Document_and_Entity_Informatio
Document and Entity Information | 6 Months Ended | |
Jun. 30, 2014 | Aug. 01, 2014 | |
Document And Entity Information [Abstract] | ' | ' |
Document Type | '10-Q | ' |
Amendment Flag | 'false | ' |
Document Period End Date | 30-Jun-14 | ' |
Document Fiscal Year Focus | '2014 | ' |
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 | ' | 27,753,172 |
Consolidated_Balance_Sheets
Consolidated Balance Sheets (USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
Current assets: | ' | ' |
Cash and cash equivalents | $16,214,690 | $23,644,542 |
Other current assets | 1,481,526 | 1,122,576 |
Total current assets | 17,696,216 | 24,767,118 |
Property & equipment, net of accumulated depreciation of $1,905,854 and $1,718,477, respectively | 1,234,826 | 1,295,024 |
Other long-term assets | 162,045 | 177,666 |
Total assets | 19,093,087 | 26,239,808 |
Current liabilities: | ' | ' |
Accounts payable | 835,570 | 696,155 |
Accrued expenses | 1,627,271 | 1,232,990 |
Deferred revenue | 1,230,746 | 1,395,348 |
Total current liabilities | 3,693,587 | 3,324,493 |
Long term liabilities: | ' | ' |
Deferred revenue, net of current portion | 1,846,120 | 2,338,041 |
Total liabilities | 5,539,707 | 5,662,534 |
Commitments and contingencies | 0 | 0 |
Stockholders' equity: | ' | ' |
Preferred stock, no par value, 10,000,000 shares authorized, none issued and outstanding | 0 | 0 |
Common stock, $0.01 par value, 100,000,000 shares authorized, 27,661,675 and 27,546,058 shares issued and outstanding | 276,617 | 275,461 |
Additional paid in capital | 147,363,541 | 146,569,758 |
Deficit accumulated during the development stage | -134,086,778 | -126,267,945 |
Total stockholders' equity | 13,553,380 | 20,577,274 |
Total liabilities and stockholders' equity | $19,093,087 | $26,239,808 |
Consolidated_Balance_Sheets_Pa
Consolidated Balance Sheets (Parenthetical) (USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
Statement of Financial Position [Abstract] | ' | ' |
Property & equipment, accumulated depreciation | $1,905,854 | $1,718,477 |
Preferred stock, no par value | $0 | $0 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $0.01 | $0.01 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 27,661,675 | 27,546,058 |
Common stock, shares outstanding | 27,661,675 | 27,546,058 |
Consolidated_Statements_of_Ope
Consolidated Statements of Operations (USD $) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 | |
Revenue: | ' | ' | ' | ' |
Option Revenue | $307,686 | $348,837 | $656,523 | $568,937 |
Research and development | 3,409,210 | 2,223,030 | 6,220,349 | 3,844,396 |
General and administrative | 967,367 | 750,605 | 2,070,247 | 1,853,040 |
Depreciation and amortization | 98,658 | 88,898 | 194,244 | 167,209 |
Operating loss | -4,167,549 | -2,713,696 | -7,828,317 | -5,295,708 |
Interest income | 4,290 | 3,066 | 9,484 | 4,940 |
Other income and expense, net | ' | ' | ' | 37,910 |
Interest expense | ' | -285,800 | ' | -1,921,054 |
Net loss | ($4,163,259) | ($2,996,430) | ($7,818,833) | ($7,173,912) |
Basic and diluted loss per share | ($0.15) | ($0.37) | ($0.28) | ($0.94) |
Weighted average shares outstanding - Basic and diluted | 27,661,675 | 7,991,559 | 27,623,358 | 7,617,409 |
Consolidated_Statements_of_Cha
Consolidated Statements of Changes in Stockholders' Equity (USD $) | Common Stock | Additional Paid-In Capital | Accumulated Deficit | Total |
Beginning Balance, Amount at Dec. 31, 2013 | $275,461 | $146,569,758 | ($126,267,945) | $20,577,274 |
Beginning Balance, Shares at Dec. 31, 2013 | 27,546,058 | ' | ' | ' |
Shares issued for services, Shares | 115,617 | ' | ' | ' |
Shares issued for services, Amount | 1,156 | 152,314 | ' | 153,470 |
Shares subscribed under the at-the-market program | ' | 49,847 | ' | 49,847 |
Option expense | ' | 591,622 | ' | 591,622 |
Net loss | ' | ' | -7,818,833 | -7,818,833 |
Ending Balance, Amount at Jun. 30, 2014 | $276,617 | $147,363,541 | ($134,086,778) | $13,553,380 |
