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NOTIFICATION OF LATE FILING of 10Q for Period Ended: September 30, 2011
[X] (b) The subject annual report, semi-annual report, transition report on Form 10-K, Form 20-F, 11-K, Form N-SAR, or portion thereof, will be filed on or before the fifteenth calendar day following the prescribed due date; or the subject quarterly report of transition report on Form 10-Q, or portion thereof will be filed on or before the fifth calendar day following the prescribed due date
The due date per the SEC is 11/14. That's probably when they will file it, unless, of course, they ask for an extension.
I just saw that...over 1.3 million shares...I did not see any news come out... is there something brewing that is not public yet?
there was one trade over 1 million @ 0.15
$0.1500 1,051,900 OBB 11:28:00
10-Q for 2nd Quarter was filed 8/22. It's on the sec.gov website
This story has been updated to include information from a recent filing with the US Securities and Exchange Commission and comments from a company official (Paul Haje).
Arrayit Q1 Revenues Rise 47 Percent on Microarray Demand
August 09, 2011
By Justin Petrone (BioArray News - Genome web)
Arrayit this week said that its first-quarter revenues jumped 47 percent — a sales spike that CEO Rene Schena attributed to "increasing use of the Arrayit platform and increasing market share."
Schena said in a statement that the Sunnyvale, Calif.-based company will "continue to aggressively innovate and bring new products and services to market."
According to the company's first-quarter results, total revenues for the three months ended March 31 were $977,267 compared to $664,858 in the year-ago quarter. The firm's net loss narrowed 98 percent to $17,561 in the first quarter of 2011 from $724,972 in the same quarter a year earlier.
Paul Haje, Arrayit's vice president of sales and marketing, told BioArray News this week that Q1 revenue growth was "driven primarily by sales increases of our life sciences instruments, and expanded research test sales through the services division."
SG&A costs for the quarter declined 57 percent to $368,399 from $848,541 in the year-ago quarter. In a filing with the US Securities and Exchange Commission, the company attributed the drop in SG&A expenses to a "reduction in shares issued in lieu of cash compensation and for services rendered by consultants."
Q1 R&D costs decreased dramatically, falling 86 percent to $11,055 from $76,275 in Q1 2010. Arrayit attributed most of its R&D expenses in the past year to the development of its SpotBot Extreme Microarray Printer.
Still, despite the improved performance, Arrayit said it ended the quarter with just $143 in cash.
According to the company's SEC filing, Arrayit spends a "significant amount of its resources" on developing clinical protein biomarker diagnostic products and services, and it "does not expect to generate substantial revenue until certain diagnostic tests are cleared by the United States Food and Drug Administration and commercialized."
Moreover, Arrayit management believes that current available resources will not be sufficient to fund its planned expenditures over the next 12 months. Because of this, Arrayit will have to raise additional capital to support its activities. Specifically, Arrayit may require as much as $1.2 million over the next year to meet its expenses, the firm said.
Haje said that Arrayit "remains open to structuring a capital raise on favorable terms to the company." With revenues and gross margins increasing, though, he said the "investment timeline is flexible."
Including accounts receivable and inventory, Arrayit had $456,634 worth of assets as of March 31.
The company's dwindling cash position comes as it awaits a multi-million-dollar legal settlement related to ongoing litigation between the firm and Pediatrix Screening.
The case evolved out of a contract dispute between the firms, which had initially sought to co-develop array-based tools for newborn screening.
Arrayit and Pediatrix went to trial in the United States District Court in the Western District of Pennsylvania in 2007. The jury awarded Arrayit $5 million in damages for Pediatrix's breach of contract, fraudulent misrepresentation, and punitive damages, while awarding Pediatrix $1 million for Arrayit's breach of contract.
According to the SEC filing, Pediatrix put $5 million in bond, and submitted an appeal to the Third Circuit Court of Appeals to request that the damages be reduced. Last year, that court ordered a new trial on Arrayit's counterclaim for fraudulent misrepresentation and damages. The case is awaiting a status conference later this month.
Haje declined to comment on the case.
Founded in 1996, Arrayit offers a menu of arrays, reagents, instrumentation, and data analysis software for research use, as well as services. The company has looked to expand into the molecular diagnostics market since it went public in 2009 (BAN 5/12/2009).
