|   |   |                                                                                    |
|--------|--------|-----------------------------------------------------------------------------------------|
| þ |   | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
|   |   |     For the Quarterly Period Ended March 31, 2011                   |

|   |   |                                                                                                                                                                                                                                                                                                             |
|--------|--------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| o      |   | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934                                                                                                                                                                                                                         |
|   |   |     For the Transition Period from                      to                      |

| Texas                           | 2635 Technology Forest Blvd.    | 76-0333165          |
|---------------------------------|---------------------------------|---------------------|
| (State or other jurisdiction of | The Woodlands, Texas 77381      | (I.R.S. Employer    |
| Incorporation or organization)  | (Address of principal executive | Identification No.) |
|                            | offices and zip code)           |                |

|             Large accelerated filer o                                                              |   | Accelerated filer   o        |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|---------------------------------------------|
|             Non-accelerated filer   o (Do not check if a smaller reporting company) |   | Smaller reporting company  þ |

----

|  PART I – FINANCIAL INFORMATION  | Page                                                                                                                                               |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Item 1.                                          | Financial Statements                                                                                                                               |   |
|                                             |                                                                                                                                               |   |
|                                             | Unaudited Balance Sheets as of March 31, 2011 and December 31, 2010                                                                                | 1 |
|                                             |                                                                                                                                               |   |
|                                             | Unaudited Statements of Expenses:For the three months ended March 31, 2011 and 2010 and from Inception (January 22, 2003) through March 31, 2011   | 2 |
|                                             |                                                                                                                                               |   |
|                                             | Unaudited Statements of Cash Flows:For the three months ended March 31, 2011 and 2010 and from Inception (January 22, 2003) through March 31, 2011 | 3 |
|                                             |                                                                                                                                               |   |
|                                             | Notes to Unaudited Financial Statements                                                                                                            | 4 |
|                                             |                                                                                                                                               |   |
| Item 2.                                          | Management’s Discussion and Analysis of Financial Condition and Results of Operations                                                        | 7 |
|                                             |                                                                                                                                               |   |
| Item 3.                                          | Quantitative and Qualitative Disclosures About Market Risk                                                                                         | 11 |
|                                             |                                                                                                                                               |   |
| Item 4.                                          | Controls and Procedures                                                                                                                            | 11 |
|                                             |                                                                                                                                               |   |
| PART II – OTHER INFORMATION                |                                                                                                                                               |
|                                             |                                                                                                                                               |
| Item 1.                                          | Legal Proceedings                                                                                                                                  | 12 |
|                                             |                                                                                                                                               |   |
| Item 1A.                                         | Risk Factors                                                                                                                                       | 12 |
|                                             |                                                                                                                                               |   |
| Item 2.                                          | Unregistered Sales of Equity Securities and Use of Proceeds                                                                                        | 13 |
|                                             |                                                                                                                                               |   |
| Item 3.                                          | Defaults Upon Senior Securities                                                                                                                    | 13 |
|                                             |                                                                                                                                               |   |
| Item 4.                                          | [Removed and Reserved]                                                                                                                             | 13 |
|                                             |                                                                                                                                               |   |
| Item 5.                                          | Other Information                                                                                                                                  | 14 |
|                                             |                                                                                                                                               |   |
| Item 6.                                          | Exhibits                                                                                                                                           | 14 |
|                                             |                                                                                                                                               |   |
| Signatures                                       |                                                                                                                                               |   |

----

PART I - FINANCIAL INFORMATION

Item 1. Financial Statements.

