rate for Tus/Ven doublet was 9/31 or 29% for all patients. At ASH, it is 9/36 or 25%. So, no new responses. It is kind of in line with our ASH expectations from Aptose. As for efficacy in different patient populations, Flt3 WT with Ven exposure doesn’t look good. CRc rate of 16% is low. Don’t think that FDA will be excited. On the other hand, for Flt3mut patients CRc rate is 30%. To me it means that in AML Tus is a Flt3 inhibitor in first place and other kinases inhibitor in second. My guess is they need to focus on Flt3mut patients with a doublet. Possibly, Flt3 WT population is OK but not for Ven R/R patients. And it is clear why their best option is to run a Tus/Ven/HMA triplet study in first line.

[Wolverine3]

Data looks pretty shiny, even to this non PHD. Decaf?

[spiderman3600]

Why would they sell stock if great news was coming out this weekend?

[dcaf7]

They had it in last few years at both ASH and EHA.