Ending Balance, Shares at Jun. 30, 2014 | 27,661,675 | ' | ' | ' |
Consolidated_Statements_of_Cas
Consolidated Statements of Cash Flows (USD $) | 6 Months Ended | |
Jun. 30, 2014 | Jun. 30, 2013 | |
Cash flows from operating activities | ' | ' |
Net loss | ($7,818,833) | ($7,173,912) |
Adjustments to reconcile net loss to net cash provided by (used in) operating activities | ' | ' |
Restricted stock issued to employees | 153,470 | 0 |
Amortization of discount on notes payable due to warrants and beneficial conversion feature | 0 | 1,382,977 |
Depreciation | 194,244 | 167,209 |
Amortization of debt financing costs | 0 | 98,964 |
Option and warrant expense | 591,622 | 714,871 |
Changes in: | ' | ' |
Other current assets | -309,103 | -369,383 |
Accounts payable - third parties and related parties | 132,591 | 635,368 |
Accrued expenses | 394,281 | 637,636 |
Deferred revenue | -656,523 | 4,431,063 |
Other assets | 15,621 | -96,064 |
Net cash provided by (used in) operating activities | -7,302,630 | 428,729 |
Cash flows from investing activities | ' | ' |
Purchase of property & equipment | -127,222 | -22,894 |
Restricted cash | 0 | 500,000 |
Net cash provided by (used in) investing activities | -127,222 | 477,106 |
Cash flows from financing activities | ' | ' |
Common stock and warrants sold for cash, net of offering costs | 0 | 3,578,288 |
Proceeds from convertible debt | 0 | 550,000 |
Proceeds from related party debt | 0 | 100,000 |
Deferred financing and offering costs | 0 | -147,847 |
Repayment on related party notes payable | 0 | -100,000 |
Repayments on notes payable | 0 | -450,000 |
Net cash provided by financing activities | 0 | 3,530,441 |
Net change in cash and cash equivalents | -7,429,852 | 4,436,276 |
Cash and cash equivalents at beginning of period | 23,644,542 | 592,004 |
Cash and cash equivalents at end of period | 16,214,690 | 5,028,280 |
Cash paid for: | ' | ' |
Interest | 0 | 19,128 |
NON-CASH TRANSACTIONS | ' | ' |
Conversion of notes payable to common stock | 0 | 1,000,000 |
Discount on convertible notes relating to: | ' | ' |
Warrants | 0 | 195,969 |
Beneficial conversion feature | 0 | 141,829 |
Unpaid additions to property and equipment | 6,825 | 108,607 |
Subscription receivable | 49,847 | 0 |
Shares issued as deferred offering costs | $0 | $1,234 |
1_Basis_of_Presentation
1. Basis of Presentation | 6 Months Ended |
Jun. 30, 2014 | |
Accounting Policies [Abstract] | ' |
Basis of Presentation | ' |
The accompanying interim unaudited consolidated financial statements of Opexa Therapeutics, Inc. (“Opexa” or the “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 (“SEC”) and should be read in conjunction with the audited financial statements and notes thereto contained in Opexa’s latest Annual Report filed with the SEC on Form 10-K. 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. | |
The accompanying consolidated financial statements include the accounts of Opexa and its wholly owned subsidiary, Opexa Hong Kong Limited (“Opexa Hong Kong”). All intercompany balances and transactions have been eliminated in the consolidation. | |
During the six months ended June 30, 2014, the Company has elected to early adopt Accounting Standards Update No. 2014-10, Development Stage Entities (Topic 915): Elimination of Certain Financial Reporting Requirements. The adoption of this ASU allows the Company to remove the inception to date information and all references to development stage. |
2_Significant_Accounting_Polic
2. Significant Accounting Polices | 6 Months Ended |
Jun. 30, 2014 | |
Accounting Policies [Abstract] | ' |
Significant Accounting Polices | ' |
Revenue Recognition. Opexa recognizes revenue in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 605, “Revenue Recognition.” ASC 605 requires that four basic criteria must be met before revenue can be recognized: (1) persuasive evidence of an arrangement exists; (2) delivery has occurred or services rendered; (3) consideration is fixed or determinable; and (4) collectability is reasonably assured. | |
