Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2015 | Nov. 01, 2015 | |
Document And Entity Information [Abstract] | ||
Entity Registrant Name | OPEXA THERAPEUTICS, INC. | |
Entity Central Index Key | 1,069,308 | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2015 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Is Entity a Well-known Seasoned Issuer? | No | |
Is Entity a Voluntary Filer? | No | |
Is Entity's Reporting Status Current? | Yes | |
Entity Filer Category | Smaller Reporting Company | |
Entity Common Stock, Shares Outstanding | 6,864,340 | |
Document Fiscal Period Focus | Q3 | |
Document Fiscal Year Focus | 2,015 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Sep. 30, 2015 | Dec. 31, 2014 |
Current assets: | ||
Cash and cash equivalents | $ 15,592,500 | $ 9,906,373 |
Subscription receivable | 232,934 | 0 |
Other current assets | 329,323 | 758,943 |
Total current assets | 16,154,757 | 10,665,316 |
Property & equipment, net of accumulated depreciation of $2,372,198 and $2,099,389, respectively | 886,878 | 1,098,104 |
Other long-term assets | 9,734 | 38,939 |
Total assets | 17,051,369 | 11,802,359 |
Current liabilities: | ||
Accounts payable | 1,018,179 | 702,494 |
Accrued expenses | 1,041,220 | 1,199,184 |
Deferred revenue | 2,905,165 | 1,230,746 |
Total current liabilities | 4,964,564 | 3,132,424 |
Long term liabilities: | ||
Deferred revenue, net of current portion | 726,293 | 1,230,748 |
Total liabilities | 5,690,857 | $ 4,363,172 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Preferred stock, no par value, 10,000,000 shares authorized, none issued and outstanding | 0 | $ 0 |
Common stock, $0.01 par value, 150,000,000 shares authorized, 6,864,340 and 3,529,344 shares issued and outstanding | 68,643 | 35,293 |
Additional paid in capital | 162,253,818 | 148,724,102 |
Accumulated deficit | (150,961,949) | (141,320,208) |
Total stockholders' equity | 11,360,512 | 7,439,187 |
Total liabilities and stockholders' equity | $ 17,051,369 | $ 11,802,359 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) | Sep. 30, 2015 | Dec. 31, 2014 |
Statement of Financial Position [Abstract] | ||
Property & equipment, accumulated depreciation | $ 2,372,198 | $ 2,099,389 |
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 | 150,000,000 | 100,000,000 |
Common stock, shares issued | 6,864,340 | 3,529,344 |
Common stock, shares outstanding | 6,864,340 | 3,529,344 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Revenue: | ||||
Option Revenue | $ 726,291 | $ 307,686 | $ 1,830,036 | $ 964,209 |
Research and development | 2,420,220 | 3,173,538 | 7,853,076 | 9,393,887 |
General and administrative | 1,023,848 | 917,335 | 3,375,602 | 2,987,582 |
Loss on disposition of assets | 1,167 | 0 | 1,167 | 0 |
Depreciation and amortization | 89,018 | 97,364 | 280,003 | 291,608 |
Operating loss | (2,807,962) | (3,880,551) | (9,679,812) | (11,708,868) |
Interest income, net | 2,222 | 2,498 | 5,290 | 11,982 |
Other income, net | 11,760 | 0 | 32,781 | 0 |
Net loss | $ (2,793,980) | $ (3,878,053) | $ (9,641,741) | $ (11,696,886) |
Basic and diluted loss per share | $ (0.42) | $ (1.11) | $ (1.75) | $ (3.38) |
Weighted average shares outstanding - Basic and diluted | 6,709,251 | 3,478,324 | 5,498,228 | 3,461,479 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity - 9 months ended Sep. 30, 2015 - USD ($) | Common Stock [Member] | Additional Paid In Capital [Member] | Accumulated Deficit [Member] | Total |
Beginning Balance, Shares at Dec. 31, 2014 | 3,529,344 | |||
Beginning Balance, Amount at Dec. 31, 2014 | $ 35,293 | $ 148,724,102 | $ (141,320,208) | $ 7,439,187 |
Cancellation of fractional shares, Shares | (1,365) | |||
Cancellation of fractional shares, Amount | $ (13) | (5,015) | 0 | (5,028) |
Shares issued for services, Shares | 9,317 | |||
Shares issued for services, Amount | $ 93 | 66,870 | 0 | 66,963 |
Common stock sold for cash, Shares | 3,325,941 | |||
Common stock sold for cash, Amount | $ 33,259 | 12,802,093 | 0 | 12,835,352 |
Exercise of warrants, Shares | 1,103 | |||
Exercise of warrants, Amount | $ 11 | 4,399 | 0 | 4,410 |
Option expense | 0 | 661,369 | 0 | 661,369 |
Net loss | $ 0 | 0 | (9,641,741) | (9,641,741) |
Ending Balance, Shares at Sep. 30, 2015 | 6,864,340 | |||
Ending Balance, Amount at Sep. 30, 2015 | $ 68,643 | $ 162,253,818 | $ (150,961,949) | $ 11,360,512 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 9 Months Ended | |
Sep. 30, 2015 | Sep. 30, 2014 | |
Cash flows from operating activities | ||
Net loss | $ (9,641,741) | $ (11,696,886) |
