Acer Therapeutics (ACER) 10-K 15 Mar 16 2015 FY Annual report Financial data

Document and Entity Information

Document and Entity Information - USD ($)	12 Months Ended
	Dec. 31, 2015	Mar. 10, 2016	Jun. 30, 2015
Document And Entity Information [Abstract]
Entity Registrant Name	OPEXA THERAPEUTICS, INC.
Entity Central Index Key	1,069,308
Document Type	10-K
Document Period End Date	Dec. 31, 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 Public Float			$ 22,589,234
Entity Common Stock, Shares Outstanding		6,986,971
Document Fiscal Period Focus	FY
Document Fiscal Year Focus	2,015

Consolidated Balance Sheets

Consolidated Balance Sheets - USD ($)	Dec. 31, 2015	Dec. 31, 2014
Current assets:
Cash and cash equivalents	$ 12,583,764	$ 9,906,373
Other current assets	995,067	758,943
Total current assets	13,578,831	10,665,316
Property & equipment, net of accumulated depreciation of $2,443,600 and $2,099,389, respectively	837,867	1,098,104
Other long-term assets	0	38,939
Total assets	14,416,698	11,802,359
Current liabilities:
Accounts payable	739,850	702,494
Accrued expenses	1,008,077	1,049,513
Deferred revenue	2,905,165	1,230,746
Notes payable - Insurance	148,344	149,671
Total current liabilities	4,801,436	3,132,424
Long term liabilities:
Deferred revenue	0	1,230,748
Total liabilities	4,801,436	4,363,172
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, 6,982,909 and 3,529,344 shares issued and outstanding	69,829	35,293
Additional paid in capital	162,884,919	148,724,102
Accumulated deficit	(153,339,486)	(141,320,208)
Total stockholders' equity	9,615,262	7,439,187
Total liabilities and stockholders' equity	$ 14,416,698	$ 11,802,359

Consolidated Balance Sheets (Pa

Consolidated Balance Sheets (Parenthetical) - USD ($)	Dec. 31, 2015	Dec. 31, 2014
Statement of Financial Position [Abstract]
Property & equipment, accumulated depreciation	$ 2,443,600	$ 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	150,000,000
Common stock, shares issued	6,982,909	3,529,344
Common stock, shares outstanding	6,982,909	3,529,344

Consolidated Statements of Oper

Consolidated Statements of Operations - USD ($)	12 Months Ended
	Dec. 31, 2015	Dec. 31, 2014
Revenue:
Option Revenue	$ 2,556,329	$ 1,271,895
Research and development	10,039,496	12,118,629
General and administrative	4,258,147	3,833,370
Depreciation and amortization	351,403	387,779
Loss on disposal of fixed assets	1,167	0
Operating loss	(12,093,884)	(15,067,883)
Interest income, net	5,911	13,473
Other income and expense, net	68,695	2,147
Net loss	$ (12,019,278)	$ (15,052,263)
Basic and diluted loss per share	$ (2.05)	$ (4.33)
Weighted average shares outstanding	5,854,438	3,477,628

Consolidated Statements of Chan

Consolidated Statements of Changes in Stockholders' Equity - USD ($)	Common Stock [Member]	Additional Paid In Capital [Member]	Accumulated Deficit	Total
Beginning Balance, Shares at Dec. 31, 2013	3,443,257
Beginning Balance, Amount at Dec. 31, 2013	$ 34,433	$ 146,810,786	$ (126,267,945)	$ 20,577,274
Shares issued for services, Shares	21,285
Shares issued for services, Amount	$ 212	305,891	0	306,103
Cancellation of fractional shares, Amount				0
Shares sold for cash, Shares	64,802
Shares sold for cash, Amount	$ 648	647,527	0	648,175
Exercise of warrants, Amount				0
Option expense	0	959,898	0	959,898
Net loss	$ 0	0	(15,052,263)	(15,052,263)
Ending Balance, Shares at Dec. 31, 2014	3,529,344
Ending Balance, Amount at Dec. 31, 2014	$ 35,293	148,724,102	(141,320,208)	7,439,187
Shares issued for services, Shares	13,379
Shares issued for services, Amount	$ 134	78,079	0	78,213
Cancellation of fractional shares, Shares	(1,365)
Cancellation of fractional shares, Amount	$ (13)	(5,015)	0	(5,028)
Shares sold for cash, Shares	3,440,448
Shares sold for cash, Amount	$ 34,404	13,247,631	0	13,282,035
Exercise of warrants, Shares	1,103
Exercise of warrants, Amount	$ 11	4,399	0	4,410
Option expense	0	835,723	0	835,723
Net loss	$ 0	0	(12,019,278)	(12,019,278)
Ending Balance, Shares at Dec. 31, 2015	6,982,909
Ending Balance, Amount at Dec. 31, 2015	$ 69,829	$ 162,884,919	$ (153,339,486)	$ 9,615,262

Consolidated Statements of Cash

Consolidated Statements of Cash Flows - USD ($)	12 Months Ended
	Dec. 31, 2015	Dec. 31, 2014
Cash flows from operating activities
Net loss	$ (12,019,278)	$ (15,052,263)
Adjustments to reconcile net loss to net cash used in operating activities
Shares issued for services	78,213	306,103
Depreciation	351,403	387,779
Option expense	835,723	959,898
Loss on disposal of fixed assets	1,167	0
Changes in:
Other current assets	(87,780)	513,304
Accounts payable	37,356	6,339
Accrued expenses	(191,107)	(183,477)
Deferred revenue	443,671	138,727
Other long-term assets	38,939	(1,271,895)
Net cash used in operating activities	(10,511,693)	(14,195,485)
Cash flows from investing activities
Purchase of property & equipment	(92,333)	(190,859)
Net cash provided by (used in) investing activities	(92,333)	(190,859)
Cash flows from financing activities
Common stock and warrants sold for cash, net of offering costs	13,282,035	648,175
Cash generated from exercise of warrants	4,410	0
Repurchase of fractional shares	(5,028)	0
Net cash provided by financing activities	13,281,417	648,175
Net change in cash and cash equivalents	2,677,391	(13,738,169)
Cash and cash equivalents at beginning of period	9,906,373	23,644,542
Cash and cash equivalents at end of period	12,583,764	9,906,373
Cash paid for:
Income tax	0	0
Interest	$ 2,315	$ 1,983