On February 4, 2013, Opexa entered into an Option and License Agreement (the “Merck Agreement”) with Ares Trading SA (“Merck”), a wholly owned subsidiary of Merck Serono S.A. Pursuant to the terms, Merck has an option to acquire an exclusive, worldwide (excluding Japan) license of the Company’s Tcelna® program for the treatment of multiple sclerosis (“MS”). Tcelna is currently in a Phase IIb clinical trial in patients with Secondary Progressive MS (“SPMS”). The option may be exercised by Merck prior to or upon the Company’s completion of the Phase IIb Trial. | |
Opexa received an upfront payment of $5 million for granting the option. If the option is exercised, Merck would pay the Company an upfront license fee of $25 million unless Merck is unable to advance directly into a Phase III clinical trial of Tcelna for SPMS without a further Phase II clinical trial (as determined by Merck), in which event the upfront license fee would be $15 million. After exercising the option, Merck would be solely responsible for funding development, regulatory and commercialization activities for Tcelna in MS, although the Company would retain an option to co-fund certain development in exchange for increased royalty rates. The Company would also retain rights to Tcelna in Japan, certain rights with respect to the manufacture of Tcelna, and rights outside of MS. | |
Opexa evaluated the Merck Agreement and determined that the $5 million upfront payment from Merck has “stand-alone value.” Opexa’s continuing performance obligations, in connection with the $5 million payment, include the execution and completion of the Phase IIb clinical trial in SPMS using commercially reasonable efforts at the Company’s own costs. As a “stand-alone value” term in the Merck Agreement, the $5 million upfront payment is determined to be a single unit of accounting, and is recognized as revenue on a straight-line basis over the exclusive option period based on the expected completion term of the Phase IIb clinical trial in SPMS. Opexa includes the unrecognized portion of the $5 million as deferred revenue on the consolidated balance sheets. During the second quarter of 2014, Opexa adjusted the number of months over which it was recognizing the deferred revenue from 43 to 47 months. This extension will align the period for recognition of the revenue to the present projection for expiration of the Merck Agreement. | |
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. | |
Opexa primarily maintains cash balances on deposit in accounts at a U.S.-based financial institution. The aggregate cash balance on deposit in these accounts is insured by the Federal Deposit Insurance Corporation up to $250,000. Opexa’s cash balances on deposit in these accounts may, at times, exceed the federally insured limits. Opexa has not experienced any losses in such accounts. | |
At June 30, 2014, Opexa has approximately $15.5 million in a savings account. For the six months ended June 30, 2014, the savings account recognized an average market yield of 0.10%. Interest income of $9,484 was recognized for the six months ended June 30, 2014 in the consolidated statements of operations. |
3_Other_Current_Assets
3. Other Current Assets | 6 Months Ended | ||||||||
Jun. 30, 2014 | |||||||||
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ' | ||||||||
Other Current Assets | ' | ||||||||
Other current assets consisted of the following at June 30, 2014 and December 31, 2013: | |||||||||
Description | 30-Jun-14 | 31-Dec-13 | |||||||
Prepaid expenses | $ | 670,041 | $ | 315,014 | |||||
Subscriptions receivable | 49,847 | ||||||||
Supplies inventory | 599,572 | 673,044 | |||||||
Deferred offering costs | 162,066 | 134,518 | |||||||
1,481,526 | 1,122,576 | ||||||||
