Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2016 | Aug. 01, 2016 | |
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 | Jun. 30, 2016 | |
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 | 7,049,050 | |
Document Fiscal Period Focus | Q2 | |
Document Fiscal Year Focus | 2,016 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Jun. 30, 2016 | Dec. 31, 2015 |
Current assets: | ||
Cash and cash equivalents | $ 7,847,360 | $ 12,583,764 |
Subscription receivable | 57,985 | 0 |
Other current assets | 339,782 | 498,798 |
Total current assets | 8,245,127 | 13,082,562 |
Property & equipment, net of accumulated depreciation of $2,581,842 and $2,443,600, respectively | 700,846 | 837,867 |
Other long-term assets | 489,517 | 496,269 |
Total assets | 9,435,490 | 14,416,698 |
Current liabilities: | ||
Accounts payable | 577,826 | 739,850 |
Accrued expenses | 1,455,126 | 1,008,077 |
Deferred revenue | 1,452,583 | 2,905,165 |
Notes payable - insurance | 37,476 | 148,344 |
Total current liabilities | 3,523,011 | 4,801,436 |
Long term liabilities: | ||
Total liabilities | 3,523,011 | 4,801,436 |
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, 7,049,050 and 6,982,909 shares issued and outstanding | 70,491 | 69,829 |
Additional paid in capital | 163,446,589 | 162,884,919 |
Accumulated deficit | (157,604,601) | (153,339,486) |
Total stockholders' equity | 5,912,479 | 9,615,262 |
Total liabilities and stockholders' equity | $ 9,435,490 | $ 14,416,698 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) | Jun. 30, 2016 | Dec. 31, 2015 |
Statement of Financial Position [Abstract] | ||
Property & equipment, accumulated depreciation | $ 2,581,842 | $ 2,443,600 |
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 | $ .01 | $ 0.01 |
Common stock, shares authorized | 150,000,000 | 150,000,000 |
Common stock, shares issued | 7,049,050 | 6,982,909 |
Common stock, shares outstanding | 7,049,050 | 6,982,909 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Revenue: | ||||
Option Revenue | $ 726,291 | $ 726,292 | $ 1,452,582 | $ 1,103,745 |
Research and development | 1,814,940 | 2,795,858 | 3,644,002 | 5,432,857 |
General and administrative | 953,582 | 1,345,624 | 1,940,830 | 2,351,754 |
Depreciation and amortization | 65,653 | 94,002 | 138,242 | 190,984 |
Operating loss | (2,107,884) | (3,509,192) | (4,270,492) | (6,871,850) |
Interest income, net | 414 | 2,337 | 522 | 3,068 |
Other income and expense, net | 2,749 | 9,974 | 4,855 | 21,021 |
Net loss | $ (2,104,721) | $ (3,496,881) | $ (4,265,115) | $ (6,847,761) |
Basic and diluted loss per share | $ (0.30) | $ (0.56) | $ (0.61) | $ (1.40) |
Weighted average shares outstanding - Basic and diluted | 6,995,686 | 6,221,152 | 6,989,298 | 4,882,680 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity - 6 months ended Jun. 30, 2016 - USD ($) | Common Stock [Member] | Additional Paid In Capital [Member] | Accumulated Deficit [Member] | Total |
Beginning Balance, Shares at Dec. 31, 2015 | 6,982,909 | |||
Beginning Balance, Amount at Dec. 31, 2015 | $ 69,829 | $ 162,884,919 | $ (153,339,486) | $ 9,615,262 |
Shares issued for services, Shares | 51,640 | |||
Shares issued for services, Amount | $ 517 | 161,117 | 161,634 | |
Exercise of warrants, Shares | 14,501 | |||
Exercise of warrants, Amount | $ 145 | 57,840 | 0 | 57,985 |
Option expense | 342,713 | 342,713 | ||
Net loss | (4,265,115) | (4,265,115) | ||
Ending Balance, Shares at Jun. 30, 2016 | 7,049,050 | |||
Ending Balance, Amount at Jun. 30, 2016 | $ 70,491 | $ 163,446,589 | $ (157,604,601) | $ 5,912,479 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 6 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
Cash flows from operating activities | ||
Net loss | $ (4,265,115) | $ (6,847,761) |
Adjustments to reconcile net loss to net cash provided by (used in) operating activities | ||
Shares issued for services | 161,634 | 55,713 |
Depreciation | 138,242 | 190,984 |
Option expense | 342,713 | 472,350 |
Changes in: | ||
Other current assets | 209,297 | 355,309 |
Accounts payable | (162,024) | 446,234 |
Accrued expenses | 447,049 | (298,692) |
Deferred revenue | (1,452,582) | 1,896,255 |
Other long-term assets | 6,752 | 19,470 |
Net cash used in operating activities | (4,574,034) | (3,710,138) |
Cash flows from investing activities | ||