OPEXA THERAPEUTICS, INC.

|                                                          |   | March 31, |        |   | December 31, |   |
|---------------------------------------------------------------|--------|-----------|-------------|--------|--------------|--------|
|                                                          |   | 2011      |        |   | 2010         |   |
|                                                          |   |      |        |   |         |   |
| Assets                                                        |   |      |        |   |         |   |
|                                                          |   |      |        |   |         |   |
| Current assets:                                               |   |      |        |   |         |   |
| Cash and cash equivalents                                     |   | $         | 11,427,985  |   |         | $      | 3,812,535 |   |
| Other current assets                                          |   |      | 113,774     |   |         |   | 85,525 |   |
| Total current assets                                          |   |      | 11,541,759  |   |         |   | 3,898,060 |   |
|                                                          |   |      |        |   |         |   |   |   |
| Property & equipment, net of accumulated depreciation     |   |      |        |   |         |   |   |   |
| of $1,139,191 and $1,109,558, respectively                    |   |      | 980,358     |   |         |   | 815,958 |   |
| Total assets                                                  |   | $         | 12,522,117  |   |         | $      | 4,714,018 |   |
|                                                          |   |      |        |   |         |   |   |   |
| Liabilities and Stockholders' Equity                          |   |      |        |   |         |   |   |   |
|                                                          |   |      |        |   |         |   |   |   |
| Current liabilities:                                          |   |      |        |   |         |   |   |   |
| Accounts payable                                              |   | $         | 652,870     |   |         | $      | 358,837 |   |
| Accounts payable - related parties                            |   |      | 15,000      |   |         |   | 15,000 |   |
| Accrued expenses                                              |   |      | 374,686     |   |         |   | 335,861 |   |
| Current maturity of loan payable                              |   |      | 17,970      |   |         |   | 35,607 |   |
| Total current liabilities                                     |   |      | 1,060,526   |   |         |   | 745,305 |   |
|                                                          |   |      |        |   |         |   |   |   |
| Total liabilities                                             |   |      | 1,060,526   |   |         |   | 745,305 |   |
|                                                          |   |      |        |   |         |   |   |   |
| Commitments and contingencies                                 |   |      | -           |   |         |   | - |   |
|                                                          |   |      |        |   |         |   |   |   |
| Stockholders' equity:                                         |   |      |        |   |         |   |   |   |
| Preferred stock, no par value, 10,000,000 shares authorized,  |   |      |        |   |         |   |   |   |
| none issued and outstanding                                   |   |      | -           |   |         |   | - |   |
| Common stock, $0.01 par value, 100,000,000 shares authorized, |   |      |        |   |         |   |   |   |
| 23,048,488 and 18,466,924 shares issued and outstanding       |   |      | 230,485     |   |         |   | 184,670 |   |
| Additional paid in capital                                    |   |      | 107,251,222 |   |         |   | 98,496,382 |   |
| Deficit accumulated during the development stage              |   |      | (96,020,116 | )      |         |   | (94,712,339 | ) |
| Total stockholders' equity                                    |   |      | 11,461,591  |   |         |   | 3,968,713 |   |
| Total liabilities and stockholders' equity                    |   | $         | 12,522,117  |   |         | $      | 4,714,018 |   |
|                                                          |   |      |        |   |         |   |   |   |

----

OPEXA THERAPEUTICS, INC.

