Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2015 | Aug. 07, 2015 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2015 | |
Document Fiscal Year Focus | 2,015 | |
Document Fiscal Period Focus | Q2 | |
Trading Symbol | OGEN | |
Entity Registrant Name | ORAGENICS INC | |
Entity Central Index Key | 1,174,940 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Smaller Reporting Company | |
Entity Common Stock, Shares Outstanding | 36,477,536 |
Balance Sheets
Balance Sheets - USD ($) | Jun. 30, 2015 | Dec. 31, 2014 |
Current assets: | ||
Cash and cash equivalents | $ 8,043,503 | $ 10,448,921 |
Accounts receivables, net | 26,798 | 15,608 |
Inventory, net | 364,074 | 439,189 |
Prepaid expenses and other current assets | 90,389 | 119,410 |
Total current assets | 8,524,764 | 11,023,128 |
Property and equipment, net | 170,724 | 109,292 |
Total assets | 8,695,488 | 11,132,420 |
Current liabilities: | ||
Accounts payable and accrued expenses | 548,686 | 710,210 |
Short-term notes payable | 34,767 | 64,840 |
Convertible note payable to shareholder | 5,000,000 | |
Deferred revenue | 17,855 | 21,222 |
Total current liabilities | $ 5,601,308 | $ 796,272 |
Shareholders' equity: | ||
Preferred stock, no par value; 20,000,000 shares authorized; none issued and outstanding | ||
Common stock, $0.001 par value; 100,000,000 shares authorized 36,378,944 and 36,178,944 shares issued and outstanding at June 30, 2015 and December 31, 2014 | $ 36,379 | $ 36,179 |
Additional paid-in capital | 86,630,684 | 86,244,604 |
Accumulated deficit | (83,572,883) | (75,944,635) |
Total shareholders' equity | 3,094,180 | 10,336,148 |
Total liabilities and shareholders' equity | $ 8,695,488 | $ 11,132,420 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2015 | Dec. 31, 2014 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | ||
Preferred stock, shares authorized | 20,000,000 | 20,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 36,378,944 | 36,178,944 |
Common stock, shares outstanding | 36,378,944 | 36,178,944 |
Statements of Operations (Unaud
Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | |
Income Statement [Abstract] | ||||
Revenue, net | $ 242,038 | $ 303,752 | $ 605,812 | $ 518,412 |
Cost of sales | 86,782 | 125,605 | 254,779 | 205,365 |
Gross profit | 155,256 | 178,147 | 351,033 | 313,047 |
Operating expenses: | ||||
Research and development | 5,611,921 | 903,328 | 6,288,516 | 1,919,792 |
Selling, general and administrative | 873,630 | 1,177,335 | 1,689,095 | 1,944,729 |
Total operating expenses | 6,485,551 | 2,080,663 | 7,977,611 | 3,864,521 |
Loss from operations | (6,330,295) | (1,902,516) | (7,626,578) | (3,551,474) |
Other income (expense): | ||||
Interest income | 5,755 | 9,680 | 12,371 | 20,519 |
Interest expense | (10,031) | (980) | (10,637) | (1,551) |
Local business tax | (900) | (1,500) | (2,900) | (3,694) |
Other income (expense): | (203) | (504) | (203) | |
Total other income (expense), net | (5,176) | 6,997 | (1,670) | 15,071 |
Loss before income taxes | (6,335,471) | (1,895,519) | (7,628,248) | (3,536,403) |
Income tax benefit | 0 | 0 | 0 | 0 |
Net loss | $ (6,335,471) | $ (1,895,519) | $ (7,628,248) | $ (3,536,403) |
Basic and diluted net loss per share | $ (0.17) | $ (0.05) | $ (0.21) | $ (0.10) |
Shares used to compute basic and diluted net loss per share | 36,378,944 | 36,145,977 | 36,295,428 | 36,127,076 |
Statements of Cash Flows (Unaud
Statements of Cash Flows (Unaudited) - USD ($) | 6 Months Ended | |
Jun. 30, 2015 | Jun. 30, 2014 | |
Cash flows from operating activities: | ||
Net loss | $ (7,628,248) | $ (3,536,403) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Technology access fee paid in convertible note payable to shareholder | 5,000,000 | |
Depreciation and amortization | 32,457 | 13,299 |
Loss on sale of fixed assets | 203 | |
Stock issued as compensation to non-employee directors | 132,000 | 102,500 |
Stock-based compensation expense | 254,280 | 154,221 |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | (11,190) | 41,609 |
Inventory, net | 75,115 | 49,408 |
Prepaid expenses and other current assets | 78,416 | 81,367 |
Accounts payable and accrued expenses | (161,524) | (206,743) |
Deferred revenue | (3,367) | 20,037 |
Net cash used in operating activities | (2,232,061) | (3,280,502) |
Cash flows from investing activities: | ||
Proceeds from sale of fixed asset | 424 | |
Purchase of property and equipment | (93,889) | (18,889) |
Net cash used in investing activities | (93,889) | (18,465) |
Cash flows from financing activities: | ||
Payments on short-term notes payable | (79,468) | (78,970) |
Net cash used by financing activities | (79,468) | (78,970) |
Net decrease in cash and cash equivalents | (2,405,418) | (3,377,937) |
