OPEXA THERAPEUTICS, INC., 10-Q filed on 8/11/2011
Quarterly Report
Document and Entity Information
6 Months Ended
Jun. 30, 2011
Jul. 31, 2011
Document Type
10-Q 
 
Amendment Flag
FALSE 
 
Document Period End Date
Jun. 30, 2011 
 
Document Fiscal Year Focus
2011 
 
Document Fiscal Period Focus
Q2 
 
Trading Symbol
OPXA 
 
Entity Registrant Name
OPEXA THERAPEUTICS, INC. 
 
Entity Central Index Key
0001069308 
 
Current Fiscal Year End Date
--12-31 
 
Entity Filer Category
Smaller Reporting Company 
 
Entity Common Stock, Shares Outstanding
 
23,048,488 
BALANCE SHEETS (USD $)
Jun. 30, 2011
Dec. 31, 2010
Current assets:
 
 
Cash and cash equivalents
$ 9,876,675 
$ 3,812,535 
Other current assets
119,619 
85,525 
Total current assets
9,996,294 
3,898,060 
Property & equipment, net of accumulated depreciation of $1,196,500 and $1,109,558, respectively
930,141 
815,958 
Total assets
10,926,435 
4,714,018 
Current liabilities:
 
 
Accounts payable
495,838 
358,837 
Accounts payable - related parties
15,000 
15,000 
Accrued expenses
243,987 
335,861 
Current maturity of loan payable
 
35,607 
Total current liabilities
754,825 
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
107,447,625 
98,496,382 
Deficit accumulated during the development stage
(97,506,500)
(94,712,339)
Total stockholders' equity
10,171,610 
3,968,713 
Total liabilities and stockholders' equity
$ 10,926,435 
$ 4,714,018 
BALANCE SHEETS (Parenthetical) (USD $)
Jun. 30, 2011
Dec. 31, 2010
Property & equipment, accumulated depreciation
$ 1,196,500 
$ 1,109,558 
Preferred stock, no par value
$ 0 
$ 0 
Preferred stock, authorized
10,000,000 
10,000,000 
Preferred stock, issued
Preferred stock, outstanding
Common stock, par value
$ 0.01 
$ 0.01 
Common stock, shares authorized
100,000,000 
100,000,000 
Common stock, shares issued
23,048,488 
18,466,924 
Common stock, shares outstanding
23,048,488 
18,466,924 
STATEMENTS OF EXPENSES (USD $)
3 Months Ended
Jun. 30,
6 Months Ended
Jun. 30,
2011
2010
2011
2010
102 Months Ended
Jun. 30, 2011
Research and development
$ 854,208 
$ 785,103 
$ 1,539,369 
$ 1,568,637 
$ 68,378,206 
General and administrative
560,834 
595,424 
1,152,892 
1,079,849 
26,355,698 
Depreciation and amortization
70,732 
48,729 
100,366 
98,375 
1,236,595 
Loss on disposal of assets
 
 
 
 
500,562 
Operating loss
(1,485,774)
(1,429,256)
(2,792,627)
(2,746,861)
(96,471,061)
Interest income
260 
395 
471 
580 
1,357,956 
Other income and expense, net
 
 
 
 
661,146 
Gain 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
(870)
(392,121)
(2,005)
(497,196)
(9,055,829)
Net loss
$ (1,486,384)
$ (1,820,982)
$ (2,794,161)
$ (3,243,477)
$ (97,506,500)
Basic and diluted loss per share
$ (0.06)
$ (0.12)
$ (0.13)
$ (0.21)
 
Weighted average shares outstanding
23,048,488 
15,827,353 
22,007,955 
15,569,623 
 
STATEMENTS OF CASH FLOWS (USD $)
6 Months Ended
Jun. 30,
2011
2010
102 Months Ended
Jun. 30, 2011
Cash flows from operating activities
 
 
 
Net loss
$ (2,794,161)
$ (3,243,477)
$ (97,506,500)
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
 
314,749 
6,752,698 
Gain on extinguishment of debt
 
 
(1,612,440)
Depreciation
100,366 
98,375 
1,236,595 
Amortization of debt financing costs
 
108,116 
524,378 
Option expense
291,873 
305,294 
15,377,166 
Loss on derivative instruments
 
 
(1,388,848)
Loss on disposal of assets
 
 
500,562 
Changes in:
 
 
 
Other current assets
(34,094)
(14,857)
(536,292)
Accounts payable - third parties and related parties
100,534 
(118,218)
24,321 
Accrued expenses
(97,806)
183,204 
189,491 
Net cash used in operating activities
(2,346,260)
(2,366,814)
(47,869,027)
Cash flows from investing activities
 
 
 
Purchase of property & equipment
(172,150)
 
(1,547,011)
Net cash used in investing activities
(172,150)
 