Adjustments to reconcile net loss to net cash provided by (used in) operating activities | ||
Restricted stock expense | 66,963 | 201,998 |
Depreciation | 280,003 | 291,608 |
Loss on disposition of equipment | 1,167 | 0 |
Option expense | 661,369 | 840,303 |
Changes in: | ||
Other current assets | 429,620 | 394,746 |
Accounts payable | 315,685 | (324,156) |
Accrued expenses | (157,964) | 621,493 |
Deferred revenue | 1,169,964 | (964,209) |
Other assets | 29,205 | 128,992 |
Net cash used in operating activities | (6,845,729) | (10,506,111) |
Cash flows from investing activities | ||
Purchase of property & equipment | (69,944) | (149,187) |
Net cash used in investing activities | (69,944) | (149,187) |
Cash flows from financing activities | ||
Common stock and warrants sold for cash, net of offering costs | 12,602,418 | 648,175 |
Cash generated from exercise of warrants | 4,410 | 0 |
Cash paid for fractional shares | (5,028) | 0 |
Net cash provided by financing activities | 12,601,800 | 648,175 |
Net change in cash and cash equivalents | 5,686,127 | (10,007,123) |
Cash and cash equivalents at beginning of period | 9,906,373 | 23,644,542 |
Cash and cash equivalents at end of period | 15,592,500 | 13,637,419 |
Cash paid for: | ||
Interest | 50 | 958 |
Income taxes | $ 0 | $ 0 |
1. Basis of Presentation
1. Basis of Presentation | 9 Months Ended |
Sep. 30, 2015 | |
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 Opexas 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 consolidated financial statements that would substantially duplicate the disclosure contained in the audited consolidated 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. At our annual meeting on August 28, 2015, shareholders approved an amendment to the Companys Restated Certificate of Formation to increase the number of authorized shares of common stock from 100 million to 150 million, and the amendment was effect as of September 9, 2015. Reverse Stock Split. Unless otherwise noted, impacted amounts included in the consolidated financial statements and notes thereto have been retroactively adjusted for the stock splits as if such stock splits occurred on the first day of the first period presented. Impacted amounts include shares of common stock issued and outstanding, shares underlying warrants and stock options, shares reserved, exercise prices of warrants and options, and loss per share. There was no impact on preferred or common stock authorized resulting from the 1:8 Reverse Stock Split. |
2. Significant Accounting Polic
2. Significant Accounting Polices | 9 Months Ended |
Sep. 30, 2015 | |
Accounting Policies [Abstract] | |
Significant Accounting Polices | Revenue Recognition. On February 4, 2013, Opexa entered into an Option and License Agreement (the Merck Serono Agreement) with Ares Trading SA (Merck Serono), a wholly owned subsidiary of Merck Serono S.A. Pursuant to the terms, Merck Serono has an option to acquire an exclusive, worldwide (excluding Japan) license of Opexas Tcelna® program for the treatment of multiple sclerosis (MS). Tcelna is currently in a Phase IIb clinical trial (Abili-T) in patients with Secondary Progressive MS (SPMS). The option may be exercised by Merck Serono prior to or upon Opexas completion of the Phase IIb Trial. Opexa received an upfront payment of $5 million for granting the option. Opexa recognized revenues from nonrefundable, up-front $5 million option fees related to the Merck Serono Agreement on a straight-line basis over the estimated option exercise period which coincides with the expected completion term of the Abili-T clinical trial in SPMS. If the option is exercised, Merck Serono would pay the Company an upfront license fee of $25 million unless Merck Serono 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 Serono), in which event the upfront license fee would be $15 million. After exercising the option, Merck Serono 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. On March 9, 2015 Opexa entered into a First Amendment of Option and License Agreement with Merck Serono, to amend the Merck Serono Agreement (the Merck Serono Amendment). Opexa received $3 million in consideration for the following: (i) Creating a detailed plan for potential Phase III development of Tcelna (the Pre-Phase III Plan), including documenting all of the activities necessary for laboratory facilities both in the U.S. and Europe to reach operational readiness by the end of December 2016. The Joint Steering Committee (JSC) established pursuant to the Merck Serono Agreement will be responsible for reviewing, approving and