1. BUSINESS OVERVIEW AND SUMMAR

1. BUSINESS OVERVIEW AND SUMMARY OF ACCOUNTING POLICIES	12 Months Ended
	Dec. 31, 2015
Accounting Policies [Abstract]
BUSINESS OVERVIEW AND SUMMARY OF ACCOUNTING POLICIES	Description of Business In September 2012, Opexa initiated a Phase IIb clinical trial of Tcelna in patients with secondary progressive MS (“SPMS”). Previously, in September 2008, the Company completed a Phase IIb clinical study of Tcelna in the relapsing-remitting MS (“RRMS”) indication. Opexa operates in a highly regulated and competitive environment. The manufacturing and marketing of pharmaceutical products require approval from, and are subject to, ongoing oversight by the Food and Drug Administration, or FDA, in the United States, by the European Medicines Agency, or EMA, in the E.U. and by comparable agencies in other countries. Obtaining approval for a new therapeutic product is never certain and may take many years and may involve expenditure of substantial resources. Tcelna is in development stage and Opexa has not applied for a Biologics License Application (BLA) for Tcelna with the FDA nor a similar regulatory licensure in any other country, and thus Tcelna is not approved to be marketed in any country. 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 the amount of preferred or common stock authorized resulting from the 1:8 Reverse Stock Split. Principles of Consolidation. Use of Estimates in Financial Statement Preparation. Certain Risks and Concentrations. Revenue Recognition. Opexa received an upfront payment of $5 million for granting the option. 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. 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 Opexa’s current Phase IIb clinical trial for Tcelna in patients with SPMS. Opexa is required to make estimates regarding the clinical trial timelines which impact the period over which the option exercise may occur. Opexa’s estimates regarding the option exercise period were adjusted in 2014 once the enrollments for the Abili-T clinical trial were completed. This adjustment was made on a prospective basis beginning in the periods in which the change was identified and resulted in a decrease in the amount of revenue we recognized on a quarterly basis from the Merck Serono Agreement. No changes to estimates for the option exercise milestone were made in 2015. The expected completion term for revenue recognition is December 2016. 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 activities described below: ● Opexa will create a detailed Pre-Phase III Plan (including a GANTT chart containing key tasks, decision points, timing, budget and milestones) 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 (e.g., review and identification of a preferred contract manufacturing organization in Europe; set-up, identification and qualification of third parties for raw materials; validation of laboratory facilities in the U.S. and Europe; and a hiring plan for key personnel). For Europe, the Pre-Phase III Plan would address the creation of a dedicated lab to support a Phase III trial, and for the U.S., the Pre-Phase III Plan would address the expansion of existing capabilities and infrastructure for a Phase III trial. The Joint Steering Committee (“JSC”) established pursuant to the Merck Serono Agreement will be responsible for reviewing, approving and ultimately overseeing Opexa’s completion of the Pre-Phase III Plan, which approval may not be unreasonably withheld or delayed. The JSC will meet at least quarterly to advise and make specific recommendations with respect to the Pre-Phase III Plan. In the event the JSC has not approved the Pre-Phase III Plan prior to the end of the Option Period (as defined in the Merck Serono Agreement), the Option Period will be extended for 60 days following approval of the Pre-Phase III Plan by the JSC. ● Opexa will provide Merck Serono updates and analysis on a blinded basis, grouped in patient batches according to Opexa’s analysis timetable, on the progress of Opexa’s immune monitoring program (the “Program”) being conducted in conjunction with Opexa’s ongoing Abili-T clinical trial, with such updates and analysis to be shared with Merck Serono within 30 days of Opexa’s initial assessment of such information. Opexa will inform Merck Serono of any existing or future external bioinformatics vendor used by Opexa for the Program, and Merck Serono will have the right, at its expense, to review current and future data storage and integrity measures for the on-going Abili-T clinical trial. Opexa evaluated the Merck Serono Amendment and determined that the $3 million payment from Merck Serono has stand-alone value. Opexa’s 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 the 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 $3 million as deferred revenue on the consolidated balance sheets. Cash and Cash Equivalents. Supplies Inventory. Long-lived Assets. Deferred costs. Income Taxes. Stock-Based Compensation. Research and Development. Research and Development Foreign Currency Translation and Transaction Gains and Losses Foreign Currency Matters Net Loss per Share Reclassifications

2. CASH AND CASH EQUIVALENTS

2. CASH AND CASH EQUIVALENTS	12 Months Ended
	Dec. 31, 2015
Cash and Cash Equivalents [Abstract]
CASH AND CASH EQUIVALENTS	As of December 31, 2015, Opexa invested approximately $11.7 million in a savings account. For the year ended December 31, 2015, the savings account recognized an average market yield of 0.07%. Interest income of $8,203 from the savings account was recognized for the year ended December 31, 2015 in the consolidated statements of operations. As of December 31, 2015 and 2014, Opexa invested approximately $24,500 in a money market fund investing exclusively in high-quality, short-term money market instruments consisting of U.S. government obligations and repurchase agreements collateralized by the U.S. Government. While this fund seeks current income while preserving capital and liquidity, the fund is subject to risk, including U.S. government obligations risk, and is not federally insured or guaranteed by or obligations of the Federal Deposit Insurance Corporation or any other agency. For the years ended December 31, 2015 and 2014, the money market fund recognized an average market yield of 0.01%. Interest income of $3 was recognized for the year ended December 31, 2015 in the consolidated statements of operations.