|                                  |   | Three Months Ended |       |   | Inception |   |
|---------------------------------------|--------|--------------------|------------|--------|-----------|--------|
|                                  |   | March 31,          |       |   | through   |   |
|                                  |   | 2011               |       |   | 2010      |   |   | March 31, 2011 |   |
| Research and development              |   | $                  | 685,161    |   |      | $      | 783,534 |   |   | $ | 67,523,998 |   |
| General and administrative            |   |               | 592,058    |   |      |   | 484,425 |   |   |   | 25,794,864 |   |
| Depreciation and amortization         |   |               | 29,634     |   |      |   | 49,646 |   |   |   | 1,165,863 |   |
| Loss on disposal of assets            |   |               | -          |   |      |   | - |   |   |   | 500,562 |   |
| Operating loss                        |   |               | (1,306,853 | )      |      |   | (1,317,605 | ) |   |   | (94,985,287 | ) |
|                                  |   |               |       |   |      |   |   |   |   |   |   |   |
| Interest income                       |   |               | 211        |   |      |   | 185 |   |   |   | 1,357,696 |   |
| Other income and expense, net         |   |               | -          |   |      |   | - |   |   |   | 661,146 |   |
| Gain (loss) on extinguishment of debt |   |               | -          |   |      |   | - |   |   |   | 1,612,440 |   |
| Gain (loss) on derivative instruments |   |               | -          |   |      |   | - |   |   |   | 1,388,848 |   |
| Gain on sale of technology            |   |               | -          |   |      |   | - |   |   |   | 3,000,000 |   |
| Interest expense                      |   |               | (1,135     | )      |      |   | (105,075 | ) |   |   | (9,054,959 | ) |
| Net loss                              |   | $                  | (1,307,777 | )      |      | $      | (1,422,495 | ) |   | $ | (96,020,116 | ) |
|                                  |   |               |       |   |      |   |   |   |   |   |   |   |
|                                  |   |               |       |   |      |   |   |   |   |   |   |   |
| Basic and diluted loss per share      |   | $                  | (0.06      | )      |      | $      | (0.09 | ) |   |   |   |   |
|                                  |   |               |       |   |      |   |   |   |   |   |   |   |
| Weighted average shares outstanding   |   |               | 20,955,860 |   |      |   | 15,523,710 |   |   |   |   |   |

----

OPEXA THERAPEUTICS, INC.

|                                                           |   | Three Months Ended |       |   | Inception |   |
|----------------------------------------------------------------|--------|--------------------|------------|--------|-----------|--------|
|                                                           |   | March 31,          |       |   | through   |   |
|                                                           |   | 2011               |       |   | 2010      |   |   | March 31, 2011 |   |
| Cash flows from operating activities                           |   |               |       |   |      |   |   |   |   |
| Net loss                                                       |   | $                  | (1,307,777 | )      |      | $      | (1,422,495 | ) |   | $ | (96,020,116 | ) |
| Adjustments to reconcile net loss to net cash                  |   |               |       |   |      |   |   |   |   |   |   |   |
| used in operating activities                                   |   |               |       |   |      |   |   |   |   |   |   |   |
| Stock payable for acquired research and development            |   |               | -          |   |      |   | - |   |   |   | 112,440 |   |
| Stock issued for acquired research and development             |   |               | -          |   |      |   | - |   |   |   | 26,286,589 |   |
| Stock issued for services                                      |   |               | 87,028     |   |      |   | - |   |   |   | 2,061,743 |   |
| Stock issued for debt in excess of principal                   |   |               | -          |   |      |   | - |   |   |   | 109,070 |   |
| Amortization of discount on notes payable due                  |   |               |       |   |      |   |   |   |   |   |   |   |
| to warrants and beneficial conversion feature                  |   |               | -          |   |      |   | 51,166 |   |   |   | 6,752,698 |   |
| Loss (Gain) on extinguishment of debt                          |   |               | -          |   |      |   | - |   |   |   | (1,612,440 | ) |
| Depreciation                                                   |   |               | 29,634     |   |      |   | 49,646 |   |   |   | 1,165,863 |   |
| Amortization of debt financing costs                           |   |               | -          |   |      |   | 19,173 |   |   |   | 524,378 |   |
| Option expense                                                 |   |               | 95,470     |   |      |   | 105,358 |   |   |   | 15,180,763 |   |
| Loss on derivative instruments                                 |   |               | -          |   |      |   | - |   |   |   | (1,388,848 | ) |
| Loss on disposition of fixed assets                            |   |               | -          |   |      |   | - |   |   |   | 500,562 |   |
| Changes in:                                                    |   |               |       |   |      |   |   |   |   |   |   |   |
| Other current assets                                           |   |               | (28,249    | )      |      |   | (30,984 | ) |   |   | (530,447 | ) |
| Accounts payable - third parties and related parties           |   |               | 294,033    |   |      |   | (121,286 | ) |   |   | 217,820 |   |
| Accrued expenses                                               |   |               | 38,825     |   |      |   | 219,262 |   |   |   | 326,122 |   |
| Net cash used in operating activities                          |   |               | (791,036   | )      |      |   | (1,130,160 | ) |   |   | (46,313,803 | ) |
|                                                           |   |               |       |   |      |   |   |   |   |   |   |   |
| Cash flows from investing activities                           |   |               |       |   |      |   |   |   |   |   |   |   |
| Purchase of property & equipment                           |   |               | (194,034   | )      |      |   | - |   |   |   | (1,568,895 | ) |
| Net cash used in investing activities                          |   |               | (194,034   | )      |      |   | - |   |   |   | (1,568,895 | ) |
|                                                           |   |               |       |   |      |   |   |   |   |   |   |   |
| Cash flows from financing activities                           |   |               |       |   |      |   |   |   |   |   |   |   |
| Common stock and warrants sold for cash, net of offering costs |   |               | 8,618,157  |   |      |   | - |   |   |   | 49,072,488 |   |
| Common stock repurchased and canceled                          |   |               | -          |   |      |   | - |   |   |   | (325 | ) |
| Proceeds from exercise of warrants and options                 |   |               | -          |   |      |   | 56,966 |   |   |   | 1,248,588 |   |
| Proceeds from debt                                             |   |               | -          |   |      |   | - |   |   |   | 9,283,184 |   |
| Repayments on notes payable                                    |   |               | (17,637    | )      |      |   | (16,352 | ) |   |   | (293,252 | ) |
| Net cash provided by financing activities                      |   |               | 8,600,520  |   |      |   | 40,614 |   |   |   | 59,310,683 |   |
|                                                           |   |               |       |   |      |   |   |   |   |   |   |   |
| Net change in cash and cash equivalents                        |   |               | 7,615,450  |   |      |   | (1,089,546 | ) |   |   | 11,427,985 |   |
| Cash and cash equivalents at beginning of period               |   |               | 3,812,535  |   |      |   | 8,181,582 |   |   |   | - |   |
| Cash and cash equivalents at end of period                     |   | $                  | 11,427,985 |   |      | $      | 7,092,036 |   |   | $ | 11,427,985 |   |