Prepaid expenses at June 30, 2014 and December 31, 2013 include advance payments totaling $415,685 and $21,982, respectively, made to vendors and consultants for the conduct of the Phase IIb clinical trial in SPMS. | |||||||||
Prepaid expenses at June 30, 2014 and December 31, 2013 also include costs incurred from third parties in connection with the Merck Agreement (see Note 2). As of June 30, 2014 and December 31, 2013, the remaining costs of $38,938 in connection with the Merck Agreement that are expected to be amortized over the upcoming 12-month period are capitalized and included in other current assets in the consolidated balance sheets. The remaining costs of $58,409 in connection with the Merck Agreement that are expected to be amortized beyond the upcoming 12-month period are capitalized and included in other long term assets in the consolidated balance sheets (see Note 4). | |||||||||
Supplies inventory at June 30, 2014 and December 31, 2013 includes reagents and supplies that will be used to manufacture Tcelna and placebo product in Opexa’s Phase IIb clinical study. Opexa expects to amortize these prepaid reagents and supplies to research and development costs in the consolidated statements of operations over the course of the clinical study. | |||||||||
Deferred offering costs at June 30, 2014 and December 31, 2013 include costs incurred from third parties in connection with the implementation of a $1.5 million Purchase Agreement in November 2012 pursuant to which Opexa has the right to sell to Lincoln Park Capital Fund, LLC (“Lincoln Park”) up to $1.5 million in shares of its common stock, subject to certain conditions and limitations. As of June 30, 2014 and December 31, 2013, the remaining costs of $134,518 in connection with the implementation of the $1.5 million Purchase Agreement remained capitalized and are included in other current assets in the consolidated balance sheets. Upon the sales of shares of common stock under the $1.5 million Purchase Agreement, the remaining capitalized costs are offset against the proceeds of such sales of shares of common stock. | |||||||||
Deferred offering costs at June 30, 2014 also include costs incurred from third parties in connection with the implementation of an at-the-market program (“ATM Agreement”) in March 2014 pursuant to which Opexa may sell shares of its common stock from time to time depending upon market demand through a sales agent in transactions deemed to be an “at-the-market” offering as defined in Rule 415 of the Securities Act of 1933. As of June 30, 2014, the remaining costs of $27,548 in connection with the implementation of the ATM Agreement remained capitalized and are included in other current assets in the consolidated balance sheets. Upon the sales of shares of common stock under the ATM Agreement, the remaining capitalized costs are offset against the proceeds of such sales of shares of common stock. | |||||||||
4_Other_Long_Term_Assets
4. Other Long Term Assets | 6 Months Ended |
Jun. 30, 2014 | |
Text Block [Abstract] | ' |
Other Long Term Assets | ' |
Other long term assets at June 30, 2014 and December 31, 2013 include deferred offering costs of $103,636 which were incurred from third parties in connection with the implementation of a $15.0 million Purchase Agreement in November 2012 pursuant to which Opexa has the right to sell to Lincoln Park up to $15.0 million in shares of its common stock, subject to certain conditions and limitations. | |
Other long term assets at June 30, 2014 and December 31, 2013 also include costs incurred from third parties in connection with the Merck Agreement (see Note 2) amount to $58,409 that are expected to be amortized beyond the upcoming 12-month period. | |
5_Equity
5. Equity | 6 Months Ended | |
Jun. 30, 2014 | ||
Equity [Abstract] | ' | |
Equity | ' | |
For the six months ended June 30, 2014, equity related transactions were as follows: | ||