Cash and cash equivalents at beginning of period | 10,448,921 | 16,276,510 |
Cash and cash equivalents at end of period | 8,043,503 | 12,898,573 |
Supplemental disclosure of cash flow information: | ||
Interest paid | 1,471 | 1,579 |
Non-cash investing and financing activities: | ||
Borrowings under short-term notes payable for prepaid expense | 49,395 | 50,694 |
Par value of common stock issued for cashless exercise of warrants | $ 135 | |
Par value of restricted shares issued | $ 200 |
Organization
Organization | 6 Months Ended |
Jun. 30, 2015 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization | 1. Organization Oragenics, Inc. (formerly known as Oragen, Inc.) (the “Company” or “we”) was incorporated in November 1996; however, operating activity did not commence until 1999. We are focused on becoming the world leader in novel antibiotics against infectious disease. We also develop, market and sell proprietary probiotics specifically designed to enhance oral health for humans and pets. |
Basis of Presentation
Basis of Presentation | 6 Months Ended |
Jun. 30, 2015 | |
Accounting Policies [Abstract] | |
Basis of Presentation | 2. Basis of Presentation The accompanying unaudited interim financial statements as of June 30, 2015 and December 31, 2014 (audited) and for the three and six months ended June 30, 2015 and 2014 have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, the accompanying financial statements include all adjustments, consisting of normal recurring accruals, necessary for a fair presentation of the financial condition, results of operations and cash flows for the periods presented. The results of operations for the interim period June 30, 2015 are not necessarily indicative of the results that may be expected for the year ending December 31, 2015 or any future period. These financial statements should be read in conjunction with the audited financial statements and notes thereto for the year ended December 31, 2014, which are included in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 27, 2015. The Company has incurred recurring losses and negative cash flows from operations since inception. To date the Company has not generated significant revenues from operations. The Company generated revenues of $605,812, incurred a net loss of $7,628,248, and used cash of $2,232,061 in its operating activities during the six months ended June 30, 2015. As of June 30, 2015, the Company had an accumulated deficit of $83,572,883. In 2013 the Company raised $3,900,000 in gross proceeds through a private placement sale of its common stock and $9,904,996 in net proceeds through an underwritten public offering. The Company expects to incur substantial expenditures to further develop each of its technologies. In June of 2015, the Company issued a convertible note payable to Intrexon Corporation (“Intrexon”) as consideration for the Technology Access Fee associated with the Oral Mucositis Exclusive Channel Collaboration agreement (See Note 8). The Company currently intends to issue its common stock as payment of the convertible note payable and any accrued interest. Assuming the Company is able to issue its common stock as payment of its convertible note payable and accrued interest, the Company believes that its cash position as of June 30, 2015 will be sufficient to meet the business objectives as presently structured over the next nine months. The Company’s ability to continue operations after its current cash resources are exhausted depends on its ability to obtain additional financing or achieve profitable operations, as to which no assurances can be given. Cash requirements may vary materially from those now planned because of changes in the Company’s focus and direction of its research and development programs, competitive and technical advances, limitation of financial resources, or other developments. Additional financing will be required for the Company to fund our further work under the Lantibiotic ECC and our normal operating costs; inclusive of selling, general, and administrative costs through March 2016. We will need to raise additional capital to begin work under the Oral Macostas ECC. There can be no assurance that any such financing can be realized by the Company, or if realized, what the terms thereof may be, or that any amount that the Company is able to raise will be adequate to support the Company’s working capital requirements until it achieves profitable operations. The Company intends to seek additional funding through public or private financing, sublicensing arrangements, joint venturing or partnering, sales of rights to technology, or government grants. The Company’s future success