|                                              |   |   |   |   |   |   |   |   |   |
|---------------------------------------------------|--------|--------|--------|--------|--------|--------|--------|--------|--------|
| Cash paid for:                                    |   |   |   |   |   |   |   |   |   |
| Income tax                                        |   | $      | -      |   |   | $      | -      |   |   | $ | - |   |
| Interest                                          |   |   | 1,135  |   |   | $      | 2,632  |   |   |   | 151,163 |   |
|                                              |   |   |   |   |   |   |   |   |   |   |   |   |
| NON-CASH TRANSACTIONS                             |   |   |   |   |   |   |   |   |   |   |   |   |
| Issuance of common stock to Sportan shareholders  |   |   | -      |   |   |   | -      |   |   |   | 147,733 |   |
| Issuance of common stock for accrued interest     |   |   | -      |   |   |   | -      |   |   |   | 603,604 |   |
| Issuance of warrants to placement agent           |   |   | -      |   |   |   | -      |   |   |   | 37,453 |   |
| Conversion of notes payable to common stock       |   |   | -      |   |   |   | -      |   |   |   | 7,709,980 |   |
| Conversion of accrued liabilities to common stock |   |   | -      |   |   |   | -      |   |   |   | 197,176 |   |
| Conversion of accounts payable to note payable    |   |   | -      |   |   |   | -      |   |   |   | 93,364 |   |
| Discount on convertible notes relating to:        |   |   | -      |   |   |   |   |   |   |   |   |   |
| Warrants                                          |   |   | -      |   |   |   | -      |   |   |   | 3,659,737 |   |
| Beneficial conversion feature                     |   |   | -      |   |   |   | -      |   |   |   | 1,805,519 |   |
| Stock attached to notes                           |   |   | -      |   |   |   | -      |   |   |   | 1,287,440 |   |
| Fair value of derivative instrument               |   |   | -      |   |   |   | -      |   |   |   | 4,680,220 |   |
| Derivative reclassified to equity                 |   |   | -      |   |   |   | -      |   |   |   | 587,609 |   |