ultimately overseeing Opexas completion of the Pre-Phase III Plan. In the event the JSC has not approved the Pre-Phase III Plan prior to the end of the period in the Merck Serono Agreement within which Merck Serono may exercise its option, such period will be extended for 60 days following approval of the Pre Phase III Plan by the JSC. (ii) Providing Merck Serono with updates and analysis on a blinded basis, grouped in patient batches according to Opexas analysis timetable, on the progress of Opexas immune monitoring program being conducted in conjunction with the ongoing Abili-T clinical trial. Opexa evaluated the Merck Serono Amendment and determined that the $3 million payment from Merck Serono has stand-alone value. Opexas continuing performance obligations in connection with the $3 million payment include the creation of the Pre-Phase III Plan and delivery of updates and analysis relating to Opexas immune monitoring program. As a stand-alone value term in the Merck Serono Amendment, the $3 million payment is determined to be a single unit of accounting, and is recognized as revenue on a straight-line basis over the period equivalent to the expected completion of the Pre-Phase III Plan in December 2016. Opexa includes the unrecognized portion of the $5 million option payment and the $3 million amendment payment as deferred revenue on its consolidated balance sheets. Cash and Cash Equivalents 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. Opexas cash balances on deposit in these accounts may, at times, exceed the federally insured limits. Opexa has not experienced any losses in such accounts. As of September 30, 2015, Opexa had approximately $13.8 million in a savings account. For the nine months ended September 30, 2015, the savings account recognized an average market yield of 0.1%. Interest income of $6,359 was recognized for the nine months ended September 30, 2015 in the consolidated statements of operations. |
3. Subscription Receivable
3. Subscription Receivable | 9 Months Ended |
Sep. 30, 2015 | |
Subscription Receivable | |
Subscription Receivable | Subscription receivable consisted of net proceeds generated from the sale of common stock under the ATM Agreement. On September 30, 2015, Opexa sold an aggregate of 75,000 shares of common stock under the ATM Agreement at an average price per share of $3.2019 generating gross and net proceeds of $240,143 and $232,934. These sales settled in early October. |
4. Other Current Assets
4. Other Current Assets | 9 Months Ended |
Sep. 30, 2015 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Other Current Assets | Other current assets consisted of the following at September 30, 2015 and December 31, 2014: Description September 30, 2015 December 31, 2014 Deferred offering costs $ 15,224 $ 259,989 Prepaid expenses 314,099 498,954 $ 329,323 $ 758,943 Prepaid expenses at September 30, 2015 and December 31, 2014 include advance payments totaling $93,549 and $131,289, respectively, made to vendors and consultants for the conduct of the Phase IIb clinical trial in SPMS. Prepaid expenses at September 30, 2015 and December 31, 2014 also include costs incurred from third parties in connection with the Merck Serono Agreement (see Note 2). As of September 30, 2015 and December 31, 2014, the remaining costs of $38,938 in connection with the Merck Serono 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 $9,734 in connection with the Merck Serono 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 5). Deferred offering costs at September 30, 2015 and December 31, 2014 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 September 30, 2015, the remaining costs of $15,224 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. Deferred offering costs at December 31, 2014 also included costs of $238,154 incurred from third parties in connection with the implementation of $1.5 million and $15.0 million purchase agreements in November 2012 pursuant to which Opexa had and has the right to sell to Lincoln Park Capital Fund, LLC (Lincoln Park) up to $16.5 million in shares of its common stock, subject to certain conditions and limitations for a period of 30 months from the commencement date of the respective agreements. The $1.5 million purchase agreement expired in June 2015, and the $15.0 million purchase agreement expired on November 1, 2015. The remaining costs were expensed in the quarter ended June 30, 2015. |
5. Other Long Term Assets
5. Other Long Term Assets | 9 Months Ended |
Sep. 30, 2015 | |
Text Block [Abstract] | |
