Replies to post #151443 on Biotech Values

[poorgradstudent]

ARRY:

Multiple myeloma seems to be amenable to monotherapy. Do they have such a trial running or are they focused on combination trials?

[bladerunner1717]

Some (worrisome) thoughts on ARRY

McBio,

Are you at all concerned about the cash burn and the limited cash on hand?

Assuming that the cash burn will increase significantly as ARRY moves 520 and 614 into late-stage trials--perhaps in the $15-18 million/quarter range--that means there is only a couple of quarters' window in which ARRY has time, before they have to dilute. Assuming Squarer can't get a decent deal done soon on 797, there is not much else from which cash can be generated. (I don't expect a significant milestone from AZN, assuming AZN moves Selumetinib into Phase III trials before the end of the year--a distinct possibility, I believe--because we know the economics of ARRY's deal with AZN are not to Squarer's liking.)

I think this is the main reason the stock has been declining.

I notice that the PR did not give cash guidance going forward. I see that as a somewhat telling sign that dilution may be coming. And now it's coming at a much lower price than a couple of months ago.

Now I know you're going to say that you'd put up with some dilution in order to advance the pipeline. But it seems to me that the dilution will have to pretty substantial to advance both 520 and 614 on their own. And ARRY already has about 100 million shares outstanding, fully diluted. (And I won't even mention the Deerfield debt.)

BTW, why do you think the partnership with Amgen on diabetes was not mentioned in the PR? Do you think the program is in trouble?

Your thoughts?


Bladerunner

[turtlepower]

ARRY- It's notable that there is no mention at all of Selumetinib in BRAF-mutant Melanoma.

[mcbio]

ARRY - 1Q13 CC notes

1. ARRY is seeing disease modification in OA for cartilage and bone degradation with ARRY-797, on top of the pain relief. ARRY believes this disease modification on top of pain relief from 797 is unprecedented. ARRY guided for a 797 partner for 1H13.

2. For ARRY-520, ASH abstracts will be out next Monday and the 520 abstract, if accepted, should show the biomarker they have identified that can predict patient response. The idea is that with a biomarker in hand they can select only the patients for future trials that will respond to 520 (which would hopefully enhance chances for success). The biomarker is a relatively common biomarker and won't require a new test to be created and approved.

3. Despite not being mentioned in the results PR, ARRY mentioned AMG151 in the CC and the drug appears to be on track with mention of expectation of completion of enrollment in the P2 trial being run by AMGN.

4. Regarding discussion of the MEK indications of most interest to NVS with MEK162, the combo with the NVS BRAF inhibitor LGX818 was identified. Despite being behind in the BRAF space, it was mentioned that it appears that NVS believes they have a best-in-class BRAF inhibitor. It was also noted that the MEK162 combos with various NVS PI3K inhibitors continue to be of great interest.

5. Regarding the recent deal that CELG inked with the private VentiRX (#msg-80159597 ) for VTX-2337, ARRY is ultimately entitled to royalties on this drug and has an ownership interest in VentiRx.

[mcbio]

ARRY - 2Q13 results

http://finance.yahoo.com/news/array-biopharma-reports-financial-results-214400042.html

Array BioPharma Reports Financial Results For The Second Quarter Of Fiscal 2013
MEK162 Phase 3 Trial to Start April 2013
AstraZeneca Announced Selumetinib Potential Phase 3 NSCLC Trial Start in 2013

BOULDER, Colo., Feb. 4, 2013 /PRNewswire/ -- Array BioPharma Inc. (ARRY) today reported results for the second quarter of its fiscal year ending June 30, 2013.

(Logo: http://photos.prnewswire.com/prnh/20121029/LA02195LOGO)

Array continued its evolution into a late-stage development company, making significant progress in generating data to support our upcoming development for our wholly-owned hematology programs. During the quarter, Novartis declared its intention to begin a Phase 3 trial with MEK162 in NRAS melanoma which is now scheduled to start in April 2013. In addition, Novartis announced plans to pursue additional MEK162 late-stage clinical development in combination with their Raf inhibitor in BRAF mutant melanoma. Also, AstraZeneca recently announced a potential start of a Phase 3 trial with selumetinib in non-small cell lung cancer (NSCLC) during the second half of 2013.

Revenue for the second fiscal quarter ended December 31, 2012 was $18.4 million, compared to $23.2 million for the same period in fiscal 2012. The decline in revenue was due to the $28.0 million licensing payment from Genentech during the first half of fiscal 2012 that did not recur in 2013. Research and development expense was $13.9 million, compared to $13.2 million in the comparable prior year period. Net loss was $10.9 million, or ($0.10) per share for the second quarter, compared to a net loss of $3.8 million, or ($0.06) per share, for the same period in fiscal 2012.