(1,547,011)
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
 
92,868 
1,248,588 
Proceeds from debt
 
 
9,283,184 
Repayments on notes payable
(35,607)
(33,022)
(311,222)
Net cash provided by financing activities
8,582,550 
59,846 
59,292,713 
Net change in cash and cash equivalents
6,064,140 
(2,306,968)
9,876,675 
Cash and cash equivalents at beginning of period
3,812,535 
8,181,582 
 
Cash and cash equivalents at end of period
9,876,675 
5,874,614 
9,876,675 
Cash paid for:
 
 
 
Income tax
 
 
 
Interest
2,005 
83,040 
152,033 
NON-CASH TRANSACTIONS
 
 
 
Issuance of common stock to Sportan shareholders
 
 
147,733 
Issuance of common stock for accrued interest
 
78,091 
603,604 
Issuance of warrants to placement agent
 
 
37,453 
Conversion of notes payable to common stock
 
1,302,000 
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 
Unpaid additions to property and equipment
$ 42,399 
 
$ 42,399 
Basis of Presentation
Basis of Presentation
Note 1.  Basis of Presentation

The accompanying unaudited interim financial statements of Opexa Therapeutics, Inc. (“Opexa”), a development stage company, have been prepared in accordance with accounting principles generally accepted in the United States of America and the rules of the Securities and Exchange Commission and should be read in conjunction with the audited financial statements and notes thereto contained in Opexa’s latest Annual Report on Form 10-K filed with the SEC. In the opinion of management, all adjustments, consisting of normal recurring adjustments, necessary for a fair presentation of financial position and the results of operations for the interim periods presented have been reflected herein. The results of operations for interim periods are not necessarily indicative of the results to be expected for the full year. Notes to the financial statements that would substantially duplicate the disclosure contained in the audited financial statements for the most recent fiscal year as reported in Form 10-K, have been omitted.

Recently Issued Accounting Pronouncements

From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (FASB) or other standard setting bodies that are adopted by Opexa as of the specified effective date. Unless otherwise discussed, Opexa believes that the impact of recently issued accounting pronouncements that are not yet effective will not have a material impact on their financial position or results of operations upon adoption.
Cash and Cash Equivalents
Cash and Cash Equivalents
Note 2.  Cash and Cash Equivalents

Opexa considers all highly liquid investments with an original maturity of three months or less, when purchased, to be cash equivalents. Investments with maturities in excess of three months but less than one year are classified as short-term investments and are stated at fair market value.

At June 30, 2011, Opexa invested approximately $9.7 million in a money market fund investing exclusively in high-quality, short-term money market instruments consisting of U.S. government obligations and repurchase agreements collateralized by the U.S. Government. While this fund seeks current income while preserving capital and liquidity, the fund is subject to risk, including U.S. government obligations risk. For the six months ended June 30, 2011, the money market fund recognized an average market yield of 0.01%. Interest income of $471 was recognized for the six months ended June 30, 2011 in the statements of expenses.
Commitments and Contingencies
Commitments and Contingencies
Note 3.  Commitments and Contingencies
 
Stem Cell Technology Agreement
 
In 2009, Novartis Pharmaceuticals acquired Opexa’s stem cell technology platform, which had been in early preclinical development, and took over all future responsibilities and opportunities for this technology, although Opexa retains an option on certain manufacturing rights. As part of the transaction, Opexa was paid an upfront fee of $3 million and a milestone payment of $500,000 for certain technology transfer activities. Opexa remains eligible to receive a second technology transfer milestone fee in addition to potential clinical and commercial milestones and royalty payments from the sale of any products resulting from the use of the technology. However, there can be no assurance that Opexa will receive any future payments in respect of the stem cell technology.
Equity
Equity
Note 4. Equity
 
In January 2011, Opexa sold an aggregate of 384,759 shares of common stock under the Continuous Offering Program Agreement dated May 14, 2010 (the “ATM Agreement”) for net proceeds of $1,033,994. Opexa paid compensation and fees totaling $10,826 to the placement agent with respect to the shares sold.  The ATM Agreement was subsequently terminated by Opexa on February 7, 2011.
 
 
In February 2011, Opexa sold an aggregate of 4,146,500 units in a public offering, with each unit consisting of one share of common stock and a warrant to purchase four-tenths (0.40) of a share of common stock, at a price to the public of $2.05 per unit, for gross proceeds of $8,500,325. The shares of common stock and warrants were immediately separable and were issued separately such that no units were issued. The warrants were exercisable immediately upon issuance, having a five-year term and an exercise price of $2.61 per share. The warrants have a fair value of $3,236,584 that was calculated using the Black-Scholes valuation model using the following assumptions:  (1) discount rate of 2.38%, (2) term of 5 years, (3) expected volatility of 197.60% and (4) zero expected dividends. The net proceeds to Opexa from this offering were approximately $7,584,163, after deducting underwriting discounts and commissions and other offering expenses. The offering closed on February 11, 2011.
Stock-Based Compensation
Stock-Based Compensation
Note 5.  Stock-Based Compensation

Restricted Shares
 
Pursuant to an agreement with a consultant for professional services, Opexa granted 50,305 restricted shares of common stock which were accounted for on March 19, 2011 pursuant to the relevant accounting rules. These shares vested immediately and were issued on April 8, 2011 and have a fair value of $87,028 based on the share price at the grant date, which was recognized as share-based compensation expense for the six months ended June 30, 2011.