Other Long Term Assets | Other long term assets at September 30, 2015 and December 31, 2014 include costs incurred from third parties in connection with the Merck Serono Agreement (see Note 2), amounting to $9,734 and $38,939, respectively, that are expected to be amortized beyond the upcoming 12-month period. |
6. Equity
6. Equity | 9 Months Ended |
Sep. 30, 2015 | |
Equity [Abstract] | |
Equity | For the nine months ended September 30, 2015, equity related transactions were as follows: · Opexa recognized stock-based compensation expense of $33,213 related to vested shares of restricted common stock issued to certain members of Opexas management and non-employee directors on February 28, 2014. · On March 31, 2015, 2,557 shares of restricted common stock with an aggregate fair value of $11,250 were issued to certain non-employee directors for service on Opexas Board. Opexa recognized stock-based compensation of $11,250 related to these shares. The shares vested immediately upon grant. · On April 9, 2015, Opexa issued 3,137,305 shares of common stock and Series M warrants to purchase a like number of shares upon the closing of a rights offering. Opexa raised $13,804,140 in gross proceeds, before expenses, through subscriptions for 3,137,305 units at a price of $4.40 per unit. Net proceeds were $12,095,210 after deduction of related fees and expenses, including dealer-manager fees, totaling $1,708,847. · In June 2015, Opexa issued 953 shares of common stock and received gross proceeds of $3,810 upon the exercise of Series M warrants to purchase 953 shares of common stock. · On June 30, 2015, 3,160 shares of restricted common stock with an aggregate fair value of $11,250 were issued to certain non-employee directors for service on Opexas Board. Opexa recognized stock-based compensation of $11,250 related to these shares. The shares vested immediately upon grant. · In July 2015, Opexa issued 150 shares of common stock and received gross proceeds of $600 upon the exercise of Series M warrants to purchase 150 shares of common stock. · On September 1, 2015, Opexa sold 113,636 shares of common stock for $4.40 per share and issued Series N warrants to purchase a like number of shares for gross and net proceeds of $499,999 upon the closing of tranche one of a private placement. Opexa also agreed to sell and the purchasers agreed to purchase an additional aggregate of $4.5 million of common stock in four additional tranches upon Opexas achievement of certain milestones to further the clinical development of OPX-212, Opexas autologous T-cell immunotherapy being developed for the treatment of neuromyelitis optica. · On September 28, 2015, Opexa effected the 1:8 Reverse Stock Split. An aggregate of 1,365 shares of common stock were identified as fractional shares, and cash in the amount of $5,028 was paid in lieu of these fractional shares. · On September 30, 2015, 3,600 shares of restricted common stock with an aggregate fair value of $11,250 were issued to certain non-employee directors for service on Opexas Board. Opexa recognized stock-based compensation of $11,250 related to these shares. The shares vested immediately upon grant. · On September 30, 2015 Opexa sold an aggregate of 75,000 shares of common stock under the ATM agreement for gross and net proceed of $240,143 and $ 232,934 respectively. These sales settled and shares were issued in October 2015. |
7. Stock-Based Compensation
7. Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2015 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-Based Compensation | Stock Options The Board of Directors initially adopted the 2010 Stock Incentive Plan on September 2, 2010 for the granting of equity incentive awards to employees, directors and consultants of Opexa, and the Plan was initially approved by the Companys shareholders on October 19, 2010. On September 25, 2013, the Board approved the Amended and Restated 2010 Stock Incentive Plan (the 2010 Plan), and the Companys shareholders approved the amended 2010 Plan on November 8, 2013, in order to (i) increase the number of shares of common stock reserved for issuance by 375,000 shares and (ii) reset the number of stock-based awards issuable to a participant in any calendar year to align with the increase in the shares reserved. The 2010 Plan is the successor to and continuation of Opexas June 2004 Compensatory Stock Option Plan (the 2004 Plan). The 2010 Plan reserves a maximum of 453,125 shares of common stock for issuance plus 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 any reserved shares not issued or subject to outstanding grants, up