For the six months ended December 31, 2012, revenue was $34.2 million, compared to $45.4 million for the same period in fiscal 2012. The decline was also related to the Genentech licensing payment described above. Net loss for the six months ended December 31, 2012, was $22.7 million, or ($0.23) per share, compared to a net loss of $7.4 million, or ($0.13) per share, in the comparable prior year period.

During the quarter, Array paid Novartis its first annual co-development contribution of $9.2 million to maintain the maximum U.S. royalty rate for MEK162. These contributions are capped annually and in total. Array ended the quarter with $110 million in cash, cash equivalents and marketable securities.

Ron Squarer, Chief Executive Officer of Array, noted, "We are seeing strong progress across our pipeline. At ASH, we presented impressive ARRY-520 data as a single agent, in combination with dexamethasone, in combination with carfilzomib, and on a selection marker that may identify patients more likely to respond to ARRY-520. Our partners, Novartis with MEK162 and AstraZeneca with selumetinib, each announced plans to progress these Array-invented products into Phase 3 pivotal trials this year. In addition, ARRY-502 is on track to complete enrollment by this spring with summer top-line results. Out-licensing this product represents a potential important source of non-dilutive funding."

KEY COMPANY AND PROGRAM UPDATES

Raised $70.9 million in public offering: Array completed an underwritten public offering of 20.7 million shares of its common stock at a price of $3.65 per share in November 2012. Array received net proceeds from the sale of the shares of $70.9 million. This money will be used to fund potential Phase 3 or pivotal programs.

Elected John A. Orwin to Array's Board of Directors: Array elected John A. Orwin, chief executive officer of Affymax, Inc., to its board of directors as an independent director. Previously, he held leadership roles in marketing, sales, and operations for major pharmaceutical companies including Genentech, Johnson & Johnson, Alza Pharmaceuticals, Rhone-Poulenc Rorer, and Schering-Plough Corporation. Prior to joining Affymax, he had successfully launched or grown brands such as: Avastin®, Rituxan®, Herceptin®, Tarceva® and Taxotere®.

ARRY-520 – Advances in clinical trials, ASH data presentation, identification of potential important biomarker

During the quarter, ARRY-520, a potent, selective KSP inhibitor with a mechanism of action distinct from other drugs used to treat multiple myeloma, was advanced in three clinical trials. Positive results in any one of these trials will define a clear path to late stage development:

Phase 2 trial in combination with dexamethasone in patients with MM refractory to Revlimid® (lenalidomide), Velcade® (bortezomib) and dexamethasone therapy.
Phase 1b trial in combination with Velcade plus dexamethasone in patients with relapsed or refractory MM.
Phase 1b investigator-sponsored trial in combination with Kyprolis® (carfilzomib) in patients with relapsed or refractory MM who are refractory or intolerant to Velcade therapy.
At the 2012 Annual Meeting of the American Society of Hematology (ASH), data on Array's Phase 2 trial with ARRY-520 in patients with triple-refractory multiple myeloma and a median number of 10 prior treatment regimens was presented. ARRY-520 plus low-dose dexamethasone demonstrated a 22% overall response rate (= partial response, or PR), with manageable safety. This response rate is comparable to the response rates reported in pomalidomide and Kyprolis studies, which included patients with only half the number of median prior treatment regimens. Overall survival of 19 months and progression free survival of 3.7 months were reported in multiple myeloma patients taking ARRY-520 alone.

In addition, preclinical and clinical data suggest that AAG (acute phase protein alpha-1-acidic glycoprotein) may be an enabling patient selection marker for response to ARRY-520. A related presentation assessing the same group of ARRY-520-treated patients observed that, for patients retrospectively selected with a lower AAG level, the overall response rate (=PR) increased to 33% (from 22%) with a median time on study of 6.2 months. The clinical benefit rate (=MR) was 50% in the selected population.

Interim data from an ongoing investigator-sponsored combination trial of ARRY-520 with Kyprolis in patients with relapsed or refractory MM who are refractory or intolerant to Velcade® (bortezomib) were also reported at the conference. The combination has demonstrated early signals of activity, with a 56% clinical benefit rate (=MR). In addition, it has been well tolerated with limited hematologic toxicity and a manageable side effect profile.

ARRY-614 – FDA meeting provides guidance on primary endpoint

During the quarter, Array continued to evaluate ARRY-614 in an ongoing clinical trial in patients with low or intermediate-1 risk MDS using an optimized formulation. As presented at ASH, this new formulation has demonstrated improved bioavailability and target coverage in this patient population. With this new formulation, peak plasma concentrations and overall exposures are higher than with the original formulation. The ongoing Phase 1 dose escalation trial of the optimized ARRY-614 formulation may further our understanding of the contributions of these targets to the pathogenesis of MDS. In a prior study in a similar population, up to a 40% response rate for hematologic improvement was observed in patients.

Array also met with the FDA to discuss the development plan to support registration and received guidance from the FDA on the primary endpoint, including a discussion of endpoints other than overall survival that could be used as the basis for approval. Array has now defined a potential path to registration and, pending additional positive data from the ongoing study, will make decisions on future study designs in 2013.

