Aptose Biosciences: Expansion Studies Could Rebuild Investor Interest In This Beaten-Down Biotech

Investing in early-stage biotechs is always risky and almost never easy, and that has certainly been true for Aptose Biosciences (NASDAQ:APTO). Investors have had to deal with unexpected issues tied to its former lead drug luxeptinib and a slow build of positive clinical data for its new lead drug tuspetinib (formerly HM43239, or "239"), and all this while the biotech market has been under pressure.

Heading toward the American Society of Hematology (or ASH) meeting in mid-December, Aptose has been building up its clinical dataset for tuspetinib, and so far this looks like a promising drug worth more than the sub-$70M market capitalization of Aptose as of this writing. Of course, there is still a lot that has to be proven in the clinic, but investors looking for a high-risk play on difficult-to-treat leukemia subtypes should take a closer look.

Follow the link to the full article: 

Aptose Biosciences: Expansion Studies Could Rebuild Investor Interest In This Beaten-Down Biotech

Aptose Biosciences Continues To Drift Without Thesis-Changing Data

It wouldn't be fair to say that there's been no clinical progress at Aptose Biosciences (NASDAQ:APTO) since my last update, but there certainly hasn't been enough to really sway investor sentiment, particularly in light of a more risk-averse biotech market. Aptose has two credible hematological oncology products in the pipeline, but there is a still lot of de-risking needed for both programs.

I do believe that the market is still heavily discounting the odds of clinical success here, but given the history of oncology drug development, and Aptose's own shaky clinical progress, that's not exactly unfair. I can still see a path toward a substantially higher fair value, but the reality is that investors are likely going to need to wait a year or more for sentiment-moving data.

Read more here: 

Aptose Biosciences Continues To Drift Without Thesis-Changing Data

Aptose Deep In The Doghouse Due To Lack Of Pipeline Progress

 

I’ve been bullish on Aptose Biosciences (APTO) for some time, but have also tried to make clear that I view this as an extremely risky play on potentially class-leading drugs for hematologic oncology. So far, that bullishness has not been rewarded at all, as disappointing clinical updates have led investors to abandon ship.

There’s no arguing that the lack of clinical responses in the studies of luxeptinib has been very disappointing, and even if a new formulation of the drug can unlock the potential seen in pre-clinical studies, this is absolutely a “show me” story. While there’s an argument that recently-acquired drug HM43239 (or “’239”) is getting unfairly overlooked as investors have bailed out, the reality is that biotech sentiment has turned sour and early-stage oncology plays are among the riskiest in the sector.

I wouldn’t fault anybody for taking their losses here and moving on, or at least stepping to the side until there are more data in hand. While it’s certainly true that getting in “at the ground floor” can lead to the best returns, there should still be plenty of upside for those investors who buy in further down the clinical investment timeline. Moreover, appealing as it might be to identify those ground floor opportunities, all too often in early-stage small-cap biotechs investors find that a sinkhole opens up below that ground floor.

 

Read more here: 

Aptose Deep In The Doghouse Due To Lack Of Pipeline Progress

Aptose: High Risk, High Reward. Watch Its Phase I Studies

 

Drug development requires time and patience, and that’s not something the Street has in particularly abundant supply. Aptose Biosciences (APTO) shares rocketed higher in late March on news of a complete response in a patient with relapsed/refractory acute myeloid leukemia (or r/r AML) in the Phase I luxeptinib study, but then were subsequently stomped after a disappointing update at the June European Hematology Association meeting showed no further confirmed responses.

So it goes with this very early-stage biotech, and there really wasn’t anything in the second quarter results and conference call that is likely to change sentiment in the near term. Management has its luxeptinib studies fully enrolled at the 750mg dose level (and is starting to move into 900mg) and continues to enroll for its APTO-253 study as well, but it’s going to take confirmed partial and complete (ideally) responses to rebuild confidence in these drugs and the stock.

The mid-December American Society of Hematology (or ASH) meeting will be an important one for the company, as investors are really going to need to see more evidence of efficacy. I continue to value Aptose with low odds of success (10% to 15%), but the potential for safe and effective drugs in AML and B-cell cancers (like CLL, MCL, and DLBCL) is still significant.