depends on its ability to raise capital and ultimately generate revenue and attain profitability. The Company cannot be certain that additional capital, whether through selling additional debt or equity securities or obtaining a line of credit or other loan, will be available to it or, if available, will be on terms acceptable to the Company. If the Company issues additional securities to raise funds, these securities may have rights, preferences, or privileges senior to those of its common stock, and the Company’s current shareholders may experience dilution. If the Company is unable to obtain funds when needed or on acceptable terms, the Company may be required to substantially curtail their current development programs, cut operating costs and forego future development and other opportunities until such time as additional capital can be raised. |
Significant Accounting Policies
Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2015 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies | 3. Significant Accounting Policies Recently Issued Accounting Pronouncements In May 2014, the FASB issued guidance on Revenue from Contracts with Customers, to clarify the principles used to recognize revenue for all entities. The core principle of the new guidance is that an entity will recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods and services. The standard provides a five-step analysis of transactions to determine when and how revenue is recognized. Additionally, the guidance requires disaggregated disclosures related to the nature, amount, timing, and uncertainty of revenue that is recognized. The guidance is effective for annual and interim periods beginning after December 15, 2016. The FASB has subsequently delayed this standard by one year. Early adoption is permitted as of the original effective date. The Company is currently evaluating the effects, if any, the adoption of this guidance will have on the Company’s financial statements. There are no additional accounting pronouncements issued or effective during the six months ended June 30, 2015 that have had or are expected to have an impact on our financial statements. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. The principal areas of estimation reflected in the financial statements are anticipated milestone payments, stock based compensation, valuation of warrants, income tax valuation allowance, inventory obsolescence reserve, sales returns and allowances and the allowance for doubtful accounts. Guaranteed Rights of Return The Company has granted guaranteed rights of return to two dental distributors. The Company defers recognition of revenue on these accounts until either the distributor provides notification to the Company that the product has been sold to the end consumer or the guaranteed right of return period expires. Once notification has been received and verified, the Company records revenue in that accounting period. The Company had $17,855 and $21,222 of revenue deferred under guaranteed rights of return arrangements included in deferred revenue in the balance sheets as of June 30, 2015 and December 31, 2014, respectively. Inventory Inventory is stated at the lower of cost or market. Cost, which includes material, labor and overhead, is determined on a first-in, first-out basis. On a quarterly basis, we analyze our inventory levels and reserve for inventory that is expected to expire prior to being sold, inventory that has a cost basis in excess of its expected net realizable value, inventory in excess of expected sales requirements, or inventory that fails to meet commercial sale specifications. Expired inventory is disposed of and the related costs are written off to the reserve for inventory obsolescence. The inventory reserve was approximately $68,200 and $50,100 as of June 30, 2015 and December 31, 2014, respectively. Stock-Based Payment Arrangements Generally, all forms of stock-based payments, including stock option grants, warrants, and restricted stock grants are measured at their fair value on the awards’ grant date typically using a Black-Scholes pricing model. Stock-based compensation awards issued to non-employees for services rendered are recorded at the fair value of the stock-based payment. The expense resulting from stock-based payments are recorded in research and development expense or selling, general and administrative expense in the statement of operations, depending on the nature of the services provided. Stock-based payment expense is recorded over the requisite service period in which the grantee provides services to us, to the extent the stock option grants, warrants, or restricted stock grants do not vest at the grant date they are