● | Opexa recognized stock based compensation expense of $77,814 during the six months ended June 30, 2014 related to shares of restricted common stock issued to certain members of Opexa’s management on November 8, 2013. The shares vested in full on February 28, 2014. | |
● | On February 28, 2014, 109,617 shares of restricted common stock with an aggregate fair value of $199,503 were issued to certain members of Opexa’s management and certain non-employee directors for service on Opexa’s Board. Opexa recognized stock based compensation expense of $71,656 related to these shares during the six months ended June 30, 2014. The restricted shares issued to management vest in full on the earlier of the first anniversary of the grant date or termination of employment without cause following a change of control. The restricted shares issued to non-employee directors vest in four quarterly increments beginning on March 31, 2014. | |
● | On March 19, 2014, 6,000 shares of restricted common stock with an aggregate fair value of $12,000 were issued to a non-employee director for service on Opexa’s Board. Opexa recognized stock based compensation of $4,000 related to these shares during the six months ended June 30, 2014. The shares vest in three quarterly increments beginning on June 30, 2014. | |
● | In late June 2014, Opexa sold an aggregate of 30,700 shares of common stock under the ATM Agreement for gross and net proceeds of $51,390 and $49,847, respectively. These sales settled and the shares were issued in early July 2014. |
6_StockBased_Compensation
6. Stock-Based Compensation | 6 Months Ended | ||||||||||||||||
Jun. 30, 2014 | |||||||||||||||||
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ' | ||||||||||||||||
Stock-Based Compensation | ' | ||||||||||||||||
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 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 625,000 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, 2014, options to purchase an aggregate of 2,465,691 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, 2014, Opexa recognized option expense of $591,622. Unamortized stock compensation expense as of June 30, 2014 amounted to $1,783,965. | |||||||||||||||||
Stock Option Activity | |||||||||||||||||
A summary of stock option activity for the six months ended June 30, 204 is presented below: | |||||||||||||||||
Number of | Wtd. Avg. | Wtd. Avg. | Intrinsic | ||||||||||||||
Shares | Exercise | Remaining | Value | ||||||||||||||
Price | Contract Term | ||||||||||||||||
(# years) | |||||||||||||||||
Outstanding at January 1, 2014 | 1,162,449 | $ | 4.3 | ||||||||||||||
Granted | 1,350,440 | 1.82 | |||||||||||||||
Exercised | - | - | |||||||||||||||
Forfeited and canceled | (47,198 | ) | 3.4 | ||||||||||||||
Outstanding at June 30, 2014 | 2,465,691 | $ | 2.96 | 8.5 | $ | 43,363 | |||||||||||
Exercisable at June 30, 2014 | 828,235 | $ | 4.83 | 6.7 | $ | 41,848 | |||||||||||
Employee Options: | |||||||||||||||||
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. | |||||||||||||||||
During the six months ended June 30, 2014, performance-based options to purchase an aggregate of 510,125 shares at an exercise price of $1.82 were granted to senior management. These options have a term of ten years and vest 100% upon the earlier of achievement of a performance-based, strategic milestone objective or termination of employment without cause following a change of control. Fair value of $918,554 was calculated using the Black-Scholes option-pricing model. Variables used in the Black-Scholes option-pricing model for these options include (1) discount rate of 2.65%, (2) expected term of 10 years, (3) expected volatility of 172% and (4) zero expected dividends. | |||||||||||||||||