 

Read more here: 

Aptose: High Risk, High Reward. Watch Its Phase I Studies

Aptose Provides An Encouraging Update, But The Road Ahead Is Still Long

Now that’s more like it – after a clinical update at December’s American Society of Hematology (or ASH) meeting that offered more worries than encouragement (at least for the market), Aptose Biosciences (APTO) provided a clinical update with fourth quarter earnings that offered more encouragement on the safety and efficacy of the lead drug luxeptinib (formerly known as CG-806).

This remains a challenging and frustrating time to own Aptose shares, but also a time with significant potential ahead. While I do believe there is strong preclinical evidence of the potential of luxeptinib, proving out that potential in the clinic takes time and investors are left to sift through the dribs and drabs of information presented along the way. I do believe that the European Hematology Association meeting (or EHA) in June is probably too soon to see more definitive evidence of efficacy (or lack thereof), but investors should have a good idea of where luxeptinib stands before year-end with the 2021 ASH meeting.

I’m sticking with a $7/share fair value for now, but I want to emphasize again that this is based on pretty harsh odds of clinical success. Most Phase I drugs fail, and particularly in oncology, but if future updates provide better grounds for higher odds of success, there is still significant value to come.

Read more here: 

Aptose Provides An Encouraging Update, But The Road Ahead Is Still Long

Aptose Shares Look Undervalued Ahead Of Value-Driving Efficacy Data

It’s tough to hold early-stage biotechs through all the ups and downs of the market, and Aptose Biosciences (APTO) shareholders have had their patience tested lately, as the shares have fallen about 6% since early August (my last update) and were down roughly 25% from a recent plateau around $6 before a positive post-earnings bump. You could spend a lot of time debating and speculating on why the stock sold off (including funds repositioning ahead of the election), but the reality is that this is just sometimes what happens with early-stage biotechs.

As things stand now going into the American Society of Hematology meetings in early December (virtual meetings this year, of course), I see no reason to shift my view that Aptose has an intriguing, high-potential, but still very high-risk primary asset in CG-806 and an arguably unappreciated, but very high-risk asset in APTO-253. While there are preliminary signs of efficacy for CG-806, I believe it will take clear formal responses (partial responses or, ideally, complete responses) to really bring the spotlight onto this promising hematology asset.

To continue, click on the link below: 

Aptose Shares Look Undervalued Ahead Of Value-Driving Efficacy Data

Aptose Riding Higher As The Street Starts Paying Attention

In a relatively short span of time, Aptose (APTO) has gone from a little-known Canadian biotech toiling largely in obscurity to a promising name with wider sell-side coverage. That expanded interest isn’t unreasonable in my view, as promising (but very early) data have made an initial case that Aptose might really have something special with its pan-FLT3/pan-BTK inhibitor CG-806 for hematological cancers.

There remains a long road between commercial success and today, though, and while I do think Aptose has made a strong case for how and why CG-806 is meaningfully better than other options both on the market and in the clinic, the fields of biotech are littered with the bodies of once-promising companies whose therapies were going to change the standard of care, but didn’t come through with the clinical data when it really mattered. I believe these shares are still worth owning today, but investors need to appreciate the well above-average risks that go with investing in early-stage biotech.

Read more here:
Aptose Riding Higher As The Street Starts Paying Attention

Aptose Shoots Up As Investors Focus On Reversible BTK Inhibitors

I’ve written before that I consider Aptose Biosciences (APTO) to be a “speculation worth considering” on the strength of its two-drug pipeline for hematology, and between Merck’s (MRK) $2.7 billion bid for ArQule (ARQL) and encouraging early-stage data for the second-gen BTK inhibitor class at this past weekend’s ASH meeting, Aptose shares are having a great Monday – up about 30% as of this writing.

Is Monday’s move fair? As far as a one-day move after the ASH meeting and Merck’s bid, I would say it is probably an overreaction. Then again, this is a sparsely-followed early-stage biotech that I thought was trading meaningfully below its fair value (even incorporating the elevated risks), so more attention on the pipeline and some increased scarcity value for it should drive some upside. Even with this move, though, I still believe the shares trade at enough of a discount to fair value to be worth a look for investors who can take on the well-above average risks and odds of failure.

Click here for more:
Aptose Shoots Up As Investors Focus On Reversible BTK Inhibitors

Aptose Drifting Ahead Of Real Data From Its Intriguing Clinical Assets

I’ve tried to go to some lengths in the past to emphasize the risks that come with an investment in Aptose Biosciences (APTO) – a small biotech that has only recently seen its two lead compounds go into the clinic. Not only is there the ever-present risk of clinical trial failure (the large majority of Phase I cancer compounds fail) and the meaningful risk of further dilutive financing, but there’s a less-appreciated risk of investor sentiment (boredom, really), as biotechs can drift lower without positive data to keep investors engaged.

