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I ran into this today while wasting some time online:


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Opexa Therapeutics’ Amendment No.1 on Form 10-KSB/A Report Audit Includes ''Going Concern'' Qualification


THE WOODLANDS, Texas--(BUSINESS WIRE)--Opexa Therapeutics, Inc. (NASDAQ:OPXA) noted today that its financial statements for the fiscal year ended December 31, 2006, included in Amendment No. 1 to the Company's Report on Form 10-KSB/A filed on November 9, 2007, contains a going concern modification from its independent accounting firm, Malone & Bailey, PC.

This announcement is being made in compliance with Nasdaq Marketplace Rule 4350(b)(1)(B), which requires separate disclosure of receipt of an audit opinion that contains a going concern qualification.

About Opexa Therapeutics

Opexa Therapeutics develops and commercializes cell therapies to treat autoimmune diseases such as multiple sclerosis (MS), rheumatoid arthritis, and diabetes. The Company is focused on autologous cellular therapy applications of its proprietary T-cell and stem cell therapies. The Company’s lead product, Tovaxin®, a T-cell therapy for MS is in Phase IIb trials. The Company holds the exclusive worldwide license for adult multipotent stem cells derived from mononuclear cells of peripheral blood. The technology allows large quantities of monocyte derived stem cells to be produced efficiently for use in autologous therapy, thus circumventing the threat of rejection. The Company is in preclinical development for diabetes mellitus.

Safe Harbor Statement

This press release contains "forward-looking statements," including statements about Opexa Therapeutics' growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. These forward-looking statements are based on management's current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including those relating to Opexa Therapeutics' ability to obtain additional funding, develop its stem cell technologies, achieve its operational objectives, and obtain patent protection for its discoveries, that may cause Opexa Therapeutics' actual results to be materially different from any future results expressed or implied by such forward-looking statements. Opexa Therapeutics undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.

Perhaps I'm missing something. Opexa's SEC filings can be accessed from this page. My brief perusal of their November 9th filing did not uncover any mention of an audit statement from Malone & Bailey.

NHE

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I wrote:Perhaps I'm missing something.

Note any more. I found the report containing the audit information. Now if I could only grasp financial data the same way I read science journals.

From FORM 10KSB/A

We have audited the accompanying consolidated balance sheet of Opexa Therapeutics, Inc. (a development stage company), as of December 31, 2006 and the related consolidated statements of expenses, changes in stockholders’ equity and cash flows for the years ended December 31, 2006 and 2005 and the period from January 22, 2003 (Inception) through December 31, 2006. These consolidated financial statements are the responsibility of Opexa’s management. Our responsibility is to express an opinion on these consolidated financial statements based on our audits.

We conducted our audits in accordance with standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatements. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the consolidated financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall consolidated financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the consolidated financial position of Opexa as of December 31, 2006 and the consolidated results of its operations and its cash flows for the periods described in conformity with accounting principles generally accepted in the United States of America.

OK, so no flaky accounting like that which collapsed Enron.

As discussed in Note 15 to the consolidated financial statements, the accompanying consolidated financial statements have been prepared assuming that Opexa will continue as a going concern. Opexa requires significant amount of cash in its operations and does not have sufficient cash to fund its operations for the next twelve months, which raises substantial doubt about its ability to continue as a going concern. Management’s plans regarding those matters are also described in Note 15. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

OK, so that doesn't sound too good. Here's "Note 15"...

On November 2, 2007, Opexa filed it quarterly report for the period ended September 30, 2007. As shown in its financial statements, Opexa has negative cash flows provided by its operating activities and has a cash balance of $5.8 million as of September 30, 2007 which is not sufficient to fund its operations for the next twelve months. These conditions raise substantial doubt as to Opexa’s ability to continue as a going concern. Management will seek to raise additional capital through sales of convertible debt and/or equity. The financial statements do not include any adjustments that might be necessary if Opexa is unable to continue as a going concern.

If they don't pull out of this I fear that they might be sitting ducks for a take over bid from one of the large pharmaceuticals. Does anyone happen to have a generous venture capitalist in their midst?

NHE

NHE wrote:OK, so no flaky accounting like that which collapsed Enron.

And Enron audits had the same results. For a few years. and then...

OK,

I know their stock tanked. I am a financial idiot. In layman's terms does this mean that our extension trial may be in jeopardy? If that's the case, I'm just going to lose it. If I find out I wasted this whole last year when I could have been trying something (Tysabri, Copaxone, etc,) I will freak. There really isn't anything I could do, but man that would suck. Hopefully they get snatched up by a biggie and they keep everything going. I don't know if that's how it works, but I'm extemely distressed just thinking that I won't get an opportunity to get this therapy in the coming year.

Hi to all,

Opexa Therapeutics’ Amendment No.1 on Form 10-KSB/A Report Audit Includes ''Going Concern'' Qualification

Whenever a company has less than one year's operating expenses in the bank, they get a little asterisk, which in this case is the "Going Concern". If you look at their third quarter financial statement and divide the money that they spent in the third quarter into the remaining cash, they have less than one year of cash on hand.

What that signals is that they will need to do another fund raising before long.

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Hi Bob,

I see you have a new image.

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But opexa's share price doesn't support the contention that it is sitting on a gold mine.

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Loobie,
I think I can ease your mind a bit. I just got of the phone with my clinic, they are, as we speak, doing their required paperwork for the open label extension. All approved and official. Good luck!
As for the not so good news, I am about to re-post on the "sticky Tovaxin" thread.
Be Well,
Lars

I just talked to my coordinator yesterday to make my next appt (I am currently waiting out that big 8 week gap) and she told me the extension study protocol is finally in and we will talk about it at my 12/11 appt.

Seems this year has went by at a snails pace!

Sweety,

I have read your Sweety Profile. I always check it out, but haven't seen any new info since July. Read through your posts on this site also. How are you doing with the Tovaxin?