subject to forfeiture. Stock-Based Compensation GAAP requires all share-based payments to employees, including grants of employee stock options, to be recognized in the financial statements based on their fair values as of the grant date. Stock-based compensation expense is recorded over the requisite service period in which the grantee provides services to us, to the extent the options do not vest at the grant date and are subject to forfeiture. For performance-based awards that do not include market-based conditions, we record share-based compensation expense only when the performance-based milestone is deemed probable of achievement. We utilize both quantitative and qualitative criteria to judge whether milestones are probable of achievement. For awards with market-based performance conditions, we recognize the grant-date fair value of the award over the derived service period regardless of whether the underlying performance condition is met. Warrants The Company used the Black-Scholes Option Pricing Model in calculating the relative fair value of any warrants that are issued. Net Loss Per Share During all periods presented, the Company had securities outstanding that could potentially dilute basic earnings per share in the future, but were excluded from the computation of diluted net loss per share, as their effect would have been antidilutive. Because the Company reported a net loss for all periods presented, shares associated with the stock options and warrants are not included because they are antidilutive. Basic and diluted net loss per share amounts are the same for the periods presented. Net loss per share is computed using the weighted average number of shares of common stock outstanding. Revenue Recognition The Company recognizes revenues from the sales of product when title and risk of loss pass to the customer, which is generally when the product is shipped. The Company records allowances for discounts and product returns at the time of sale as a reduction of revenues as such allowances can be reliably estimated based on historical experience or known trends. The Company maintains a return policy that allows customers to return product within a specified period of time prior to and subsequent to the expiration date of the product. The estimate of the provision for returns is analyzed quarterly and is based upon many factors, including industry data of product return rates, historical experience of actual returns, analysis of the level of inventory in the distribution channel, if any, and reorder rates. If the history or product returns changes, the reserve will be adjusted. While the Company believes that the reserves it has established are reasonable and appropriate based upon current facts and circumstances, applying different judgments to the same facts and circumstances would result in the estimated amounts for sales returns and chargebacks to vary. Because the ProBiora3 products have only had limited distribution, the Company could experience different circumstances in the future and these differences could be material. The Company has granted guaranteed rights of return at various times to certain customers. At this time there are two dental distributors with guaranteed rights of return. Orders are processed and shipped on these accounts, however, the Company defers recognition of revenue until the customer provides notification to the Company that the product has sold to the end consumer. Once notification has been received and verified, the Company will record revenue in that accounting period. Concentrations The Company is dependent on key suppliers to provide probiotics, blending, warehousing and packaging of its EvoraPlus, EvoraKids, EvoraPro, EvoraPet, and Teddy’s Pride products. The Company had four key suppliers during the three and six months ended June 30, 2015. The majority of the Company’s cost of revenues is from these key suppliers during the three and six months ended June 30, 2015 and 2014. Accounts payable and accrued expenses for these vendors totaled approximately $60,643 and $189,120 as of June 30, 2015 and December 31, 2014, respectively. Financial instruments which potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents. The Company maintains cash accounts in commercial banks, which may, at times, exceed federally insured limits. The Company has not experienced any losses in such accounts. The Company believes it is not exposed to any significant credit risk on cash and cash equivalents. As of June 30, 2015, the uninsured portion of this balance was $7,793,503. As of December 31, 2014, the uninsured portion of this balance was $10,198,921. |
Stock-based Compensation
Stock-based Compensation | 6 Months Ended |