----

OPEXA THERAPEUTICS, INC.

----

|                           |   | Number of Shares |      |   | Wtd. Avg. Exercise Price |   |   | Wtd. Avg. Remaining Contract Term (# years) |   |   | IntrinsicValue |   |
|--------------------------------|--------|------------------|-----------|--------|--------------------------|--------|--------|---------------------------------------------|--------|--------|----------------|--------|
| Outstanding at January 1, 2011 |   |             | 1,542,072 |   |                     | $      | 2.15   |                                        |   |   |           |   |   |   |
| Granted                        |   |             | 175,000   |   |                     |   | 1.56   |                                        |   |   |           |   |   |   |
| Exercised                      |   |             | -         |   |                     |   | -      |                                        |   |   |           |   |   |   |
| Forfeited and canceled         |   |             | -         |   |                     |   | -      |                                        |   |   |           |   |   |   |
|                           |   |             |      |   |                     |   |   |                                        |   |   |           |   |   |   |
| Oustanding at March 31, 2011   |   |             | 1,717,072 |   |                     | $      | 2.09   |                                        |   |   | 7.4            |   |   | $ | 770,385 |   |
|                           |   |             |      |   |                     |   |   |                                        |   |   |           |   |   |   |   |   |
| Exercisable at March 31, 2011  |   |             | 1,331,739 |   |                     | $      | 2.18   |                                        |   |   | 6.9            |   |   | $ | 734,802 |   |

----

|                           |   | Number of Shares |       |   | Wtd. Avg. Exercise Price |   |   | Wtd. Avg. Remaining Contract Term (# years) |   |   | Intrinsic Value |   |
|--------------------------------|--------|------------------|------------|--------|--------------------------|--------|--------|---------------------------------------------|--------|--------|-----------------|--------|
| Outstanding at January 1, 2011 |   |             | 11,459,576 |   |                     | $      | 2.75   |                                        |   |   |            |   |   |   |
| Granted                        |   |             | 1,658,600  |   |                     |   | 2.61   |                                        |   |   |            |   |   |   |
| Exercised                      |   |             | -          |   |                     |   | -      |                                        |   |   |            |   |   |   |
| Forfeited and canceled         |   |             | -          |   |                     |   | -      |                                        |   |   |            |   |   |   |
|                           |   |             |       |   |                     |   |   |                                        |   |   |            |   |   |   |
| Oustanding at March 31, 2011   |   |             | 13,118,176 |   |                     | $      | 2.73   |                                        |   |   | 2.0             |   |   | $ | 1,661,327 |   |
|                           |   |             |       |   |                     |   |   |                                        |   |   |            |   |   |   |   |   |
| Exercisable at March 31, 2011  |   |             | 13,118,176 |   |                     | $      | 2.73   |                                        |   |   | 2.0             |   |   | $ | 1,661,327 |   |

----

Item 2. 