I continue to believe that, even with the risks involved, Aptose is a very interesting early-stage speculation. CG-806 could emerge as a hard-to-beat therapy option across a range of hematological cancers, while APTO-253 may prove to be the first effective drug targeting the “undruggable” MYC target, with potential applications outside of hematology.

Read more here:
Aptose Drifting Ahead Of Real Data From Its Intriguing Clinical Assets

Aptose Restarts Its Long Journey

Biotech investors have a lot to contend with just in terms of the risks that go along with novel drug development, but market sentiment is an often-overlooked component as well – one that can cause every bit as much frustration for investors. I was worried a few months ago that Aptose Biosciences (APTO) shares could be at the not-so-tender mercies of the volatile biotech market in the absence of real thesis-changing news, and the shares have continued to fall (another 30% or so) on what has been a generally worsening sentiment in biotech, and particularly for riskier names.

Aptose just announced the enrollment of the first patient in its restarted Phase Ib study of APTO-253, though, and the initiation of CG-806 studies should follow in 2019. Both drugs hold meaningful potential in hematological oncology, but both also face a very long road of clinical and commercial development; a road that swallows up the large majority of candidates. I do believe these shares are back at an interesting price, but will again re-emphasize that this is an early-stage biotech with well-above average risks.

Click here for more:
Aptose Restarts Its Long Journey

Aptose Now In 'Hurry Up And Wait' Mode

Drug development takes time, patience, and careful attention to detail, and if you follow biotech investor message threads, you’ll see that’s not exactly a perfect match between industry and its investors. While biotech investors want a steady stream of positive news and updates, the reality is that sometimes there will be dry patches as the companies do their work. Such may well be the case now for Aptose Biosciences (APTO).

These shares have pulled back about 40% from their post-ASCO peak, but without much in the way of real news. Aptose announced the expected lifting of the clinical hold on APTO-253, but since then I believe the shares have weakened on relatively weak prospects for meaningful incremental updates and worries that Aptose would raise substantial new capital. While second quarter results should put the capital-raising question temporarily to rest, investors need to accept that there likely won’t be a lot of news until later this year and into 2019.

Read more here:
Aptose Now In 'Hurry Up And Wait' Mode

Aptose Biosciences Back On Track In The Clinic

Canadian biotech Aptose Biosciences (APTO) has a lot of work ahead of it, as the company’s two lead drugs haven’t even completed Phase I testing yet. Even so, the preclinical efficacy and safety data on APTO-253 and CG’806 have looked quite encouraging, and I believe this is a highly speculative opportunity that continues to offer interesting upside. Now with the announcement that the FDA has lifted the clinical hold on APTO-253, Aptose is back on track to have at least one, and possibly two, promising compounds in the clinic before the end of 2018.

Continue here:
Aptose Biosciences Back On Track In The Clinic

Aptose Looking Toward Human Studies

I've tried to go to some length to be clear that Aptose Biosciences (NASDAQ:APTO) is a very high-risk biotech stock, and the company has continued to back up that notion. Management has not been able to resolve manufacturing issues with its promising cMyc-inhibitor APTO-253 and has shifted its focus to another preclinical candidate (CG'806), but progress toward human testing has remained frustratingly slow.

Aptose has been an interesting study in all of the “i's” that have to be dotted and “t's” that have to be crossed to get a drug from the lab and into human trials (let alone through trials and FDA and onto the market). Unfortunately, investors don't buy stocks to learn things and the shares have chopped along below $2 since my last update. I normally don't bother with preclinical biotechs, and I'm not really advising anybody else to either, but I remained intrigued by the strong preclinical signals of efficacy and safety of these two drugs. The odds are that the light at the end of the tunnel is an oncoming train (that's how it goes in biotech and that's not an Aptose-specific comment), but I can still argue for a value well above today's price.

Continue here:
Aptose Looking Toward Human Studies

Aptose Remains In Limbo

In a market that has turned unfriendly toward biotechs, Aptose Biosciences' (NASDAQ:APTO) ongoing execution issues and cash drain have become serious issues. It has taken over a year (and counting) to resolve a clinical hold on APTO-253, and that's an execution shortfall that the company can ill-afford given the progress other companies are making with clinical candidates for hematological cancers and the need for real clinical data to support further capital raises.