3. OTHER CURRENT ASSETS

3. OTHER CURRENT ASSETS	12 Months Ended
	Dec. 31, 2015
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract]
OTHER CURRENT ASSETS	Other current assets consisted of the following at December 31, 2015 and 2014: Description 2015 2014 Custom reagents $ 496,269 $ — Deferred offering costs 28,876 259,989 Prepaid expenses 469,922 498,954 Total Other Current Assets $ 995,067 $ 758,943

4. PROPERTY AND EQUIPMENT

4. PROPERTY AND EQUIPMENT	12 Months Ended
	Dec. 31, 2015
Property, Plant and Equipment [Abstract]
PROPERTY AND EQUIPMENT	Property and equipment consisted of the following at December 31, 2015 and 2014: Description Life 2015 2014 Computer equipment 3 years $ 193,596 $ 168,209 Office furniture and equipment 5-7 years 247,679 247,679 Software 3 years 125,412 116,022 Laboratory equipment 7 years 1,120,693 1,100,559 Leasehold improvements 5 years 683,295 675,672 Manufacturing equipment 7 years 910,792 889,352 Subtotal 3,281,467 3,197,493 Less: accumulated depreciation (2,443,600 ) (2,099,389 ) Property and equipment, net $ 837,867 $ 1,098,104 Property and equipment is carried at cost less accumulated depreciation. Depreciation is calculated by the straight-line method over the estimated useful life of three to seven years, depending upon the type of equipment, except for leasehold improvements which are amortized using the straight-line method over the remaining lease term or the life of the asset, whichever is shorter. The cost of repairs and maintenance is charged as an expense to the consolidated statements of operations as incurred. Depreciation expense totaled $351,403 and $387,779 for the years ended December 31, 2015 and 2014, respectively.

5. OTHER LONG TERM ASSETS

5. OTHER LONG TERM ASSETS	12 Months Ended
	Dec. 31, 2015
Text Block [Abstract]
OTHER LONG TERM ASSETS	Other long term assets include costs incurred from third parties in connection with the Merck Serono Agreement (see Note 1). At December 31, 2015 and December 31, 2014 the unamortized costs that are expected to be amortized beyond the upcoming twelve month period amounted to $0 and $38,939, respectively.

6. INCOME TAXES

6. INCOME TAXES	12 Months Ended
	Dec. 31, 2015
Income Tax Disclosure [Abstract]
INCOME TAXES	Opexa uses the liability method, where deferred tax assets and liabilities are determined based on the expected future tax consequences of temporary differences between the carrying amounts of assets and liabilities for financial and income tax reporting purposes. At December 31, 2015 and 2014, Opexa had approximately $70 million and approximately $68 million of unused net operating losses (NOLs), respectively, available for carry forward to future years. For tax purposes, Opexa elects to capitalize research & development expenses and amortize them over a 10-year period. The unused NOLs begin to expire at December 31, 2025. At December 31, 2015 and 2014, capitalized R&D amounted to $35.3 million and $25.9 million, respectively. At December 31, 2015 and 2014, Opexa had a deferred tax asset which is covered by a full valuation allowance due to uncertainty of Opexa’s ability to generate future taxable income necessary to realize the related deferred tax asset consisting of: Deferred tax asset resulting from: December 31, 2015 December 31, 2014 Net Operating Loss $ 24,806,175 $ 24,531,026 Research and development tax credits 2,593,792 1,778,030 Capitalized research and development costs 11,900,122 8,803,914 Subtotal 39,300,089 35,112,970 Less valuation allowance (39,300,089 ) (35,112,970 ) Net deferred tax asset $ — $ — Opexa’s ability to utilize the NOLs is subject to the rules of Section 382 of the Internal Revenue Code. Section 382 generally restricts the use of NOLs after an “ownership change” (generally defined as a greater than 50% change (by value) in the Company’s equity ownership over a three-year period). The Section 382 limitation is applied annually and is equal to the value of Opexa’s stock on the date of the ownership change, multiplied by a designated federal long-term tax-exempt rate.

7. COMMITMENTS AND CONTINGENCIE

7. COMMITMENTS AND CONTINGENCIES	12 Months Ended
	Dec. 31, 2015
Commitments and Contingencies Disclosure [Abstract]
COMMITMENTS AND CONTINGENCIES	In October 2005, Opexa entered into a ten-year lease for its office and research facilities. The facility including the property is leased for a term of ten years with two options for an additional five years each at the then prevailing market rate. In May 2015, we exercised the option for an additional five year lease. Rent expense in the consolidated statements of operations for the years ended December 31, 2015 and 2014 was approximately $153,000 and $136,000 respectively. The future minimum lease payments are: Year Amount 2016 $ 200,000 2017 200,000 2018 201,250 2019 206,250 2020 157,500 Total future minimum lease payments $ 965,000