----

| ●   | In the modified intent to treat patient population (n=142), the annualized relapse rate (ARR) for Tovaxin-treated patients was 0.214 as compared to 0.339 for placebo-treated patients, which represented a 37% decrease in ARR for Tovaxin as compared to placebo in the general population; |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| ●   | In a prospective group of patients with more active disease (ARR>1, n=50), Tovaxin demonstrated a 55% reduction in ARR as compared to placebo, and a 73% reduction in relapse rate was observed in Tovaxin patients in this population compared to placebo during the 24-week period following the administration of the full course of treatment; and |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| ●   | In a retrospective analysis in patients naïve to previous disease modifying treatment (i.e., patients who had not previously used any drugs other than steroids to treat their disease), the results showed that patients, when treated with Tovaxin, had a 64% reduction in ARR versus placebo (p=0.046, n=70). |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

----

----

----

Item 3. Quantitative 

Item 4. Controls and Procedures.

----

PART II

Item 1.  Legal Proceedings.

Item 1A.  Risk Factors.

| ●   | Our business is at an early stage of development. We are largely dependent on the success of our lead product candidate, Tovaxin, and we cannot be certain that Tovaxin will receive regulatory approval or be successfully commercialized. |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| ●   | We have a history of operating losses and do not expect to be profitable in the near future. |
|---------------------|----------------------------------------------------------------------------------------------|

| ●   | We will be required to raise significant additional capital, or secure a development partner, in the near-term, and our ability to obtain funding is uncertain. If sufficient capital is not available, we may not be able to continue our operations as proposed (including any clinical trial for Tovaxin), which may require us to modify our business plan, curtail various aspects of our operations, cease operations or seek relief under applicable bankruptcy laws. |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| ●   | We will depend on strategic collaborations with third parties to develop and commercialize product candidates, such as Tovaxin, and we may not have control over a number of key elements relating to the development and commercialization of any such product candidate. |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| ●   | We will need regulatory approvals for any product candidate, including Tovaxin, prior to introduction to the market, which will require successful testing in clinical trials. Clinical trials are subject to extensive regulatory requirements, and are very expensive, time-consuming and difficult to design and implement. Any product candidate, such as Tovaxin, may fail to achieve necessary safety and efficacy endpoints during clinical trials in which case we will be unable to generate revenue from the commercialization and sale of our products. |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| ●   | We will rely on third parties to conduct our clinical trials and perform data collection and analysis, which may result in costs and delays that may hamper our ability to successfully develop and commercialize any product candidate, including Tovaxin. |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| ●   | If we fail to identify and license or acquire other product candidates, we will not be able to expand our business over the long term. |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------|

| ●   | We are dependent upon our management team and a small number of employees. |
|---------------------|----------------------------------------------------------------------------|

| ●   | If we fail to meet our obligations under our license agreements, we may lose our rights to key technologies on which our business depends. |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------|

| ●   | Our current research and manufacturing facility is not large enough to manufacture product candidates, such as Tovaxin, for clinical trials or, if such clinical trials are successful, commercial applications. |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| ●   | If any product we may eventually have is not accepted by the market or if users of any such product are unable to obtain adequate coverage of and reimbursement for such product from government and other third-party payors, our revenues and profitability will suffer. |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| ●   | Any product candidate that we develop, such as Tovaxin, if approved for sale, may not gain acceptance among physicians, patients and the medical community, thereby limiting our potential to generate revenues. |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| ●   | We have incurred, and expect to continue to incur, increased costs and risks as a result of being a public company. |
|---------------------|---------------------------------------------------------------------------------------------------------------------|

----

| ●   | Patents obtained by other persons may result in infringement claims against us that are costly to defend and which may limit our ability to use the disputed technologies and prevent us from pursuing research and development or commercialization of potential products, such as Tovaxin. |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| ●   | If we are unable to obtain patent protection and other proprietary rights, our operations will be significantly harmed. |
|---------------------|-------------------------------------------------------------------------------------------------------------------------|

| ●   | Confidentiality agreements with employees and others may not adequately prevent disclosure of our trade secrets and other proprietary information and may not adequately protect our intellectual property, which could limit our ability to compete. |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| ●   | A dispute concerning the infringement or misappropriation of our proprietary rights or the proprietary rights of others could be time consuming and costly, and an unfavorable outcome could harm our business. |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| ●   | We are subject to stringent regulation of our product candidates, such as Tovaxin, which could delay development and commercialization. |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------|