During the six months ended June 30, 2014, time-based options to purchase an aggregate of 719,875 shares at exercise prices ranging from $1.65 to $1.82 were granted to employees. These options have a term of ten years and have a vesting schedule of the earlier of four years or termination of employment without cause following a change of control. Fair value of $1,274,918 was calculated using the Black-Scholes option-pricing model. Variables used in the Black-Scholes option-pricing model for these options include (1) discount rate range of 2.63% and 2.79%, (2) expected term of 6.25 years, (3) expected volatility range of 182%-186% and (4) zero expected dividends. | |||||||||||||||||
During the six months ended June 30, 2014, options to purchase 47,198 shares were forfeited and cancelled. | |||||||||||||||||
Non-Employee Options: | |||||||||||||||||
During the six months ended June 30, 2014, options to purchase an aggregate of 120,440 shares at exercise prices ranging from $1.82 to $2.00 were granted to non-employee directors for service on Opexa’s Board. Options to purchase an aggregate of 78,858 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, 2014. Options to purchase an aggregate of 26,288 shares have terms of 10 years, with 50% of the shares vesting immediately and 50% vesting on February 28, 2015. An option to purchase 8,844 shares will expire on the earlier of 10 years or a change in control of the Company, with vesting in quarterly increments beginning on March 31, 2014. An option to purchase 6,450 shares will expire on the earlier of 10 years or a change in control of the Company, with vesting in three quarterly increments beginning June 30, 2014. Fair value of $211,097 was calculated using the Black-Scholes option-pricing model. Variables used in the Black-Scholes option-pricing model for these options include (1) discount rate range of 2.65% and 2.77%, (2) expected term of 5.25 years, (3) expected volatility range of 155% and 157% and (4) zero expected dividends. | |||||||||||||||||
Restricted Stock | |||||||||||||||||
See Note 5 for a description of restricted stock awards made to employees and non-employee directors under the 2010 Plan during the six months ended June 30, 2014. | |||||||||||||||||
Warrant Activity | |||||||||||||||||
A summary of warrant activity for the six months ended June 30, 2014 is presented below: | |||||||||||||||||
Number of | Wtd. Avg. | Wtd. Avg. | Intrinsic | ||||||||||||||
Shares | Exercise | Remaining | Value | ||||||||||||||
Price | Contract Term | ||||||||||||||||
(# years) | |||||||||||||||||
Outstanding at January 1, 2014 | 3,069,113 | $ | 4.12 | ||||||||||||||
Granted | - | - | |||||||||||||||
Exercised | - | - | |||||||||||||||
Forfeited and canceled | - | - | |||||||||||||||
Outstanding at June 30, 2014 | 3,069,113 | $ | 4.12 | 2.7 | $ | 186,750 | |||||||||||
Exercisable at June 30, 2014 | 3,069,113 | $ | 4.12 | 2.7 | $ | 186,750 | |||||||||||
7_Subsequent_events
7. Subsequent events | 6 Months Ended |
Jun. 30, 2014 | |
Subsequent Events [Abstract] | ' |
7. Subsequent events | ' |
Subsequent to June 30, 2014 and through August 1, 2014, Opexa issued an aggregate of 91,497 shares of common stock under the ATM Agreement for gross and net proceeds of $152,687 and $148,103, respectively. |
2_Significant_Accounting_Polic1
2. Significant Accounting Polices (Policies) | 6 Months Ended |
Jun. 30, 2014 | |
Accounting Policies [Abstract] | ' |
Revenue Recognition | ' |
Revenue Recognition. Opexa recognizes revenue in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 605, “Revenue Recognition.” ASC 605 requires that four basic criteria must be met before revenue can be recognized: (1) persuasive evidence of an arrangement exists; (2) delivery has occurred or services rendered; (3) consideration is fixed or determinable; and (4) collectability is reasonably assured. | |
On February 4, 2013, Opexa entered into an Option and License Agreement (the “Merck Agreement”) with Ares Trading SA (“Merck”), a wholly owned subsidiary of Merck Serono S.A. Pursuant to the terms, Merck has an option to acquire an exclusive, worldwide (excluding Japan) license of the Company’s Tcelna® program for the treatment of multiple sclerosis (“MS”). Tcelna is currently in a Phase IIb clinical trial in patients with Secondary Progressive MS (“SPMS”). The option may be exercised by Merck prior to or upon the Company’s completion of the Phase IIb Trial. | |
