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by: Jonathan Faison
Jonathan Faison
Long only, biotech, event-driven
Marketplace
ROTY
( 11,006 followers)

Summary

The stock has risen substantially since my initial article and subsequent update pieces.

I provide a recap of the bullish thesis and recent events.

Initial data for reversible BTK inhibitor ARQ 531 has shown promise.

AKT inhibitor miransertib in certain oncology and rare disease indications will increasingly garner attention in the second half of the year.

I expect further upside into the end of 2018 and beyond.

Shares of ArQule () have risen by over 550% since I published my initial article advising readers that there were ¨several ways to win here¨. Shares have increased by around 290% since my latest update piece was published in which I stated that the stock was presenting investors with an enticing risk/reward setup into AACR.

Chart

Figure 1:

Figure 2:

When looking at charts, clarity often comes from taking a look at distinct time frames in order to determine important technical levels to get a feel for what's going on. In the first chart (daily advanced), we can see a steady run up which accelerated in recent months as the stock price continues to achieve new highs with little in the way of resistance. In the second chart (15-minute), we can see significant volume and positive price action as the share price breaks out yet again. This move appears sustainable with further upside ahead.

Overview

In the FAAERD Christmas Darlings Dachshunds Womens Breathable Mesh Big Air Cushion Sport Shoes Running Shoes marketable cheap price outlet low shipping fee KaZq7r
, we search for stocks that are attractive across multiple time frames with potential for high percentage upside within the near to medium term.

Figure 3:

Figure 4:

In the case of ArQule, keys to the bullish thesis included the following:

Despite substantial appreciation realized so far, I still believe the stock´s run-up is far from over.

Recent Developments

After my last update, in mid-April the company huge surprise cheap price release dates cheap online NIKE Mens Free Trainer 30 V4 Training Shoe Black/Radiant Emeraldmdm Olivewhite sale shopping online low cost cheap online Oqgfr
it´d entered into a licensing agreement with Basilea Pharmaceutica to develop and commercialize derazantinib in the US, EU, Japan and rest of the world (except China-region). ArQule received $10 million upfront and remains eligible for $326 million in milestones plus staggered single-digit to double-digit royalties on net sales when commercialized. Additionally, it´s worth noting that Basilea plans to continue the current trial in intrahepatic cholangiocarcinoma plus explore the drug candidate in other tumor settings with FGFR dysregulation.

Around the same time at AACR data was presented highlighting favorable bioavailability and pharmacokinetics from an early stage study. In its fourth quarter update competitor Sunesis Pharmaceuticals () reported a clinical setback with its candidate vecabrutinib, which further aided ArQule in reaching front-runner status. Also at AACR AKT inhibitor miransertib showed intriguing activity in patients with hormone- sensitive tumors with AKT1 or PI3K dysregulation (presented in an oral presentation) in which there was one complete responder and three patients with partial responses (total n=8).

In late May a significant green flag was identified in the form of key executive appointments with Dr. Marc Schegerin joining as senior vice president of corporate strategy, communication and finance and Dr. Shirish Hirani appointed as senior vice president of program management and product planning. The former served prior at Sage Therapeutics and Biogen, while the latter last served in the capacity of vice president of drug development at ARIAD Pharmaceuticals (acquired for $5.2 billion).

Lastly, in June at the 23rd Congress of European Hematological Association (EHA) the company presented early data from its phase 1 dose escalation study for ARQ 531 in patients with relapsed or refractory hematologic malignancies.

The trial has an open-label, single arm 3+3 design with the first 3 cohorts being treated at 5 mg, 10 mg, and 15 mg. Patients included consisted of those with relapsed or refractory chronic lymphocytic leukemia (CLL), small lymphocytic leukemia (SLL), Waldenstrom’s macroglobinemia and B-cell Non-Hodgkin lymphoma. While there´s a caveat for the low number of patients, tumor reduction of 35%, 33% and 29% for the three dose levels, respectively, was quite promising including a patient with the BTK C481S-mutation, after 5 prior systemic regimens including ibrutinib and venetoclax, for whom treatment was still ongoing (4 of 11 patients were still on treatment at the time of analysis). Importantly, there were no dose limiting toxicities or Grade 3 or greater adverse events and the maximum tolerated dose was not reached. Also of note, the 22 to 27 hour half-life supports a once-daily dosing regimen and early PK showed dose-proportional increases in exposure.

Chief Medical Officer and Head of Research and Development, Brian Schwartz, M.D., had the following remarks to add (my emphasis in bold):

Other Information

For the first quarter of 2018, the company reported cash and equivalents of $42.8 million while net loss came in at $6.5 million. Research and development expenses rose to $5.8 million. After the license agreement with Basilea management is guiding for a year end cash balance of between $40 to $42 million and full year revenue to total between $14 and $17 million.

As for future catalysts of note, later in the year investors can look forward to updated data from the phase 1a/b study evaluating BTK asset ARQ 531 to be presented at a major medical meeting. I also look forward to updated results for miransertib in patients with hormone-sensitive tumors with AKT1 or PI3K dysregulation as well as in patients with Proteus syndrome.