8. SIGNIFICANT CONTRACTUAL SERV

8. SIGNIFICANT CONTRACTUAL SERVICE AND MILESTONE AGREEMENTS	12 Months Ended
	Dec. 31, 2015
Health Care Organizations [Abstract]
SIGNIFICANT CONTRACTUAL SERVICE AND MILESTONE AGREEMENTS	In February 2012, Opexa entered into an agreement with PRA pursuant to which PRA provides Opexa with services related to the design, implementation and management of Opexa’s ongoing Phase IIb clinical trial program in SPMS (the “PRA Agreement”). Payments by Opexa to PRA under the PRA Agreement are based on the achievement of certain time and performance milestones as presented in the PRA Agreement. Total payments to PRA during the years ended December 31, 2015 and 2014, which were charged to research and development expense on the consolidated statements of operations, amounted to $1,115,868 and $1,557,824, respectively. Unless terminated by either party without cause on 60 days prior notice or on shorter notice with cause, the initial term of the PRA Agreement is for four years and automatically renews for successive one year terms. Through December 31, 2015, Opexa entered into individual Clinical Trial Agreements with 36 Institutions and 36 principal investigators acting within their employment or agent positions within their clinical institution. Under the terms of each Clinical Trial Agreement, each of the Investigators will identify and recruit subjects with SPMS meeting certain enrollment requirements and conduct clinical research in conjunction with Opexa’s Phase IIb clinical study, and each of the Institutions will provide appropriate resources and facilities so the Institution’s Investigator can conduct Opexa’s Phase IIb clinical study in a timely and professional manner and according to the terms of the Clinical Trial Agreement. Under the terms of each Clinical Trial Agreement, Opexa paid an upfront cash payment to each Institution for start-up and other costs which were charged directly to expense. Future payments by Opexa to the Institutions during the term of each Clinical Trial Agreement are based on the achievement of certain performance milestones as presented in each Clinical Trial Agreement. Unless terminated by Opexa without cause with 30 days’ notice, or unless terminated by the Institution, Investigator or Opexa for health or safety reasons, the initial term of the Clinical Trial Agreements with each Institution and Investigator is for the duration of their enrolled subjects in the Phase IIb clinical study. In November of 2014, Opexa entered into an agreement with Parexel International, LLC (“PAREXEL”), a contract research organization, in which PAREXEL will provide Opexa Regulatory Services for the conduct of the Neuromyelitis Optica (“NMO”) program. In addition, three Institutional agreements were executed in 2014, to provide preclinical research activities. Services include identification, collection and shipping of blood samples to Opexa for research purposes and conduct of preclinical activities.

9. EQUITY

9. EQUITY	12 Months Ended
	Dec. 31, 2015
Equity [Abstract]
EQUITY	Summary information regarding equity related transactions for the years ended December 31, 2014 and December 31, 2015 is as follows: During 2014, equity related transactions were as follows: ● On February 28, 2014, 13,700 shares of restricted common stock with an aggregate fair value of $199,503 were issued to certain members of Opexa’s management and certain members of the board of directors. Opexa recognized stock based compensation expense of $31,090 and $168,412 related to these shares for the year ended December 31, 2015 and 2014 respectively. The restricted shares issued to management vested 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 members of the board of directors vested in four quarterly increments beginning on March 31, 2014. ● On March 19, 2014, 750 shares of restricted common stock with an aggregate fair value of $12,000 were issued to a certain member of Opexa’s board of directors. Opexa recognized stock based compensation expense of $2,123 and $9,877 related to these shares for the year ended December 31, 2015 and 2014 respectively. The restricted shares vested in three quarterly increments beginning on June 30, 2014. ● In the third quarter of 2014, Opexa settled sales of 64,801 shares of common stock generating gross and net proceeds including amortization of deferred financing costs of $674,126 and $648,175, respectively, which were issued pursuant to the ATM facility. ● In the fourth quarter of 2014, Opexa issued 6,833 shares of restricted stock with an aggregate fair market value of $50,000 in partial consideration for the performance of services rendered by a consultant pursuant to a consulting agreement dated October 21, 2014. During 2015, equity related transactions were as follows: ● In February 2015, Opexa recognized stock-based compensation expense of $33,213 related to vested shares of restricted common stock issued, on February 28, 2014, to certain members of Opexa’s management and non-employee directors. ● 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 Opexa’s 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 $ 1,708,930. ● 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 Opexa’s Board. Opexa recognized stock-based compensation of $11,250 related to these shares. The shares vested immediately upon grant. ● 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. ● At Opexa’s annual meeting on August 28, 2015, shareholders approved an amendment to the Company’s 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. ● 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 Opexa’s achievement of certain milestones to further the clinical development of OPX-212, Opexa’s 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. 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 the amount of preferred or common stock authorized resulting from the 1:8 Reverse Stock Split. ● 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 Opexa’s 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 facility for gross and net proceed of $240,143 and $232,934, respectively. These sales settled and shares were issued in October 2015. ● In November 2015, Opexa sold an aggregate of 114,507 shares of common stock under the ATM facility for gross and net proceed of $483,634 and $469,116, respectively. These sales settled and shares were issued in December 2015. ● On December 31, 2015, 4,062 shares of restricted common stock with an aggregate fair value of $11,250 were issued to certain non-employee directors for service on Opexa’s Board. Opexa recognized stock-based compensation of $11,250 related to these shares. The shares vested immediately upon grant.