In April, Arrayit launched OvaDx, an "array-based blood test that measures the activation of the immune system in response to early stage ovarian tumor cell development." The firm said that the assay, which is advertised for research use, could be used to "analyze different tumor types and stages, the effectiveness of chemotherapies, biomarker profiles in breast cancer and other epithelial cancers, benign gynecological conditions, the efficacy of ovarian cancer drugs for treatment and prevention, and to benchmark existing tests." The firm is charging $650 for OvaDx.
Arrayit said last week that it now offers an assay for Parkinson's disease research called PDx. Haje clarified this week that Arrayit is "finalizing the markers" for PDx and said the assay will be "available for research use shortly."
In 2009, Arrayit announced a partnership with researchers in the neurodegenerative division of the Parkinson's Institute and Clinical Center, also located in Sunnyvale. The institute researchers planned to use Arrayit's Human Genome H25K array to look for biomarkers linked to Parkinson's disease (BAN 4/14/2009).
Thanks for posting this article. Once OvaDx is available for clinical use ovarian cancer could be detected before cancer has spread making unnecessary the preventive ovaries removal "medieval" approach suggested in the article.
"An estimated 230,000 women worldwide are diagnosed with ovarian cancer each year. Most are not diagnosed before the cancer has spread, and up to 70 percent of them die within five years.
Because of this, Rahman said, women with the faulty RAD51D gene may decide their best option is to have their ovaries removed after they have children -- particularly if they have already seen other family members die of the disease."
From another Reuteres article in July, women are already having preventive surgery for ovaries removal if they have defects in the BRCA1 and BRCA2 genes. We need Ovadx approved to help out these women:
NEW YORK Fri Jul 29, 2011 (Reuters Health) - Women who screen positive for gene mutations that promote breast and ovarian cancers usually opt for surgery to cut their risk of the diseases, a new study suggests
It found that more than 80 percent of women who tested positive for the harmful mutations ultimately chose to have surgery to remove their ovaries, breasts or both.
Defects in the BRCA1 and BRCA2 genes substantially raise a woman's lifetime risks of breast and ovarian cancers -- to a roughly 60 percent chance of developing breast cancer, and a 15 to 40 percent risk of ovarian cancer.
And the company has said in the past that, based on their conversations with the FDA, they are confident that OvaDx will pass muster as a PMA approved device.
Thanks Wolf, I agree. ARYC has all their ducks in a row now, and it is all set for the FDA to hopefully approve OVADx soon.
Report about ARYC from BioArray News (genomeweb). Report was written after the PR was issued but before the 10Q was available.
Arrayit Q1 Revenues Rise 47 Percent on Microarray Demand
August 04, 2011
By Justin Petrone
Arrayit this week said that its first-quarter revenues jumped 47 percent — a sales spike that CEO Rene Schena attributed to "increasing use of the Arrayit platform and increasing market share."
Schena said in a statement that the Sunnyvale, Calif.-based company will "continue to aggressively innovate and bring new products and services to market."
According to the company's preliminary results, total revenues for the three months ended March 31 were $977,267 compared to $664,858 in the year-ago quarter. The firm's net income increased 43 percent to $424,715 in the first quarter of 2011 from $297,016 in the same quarter a year earlier.
The company has not provided further information on its Q1 performance. Arrayit notified the US Securities and Exchange Commission on May 12 that it would be late in reporting its first-quarter results.
Founded in 1993, Arrayit offers a menu of arrays, reagents, instrumentation, and data analysis software for research use, as well as services. The company has looked to expand into the molecular diagnostics market since it went public in 2009 (BAN 5/12/2009).
In April, Arrayit launched OvaDx, an "array-based blood test that measures the activation of the immune system in response to early stage ovarian tumor cell development." The firm said that the assay, which is advertised for research use, could be used to "analyze different tumor types and stages, the effectiveness of chemotherapies, biomarker profiles in breast cancer and other epithelial cancers, benign gynecological conditions, the efficacy of ovarian cancer drugs for treatment and prevention, and to benchmark existing tests." The firm is charging for $650 OvaDx.
In this week's announcement, Arrayit said it now offers an assay for Parkinson's disease research called PDx, though it did not provide details on the assay.
In 2009, Arrayit announced a partnership with researchers in the neurodegenerative division of the Parkinson's Institute and Clinical Center, also located in Sunnyvale. The institute researchers planned to use Arrayit's Human Genome H25K array to look for biomarkers linked to Parkinson's disease (BAN 4/14/2009).