| ●   | We may need to change our business practices to comply with health care fraud and abuse regulations, and our failure to comply with such laws could adversely affect our business, financial condition and results of operations. |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| ●   | If our competitors develop and market products that are more effective than our product candidates, they may reduce or eliminate our commercial opportunities. |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|

| ●   | Rapid technological change could make our products obsolete. |
|---------------------|--------------------------------------------------------------|

| ●   | Consumers may sue us for product liability, which could result in substantial liabilities that exceed our available resources and damage our reputation. |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|

| ●   | Health care reform measures could adversely affect our business. |
|---------------------|------------------------------------------------------------------|

| ●   | There is currently a limited market for our securities, and any trading market that exists in our securities may be highly illiquid and may not reflect the underlying value of our net assets or business prospects. |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| ●   | Our stock may be delisted from NASDAQ, which could affect its market price and liquidity. |
|---------------------|-------------------------------------------------------------------------------------------|

| ●   | As our share price is volatile, holders may not be able to resell our shares at a profit or at all. |
|---------------------|-----------------------------------------------------------------------------------------------------|

| ●   | We may be or become the target of securities litigation, which is costly and time-consuming to defend. |
|---------------------|--------------------------------------------------------------------------------------------------------|

| ●   | Our “blank check” preferred stock could be issued to prevent a business combination not desired by management or our current majority stockholders. |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|

| ●   | Future sales of our common stock in the public market could lower our stock price. |
|---------------------|------------------------------------------------------------------------------------|

| ●   | We presently do not intend to pay cash dividends on our common stock. |
|---------------------|-----------------------------------------------------------------------|

| ●   | Our stockholders may experience substantial dilution in the value of their investment if we issue additional shares of our capital stock. |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------|

| ●   | We may issue debt and equity securities or securities convertible into equity securities, any of which may be senior to our common stock as to distributions and in liquidation, which could negatively affect the value of our common stock. |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| ●   | Our management has significant flexibility in using the net proceeds of the February 2011 public offering. |
|---------------------|------------------------------------------------------------------------------------------------------------|

Item 2.
Unregistered 

Item 3.  Defaults Upon Senior Securities.

Item 4.  [Removed and Reserved]

----

Item 5.  Other Information.

|                                |                                                                                                                                                                                     |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|  Exhibit    No. | Description                                                                                                                                                                              |
|                                |                                                                                                                                                                                     |
| 4.1                                 | Form of Series H Warrant issued by the Company on February 11, 2011 (incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K filed February 8, 2011). |
|                                |                                                                                                                                                                                     |
| 31.1*                               | Certification of Chief Executive Officer and Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.                                                          |
|                                |                                                                                                                                                                                     |
| 32.1*                               | Certification of Chief Executive Officer and Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.                                                          |

| * | Filed herewith |
|---|----------------|

----

SIGNATURES

|                    | OPEXA THERAPEUTICS, INC. |
|-------------------------|--------------------------|
|                    |                     |   |
| Date: May 6, 2011  | By:                      | /s/  Neil K. Warma         |
|                    |                     | Neil K. WarmaPresident and Chief Executive Officer(Principal Executive Officer)Acting Chief Financial Officer(Principal Financial and Accounting Officer) |

----

| ExhibitNo.      | Description                                                                                                                                                                              |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|                                     |                                                                                                                                                                                     |
| 4.1                                      | Form of Series H Warrant issued by the Company on February 11, 2011 (incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K filed February 8, 2011). |
|                                     |                                                                                                                                                                                     |
| 31.1*                                    | Certification of Chief Executive Officer and Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.                                                          |
|                                     |                                                                                                                                                                                     |
| 32.1*                                    | Certification of Chief Executive Officer and Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.                                                          |

| * | Filed herewith |
|---|----------------|