10. OPTIONS AND WARRANTS

10. OPTIONS AND WARRANTS	12 Months Ended
	Dec. 31, 2015
Disclosure of Compensation Related Costs, Share-based Payments [Abstract]
OPTIONS AND WARRANTS	The Board initially adopted the Opexa Therapeutics, Inc. 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 Company’s 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 Company’s 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 Opexa’s June 2004 Compensatory Stock Option Plan (the “2004 Plan”). The 2004 Plan reserved a maximum of 71,875 shares of common stock for issuance pursuant to incentive stock options and nonqualified stock options granted to employees, directors and consultants. Awards were made as either incentive stock options or nonqualified stock options, with the Board having discretion to determine the number, term, exercise price and vesting of grants made under the 2004 Plan. All outstanding equity awards granted under the 2004 Plan continue to be subject to the terms and conditions as set forth in the agreements evidencing such stock awards and the terms of the 2004 Plan, but no additional awards will be granted under the 2004 Plan subsequent to approval of the 2010 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. Opexa accounts for stock-based compensation, including options and nonvested shares, according to the provisions of FASB ASC 718, "Share Based Payment.” During the 12 months ended December 31, 2015, Opexa recognized stock-based compensation expense of $835,723. Unamortized stock-based compensation expense as of December 31, 2015 amounted to $1,897,092. Stock Option Activity A summary of the stock option activity for the years 2014 and 2015 are presented below: Number of Shares Weighted Avg. Exercise Price Weighted Average Remaining Contract Term (# years) Intrinsic Value Outstanding at December 31, 2013 145,233 $ 34.39 Granted 175,417 14.27 Exercised - - Forfeited and canceled (17,816 ) 23.86 Outstanding at December 31, 2014 302,834 $ 23.34 8.0 $ - Exercisable at December 31, 2014 120,485 $ 36.52 6.4 $ - Granted 135,430 5.22 Exercised - - Forfeited and canceled (20,860 ) 13.35 Outstanding at December 31, 2015 417,404 $ 18.04 7.7 $ - Exercisable at December 31, 2015 231,071 $ 23.58 7.0 $ - 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 2014, performance-based options to purchase an aggregate of 63,765 shares at an exercise price of $14.56 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 172.33% and (4) zero expected dividends. During 2014, incentive based options to purchase an aggregate of 96,609 shares were granted to employees, at exercise prices ranging from $6.88 to $14.56. These options have terms of ten years and have a vesting schedule of four years. Fair value of $1,324,070 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 2.26 to 2.79%, (2) expected term of 6.25 years, (3) expected volatility range of 176.37% to 315.10% and (4) zero expected dividends. During 2014, options to purchase 13,110 shares were forfeited and cancelled. Opexa recorded $748,697 stock-based compensation expense to management and employees during 2014, which included the related expense for the options that are expected to vest based on achievement of their related performance conditions. Unamortized stock compensation expense as of December 31, 2014 amounted to $2,239,522. During 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 1.95% to 2.19%, (2) expected term of 6.25 years, (3) expected volatility range of 134.18% to 144.83% and (4) zero expected dividends. During 2015, options to purchase 20,860 shares were forfeited and cancelled. Opexa recognized stock based compensation expense of $623,040 for grants made to employees during 2015. Unamortized stock compensation expense as of December 31, 2015 amounted to $1,890,846. Non-Employee Options: During 2014, options to purchase an aggregate of 15,055 shares were granted to directors for service on Opexa’s Board at an exercise price ranging from $14.56 to $16.00. Options to purchase an aggregate of 3,286 shares have terms of 10 years, with 50% of the shares vesting on the grant date and 50% vesting one year from the date of grant. Options to purchase 9,857 shares have terms of 10 years, with 50% of the shares vesting on the grant date and 50% vesting on December 31, 2014. An option to purchase 1,106 shares has a term of 10 years, with quarterly vesting ending on December 31, 2014. An option to purchase the remaining 806 shares has a term of 10 years, with 33.3% vesting quarterly ending on December 31, 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% to 2.77%, (2) expected term of 5.25 years, (3) expected volatility range of 155% to 157% and (4) zero expected dividends. During 2014, options to purchase 4,718 shares were forfeited and cancelled. Opexa recorded $211,201 of stock-based compensation expense to consultants and directors during 2014. Unamortized stock compensation expense as of December 31, 2014 amounted to $4,086. During 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 Opexa’s 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 $212,683 for grants made to non-employee directors during 2015. Unamortized stock compensation expense as of December 31, 2015 amounted to $6,246. Warrant Activity A summary of warrant activity for 2015 and 2014 Number of Shares Weighted Avg. Exercise Price Weighted Average Remaining Contract Term (# years) Intrinsic Value Outstanding at January 1, 2014 383,603 $ 32.96 2.46 - Granted - - - - Exercised - - - - Forfeited and canceled (2,789) 80.00 - - Outstanding at December 31, 2014 380,814 29.92 2.21 - Exercisable at December 31, 2014 380,814 29.92 2.21 - Outstanding at January 1, 2015 380,814 $ 29.92 2.21 - Granted 3,311,128 4.16 - - Exercised (1,103) 4.00 - - Forfeited and canceled (27,885) 74.96 - - Outstanding at December 31, 2015 3,662,954 6.30 2.17 - Exercisable at December 31, 2015 3,662,954 6.30 2.17 - 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 Company’s 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 original expiration on April 9, 2018.

11. LICENSES AND GAIN ON EXTING

11. LICENSES AND GAIN ON EXTINGUISHMENT OF LIABILITY	12 Months Ended
	Dec. 31, 2015
Text Block [Abstract]
LICENSES AND GAIN ON EXTINGUISHMENT OF LIABILITY	Stem Cell Technology Agreement In August 2009, Opexa entered into an exclusive agreement with Novartis for the further development of its stem cell technology. This technology, which has generated preliminary data, was in early preclinical development. Under the terms of the agreement, Novartis acquired the stem cell technology from Opexa and Novartis had full responsibility for funding and carrying out all research, development and commercialization activities. Opexa received an upfront cash payment of $3 million at the time the agreement was entered into and subsequently received $0.5 million as a technology transfer milestone fee. In November 2011, Opexa re-acquired the stem cell assets from Novartis in consideration for releasing Novartis with respect to any further payment obligations owed to Opexa by Novartis In connection with the re-acquisition of the stem cell assets, a related license agreement with the University of Chicago was re-assigned to Opexa. Opexa and the University of Chicago entered into a Fourth Amended and Restated License Agreement in connection with such assignment to Opexa. On August 12, 2014, we provided notice to the University of Chicago of our election to discontinue further prosecution of certain patents relating to the proprietary adult stem cell technology that we licensed from the University of Chicago pursuant to the Fourth Amended and Restated License Agreement dated November 2, 2011. Pursuant to the termination notice, we exercised our contractual option to return the licensed patent rights back to the University of Chicago and terminate the Fourth Amended and Restated License Agreement effective November 10, 2014 in accordance with the terms thereof.