Finally the 10Q was filed and can be seen at the sec.gov site
see link below
http://www.sec.gov/Archives/edgar/data/1084507/000079894711000024/aryc10q1q2011.htm
I think it appears in real time at the sec.gov site.
VRML filed its 2nd qtr 10q today and it is there already.
I looked in sec.gov website and the 10Q is not filed yet. Maybe tomorrow?
Thanks for the info.
Doe anyone know Why are Real-Time Level 2 Quotes not displayed
for Arrayit Corp. at the otcmarkets website? It used to display, but since yesterday it is not.
http://www.otcmarkets.com/stock/aryc/quote
But you watch, if they do not make some kind of announcement soon, buyers will get discouraged and the price will drop more each day. I've seen this happen with ARYC more than once.
Indeed, quite a performance today, Bravo!
Now the company has to make some kind of positive announcement to solidify these gains, otherwise the rally will evaporate just as quick.
It'd be nice if we knew even just an outline of "the plan".
I see that you are the new moderator for ARYC in the ihub MB.
I don't think anyone on this board has any new additional info on ovadx or Aryc. Try emailing Rene@arrayit.com and if you learn something new please share with us. Thanks!
The accountants completed their work and the 10Q was sent to the auditors. It may take a couple of weeks for the audit. So the wait continues... and its impact on the pps.
Wonder why? Could it be because of the long delay in filing the 10Q?
They are late with the filing. They had requested 5 days extension, and it is now 9 days later and no 10Q yet.
More OvaDx technical details for researchers buying the test.
Arrayit posted on its website additional information for researches purchasing OvaDx. researchers can also buy the test right from the website.
http://arrayit.com/Microarray_Diagnostics/OvaDx_Ovarian_Cancer_Test/ovadx_ovarian_cancer_test.html
One piece of information I liked was
•Detects stage IA with ~80% sensitivity
Arrayit does not give a value yet for the specificity other than saying that it is high.
According to ovarian cancer experts, the sensitivity for a successful ovarian cancer screening test has to be at least 75%, so OvaDx betters that. (See Silverfusion post #940 here in response to a question I had about the sensitivity required.)
"Because the prevalence of ovarian cancer is low (approximately 0.03%), it is estimated that a screening strategy should have greater than 75% sensitivity for early-stage ovarian cancer and specificity of 99.6%. Applied to the normal-risk population of women, this would yield a positive predictive value of 10%,"
http://www.ovariancancer.org/2010/05/03/a-step-forward-for-two-step-screening-for-ovarian-cancer/
I don't know if the number of authorized shares is out of line with other companies. All I know is that if they do issue more shares that would dilute the price per share, so they would have to be very careful about it.
If you go to the SEC.gov website, and search for ticker symbol ARYC you will see all of ARYC's filed documents, including last's 10K . It is my impression that the 10K for 2010 has more detailed information than 2009's.
http://www.sec.gov/edgar/searchedgar/companysearch.html
I agree with you tha OvaDx is best in class, and if approved by the FDA it will be the first screening test on the market. I have read that due to the low incidence (1 in 2500 women) of ovarian cancer in the general population, the ideal screening test for ovarian cancer has to be at least 99.6% specific. So it will be very useful to know what specificity OvaDx has.
good find.
Yes, after 7 months of complete silence, Arrayit came back swinging. All the public announcements were timed with the AACR meeting. In addition to OvadDx's debut and the sale of OvaDx to researchers, the meeting gave Arrayit a lot of exposure that resulted in many leads. Some of the leads may result in more business and partnerships. Now of course we wait for more news in the coming week - the 10K. I think we are heading in the right direction.
Great questions for Todd. The question of when are they going to file the PMA is in everyone's mind.
LOL. We were both writing basically the same thing simultaneously.
Good info delsurfer. It apppears then that the 1000 tests that are being offered at the AACR meeting are not free as Whitewolf had indicated in post 1509 here. Selling them makes sense to get revenues to fund the remaining OvaDX clinical trials.
Here is a link to see the picture:
http://www.facebook.com/photo.php?pid=6532766&l=df4c6379b5&id=60207997258
You're welcome.
On the arrayit.com main webpage, on the left hand side there is a link to sign up for the newsletter. It looks like this:
Corporate Newsletter
Click here to sign up for the Arrayit newsletter
Silver, good to hear from you.
