SA writeup on ARRY: Array BioPharma: Making The Transition To Commercial-Stage
Aug. 21, 2017 7:31 AM ET -- Jonathan Faison Summary
•Shares are trading flat year to date and the stock remains solidly in value territory, even in the absence of near-term drivers.
•Clinical trial collaborations with Merck and Bristol-Myers Squibb bode well for future development of binimetinib.
•Monetization of rights in Japan and Korea was merely the next step in management's successful plan to partner rights for territories outside the United States.
•Data to be presented at ESMO in September is an important catalyst, while the company's multi-asset pipeline should not be overlooked.
•Risks to thesis include disappointing data for pivotal and early stage trials, clinical and regulatory setbacks, competition from other approved BRAF/MEK inhibitors and dilution in the medium term.
Shares of Array BioPharma (ARRY) are trading flat year to date. However, shares have more than doubled over the past three years.
Earlier this year in March the company's withdrawal of their New Drug Application for binimetinib in NRAS-mutant melanoma came as a disappointment to investors, as the FDA apparently did not find the clinical benefit demonstrated in the pivotal NEMO study to be sufficient to support approval. While the unlucky change of events was obviously a negative development, shares appeared oversold as the withdrawal did not affect chances of the drug candidate finding success as a treatment for BRAF melanoma (a much larger setting).
As the year progressed other positive signs pointed to continued upside in shares. The firm announced a clinical trial collaboration with Merck (NYSE:MRK) to investigate the combination of binimetinib with anti-PD-1 treatment Keytruda in metastatic colorectal cancer patients with microsatellite stable tumors. This came as a result of preclinical data suggesting that immune activity of the latter could be enhanced when combined with a MEK inhibitor, with the hypothesis in this case to be tested with binimetinib. As if that weren't enough, Array announced another clinical research collaboration, this time with Bristol-Myers Squibb (NYSE:BMY), to investigate the combination of binimetinib with Opdivo (and Opdivo+Yervoy) as a potential treatment for metastatic colorectal cancer in patients with microsatellite stable tumors. Results from this phase 1/2 trial would be utilized to determine next steps for clinical development of the combinations, with the two companies jointly supporting the study.
Array was able to monetize rights in Japan and South Korea by licensing both of its late stage drug candidates to Ono Pharmaceutical in exchange for $31.6 million upfront and an additional $156 million in potential milestone payments (not to mention double-digit royalties).
While Array's July-inked deal with Amgen (AMGN) might not have brought in much cash, the agreement to discover and develop drugs for autoimmune disorders is another noteworthy partnering success that lends credibility to the name. Amgen will take care of clinical development, with upfront and milestone payments in addition to royalties on sales to be provided on any therapies that come as a result.
In early May Array released data from part 2 of its pivotal COLOMBUS study in patients with BRAF-mutant advanced, unresectable or metastatic melanoma. Median progression-free survival for patients treated with 45mg of binimetinib twice daily along with encorafenib 300mg was 12.9 months, which compared favorably to 9.2 months for patients treated solely with the latter drug. In July Array announced the submission of two New Drug Applications to the FDA to support use of the combination of binimetinib and encorafenib for the treatment of patients with BRAF-mutant advanced, unresectable or metastatic melanoma supported by strong data from the pivotal COLOMBUS trial. With treated patients experiencing significantly longer progression free survival compared to those receiving vemurafenib, management appears convinced the totality of the data provides a strong rationale for approval.
For the most recent quarter the company reported cash and equivalents of $235.1 million, compared to a fourth quarter net loss of $29.6 million. BEACON CRC phase 3 safety lead-in and COLUMBUS Phase 3 part 2 data to be presented at ESMO in September is an important near term catalyst.
While there may be an absence of near-term catalysts aside from ESMO data, considering the size of markets being targeted and management's partnering prowess, the stock appears to be trading in value territory. Consider that the global melanoma market for MEK/BRAF inhibitors is an opportunity in excess of $1 billion. Lastly, the company's vast pipeline and the potential to further monetize other assets should not be overlooked.
Readers looking for stocks with more near term upside might want to take a look at the ROTY model account, while those with a medium to long term time horizon could do well by establishing a pilot position in shares of Array.
Risks to thesis include disappointing data for pivotal and early stage trials, clinical setbacks and dilution in the medium term. Regulatory risk and competition with other approved BRAF/MEK inhibitors are also a key concern.
Author's note: My goal is to bring to readers' attention to undervalued stocks with catalysts that could propel shares higher, as well as provide a fresh perspective on stocks you may already be aware of. I also touch on planning trades and risk management, as those are two areas I feel are often neglected. If you found value in the above article, consider clicking the orange "follow" button and getting email alerts to receive my latest content. My sincere appreciation for readers who add value and join the discussion in the comments section, as well as those who share my work with others who could benefit from it.
Disclosure: 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.
ESMO abstracts go live Aug 31. LBA's on date of presentation.
SLNO (MC $18 M) BLOCKBUSTER in Phase 3 /Rare Disease & Orphan Status = REAL Unknown low float stock with 1000% upside Potential and more .Next billion dollar rare disease company like SRPT here .GLTA
Soleno therapeutics (SLNO)
Market Cap $18 Million Cash: $8 Million Price $0.37
Shares Out: 47.6 Million ( 36 Million shares held by Insiders & Institutions)
•Company expects to initiate pivotal Phase III clinical trial by year-end 2017; will take approximately 9-12 months to complete
Soleno Therapeutics, Inc. (Soleno) is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases. The company is currently advancing its lead candidate, DCCR, a once-daily oral tablet for the treatment of PWS, into a Phase III clinical development program at the end of 2017.
Market Opportunity for PWS is Substantial.