The good news is that the company appears to be close to a resolution of the clinical hold with APTO-253 and the resumption of Phase I testing. The other good news is that the company has added another interesting preclinical asset for its hematology pipeline. The bad news is that this is all about "potential" and potential is the one asset small biotechs never seem to lack. What's more, the company is going to need to raise capital and the share price weakness is going to increase the dilution.

It's hard to stay bullish on a biotech that has needed more than a year to reformulate a drug and resolve its clinical hold (when that is really the only value-driving asset the company has), and that's particularly true given the risk that Aptose may have to raise money with little-to-no human clinical data. There's still upside here; if APTO-253 and CG-806 work, they can redeem a lot of these issues down the road. But make no mistake - this is a highly speculative pick that is not so far removed from gambling.

Click here for more:
Aptose Remains In Limbo

Seeking Alpha: Aptose Needs To Get Moving

Certain risks are inherent to biotech; the fact that most clinical compounds fail in human testing being foremost among them. Small biotechs have additional challenges, including limited resources when it comes to driving site and trial enrollment and attending to other details. And then there are the "unforced errors" - mistakes and missteps that occur at companies of all sizes, but can hit smaller biotech companies much harder given their typical smaller cash balances and margins of error.

Aptose Biosciences (NASDAQ:APTO) hasn't done a lot since my last update on the company to inspire confidence. Slow progress with a key early-stage clinical study of APTO-253 can be forgiven as an inevitable part of the process, but the subsequent clinical hold due to mistakes that apparently tie back to prior management is not so easily forgiven.

I've cut my fair value estimate roughly in half, as I believe the breakdown in biotech valuations coupled with uncertainties and concerns about the clinical hold and trial progress with APTO-253 will make financing more expensive. I still believe there's a chance that APTO-253 proves to be a worthwhile drug, and the partnership with the Moffitt Cancer Center is interesting, but an already skittish biotech market is not going to be kind to a micro-cap biotech with one lead candidate in early-stage development and a trial that is not currently enrolling. I would note, though, that none of the issues affecting Aptose really speak to the quality or potential of the lead drug (APTO-253) and aggressive investors who can tolerate the volatility and risk shouldn't ignore the story solely for those other issues.

Read the full article here:
Aptose Needs To Get Moving

Seeking Alpha: Aptose Still Looks Like A High-Risk/Reward Call Option

For small biotechs not all that much changes for long stretches of time … and then things can change very quickly. Aptose Biosciences (NASDAQ:APTO) is moving ahead with its Phase Ib study of lead drug APTO-253, an oral KLF4 activator being developed as a possible treatment for hematological cancers including acute myeloid leukemia (or AML). Results from this study, which is testing the drug in other cancers beside AML, should be available late this year - most likely at the December ASH annual meeting. If the results show meaningful anti-cancer activity, I believe Aptose will become a more viable investment, even though the company is a long way from FDA approval and faces numerous challenges.

I continue to believe that $13 is a reasonable fair value for these shares on the assumption of 15% odds of success in AML and myelodysplastic syndromes (or MDS). If Aptose reports solid data, those approval odds can improve over time (improving the fair value), but likewise there is a very real risk of a total wipeout here - the more typical fate for most biotech investments.

Read more here:
Aptose Still Looks Like A High-Risk/Reward Call Option

Seeking Alpha: Tiny Aptose Biosciences Looks Worth A Closer Look

Right off the bat, Aptose Biosciences (NASDAQ:APTO) triggers a few warning signals. The company has been around a long time (since 1986), has had two name changes, and really hasn't accomplished much of anything. Now this biotech is targeting one of the more under-served areas of oncology and one that has seen many flame-outs (most recently Cyclacel (NASDAQ:CYCC). Coupled with a sub-$100 million market cap and a recent reverse stock split, a lot of the "beware of" biotech boxes are already checked.

One of the most dangerous phrases in investing is "it's different this time", but perhaps in the case of Aptose that is true. This company cleaned house a while back and brought in credible new senior management, naming the founder of Achillion (NASDAQ:ACHN) as its new CEO. The company also raised money and listed itself on the NASDAQ. Most importantly, though, the company has a drug in its pipeline that at least appears to have a credible mechanism of action in treating acute myeloid leukemia - a relatively common type of leukemia, but one that often has poor expected survival outcomes.

Continue reading here:
Tiny Aptose Biosciences Looks Worth A Closer Look