Purchase of property & equipment | (1,221) | (11,779) |
Net cash used in investing activities | (1,221) | (11,779) |
Cash flows from financing activities | ||
Common stock and warrants sold for cash, net of offering costs | 0 | 12,095,294 |
Cash generated from exercise of warrants | 0 | 3,810 |
Note payable - insurance | (110,868) | 0 |
Payment of deferred offering costs | (50,281) | 0 |
Net cash provided by (used in) financing activities | (161,149) | 12,099,104 |
Net change in cash and cash equivalents | (4,736,404) | 8,377,187 |
Cash and cash equivalents at beginning of period | 12,583,764 | 9,906,373 |
Cash and cash equivalents at end of period | 7,847,360 | 18,283,560 |
Cash paid for: | ||
Interest | 2,155 | 1,035 |
Income taxes | 0 | 0 |
NON-CASH TRANSACTIONS | ||
Subscription receivable - exercise of warrants | $ 57,985 | $ 0 |
1. Basis of Presentation
1. Basis of Presentation | 6 Months Ended |
Jun. 30, 2016 | |
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. The accompanying unaudited consolidated financial statements for the six months ended June 30, 2016 have been prepared assuming that the Company will continue as a going concern, meaning the Company will continue in operation for the foreseeable future and will be able to realize assets and discharge liabilities in the ordinary course of operations. As of June 30, 2016, the Company had cash and cash equivalents of $7.8 million. While the Company recognizes revenue related to the $5 million and $3 million payments from Merck received in February 2013 and March 2015 in connection with the Option and License Agreement and the Amendment over the exclusive option period based on the expected completion term of the Companys ongoing Phase IIb clinical trial (Abili-T) of Tcelna® in patients with Secondary Progressive MS (SPMS), the Company does not currently generate any commercial revenues resulting in cash receipts, nor does it expect to generate revenues during the remainder of 2016 resulting in cash receipts. The Companys burn rate during the six months ended June 30, 2016 was approximately $763,000 per month, thereby creating substantial doubt about the Companys ability to continue as a going concern. Additionally, costs associated with completing the ongoing Abili-T trial may result in an increase in the monthly operating cash burn during the remainder of 2016. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. The Company continues to explore potential opportunities and alternatives to obtain the additional resources that will be necessary to support its ongoing operations through and beyond the next 12 months including raising additional capital through either private or public equity or debt financing as well as using its at-the-market offering program and cutting expenses where possible. However, there can be no assurance that the Company will be able to secure additional funds and that if such funds are available, whether the terms or conditions would be acceptable to the Company. |
2. Significant Accounting Polic
2. Significant Accounting Polices | 6 Months Ended |
Jun. 30, 2016 | |
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). 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 June 30, 2016, Opexa had approximately $7.0 million in a savings account. For the six months ended June 30, 2016, the savings account recognized an average market yield of 0.06%. Interest income of $2,651 was recognized for the six months ended June 30, 2016 in the consolidated statements of operations. Reclassifications. |
3. Other Current Assets
3. Other Current Assets | 6 Months Ended |
Jun. 30, 2016 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Other Current Assets | Other current assets consisted of the following at June 30, 2016 and December 31, 2015: Description June 30, 2016 December 31, 2015 Deferred offering costs $ 115,064 $ 28,876 Prepaid expense 224,718 469,922 Total Other Current Assets $ 339,782 $ 498,798 Deferred offering costs at June 30, 2016 and December 31, 2015 were $115,064 and $28,876 respectively. The June 30, 2016 balance includes costs incurred from third parties in connection with the March 25, 2016 implementation of a new Sales Agreement (ATM Agreement) with IFS Securities, Inc. (doing business as Brinson