12. SUBSEQUENT EVENTS

12. SUBSEQUENT EVENTS	12 Months Ended
	Dec. 31, 2015
Subsequent Events [Abstract]
SUBSEQUENT EVENTS	On March 2, 2016, the Company announced implementation of a restructuring initiative which included a reduction of approximately 30% of its then full-time workforce of 36 employees in order to reduce operating expenses and conserve cash resources. On March 14, 2016, the Company 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 thereto was extended from April 9, 2018 to October 9, 2018.

1. BUSINESS OVERVIEW AND SUMM19

1. BUSINESS OVERVIEW AND SUMMARY OF ACCOUNTING POLICIES (Policies)	12 Months Ended
	Dec. 31, 2015
Accounting Policies [Abstract]
Description of Business	Description of Business In September 2012, Opexa initiated a Phase IIb clinical trial of Tcelna in patients with secondary progressive MS (“SPMS”). Previously, in September 2008, the Company completed a Phase IIb clinical study of Tcelna in the relapsing-remitting MS (“RRMS”) indication. Opexa operates in a highly regulated and competitive environment. The manufacturing and marketing of pharmaceutical products require approval from, and are subject to, ongoing oversight by the Food and Drug Administration, or FDA, in the United States, by the European Medicines Agency, or EMA, in the E.U. and by comparable agencies in other countries. Obtaining approval for a new therapeutic product is never certain and may take many years and may involve expenditure of substantial resources. Tcelna is in development stage and Opexa has not applied for a Biologics License Application (BLA) for Tcelna with the FDA nor a similar regulatory licensure in any other country, and thus Tcelna is not approved to be marketed in any country.
Reverse Stock Split	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 the amount of preferred or common stock authorized resulting from the 1:8 Reverse Stock Split.
Principals of Consolidation	Principles of Consolidation.
Use of Estimates in Financial Statement Preparation	Use of Estimates in Financial Statement Preparation.
Certain Risks and Concentrations	Certain Risks and Concentrations.
Revenue Recognition	Revenue Recognition. Opexa received an upfront payment of $5 million for granting the option. 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. 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 Opexa’s current Phase IIb clinical trial for Tcelna in patients with SPMS. Opexa is required to make estimates regarding the clinical trial timelines which impact the period over which the option exercise may occur. Opexa’s estimates regarding the option exercise period were adjusted in 2014 once the enrollments for the Abili-T clinical trial were completed. This adjustment was made on a prospective basis beginning in the periods in which the change was identified and resulted in a decrease in the amount of revenue we recognized on a quarterly basis from the Merck Serono Agreement. No changes to estimates for the option exercise milestone were made in 2015. The expected completion term for revenue recognition is December 2016. 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 activities described below: ● Opexa will create a detailed Pre-Phase III Plan (including a GANTT chart containing key tasks, decision points, timing, budget and milestones) 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 (e.g., review and identification of a preferred contract manufacturing organization in Europe; set-up, identification and qualification of third parties for raw materials; validation of laboratory facilities in the U.S. and Europe; and a hiring plan for key personnel). For Europe, the Pre-Phase III Plan would address the creation of a dedicated lab to support a Phase III trial, and for the U.S., the Pre-Phase III Plan would address the expansion of existing capabilities and infrastructure for a Phase III trial. The Joint Steering Committee (“JSC”) established pursuant to the Merck Serono Agreement will be responsible for reviewing, approving and ultimately overseeing Opexa’s completion of the Pre-Phase III Plan, which approval may not be unreasonably withheld or delayed. The JSC will meet at least quarterly to advise and make specific recommendations with respect to the Pre-Phase III Plan. In the event the JSC has not approved the Pre-Phase III Plan prior to the end of the Option Period (as defined in the Merck Serono Agreement), the Option Period will be extended for 60 days following approval of the Pre-Phase III Plan by the JSC. ● Opexa will provide Merck Serono updates and analysis on a blinded basis, grouped in patient batches according to Opexa’s analysis timetable, on the progress of Opexa’s immune monitoring program (the “Program”) being conducted in conjunction with Opexa’s ongoing Abili-T clinical trial, with such updates and analysis to be shared with Merck Serono within 30 days of Opexa’s initial assessment of such information. Opexa will inform Merck Serono of any existing or future external bioinformatics vendor used by Opexa for the Program, and Merck Serono will have the right, at its expense, to review current and future data storage and integrity measures for the on-going Abili-T clinical trial. Opexa evaluated the Merck Serono Amendment and determined that the $3 million payment from Merck Serono has stand-alone value. Opexa’s 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 the 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 $3 million as deferred revenue on the consolidated balance sheets.
Cash and Cash Equivalents	Cash and Cash Equivalents.
Supplies Inventory	Supplies Inventory.
Long-lived Assets	Long-lived Assets.
Deferred costs	Deferred costs.
Income Taxes	Income Taxes.
Stock-Based Compensation	Stock-Based Compensation.
Research and Development	Research and Development. Research and Development
Foreign Currency Translation and Transaction Gains and Losses	Foreign Currency Translation and Transaction Gains and Losses Foreign Currency Matters
Net Loss per Share	Net Loss per Share
Reclassifications	Reclassifications

3. OTHER CURRENT ASSETS (Tables

3. OTHER CURRENT ASSETS (Tables)	12 Months Ended
	Dec. 31, 2015
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract]
Other Current Assets	Description 2015 2014 Custom reagents $ 496,269 $ — Deferred offering costs 28,876 259,989 Prepaid expenses 469,922 498,954 Total Other Current Assets $ 995,067 $ 758,943