Stock Options
 
      The 2010 Stock Incentive Plan (the “2010 Plan”) provides for the grant of equity incentive awards to employees, directors and consultants of Opexa in the form of either incentive stock options or nonqualified stock options, as well as restricted stock, stock appreciation rights, restricted stock units and performance awards that may be settled in cash, stock or other property.  The 2010 Plan is the successor to and continuation of Opexa’s June 2004 Compensatory Stock Option Plan (the “2004 Plan”). A total of 2,500,000 shares of common stock are authorized to be issued for awards made under the 2010 Plan through September 2020, plus (i) the number of shares subject to stock options outstanding under the 2004 Plan that are forfeited or terminate prior to exercise and would otherwise be returned to the share reserves under the 2004 Plan and (ii) any reserved shares under the 2004 Plan that were not issued or subject to outstanding grants.  In addition, shares subject to awards granted under the 2010 Plan that terminate or expire before being exercised or settled will become available for grant under the 2010 Plan. As of June 30, 2011, options to purchase an aggregate of 1,739,072 shares were issued and outstanding.

Opexa accounts for share-based compensation, including options and nonvested shares, according to the provisions of FASB ASC 718, "Share Based Payment.” During the six months ended June 30, 2011, Opexa recognized share-based compensation expense of $291,873. Unamortized stock compensation expense as of June 30, 2011 amounted to $549,350.

Stock Option Activity
     
         A summary of stock option activity for the six months ended June 30, 2011 is presented below:
 
   
Number of
Shares
   
Wtd. Avg.
Exercise Price
   
Wtd. Avg.
Remaining
Contract Term
(# years)
   
Intrinsic
Value
 
Outstanding at January 1, 2011
    1,542,072     $ 2.15              
Granted
    272,000       1.64              
Exercised
    -       -              
Forfeited and canceled
    (75,000 )     5.00              
                             
Outstanding at June 30, 2011
    1,739,072     $ 1.94       7.6     $ 689,579  
                                 
Exercisable at June 30, 2011
    1,382,655     $ 1.99       7.2     $ 683,417  
 
Option awards are granted with an exercise price equal to the market price of Opexa’s stock at the date of issuance, generally have a ten-year life, and have various vesting dates that range from no vesting or partial vesting upon date of grant to full vesting on a specified date. Opexa estimates the fair value of stock options using the Black-Scholes option-pricing model and records the compensation expense ratably over the service period.

Employee Options

During the six months ended June 30, 2011, options to purchase an aggregate of 175,000 shares were granted to employees, based on 2010 performance objectives, at an exercise price of $1.56. These options have terms of 10 years and have a vesting schedule of three years. Fair value of $268,451 was calculated using the Black-Scholes option-pricing model.  Variables used in the Black-Scholes option-pricing model for the options issued during the six month period ended June 30, 2011 include (1) discount rate of 3.36%, (2) expected term of 6 years, (3) expected volatility of 192.44% and (4) zero expected dividends.
 
Non-Employee Options

During the six months ended June 30, 2011, options to purchase an aggregate of 82,000 shares were granted to non-employee directors for service on Opexa’s Board at an exercise price of $1.78. Options to purchase an aggregate of 40,000 shares have terms of 10 years, with 50% of the shares vesting immediately and 50% vesting in one year from the date of grant. Options to purchase the remaining 42,000 shares will expire on the earlier of 10 years or a change in control of the Company, with 50% of the shares vesting immediately and 50% vesting on December 31, 2011. Fair value of $142,877 was calculated using the Black-Scholes option-pricing model.

During the six months ended June 30, 2011, an option to purchase 15,000 shares was granted to a consultant at an exercise price of $1.78. This option has a term of 10 years, with 50% of the shares vesting immediately and 50% vesting on December 31, 2011. Fair value of $26,136 was calculated using the Black-Scholes option-pricing model.

Variables used in the Black-Scholes option-pricing model for the options issued during the six months ended June 30, 2011 include (1) discount rate of 3.50%, (2) expected term of 5.3 years, (3) expected volatility of 198.22% and (4) zero expected dividends.

Warrant Activity

A summary of warrant activity for the six months ended June 30, 2011 is presented below:
 
 
   
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
    (2,687,890 )     5.93              
                             
Outstanding at June 30, 2011
    10,430,286     $ 1.90       2.3     $ 1,528,849  
                                 
Exercisable at June 30, 2011
    10,430,286     $ 1.90       2.3     $ 1,528,849  
 
In connection with Opexa’s February 2011 public offering, as disclosed in Note 4, Opexa issued warrants to purchase an aggregate of 1,658,600 shares of common stock to the investors at an exercise price of $2.61 per share. These warrants have a term of five years and are immediately exercisable.