Patrick, a division of IFS Securities, Inc.) as sales agent, pursuant to which Opexa can offer and sell shares of common stock from time to time depending upon market demand, in transactions deemed to be an at the market offering as defined in Rule 415 of the Securities Act of 1933. These are included in other current assets in the consolidated balance sheets. Upon the sales of shares of common stock under the ATM Agreement, these capitalized costs will be offset against the proceeds of such sales of shares of common stock and recorded in additional paid in capital. Prepaid expenses at June 30, 2016 and December 31, 2015 include costs incurred from third parties in connection with the Merck Serono Agreement (see Note 2). As of June 30, 2016 and December 31, 2015, the remaining costs of $19,468 and $38,938, respectively, in connection with the Merck Serono Agreement are expected to be amortized over the upcoming 6-month period. Also included in prepaid expenses at June 30, 2016 and December 31, 2015 is an advance to Pharmaceutical Research Associates, Inc. (PRA), a contract research organization providing services to Opexa with respect to the Abili-T study, in the amount of $45,365 and $45,365 respectively, as well as $9,375 and $31,250 remaining from a prior payment to PRA of $75,000 upon execution of an amendment to Opexas agreement with PRA. The remaining balance of Opexas NASDAQ Capital Market All-Inclusive Annual Fee is also included in the June 30, 2016 prepaid expenses balance. Prepaid insurance in the amount of $74,827 is included in prepaid expenses at June 30, 2016 and December 31, 2015 as well as the remaining balances attributable to various service and maintenance contracts. |
4. Other Long Term Assets
4. Other Long Term Assets | 6 Months Ended |
Jun. 30, 2016 | |
Other Long Term Assets | |
Other Long Term Assets | Other long term assets consists solely of a single custom reagent that will be used primarily for the NMO program and other Pre-Phase III research activities. Upon consumption, the costs of this reagent are amortized to research and development expenses in the consolidated statements of operations. |
5. Equity
5. Equity | 6 Months Ended |
Jun. 30, 2016 | |
Equity [Abstract] | |
Equity | For the six months ended June 30, 2016, equity related transactions were as follows: On March 14, 2016, Opexa entered into an amendment to the September 1, 2015 Stock Purchase Agreement with the purchasers party thereto, to extend by six months the original dates for the milestones relating to the subsequent tranches. As part of the amendment, the expiration date of the Series N warrants issued pursuant to the Stock Purchase Agreement was also extended from April 9, 2018 to October 9, 2018. The Company determined that there is no accounting impact to the modification of the Series N warrants since these are investor warrants. On May 16, 2016, a total of 103,280 shares of common stock with an aggregate fair value of $219,986 were granted to certain non-employee directors for service on Opexas Board of Directors. Of these common stock awards, 25% vest immediately and 25% on each of June 30, 2016, September 30, 2016 and December 31, 2016 respectively, assuming continued Board service through each such date as applicable. The total expense recognized for the quarter was $161,634. In June 2016, Opexa issued 14,501 shares of common stock upon the exercise of Series M warrants for net proceeds of $57,985 which were recognized as a subscription receivable as of June 30, 2016 in the consolidated balance sheet and collected on July 5, 2016. |
6. Stock-Based Compensation
6. Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2016 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-Based Compensation | Stock Options Opexa accounts for stock-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, 2016, Opexa recognized stock-based compensation expense of $342,713. Unamortized stock-based compensation expense as of June 30, 2015 amounted to $1,784,159. Stock Option Activity A summary of stock option activity for the six months ended June 30, 2016 Number of Shares Weighted Avg. Exercise Price Weighted Average Remaining Contract Term (# years) Intrinsic Value Outstanding at December 31, 2015 417,404 $ 18.04 Granted 250,000 2.13 