Figure 5:

Initial activity for next-generation AKT inhibitor ARQ 751 in solid tumor with specific genetic alterations (AKT/PI3K/PTEN) adds another value driver into the mix.

I want to remind readers that if the company can prove that ARQ 531 is a best-in-class BTK inhibitor, it is addressing a substantial patient population (has progressed due to C481S mutation) that could translate into a large market opportunity (potentially even blockbuster). Additionally, the market opportunity for miransertib was thought to be smaller due to the rarity of Proteus syndrome, but the phase 2 study in other overgrowth diseases could expand the addressable population from a few hundred patients to over 1,000.

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, Biotechnology Value Fund continues to hold a very large position. DAFNA Capital Management, NEA Management Company and others hold significant stakes as well.

Final Thoughts

To conclude, in hindsight this is a position I should have kept in ROTY for far longer than I did. A weakness I´m trying to work on is showing more patience with winners where the thesis is on track (and especially when surpassing expectations and prior projections).

For readers who´ve established positions since my original articles and done well here, I suggest taking partial profits while continuing to hold for additional upside. For those new to the story and who have done their due diligence, accumulating on dips appears to be the logical course of action.

Risks include disappointing data later in the year or setbacks in the clinic, especially for ARQ 531 and miransertib. Competition (ie. data from Sunesis Pharmaceuticals´ vecabrutinib), safety signals, regulatory setbacks and dilution via another financing are all possible areas of concern as well.

Author's note:

While returns so far are attractive, what's more important is the experience of each ROTY member ( see recent reviews ).

I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Editor's Note: This article covers one or more stocks trading at less than $1 per share and/or with less than a $100 million market cap. Please be aware of the risks associated with these stocks.

Preliminary data from our Phase 1 dose escalation trial highlights the potential of ARQ 531 to become a new therapeutic option for patients with B-cell malignancies . There is a significant unmet need for patients with relapsed or refractory B-cell malignancies, in particular those with C481S-mediated resistance to irreversible BTK inhibitors such as ibrutinib . We are especially encouraged by the early signs of anti-tumor activity observed in the first three cohorts.

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Rob Strauber is a Nationally Certified Intervention Professional, ARISE Invitational Interventionist and Certified Recovery Specialist

Rob Strauber is a Nationally Certified Intervention Professional, ARISE Invitational Interventionist and Certified Recovery Specialist. As a person in long term recovery, Rob has witnessed first-hand the devastation that Substance Use Disorder can bring to the individual and their families. Rob works at Recovery Centers of America as an interventionist, family change agent, and an advocate for recovery. The need for a professional to help guide a family through a process of intervention, education and recovery can be very valuable by getting ahead of the addiction and helping the afflicted individual access treatment often times before they are actually “ready” or “hit bottom”. Rob has performed over 350 interventions to date.

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She has effectively taken her and her families dark past of substance use disorder and utilized that past to benefit others, through education, intervention and advocating for this still misunderstood disorder. Her passion found her.

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April 24, 2018 at 3:11 pm

Hello again Amy – I’m not a physician (I have to keep saying that just to reinforce the reality that I’m not actually a “qualified person to consult!”)

But it is entirely possible that costochondritis could make sense as a diagnosis. Please read this blog post about costo , and make sure you watch the two videos there by Steve August , a physiotherapist in New Zealand (where costo is widely treated successfully by physiotherapists, not physicians with antibiotics). One hint that it might be musculo-skeletal is if the pain can be reproduced by pushing on the chest…

Steve August

I think it’s worth a try to consider this possible diagnostic option.

Reply
Amy April 25, 2018 at 5:47 am

Thank you! I will start researching.

Reply
Sandra Sizer April 29, 2018 at 7:33 am

Amy, PLEASE research another cardiologist for a second [or third, if necessary] opinion.

Reply
Ankit Karma October 28, 2017 at 4:59 am

You provide me a great answer to my questions. Thanks for sharing this article.

Reply
Shar October 22, 2017 at 12:57 pm

I found that a very low carb diet reduced many of my symptoms. The inflammatory response from carbs is something to look at.

Reply
Carolyn Thomas October 22, 2017 at 3:25 pm

Hi Shar – I too have heard this. I’ve also read, however, that some studies show low-carb diets were associated with more damaging heart attacks than control groups, and may impair recovery immediately following a heart attack. For severe cases of refractory angina, it may be worth a (short-term) try to personally assess symptom management. Always best for MVD patients to check with their docs first…

Reply
Connie Crogal October 22, 2017 at 10:10 am

Great information. Thank you.

Can coronary microvascular disease be reversed if caught early? Can testing for microvascular disease be included as part of a regular checkup for women to diagnose it early and prevent further damage? Treating to reverse this serious heart disease early would be less expensive with no suffering and save countless lives in the process the way I see it.

Is a simple, non-invasive test available for that purpose for doctors at the General Practitioner level to use routinely for (early prevention) to help women who are underrepresented and under treated?

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