ARRY-797 – Data presented at ACR meeting, biomarkers suggest disease state modification potential

Array gave a "late-breaker" presentation at the 2012 American College of Rheumatology Annual Meeting. The presentation included data on ARRY-797's analgesic effect and markers of disease modification. In addition, biomarkers of cartilage (COMP) and bone (CTX-I) degradation were assessed. ARRY-797 treatment resulted in statistically significant decreases in COMP and CTX-I at week 4 (decreases of 10% and 38% versus placebo, respectively). The decrease in CTX-I was sustained and returned to baseline by the follow-up visit. Further evaluation of the potential for disease modifying activity is warranted.

Array announced in July 2012 that treatment with ARRY-797, a non-opioid, resulted in a statistically significant reduction in pain over a 28-day period compared to placebo, as measured using the Western Ontario and McMaster Universities Arthritis Index (WOMAC®) pain subscale (a 0 – 10 numerical pain rating scale), in a randomized, placebo-controlled and active-controlled (oxycodone ER) Phase 2 clinical trial in osteoarthritis patients suffering from moderate to severe knee pain despite the use of non-steroidal anti-inflammatory drugs (NSAIDs). ARRY-797 is a novel, oral, selective inhibitor with a mechanism of action unique from that of currently approved pain medications. Given our internal focus on hematology/oncology, Array is seeking a partnership to maximize the value of this drug.

MEK-162 – Phase 3 pivotal trial announced and posted by Novartis

At its R&D Investor event in November 2012, Novartis indicated that it intends to initiate a Phase 3 pivotal trial for MEK-162 in patients with NRAS mutant melanoma. This study was recently posted on ClinicalTrials.gov and has a scheduled start date of April 2013. Please click here to view. Novartis has also recently accelerated its goal of regulatory submissions for MEK162 to 2015. In addition, Novartis announced plans to pursue additional clinical development in combination with a Raf inhibitor in BRAF mutant melanoma.

Selumetinib – AstraZeneca may initiate Phase 3 trial in 2013

AstraZeneca recently announced with their quarterly financial results that they expect to initiate a Phase 3 selumetinib trial in 2013 in patients with NSCLC. Selumetinib is advancing in 65 trials, 39 of which are in Phase 2. AstraZeneca initiated a 225-patient Phase 2 randomized trial with selumetinib in combination with docetaxel in 2nd line unselected NSCLC. The trial will evaluate two different doses of docetaxel with selumetinib versus docetaxel alone. We believe this will help optimize the product's profile, validate biomarker diagnostics and generate preliminary efficacy in selective subsets of NSCLC patients. Additionally, AstraZeneca will specifically assess efficacy within KRAS subgroups in terms of progression free survival, overall survival, overall response rate and change in tumor size at week 6.

In addition to NSCLC, positive results were presented last year with selumetinib in thyroid and ovarian cancers. In a Phase 2 trial in recurrent low-grade serous ovarian or peritoneal cancer, patients taking selumetinib showed a disease control rate of 81%, defined as either complete or partial response or progression-free survival or progression-free survival of greater than 6 months. Eight patients had complete (1) or partial (7) responses. The median survival rate without cancer progression was 11 months. And in patients with thyroid cancer, selemetinib showed a 71% partial response and 91% mean reduction in tumor growth. In this study, selumetinib resensitized patients to radioactive iodine to warrant further therapy.

CONFERENCE CALL INFORMATION

Array will hold a conference call on Tuesday, February 5, 2013, at 9:00 a.m. eastern time to discuss these results. Ron Squarer, Chief Executive Officer, and Michael Carruthers, Chief Financial Officer, will lead the call.

Conference Call Information


Date:
Tuesday, February 5, 2013

Time:
9:00 a.m. eastern time

Toll-Free:
[phone]

Toll:
[phone]

Pass Code:
34113160

Webcast & Conference Call Slides:


http://investor.arraybiopharma.com/phoenix.zhtml?c=123810&p=irol-irhome



About Array BioPharma

Array BioPharma Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of targeted small molecule drugs to treat patients afflicted with cancer. Array is evolving into a late-stage development company with significant progress toward generating data to support our upcoming Phase 3 / pivotal trial decisions. Array-invented MEK162 will begin testing in a Phase 3 trial in NRAS melanoma in April 2013 as well as BRAF mutant melanoma later in the year (with Novartis). Also, AstraZeneca announced they may start a Phase 3 trial with selumetinib in non-small cell lung cancer during the second half of 2013. Three other Array invented drugs are also approaching Phase 3 decisions by the end of calendar year 2013. These include Array's wholly-owned drugs, ARRY-520 and ARRY-614, and one partnered program, danoprevir (with InterMune/Roche). For more information on Array, please go to www.arraybiopharma.com.