Exercised Forfeited and canceled (31,844 ) 7.79 Outstanding at June 30, 2016 635,560 $ 10.91 7.46 $ 502,928 Exercisable at June 30, 2016 309,495 $ 16.33 7.29 $ 100,000 Employee Options and Non-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. Opexa recognized stock based compensation expense of $342,713 and $472,350 during the six months ended June 30, 2016 and 2015, respectively, for grants made to employees. On May 16, 2016, Opexas shareholders approved an amendment and restatement of the 2010 Stock Incentive Plan (the 2010 Plan) to increase the number of shares of common stock reserved for issuance by an additional 650,000 shares and to reset the number of stock-based awards issuable to a participant in any calendar year. On May 16, 2016, time-based options to purchase an aggregate of 200,000 shares at an exercise price of $2.13 were granted to various officers and employees. These options have a term of ten years and become exercisable over a three-year period, with 25% vesting on the grant date and the remaining 75% vesting in equal increments quarterly thereafter (in arrears) over the ensuing three years, subject to continuous service or termination of employment without cause. The fair value of these options of $384,501 was calculated using the Black-Scholes option pricing model. Variables used in the Black-Scholes option model for these options include (1) discount rate of 1.75% (2) expected term of 5.56 years (3) expected volatility rate of 138.59% and (4) zero expected dividends. On May 16, 2016, a performance-based option to purchase 50,000 shares of common stock at an exercise price of $2.13 was granted to the Chief Executive Officer. This option vests in full if, on or before December 31, 2016, Merck Serono exercises its option to acquire an exclusive, worldwide (excluding Japan) license to Opexas Tcelna program for the treatment of multiple sclerosis under that certain Option and License Agreement between Opexa and Merck Serono dated February 4, 2013. The fair value of this milestone option is $105,721 and was calculated using the Black-Scholes option pricing model. Variables used in the Black-Scholes option model for these options include (1) discount rate of 1.75% (2) expected term of 10 years (3) expected volatility rate of 167.77% and (4) zero expected dividends. In addition, during the six months ended June 30, 2016 there were 31,844 shares underlying options that were forfeited and cancelled. Warrant Activity A summary of warrant activity for the six months ended June 30, 2016 Number of Shares Weighted Avg. Exercise Price Weighted Average Remaining Contract Term (# years) Intrinsic Value Outstanding at December 31, 2015 3,662,954 $ 6.30 Granted Exercised (14,501 ) 4.00 Forfeited and canceled (51,823 ) 83.52 Outstanding at June 30, 2016 3,596,630 $ 5.19 1.71 $ 420,594 Exercisable at June 30, 2016 3,596,630 $ 5.19 1.71 $ 420,594 In connection with the amended stock purchase agreement entered in on March 14, 2016 (See Note 5), the Company also amended and restated the Series N Warrants to purchase shares of the Companys common stock previously issued to the Purchasers, and extend the expiration date of the Series N Warrants by six months (i.e., from April 9, 2018 to October 9, 2018). The Company determined that there is no accounting impact to the modification of the Series N warrants since these are investor warrants. During the three months ended June 30, 2016, 14,501 shares of common stock were issued upon the exercise of Series M warrants. The net proceeds from the exercise of these warrants was $57,985 which was received by Opexa on July 5, 2016. |
7. Subsequent Events
7. Subsequent Events | 6 Months Ended |
Jun. 30, 2015 | |
Subsequent Events [Abstract] | |
Subsequent Events | On July 29, 2016, the Company entered into an amendment with PRA for a change order relating to its clinical trials management services agreement for the ongoing Abili-T study. The amendment encompasses additional services with a total cost of approximately $1.3 million in excess of the previously contracted amount, of which approximately $865,000 is currently payable in satisfaction of milestones that have been deemed met and approximately $404,000 will be payable as additional services are rendered. |
1. Basis of Presentation (Polic