Opexa received an upfront payment of $5 million for granting the option. If the option is exercised, Merck would pay the Company an upfront license fee of $25 million unless Merck is unable to advance directly into a Phase III clinical trial of Tcelna for SPMS without a further Phase II clinical trial (as determined by Merck), in which event the upfront license fee would be $15 million. After exercising the option, Merck would be solely responsible for funding development, regulatory and commercialization activities for Tcelna in MS, although the Company would retain an option to co-fund certain development in exchange for increased royalty rates. The Company would also retain rights to Tcelna in Japan, certain rights with respect to the manufacture of Tcelna, and rights outside of MS. | |
Opexa evaluated the Merck Agreement and determined that the $5 million upfront payment from Merck has “stand-alone value.” Opexa’s continuing performance obligations, in connection with the $5 million payment, include the execution and completion of the Phase IIb clinical trial in SPMS using commercially reasonable efforts at the Company’s own costs. As a “stand-alone value” term in the Merck Agreement, the $5 million upfront payment is determined to be a single unit of accounting, and is recognized as revenue on a straight-line basis over the exclusive option period based on the expected completion term of the Phase IIb clinical trial in SPMS. Opexa includes the unrecognized portion of the $5 million as deferred revenue on the consolidated balance sheets. During the second quarter of 2014, Opexa adjusted the number of months over which it was recognizing the deferred revenue from 43 to 47 months. This extension will align the period for recognition of the revenue to the present projection for expiration of the Merck Agreement. | |
Cash and Cash Equivalents | ' |
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. | |
Opexa primarily maintains cash balances on deposit in accounts at a U.S.-based financial institution. The aggregate cash balance on deposit in these accounts is insured by the Federal Deposit Insurance Corporation up to $250,000. Opexa’s cash balances on deposit in these accounts may, at times, exceed the federally insured limits. Opexa has not experienced any losses in such accounts. | |
At June 30, 2014, Opexa has approximately $15.5 million in a savings account. For the six months ended June 30, 2014, the savings account recognized an average market yield of 0.10%. Interest income of $9,484 was recognized for the six months ended June 30, 2014 in the consolidated statements of operations. |
3_Other_Current_Assets_Tables
3. Other Current Assets (Tables) | 6 Months Ended | ||||||||
Jun. 30, 2014 | |||||||||
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ' | ||||||||
Other Current Assets | ' | ||||||||
Description | 30-Jun-14 | 31-Dec-13 | |||||||
Prepaid expenses | $ | 670,041 | $ | 315,014 | |||||
Subscriptions receivable | 49,847 | ||||||||
Supplies inventory | 599,572 | 673,044 | |||||||
Deferred offering costs | 162,066 | 134,518 | |||||||
1,481,526 | 1,122,576 |
6_StockBased_Compensation_Tabl
6. Stock-Based Compensation (Tables) | 6 Months Ended | ||||||||||||||||
Jun. 30, 2014 | |||||||||||||||||
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ' | ||||||||||||||||
Stock Option Activity | ' | ||||||||||||||||
Number of | Wtd. Avg. | Wtd. Avg. | Intrinsic | ||||||||||||||
Shares | Exercise | Remaining | Value | ||||||||||||||
Price | Contract Term | ||||||||||||||||
(# years) | |||||||||||||||||
Outstanding at January 1, 2014 | 1,162,449 | $ | 4.3 | ||||||||||||||
Granted | 1,350,440 | 1.82 | |||||||||||||||