to a maximum of 64,152 shares. The 2010 Plan provides for the grant 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 Board of Directors or Compensation Committee, as applicable, administers the 2010 Plan and has discretion to determine the recipients, the number and types of stock awards to be granted and the terms and conditions of the stock awards, including the period of their exercisability and vesting. Subject to a limitation on repricing without shareholder approval, the Board or Compensation Committee, as applicable, may also determine the exercise price of options granted under the 2010 Plan. As of September 30, 2015, options to purchase an aggregate of 418,248 shares were issued and outstanding under the 2004 Plan and the 2010 Plan, and 64,024 shares remained available for the grant of options under the 2010 Plan. Opexa accounts for stock-based compensation, including options and nonvested shares, according to the provisions of FASB ASC 718, "Share Based Payment. During the nine months ended September 30, 2015, Opexa recognized stock-based compensation expense of $661,369. Unamortized stock-based compensation expense as of September 30, 2015 amounted to $2,070,437. Stock Option Activity A summary of stock option activity for the nine months ended September 30, 2015 Number of Shares Weighted Avg. Exercise Price Weighted Average Remaining Contract Term (# years) Intrinsic Value Outstanding at January 1, 2015 302,834 $ 23.34 Granted 135,430 5.22 Exercised - - Forfeited and canceled (20,016 ) 10.03 Outstanding at September 30, 2015 418,248 $ 18.11 7.9 $ 802 Exercisable at September 30, 2015 199,524 $ 26.37 6.9 $ - Employee Options: Option awards are granted with an exercise price equal to the market price of Opexas 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 nine months ended September 30, 2015, time-based options to purchase an aggregate of 71,462 shares at exercise prices ranging from $3.04 to $6.56 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 $406,713 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 2.05% to 2.19%, (2) expected term of 6.25 years, (3) expected volatility range of 134.18% to 143.46% and (4) zero expected dividends. During the nine months ended September 30, 2015, options to purchase 20,016 shares were forfeited and cancelled. Opexa recognized stock based compensation expense of $483,660 and $668,266 for grants made to employees during the nine months ended September 30, 2015 and September 30, 2014 respectively. Non-Employee Options: During the nine months ended September 30, 2015, options to purchase an aggregate of 63,968 shares at an exercise price of $4.24 were granted to non-employee directors for service on Opexas Board. Options to purchase an aggregate of 44,630 shares will expire on the earlier of 10 years or a change in control of Opexa, with 50% of the shares vesting immediately and 50% vesting on December 31, 2015. Options to purchase an aggregate of 14,875 shares have terms of 10 years, with 50% of the shares vesting immediately and 50% vesting on March 30, 2016. An option to purchase 4,463 shares will expire on the earlier of 10 years or a change in control of Opexa, with vesting in four quarterly increments beginning on June 30, 2015. Fair value of $214,844 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 1.95%, (2) expected term of 5.25 years, (3) expected volatility of 107.33% and (4) zero expected dividends. Opexa recognized stock based compensation expense of $ 177,709 and $172,037 for grants made to non-employee directors during the nine months ended September 30, 2015 and September 30, 2014 respectively. Restricted Stock See Note 6 for a description of restricted stock awards made to non-employee directors under the 2010 Plan during the nine months ended September 30, 2015. Warrant Activity A summary of warrant activity for the nine months ended September 30, 2015 Number of Shares Weighted Avg. Exercise Price Weighted Average Remaining Contract Term (# years) Intrinsic Value Outstanding at January 1, 2015 380,814 $ 29.92 Granted 3,311,128 4.16 Exercised (1,103) 4.00 Forfeited and canceled (27,885) 74.96 Outstanding at September 30, 2015 3,662,954 6.30 2.42 - Exercisable at September 30, 2015 3,662,954 6.30 2.42 - On April 9, 2015, the Company issued Series M warrants to purchase an aggregate of 3,137,305 shares of common stock upon the closing of a rights offering. The Series M warrants entitle the holders to purchase common stock at an exercise price of (i) $4.00 per share from the date of issuance (April 9, 2015) through