4. PROPERTY AND EQUIPMENT (Tabl

4. PROPERTY AND EQUIPMENT (Tables)	12 Months Ended
	Dec. 31, 2015
Property, Plant and Equipment [Abstract]
Property and Equipment	Description Life 2015 2014 Computer equipment 3 years $ 193,596 $ 168,209 Office furniture and equipment 5-7 years 247,679 247,679 Software 3 years 125,412 116,022 Laboratory equipment 7 years 1,120,693 1,100,559 Leasehold improvements 5 years 683,295 675,672 Manufacturing equipment 7 years 910,792 889,352 Subtotal 3,281,467 3,197,493 Less: accumulated depreciation (2,443,600 ) (2,099,389 ) Property and equipment, net $ 837,867 $ 1,098,104

6. INCOME TAXES (Tables)

6. INCOME TAXES (Tables)	12 Months Ended
	Dec. 31, 2015
Income Taxes Tables
Schedule of deferred tax assets	Deferred tax asset resulting from: December 31, 2015 December 31, 2014 Net Operating Loss $ 24,806,175 $ 24,531,026 Research and development tax credits 2,593,792 1,778,030 Capitalized research and development costs 11,900,122 8,803,914 Subtotal 39,300,089 35,112,970 Less valuation allowance (39,300,089 ) (35,112,970 ) Net deferred tax asset $ — $ —

7. COMMITMENTS AND CONTINGENC23

7. COMMITMENTS AND CONTINGENCIES (Tables)	12 Months Ended
	Dec. 31, 2015
Commitments And Contingencies Tables
Future minimum lease payments	Year Amount 2016 $ 200,000 2017 200,000 2018 201,250 2019 206,250 2020 157,500 Total future minimum lease payments $ 965,000

10. OPTIONS AND WARRANTS (Table

10. OPTIONS AND WARRANTS (Tables)	12 Months Ended
	Dec. 31, 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 December 31, 2013 145,233 $ 34.39 Granted 175,417 14.27 Exercised - - Forfeited and canceled (17,816 ) 23.86 Outstanding at December 31, 2014 302,834 $ 23.34 8.0 $ - Exercisable at December 31, 2014 120,485 $ 36.52 6.4 $ - Granted 135,430 5.22 Exercised - - Forfeited and canceled (20,860 ) 13.35 Outstanding at December 31, 2015 417,404 $ 18.04 7.7 $ - Exercisable at December 31, 2015 231,071 $ 23.58 7.0 $ -
Warrant Activity	Number of Shares Weighted Avg. Exercise Price Weighted Average Remaining Contract Term (# years) Intrinsic Value Outstanding at January 1, 2014 383,603 $ 32.96 2.46 - Granted - - - - Exercised - - - - Forfeited and canceled (2,789) 80.00 - - Outstanding at December 31, 2014 380,814 29.92 2.21 - Exercisable at December 31, 2014 380,814 29.92 2.21 - Outstanding at January 1, 2015 380,814 $ 29.92 2.21 - Granted 3,311,128 4.16 - - Exercised (1,103) 4.00 - - Forfeited and canceled (27,885) 74.96 - - Outstanding at December 31, 2015 3,662,954 6.30 2.17 - Exercisable at December 31, 2015 3,662,954 6.30 2.17 -

2. CASH AND CASH EQUIVALENTS (D

2. CASH AND CASH EQUIVALENTS (Detail Narratives) - USD ($)	12 Months Ended
	Dec. 31, 2015	Dec. 31, 2014
Cash and Cash Equivalents [Abstract]
Investment in savings account	$ 11,700,000
Percentage of interest recognized from savings account investment	0.07%
Interest income from savings account investment	$ 8,203
Cash and cash equivalents, money market accounts	$ 24,500	$ 24,500
Percentage of interest recognized from money market fund	0.01%	0.01%
Interest income from money market fund	$ 3

3. OTHER CURRENT ASSETS (Detail

3. OTHER CURRENT ASSETS (Details) - USD ($)	Dec. 31, 2015	Dec. 31, 2014
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract]
Custom reagents	$ 496,269	$ 0
Deferred offering costs	28,876	259,989
Prepaid expenses	469,922	498,954
Other current assets	$ 995,067	$ 758,943

4. PROPERTY AND EQUIPMENT (Deta

4. PROPERTY AND EQUIPMENT (Details) - USD ($)	12 Months Ended
	Dec. 31, 2015	Dec. 31, 2014
Property Plant And Equipment Disclosure [Line Items]
Property, plant and equipment, gross	$ 3,281,467	$ 3,197,493
Less: accumulated depreciation	(2,443,600)	(2,099,389)
Property and equipment, net	$ 837,867	1,098,104
Computer Equipment [Member]
Property Plant And Equipment Disclosure [Line Items]
Property, plant and equipment, useful life	3 years
Property, plant and equipment, gross	$ 193,596	168,209
Office Furniture And Equipment [Member]
Property Plant And Equipment Disclosure [Line Items]
Property, plant and equipment, gross	$ 247,679	247,679
Office Furniture And Equipment [Member] | Maximum [Member]
Property Plant And Equipment Disclosure [Line Items]
Property, plant and equipment, useful life	5 years
Office Furniture And Equipment [Member] | Minimum [Member]
Property Plant And Equipment Disclosure [Line Items]
Property, plant and equipment, useful life	7 years
Computer Software Intangible Asset [Member]
Property Plant And Equipment Disclosure [Line Items]
Property, plant and equipment, useful life	3 years
Property, plant and equipment, gross	$ 125,412	116,022
Laboratory Equipment [Member]
Property Plant And Equipment Disclosure [Line Items]
Property, plant and equipment, useful life	7 years
Property, plant and equipment, gross	$ 1,120,693	1,100,559
Leasehold Improvements [Member]
Property Plant And Equipment Disclosure [Line Items]
Property, plant and equipment, useful life	5 years
Property, plant and equipment, gross	$ 683,295	675,672
Manufacturing Equipment [Member]
Property Plant And Equipment Disclosure [Line Items]
Property, plant and equipment, useful life	7 years
Property, plant and equipment, gross	$ 910,792	$ 889,352