Exercised | - | - | |||||||||||||||
Forfeited and canceled | (47,198 | ) | 3.4 | ||||||||||||||
Outstanding at June 30, 2014 | 2,465,691 | $ | 2.96 | 8.5 | $ | 43,363 | |||||||||||
Exercisable at June 30, 2014 | 828,235 | $ | 4.83 | 6.7 | $ | 41,848 | |||||||||||
Warrant Activity | ' | ||||||||||||||||
Number of | Wtd. Avg. | Wtd. Avg. | Intrinsic | ||||||||||||||
Shares | Exercise | Remaining | Value | ||||||||||||||
Price | Contract Term | ||||||||||||||||
(# years) | |||||||||||||||||
Outstanding at January 1, 2014 | 3,069,113 | $ | 4.12 | ||||||||||||||
Granted | - | - | |||||||||||||||
Exercised | - | - | |||||||||||||||
Forfeited and canceled | - | - | |||||||||||||||
Outstanding at June 30, 2014 | 3,069,113 | $ | 4.12 | 2.7 | $ | 186,750 | |||||||||||
Exercisable at June 30, 2014 | 3,069,113 | $ | 4.12 | 2.7 | $ | 186,750 |
3_Other_Current_Assets_Detail
3. Other Current Assets (Detail) (USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ' | ' |
Prepaid expenses | $670,041 | $315,014 |
Subscriptions receivable | 49,847 | 0 |
Supplies Inventory | 599,572 | 673,044 |
Deferred offering costs | 162,066 | 134,518 |
Other current assets | $1,481,526 | $1,122,576 |
4_Other_Long_Term_Assets_Detai
4. Other Long Term Assets (Details) (USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
Other Long Term Assets Details | ' | ' |
Deferred Offering Costs | $103,636 | $103,636 |
6_Stock_Option_Activity_Detail
6. Stock Option Activity (Detail) (USD $) | 6 Months Ended |
Jun. 30, 2014 | |
Number of Shares | ' |
Number of Shares, Outstanding at beginning of period | 1,162,449 |
Number of Shares, Granted | 1,350,440 |
Number of Shares, Exercised | 0 |
Number of Shares, Forfeited and canceled | -47,198 |
Number of Shares, Outstanding at end of period | 2,465,691 |
Number of Shares, Exercisable at end of period | 828,235 |
Weighted average exercise price | ' |
Weighted average exercise price, Outstanding at beginning of period | $4.30 |
Weighted average exercise price, Granted | $1.82 |
Weighted average exercise price, Exercised | $0 |
Weighted average exercise price, Forfeited and canceled | $3.40 |
Weighted average exercise price, Outstanding at end of period | $2.96 |
Weighted average exercise price, Exercisable at end of period | $4.83 |
Weighted average remaining contract term | ' |
Weighted average remaining contract term, Outstanding at end of period | '8 years 6 months |
Weighted average remaining contract term, Exercisable at end of period | '6 years 8 months 12 days |
Intrinsic Value | ' |
Intrinsic Value, Outstanding at end of period | $43,363 |
Intrinsic Value, Exercisable at end of period | $41,848 |
6_Warrant_Activity_Detail
6. Warrant Activity (Detail) (Warrant Share [Member], USD $) | 6 Months Ended |
Jun. 30, 2014 | |
Warrant Share [Member] | ' |
Number of Shares | ' |
Number of Shares, Outstanding at beginning of period | 3,069,113 |
Number of Shares, Granted | 0 |
Number of Shares, Exercised | 0 |
Number of Shares, Forfeited and canceled | 0 |
Number of Shares, Outstanding at end of period | 3,069,113 |
Number of Shares, Exercisable at end of period | 3,069,113 |
Weighted average exercise price | ' |
Weighted average exercise price, Outstanding at beginning of period | $4.12 |
Weighted average exercise price, Granted | $0 |
Weighted average exercise price, Exercised | $0 |
Weighted average exercise price, Forfeited and canceled | $0 |
Weighted average exercise price, Outstanding at end of period | $4.12 |
Weighted average exercise price, Exercisable at end of period | $4.12 |
Weighted average remaining contract term | ' |
Weighted average remaining contract term, Outstanding at end of period | '2 years 8 months 12 days |
Weighted average remaining contract term, Exercisable at end of period | '2 years 8 months 12 days |
Intrinsic Value | ' |
Intrinsic Value, Outstanding at end of period | $186,750 |
Intrinsic Value, Exercisable at end of the period | $186,750 |