A couple of things, the price droped to 0.13 Friday when the delay of the 10K became public and the bashers in the Message Boards were in full swing. This was before the PR came out not after as you state. After the PR came put he price went up. But the 10K delay still clouds the picture because it causes people to speculate what's going to be in it.
Also Arrayit announced the OvaDx product launch. This in itself is very significant. Product launch by definition is "the orchestrated introduction of a new product (or version of a product) to the market; the events surrounding making the product available for purchase for the first time"
Up to now OvaDx was not available to anyone else outside Arrayit.
From Arrayit newsletter email last night. It also has a picture of the booth showing Khrystyne Haje and 5 other hosts (3 women, 2 men) all dressed in white
"Arrayit Corporation coordially invites members of the scientific, medical, clinical, regulatory and investment communities to visit Arrayit in Booth #1478 (shown here) at the 102nd meeting of the American Association for Cancer Research at the Orange County Convention Center in Orlando, Florida from April 2-6, 2011. Arrayit is currently exhibiting its new OvaDx® Pre-Symptomatic Ovarian Cancer Research Screening Test, and a complete line of the company's leading edge microarray life science platforms, instruments, tools, kits, reagents and consummables.
Customers, prospective customers, friends, affiliates and members of the media are encouraged to visit booth #1478 for expert demonstrations of our industry-leading SpotBot® 3 Personal Microarrayers, SpotLight™ Microarray Scanners, and the newly-available SpotBot® Extreme Mid-Size and SpotBot® Titan Full-Size Microarrayers. Gene expression profiling, genotyping, serum analysis, and a complete range of additional genomic, transcriptomic, proteomic and glycomic applications are fully empowered by Arrayit technology.
Arrayit Booth #1478 at AACR
Arrayit Corporation (ARYC) 524 East Weddell Drive, Sunnyvale CA 94089, USA.
Email: arrayit@arrayit.com, Phone (408) 744-1331, Fax (408) 744-1331
I expected a much bigger bounce of the stock price from the OvaDx launch.
As an example, MBCI jumped from 0.25 to 0.84 late July after they announced results from a blinded study of several of its ovarian cancer MAbs against 54 different blood samples with a diagnostic sensitivity of 94 percent and 100 percent correct diagnosis of benign tumors. Really, MBCI is far away form a product launch and they go up that high on the that news and ARYC is still at 0.25?
MBCI does have a better Public Relations department. ARYC may be lacking that.
I don't believe that the OvaDx news has spread widely. I have not seen it yet on any newspaper, TV, online magazine and the like. In the past I have seen just promising cancer diagnostic test tests from other companies or universities, years from coming to market, get better coverage.
I sent email today to the wire services (AP, UPI, Reuters) making them aware of the OvaDx product launch. Hopefully they'll pick it up and spread the word.
I believe some people in the message boards (mainly kingsolomon in this board who also goes by several handle names in the yahoo board) was trying to manipulate down the pps to cover his position just as the news about the launch of Ovadx was about to take place. He was helped by the delay of the 10K for which he spread all kind of doomsday scenarios. You notice that once the news about OvaDx broke he went back into hiding. Less than 300,000 shares (less than $60,000) were traded after the OvaDx news late afternoon, so I think it is small potatoes.
There is also talk in the yahoo message board about some people excercising stock warrants at low prices and that has to play out over time. Not sure what all that means. I'm not that well versed on the different trading instruments people use.
The true picture I believe will be this coming week when hopefully more real buyers come out to play.
You probably read the post here by Whitewolf saying that the first 1000 tests at the conference will be free of cost.
The Arrayit strategy back in Dec 2009 was to hopefully get FDA approval about six months after the launch for research purposes only. Hope that is still the strategy.
Thanks for the clarification. The PR was then just missing the word "free" in the first paragraph.
I wonder how that works with the test at the conference. I supposed it is under a doctor's supervision so that the results are given out to the patient in a professional manner.
Silverfusion, Admiral, Delsurfer(Bill). I'm surprised you have not commented on the OvaDx product launch.
Bart, yours sounds like an excellent strategy. ARYC should try this approach.
Interesting that the actual "for research purposes only" launch came almost a year to the day of the initial projected launch. Lets hope that the official commercial launch folllows the same path.
Dec 2009 PR:.."We are optimistic that we will be in position to begin marketing the test for research purposes late in the first quarter of 2010, followed by official commercial launch to the medical diagnostics industry as early as the third quarter of 2010."