June 30, 2016 and (ii) $12.00 per share from July 1, 2016 through their expiration on April 9, 2018. Pursuant to the anti-dilution provisions of certain of the Companys outstanding warrants and as a result of the rights offering (i) the per share exercise prices of the Series A, J, K and L warrants were adjusted to $74.96, $8.24, $8.00 and $12.72, respectively, and (ii) Series L warrants to purchase an aggregate of an additional 60,187 shares of common stock were issued. The Series A warrants expired on June 15, 2015. On September 1, 2015, the Company issued Series N warrants to purchase an aggregate of 113,636 shares of common stock at an exercise price of (i) $4.00 per share from the date of issuance through June 30, 2016 and (ii) $12.00 per share from July 1, 2016 through their expiration on April 9, 2018. |
2. Significant Accounting Pol14
2. Significant Accounting Polices (Policies) | 9 Months Ended |
Sep. 30, 2015 | |
Accounting Policies [Abstract] | |
Revenue Recognition | Revenue Recognition. On February 4, 2013, Opexa entered into an Option and License Agreement (the Merck Serono Agreement) with Ares Trading SA (Merck Serono), a wholly owned subsidiary of Merck Serono S.A. Pursuant to the terms, Merck Serono has an option to acquire an exclusive, worldwide (excluding Japan) license of Opexas Tcelna® program for the treatment of multiple sclerosis (MS). Tcelna is currently in a Phase IIb clinical trial (Abili-T) in patients with Secondary Progressive MS (SPMS). The option may be exercised by Merck Serono prior to or upon Opexas completion of the Phase IIb Trial. Opexa received an upfront payment of $5 million for granting the option. Opexa recognized revenues from nonrefundable, up-front $5 million option fees related to the Merck Serono Agreement on a straight-line basis over the estimated option exercise period which coincides with the expected completion term of the Abili-T clinical trial in SPMS. If the option is exercised, Merck Serono would pay the Company an upfront license fee of $25 million unless Merck Serono 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 Serono), in which event the upfront license fee would be $15 million. After exercising the option, Merck Serono 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. On March 9, 2015 Opexa entered into a First Amendment of Option and License Agreement with Merck Serono, to amend the Merck Serono Agreement (the Merck Serono Amendment). Opexa received $3 million in consideration for the following: (i) Creating a detailed plan for potential Phase III development of Tcelna (the Pre-Phase III Plan), including documenting all of the activities necessary for laboratory facilities both in the U.S. and Europe to reach operational readiness by the end of December 2016. The Joint Steering Committee (JSC) established pursuant to the Merck Serono Agreement will be responsible for reviewing, approving and ultimately overseeing Opexas completion of the Pre-Phase III Plan. In the event the JSC has not approved the Pre-Phase III Plan prior to the end of the period in the Merck Serono Agreement within which Merck Serono may exercise its option, such period will be extended for 60 days following approval of the Pre Phase III Plan by the JSC. (ii) Providing Merck Serono with updates and analysis on a blinded basis, grouped in patient batches according to Opexas analysis timetable, on the progress of Opexas immune monitoring program being conducted in conjunction with the ongoing Abili-T clinical trial. Opexa evaluated the Merck Serono Amendment and determined that the $3 million payment from Merck Serono has stand-alone value. Opexas continuing performance obligations in connection with the $3 million payment include the creation of the Pre-Phase III Plan and delivery of updates and analysis relating to Opexas immune monitoring program. As a stand-alone value term in the Merck Serono Amendment, the $3 million payment is determined to be a single unit of accounting, and is recognized as revenue on a straight-line basis over the period equivalent to the expected completion of the Pre-Phase III Plan in December 2016. Opexa includes the unrecognized portion of the $5 million option payment and the $3 million amendment payment as deferred revenue on its consolidated balance sheets. |