1. Basis of Presentation (Policies) | 6 Months Ended |
Jun. 30, 2016 | |
Basis Of Presentation Policies | |
Basis of Presentation and Going Concern | The accompanying unaudited consolidated financial statements for the six months ended June 30, 2016 have been prepared assuming that the Company will continue as a going concern, meaning the Company will continue in operation for the foreseeable future and will be able to realize assets and discharge liabilities in the ordinary course of operations. As of June 30, 2016, the Company had cash and cash equivalents of $7.8 million. While the Company recognizes revenue related to the $5 million and $3 million payments from Merck received in February 2013 and March 2015 in connection with the Option and License Agreement and the Amendment over the exclusive option period based on the expected completion term of the Companys ongoing Phase IIb clinical trial (Abili-T) of Tcelna® in patients with Secondary Progressive MS (SPMS), the Company does not currently generate any commercial revenues resulting in cash receipts, nor does it expect to generate revenues during the remainder of 2016 resulting in cash receipts. The Companys burn rate during the six months ended June 30, 2016 was approximately $763,000 per month, thereby creating substantial doubt about the Companys ability to continue as a going concern. Additionally, costs associated with completing the ongoing Abili-T trial may result in an increase in the monthly operating cash burn during the remainder of 2016. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. The Company continues to explore potential opportunities and alternatives to obtain the additional resources that will be necessary to support its ongoing operations through and beyond the next 12 months including raising additional capital through either private or public equity or debt financing as well as using its at-the-market offering program and cutting expenses where possible. However, there can be no assurance that the Company will be able to secure additional funds and that if such funds are available, whether the terms or conditions would be acceptable to the Company. |
2. Significant Accounting Pol15
2. Significant Accounting Polices (Policies) | 6 Months Ended |
Jun. 30, 2016 | |
Accounting Policies [Abstract] | |
Revenue Recognition | Opexa recognizes revenue in accordance with Financial Accounting Standards Board (FASB) Accounting Standards Codification (FASB 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 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). 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 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. 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 June 30, 2016, Opexa had approximately $7.0 million in a savings account. For the six months ended June 30, 2016, the savings account recognized an average market yield of 0.06%. Interest income of $2,651 was recognized for the six months ended June 30, 2016 in the consolidated statements of operations. |
Reclassifications | Certain reclassifications of prior year reported amounts have been made for comparative purposes. Opexa does not consider such reclassifications to be material and they had no effect on net income. |
3. Other Current Assets (Tables
3. Other Current Assets (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Other Current Assets | Description June 30, 2016 December 31, 2015 Deferred offering costs $ 115,064 $ 28,876 Prepaid expense 224,718 469,922 Total Other Current Assets $ 339,782 $ 498,798 |
6. Stock-Based Compensation (Ta
6. Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
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 December 31, 2015 417,404 $ 18.04 Granted 250,000 2.13 Exercised Forfeited and canceled (31,844 ) 7.79 Outstanding at June 30, 2016 635,560 $ 10.91 7.46 $ 502,928 Exercisable at June 30, 2016 309,495 $ 16.33 7.29 $ 100,000 |
Warrant Activity | Number of Shares Weighted Avg. Exercise Price Weighted Average Remaining Contract Term (# years) Intrinsic Value Outstanding at December 31, 2015 3,662,954 $ 6.30 Granted Exercised (14,501 ) 4.00 Forfeited and canceled (51,823 ) 83.52 Outstanding at June 30, 2016 3,596,630 $ 5.19 1.71 $ 420,594 Exercisable at June 30, 2016 3,596,630 $ 5.19 1.71 $ 420,594 |