While the lack of approved treatments for PWS alone make it difficult to assess the market, sales of Pfizer’s (NYSE: PFE) Genotrop in (somatropin) can provide some insight despite being indicate for PWS, in addition to, growth failure due to growth hormone deficiency(GHD),Turner syndrome,idiopathic short stature,and small for gestational age.This product achieved its highest revenue in 2008,with worldwide sales of approximately $900 million.While somatropin has been proven to improve growth and body composition, it does not affect the key disease component of hyperphagia and use is associated with substantial risk. Soleno is developing DCCR for the treatment of PWS,to help address the unmet need of this patient population. To assess the potential of DCCR for PWS, we performed a scenario analysis, which indicates that annual sales could be in the range of $1.1 billion given a moderate price point and 50% market penetrance.
this new lawyer hire has some I'mpressive credentials including nda application thru to approval and mergers and aquisitions all with big pharma, lets hope he was brought in to finalize the deal!
Nice to see management putting their money where their mouth is.
BRAF inhibitors amplify the pro-apoptotic activity of MEK inhibitors by inducing ER stress in NRAS-mutant melanoma Heike Niessner, Tobias Sinnberg, Corinna Kosnopfel, Keiran S. M. Smalley, Daniela Beck, Christian Praetorius, Marion Mai, Stefan Beissert, Dagmar Kulms, Martin Schaller, Claus Garbe, Keith T. Flaherty, Dana Westphal, Ines Wanke and Friedegund Meier
ArticleFigures & DataInfo & Metrics PDF
NRAS mutations in malignant melanoma are associated with aggressive disease requiring rapid antitumor intervention, but there is no approved targeted therapy for this subset of patients. In clinical trials, the MEK inhibitor (MEKi) binimetinib displayed modest antitumor activity, making combinations a requisite. In a previous study, the BRAF inhibitor (BRAFi) vemurafenib was shown to induce endoplasmic reticulum (ER) stress that together with inhibition of the RAF-MEK-ERK (MAPK) pathway amplified its pro-apoptotic activity in BRAF-mutant melanoma. The present study investigated whether this effect might extent to NRAS-mutant melanoma, in which MAPK activation would be expected.
Experimental Design and results:
BRAFi increased pERK, but also significantly increased growth inhibition and apoptosis induced by the MEKi in monolayer, spheroids, organotypic and patient-derived tissue slice cultures of NRAS-mutant melanoma. BRAFi such as encorafenib induced an ER stress response via the PERK pathway, as detected by phosphorylation of eIF2α and upregulation of the ER stress-related factors ATF4, CHOP and NUPR1 and the pro-apoptotic protein PUMA. MEKi such as binimetinib induced the expression of the pro-apoptotic protein BIM and activation of the mitochondrial pathway of apoptosis, the latter of which was enhanced by combination with encorafenib. The increased apoptotic rates caused by the combination treatment were significantly reduced through siRNA knockdown of ATF4 and BIM, confirming its critical roles in this process.
The data presented herein encourage further advanced in vivo and clinical studies to evaluate MEKi in combination with ER stress inducing BRAFi as a strategy to treat rapidly progressing NRAS-mutant melanoma.
@Brumbo I meant Bruno, hold on to your girly panties
trend shows that ARRY's going up to $12 again by end of month. I've just added another 1200 shares today.
King of Kings
Back to 7.
Wow. Close to 850,000 shares total on close (564k+217k+56k+ smaller lots)
Really tight range this morning.
Very nice pps increase on low volume indicates not many shares left for sale. Short squeeze could begin soon!
all ready know
Trade Tip...News is leaking for positive Phase 3 data to be released by Monday. Stock price is beginning to rise on the leak. Cancer/Leukemia drug will spike big time upon press release.
VSTM $3.16 +0.01 (+0.31%) Duvelisib - DUO Cancer - relapsed/refractory chronic lymphocytic leukemia (CLL) Phase 3
08/31/2017 Phase 3 data due late summer 2017.
MicroCap News Alert: - Startup - Clean Energy Technologies (CETY) buys General Electric “Heat Recovery Systems Division” and within 2 years achieves break-even with sales now set to soar and to be profitable.
CETY announced today the launch of Pacific Rim Initiative with over 20 locations already identified by CETY and PPA power company authorities.
Early orders likely to exceed $25 million in annuitized sales. 12 month target price $.25
CETY/GE proprietary oil-free magnetic levitation turbine technology shatters the competition’s old oil-lubricated screw expander technologies.
Company expects to up list to NASDAQ.
CETY's implementation includes creative lease financing structure, that facilitates rapid adoption and ease of entry with long-term payment structure that allows the utility user to align its investment with actual energy and cost savings realized through use of Clean Cycle™ units," said Kam Mahdi, CEO of CETY.
CETY being welcomed with red carpet to largest markets in the world in need of clean energy.
Clean Energy Technologies (CETY) Launches Pacific Rim Initiative
COSTA MESA, Calif. , Aug. 15, 2017 Clean Energy Technologies, Inc. (OTC: CETY) announced that CETY officially launched its new campaign to deliver its energy solutions to Island Nations utilities at the ...
What a great time to buy!
OK todays filing a little more bullish MORE FREE options for the new counsel 450k shares but his exercise price is 8.94 or so BULLISH SHUT UP ATLANTIC PIKER !!! with your 200 shares
Folks, just as a reminder, small cap biotech companies do not normally report a positive earnings per share. ARRY just reported a lower EPS loss and higher revenue than what was expected. In addition, they have a robust pipeline and making good progress on their trials. The ops may decline a little due to profit taking in the next couple of days, but I believe this will be a start of good things to come in the future. GLTA longs!
Great way to start the day!
Good article from Motley Fool yesterday on why ARRY shares feel over 13% in the month of July. Bottom line if you are believer and not looking just to trade there is no need to panic.