Cash and Cash Equivalents | Cash and Cash Equivalents 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. Opexas cash balances on deposit in these accounts may, at times, exceed the federally insured limits. Opexa has not experienced any losses in such accounts. As of September 30, 2015, Opexa had approximately $13.8 million in a savings account. For the nine months ended September 30, 2015, the savings account recognized an average market yield of 0.1%. Interest income of $6,359 was recognized for the nine months ended September 30, 2015 in the consolidated statements of operations. |
4. Other Current Assets (Tables
4. Other Current Assets (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Other Current Assets | Description September 30, 2015 December 31, 2014 Deferred offering costs $ 15,224 $ 259,989 Prepaid expenses 314,099 498,954 $ 329,323 $ 758,943 |
7. Stock-Based Compensation (Ta
7. Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock Option Activity | Number of Shares Weighted Avg. Exercise Price Weighted Average Remaining Contract Term (# years) Intrinsic Value Outstanding at January 1, 2015 302,834 $ 23.34 Granted 135,430 5.22 Exercised - - Forfeited and canceled (20,016 ) 10.03 Outstanding at September 30, 2015 418,248 $ 18.11 7.9 $ 802 Exercisable at September 30, 2015 199,524 $ 26.37 6.9 $ - |
Warrant Activity | Number of Shares Weighted Avg. Exercise Price Weighted Average Remaining Contract Term (# years) Intrinsic Value Outstanding at January 1, 2015 380,814 $ 29.92 Granted 3,311,128 4.16 Exercised (1,103) 4.00 Forfeited and canceled (27,885) 74.96 Outstanding at September 30, 2015 3,662,954 6.30 2.42 - Exercisable at September 30, 2015 3,662,954 6.30 2.42 - |
4. Other Current Assets (Detail
4. Other Current Assets (Details) - USD ($) | Sep. 30, 2015 | Dec. 31, 2014 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ||
Deferred offering costs | $ 15,224 | $ 259,989 |
Prepaid expenses | 314,099 | 498,954 |
Other current assets | $ 329,323 | $ 758,943 |
4. Other Current Assets (Deta18
4. Other Current Assets (Details Narrative) - USD ($) | Sep. 30, 2015 | Dec. 31, 2014 |
Other Current Assets Details Narrative | ||
Advance payments to vendors and consultants | $ 93,549 | $ 131,289 |
7. Stock Option Activity (Detai
7. Stock Option Activity (Details) | 9 Months Ended |
Sep. 30, 2015USD ($)$ / sharesshares | |
Number of Shares | |
Number of Shares, Outstanding at beginning of period | 302,834 |
Number of Shares, Granted | 135,430 |
Number of Shares, Exercised | 0 |
Number of Shares, Forfeited and canceled | (20,016) |
Number of Shares, Outstanding at end of period | 418,248 |
Number of Shares, Exercisable at end of period | 199,524 |
Weighted average exercise price | |
Weighted average exercise price, Outstanding at beginning of period | $ / shares | $ 23.34 |
Weighted average exercise price, Granted | $ / shares | 5.22 |
Weighted average exercise price, Exercised | $ / shares | 0 |
Weighted average exercise price, Forfeited and canceled | $ / shares | 10.03 |
Weighted average exercise price, Outstanding at end of period | $ / shares | 18.11 |
Weighted average exercise price, Exercisable at end of period | $ / shares | $ 26.37 |
Weighted average remaining contract term | |
Weighted average remaining contract term, Outstanding at end of period | 7 years 10 months 24 days |
Weighted average remaining contract term, Exercisable at end of period | 6 years 10 months 24 days |
Intrinsic Value, Outstanding at end of period | $ | $ 802 |
Intrinsic Value, Exercisable at end of period | $ | $ 0 |
7. Warrant Activity (Details)
7. Warrant Activity (Details) - Warrant Share [Member] | 9 Months Ended |
Sep. 30, 2015USD ($)$ / sharesshares | |
Class of Warrant or Right [Line Items] | |
Number of Shares, Outstanding at beginning of period | 380,814 |
Number of Shares, Granted | 3,311,128 |
Number of Shares, Exercised | (1,103) |
Number of Shares, Forfeited and canceled | (27,885) |
Number of Shares, Outstanding at end of period | 3,662,954 |
Number of Shares, Exercisable at end of period | 3,662,954 |
Weighted average exercise price, Outstanding at beginning of period | $ / shares | $ 29.92 |
Weighted average exercise price, Granted | $ / shares | 4.16 |
Weighted average exercise price, Exercised | $ / shares | 4 |
Weighted average exercise price, Forfeited and canceled | $ / shares | 74.96 |
Weighted average exercise price, Outstanding at end of period | $ / shares | 6.30 |
Weighted average exercise price, Exercisable at end of period | $ / shares | $ 6.30 |
Weighted average remaining contract term, Outstanding at end of period | 2 years 5 months 1 day |
Weighted average remaining contract term, Exercisable at end of period | 2 years 5 months 1 day |
Intrinsic Value, Outstanding at end of period | $ | $ 0 |
Intrinsic Value, Exercisable at end of the period | $ | $ 0 |