2. Significant Accounting Pol18
2. Significant Accounting Polices (Details) | 6 Months Ended |
Jun. 30, 2016USD ($) | |
Significant Accounting Polices Details | |
Cash in savings account | $ 7,000,000 |
Interest income | $ 2,651 |
3. Other Current Assets (Detail
3. Other Current Assets (Details) - USD ($) | Jun. 30, 2016 | Dec. 31, 2015 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ||
Deferred offering costs | $ 115,064 | $ 28,876 |
Prepaid expenses | 224,718 | 469,922 |
Total Other Current Assets | $ 339,782 | $ 498,798 |
3. Other Current Assets (Deta20
3. Other Current Assets (Details Narrative) - USD ($) | Jun. 30, 2016 | Dec. 31, 2015 |
Deferred offering costs | $ 115,064 | $ 28,876 |
Prepaid Insurance | 74,827 | 74,827 |
Merck Serono Agreement | ||
Advance payments to vendors and consultants | 19,468 | 38,938 |
Pharmaceutical Research Associates, Inc | ||
Advance payments to vendors and consultants | 45,365 | 45,365 |
Remaining Balance From Prior Payment To Pharmaceutical Research Associates, Inc. | ||
Advance payments to vendors and consultants | $ 9,375 | $ 31,250 |
6. Stock-Based Compensation (De
6. Stock-Based Compensation (Details) | 6 Months Ended |
Jun. 30, 2016USD ($)$ / sharesshares | |
Options | |
Number of Shares, Outstanding at beginning of period | shares | 417,404 |
Options, Granted | shares | 250,000 |
Options, Exercised | shares | 0 |
Options, Forfeited and canceled | shares | (31,844) |
Number of Shares, Outstanding at end of period | shares | 635,560 |
Number of Shares, Exercisable at end of period | shares | 309,495 |
Weighted Average Exercise Price, Options | |
Weighted average exercise price, Outstanding at beginning of period | $ / shares | $ 18.04 |
Weighted average exercise price options, Granted | $ / shares | 2.13 |
Weighted average exercise price options, Exercised | $ / shares | 0 |
Weighted average exercise price options, Forfeited and canceled | $ / shares | 7.79 |
Weighted average exercise price, Outstanding at end of period | $ / shares | 10.91 |
Weighted average exercise price, Exercisable at end of period | $ / shares | $ 16.33 |
Weighted Average Remaining Contract Term, Options | |
Weighted Average Remaining Contract Term, Outstanding at end of period | 7 years 5 months 16 days |
Weighted Average Remaining Contract Term, Exercisable | 7 years 3 months 14 days |
Intrinsic Value, Options | |
Outstanding Aggregate Intrinsic Value, end of period | $ | $ 502,928 |
Exercisable Aggregate Intrinsic Value | $ | $ 100,000 |
6. Stock-Based Compensation (22
6. Stock-Based Compensation (Details 1) - Warrants | 6 Months Ended |
Jun. 30, 2016USD ($)$ / sharesshares | |
Class of Warrant or Right [Line Items] | |
Number of Shares, Outstanding at beginning of period | shares | 3,662,954 |
Warrants, Granted | shares | 0 |
Warrants, Exercised | shares | (14,501) |
Warrants, Forfeited and canceled | shares | (51,823) |
Number of Shares, Outstanding at end of period | shares | 3,596,630 |
Number of Shares, Exercisable at end of period | shares | 3,596,630 |
Weighted Average Exercise Price, Warrants | |
Weighted average exercise price, Outstanding at beginning of period | $ / shares | $ 6.30 |
Weighted average exercise price warrants, Granted | $ / shares | 0 |
Weighted average exercise price warrants, Exercised | $ / shares | 4 |
Weighted average exercise price warrants, Forfeited and canceled | $ / shares | 83.52 |
Weighted average exercise price, Outstanding at end of period | $ / shares | 5.19 |
Weighted average exercise price, Exercisable at end of period | $ / shares | $ 5.19 |
Weighted Average Remaining Contract Term, Warrants | |
Weighted Average Remaining Contract Term, Outstanding at end of period | 1 year 8 months 16 days |
Weighted Average Remaining Contract Term, Exercisable | 1 year 8 months 16 days |
Intrinsic Value, Warrants | |
Outstanding Aggregate Intrinsic Value, End of period | $ | $ 420,594 |
Exercisable Aggregate Intrinsic Value | $ | $ 420,594 |
6. Stock-Based Compensation (23
6. Stock-Based Compensation (Details Narrative) - USD ($) | 6 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
Stock-based Compensation Details Narrative | ||
Unamortized stock-based compensation expense | $ 1,784,159 | |
Option expense | $ 342,713 | $ 472,350 |