4. PROPERTY AND EQUIPMENT (De28

4. PROPERTY AND EQUIPMENT (Detail Narratives) - USD ($)	12 Months Ended
	Dec. 31, 2015	Dec. 31, 2014
Property Plant And Equipment Disclosure [Line Items]
Depreciation expense	$ 351,403	$ 387,779

5. OTHER LONG TERM ASSETS (Deta

5. OTHER LONG TERM ASSETS (Details) - USD ($)	Dec. 31, 2015	Dec. 31, 2014
Other Long Term Assets Details
Unamortized costs	$ 0	$ 38,939

6. INCOME TAXES (Details)

6. INCOME TAXES (Details) - USD ($)	Dec. 31, 2015	Dec. 31, 2014
Deferred tax asset resulting from:
Net Operating Loss	$ 24,806,175	$ 24,531,026
Research and development tax credits	2,593,792	1,778,030
Capitalized research and development costs	11,900,122	8,803,914
Subtotal	39,300,089	35,112,970
Less valuation allowance	(39,300,089)	(35,112,970)
Net deferred tax asset	$ 0	$ 0

6. INCOME TAXES (Detail Narrati

6. INCOME TAXES (Detail Narratives) - USD ($)	12 Months Ended
	Dec. 31, 2015	Dec. 31, 2014
Income Tax Disclosure [Abstract]
Unused net operating losses	$ 70,000,000	$ 68,000,000
Capitalized research and development costs	$ 11,900,122	$ 8,803,914
Net operating losses begin to expire	Dec. 31, 2025

7. COMMITMENTS AND CONTINGENC32

7. COMMITMENTS AND CONTINGENCIES (Details)	Dec. 31, 2015USD ($)
Commitments And Contingencies Details
2,016	$ 200,000
2,017	200,000
2,018	201,250
2,019	206,250
2,020	157,500
Total future minimum lease payments	$ 965,000

7. COMMITMENTS AND CONTINGENC33

7. COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($)	12 Months Ended
	Dec. 31, 2015	Dec. 31, 2014
Commitments And Contingencies Details Narrative
Rent expense	$ 153,000	$ 136,000

10. OPTIONS AND WARRANTS (Detai

10. OPTIONS AND WARRANTS (Details) - USD ($)	12 Months Ended
	Dec. 31, 2015	Dec. 31, 2014
Options
Number of Shares, Outstanding at beginning of period	302,834	145,233
Options, Granted	135,430	175,417
Options, Exercised	0	0
Options, Forfeited and canceled	(20,860)	(17,816)
Number of Shares, Outstanding at end of period	417,404	302,834
Number of Shares, Exercisable at end of period	231,071	120,485
Weighted Average Exercise Price, Options
Weighted average exercise price, Outstanding at beginning of period	$ 23.34	$ 34.39
Weighted average exercise price options, Granted	5.22	14.27
Weighted average exercise price options, Exercised	0	0
Weighted average exercise price options, Forfeited and canceled	13.35	23.86
Weighted average exercise price, Outstanding at end of period	18.04	23.34
Weighted average exercise price, Exercisable at end of period	$ 23.58	$ 36.52
Weighted Average Remaining Contract Term, Options
Weighted Average Remaining Contract Term, Outstanding at end of period	7 years 8 months 12 days	8 years
Weighted Average Remaining Contract Term, Exercisable	7 years	6 years 4 months 24 days
Intrinsic Value, Options
Outstanding Aggregate Intrinsic Value, beginning of period	$ 0	$ 0
Outstanding Aggregate Intrinsic Value, end of period	0	0
Exercisable Aggregate Intrinsic Value	$ 0	$ 0

10. OPTIONS AND WARRANTS (Det35

10. OPTIONS AND WARRANTS (Details 1) - Warrants - USD ($)	12 Months Ended
	Dec. 31, 2015	Dec. 31, 2014
Number of Shares, Outstanding at beginning of period	380,814	383,603
Warrants, Granted	3,311,128	0
Warrants, Exercised	(1,103)	0
Warrants, Forfeited and canceled	(27,885)	(2,789)
Number of Shares, Outstanding at end of period	3,662,954	380,814
Number of Shares, Exercisable at end of period	3,662,954	380,814
Weighted Average Exercise Price, Warrants
Weighted average exercise price, Outstanding at beginning of period	$ 29.92	$ 32.96
Weighted average exercise price warrants, Granted	4.16	0
Weighted average exercise price warrants, Exercised	4	0
Weighted average exercise price warrants, Forfeited and canceled	74.96	80
Weighted average exercise price, Outstanding at end of period	6.30	29.92
Weighted average exercise price, Exercisable at end of period	$ 6.30	$ 29.92
Weighted Average Remaining Contract Term, Warrants
Weighted Average Remaining Contract Term, Outstanding at beginning of period	2 years 2 months 16 days	2 years 5 months 16 days
Weighted Average Remaining Contract Term, Outstanding at end of period	2 years 2 months 1 day	2 years 2 months 16 days
Weighted Average Remaining Contract Term, Exercisable	2 years 2 months 1 day	2 years 2 months 16 days
Intrinsic Value, Warrants
Outstanding Aggregate Intrinsic Value, Beginning of period	$ 0	$ 0
Aggregate Intrinsic Value Granted	0	0
Aggregate Intrinsic Value Exercised	0	0
Aggregate Intrinsic Value Forfeited	0	0
Outstanding Aggregate Intrinsic Value, End of period	0	0
Exercisable Aggregate Intrinsic Value	$ 0	$ 0