Jun. 30, 2015 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-based Compensation | 4. Stock-based Compensation The Company recognized stock-based compensation on all employee and non-employee awards as follows: Three Months Ended Three Months Ended Six Months Ended Six Months Ended Research and development $ 82,953 $ 127,730 $ 103,870 $ 137,767 Selling, general and administrative 191,187 123,446 282,410 118,954 Total Stock based compensation $ 274,140 $ 251,176 $ 386,280 $ 256,721 The Company granted 10,000 and 910,000 stock options, with a weighted-average grant date fair value of $0.77 and $1.29 per share, during the three and six months ended June 30, 2015, respectively. The Company granted 100,000 stock options, with a weighted-average grant date fair value of $2.81per share, during the three and six months ended June 30, 2014. During the six months ended June 30, 2015, 28,333 stock options previously granted have vested and 278,334 stock options were forfeited and no stock options were exercised. The Company’s long-term performance-based incentive program for executive officers (the “Executive LTIP Program”) and its long-term performance-based equity incentive based component for the non-employee directors (“Non-Employee Director LTIP Program” and together with the Executive LTIP the “LTIP Programs”) expired and terminated in accordance with their terms on December 31, 2014. The Compensation Committee of the Board of Directors (the “Compensation Committee”) recommended and approved, and the Board of Directors approved, a program of equity based awards from the Company’s 2012 Equity Incentive Plan (the “2012 Plan”) which are intended to align interests of executive officers and directors with stockholders over a long-term basis and thereby replace the expired LTIP Programs. The new equity based programs also include a minimum dollar value stock ownership holding requirement threshold before shares can be sold. On March 16, 2015, in connection with and in furtherance of the new equity based award program, the Board of Directors of the Company approved stock option awards as previously recommended and approved by the Compensation Committee for the Company’s named executive officers currently employed with the Company. Mr. Sullivan, the Company’s Chief Financial Officer, Mr. Fosmoe, the Company’s Senior Vice President of Operations/Product Development and Dr. Handfield, the Company’s Senior Vice President of Discovery Research, were granted options to purchase 200,000, 150,000 and 150,000 shares of Company common stock, respectively, under the Company’s 2012 Plan at an exercise price of $1.32 per share, the closing price on the date of grant. The options are subject to time-based vesting in equal annual installments over a three-year period on the first, second and third anniversaries of the date of the grant, provided that the recipient remains employed with the Company through the vesting dates. Also on March 16, 2015, in connection with and in furtherance of the new equity based award program, the Board approved stock option awards in the amount of 80,000 to each of the Company’s non-employee directors, Frederick Telling, Charles Pope, Alan Dunton, Christine Koski and Robert Koski under the Company’s 2012 Plan at an exercise price of $1.32 per share, the closing price on the date of grant. Dr. Telling, Mr. Pope, Dr. Dunton, Ms. Koski and Mr. Koski were each also awarded 40,000 restricted shares of Company common stock under the Company’s 2012 Plan, of which 10,000 restricted shares vest at the end of each calendar quarter in 2015, provided the recipient remains a director through the vesting date. Each executive officer and non-employee director receiving the above equity based awards will be subject to a minimum dollar value stock ownership holding requirement with respect to the awards received as well as all prior equity awards under the 2012 Plan which requirements are intended to align the ability to sell shares with the performance of the Company’s stock price. The above named executive officer recipients will each have a minimum dollar value stock ownership holding requirement threshold equal to two times (2x) their then base salaries below which dollar threshold they would be precluded from selling any shares of Company stock obtained from the Company under its 2012 Plan. Also, the above non-employee directors will each be subject to a minimum dollar value stock ownership holding requirement threshold equal to six times the annual Board retainer ($270,000) below which dollar threshold they would be precluded from selling shares of Company stock acquired from the Company under its 2012 Plan. |
Warrants
Warrants | 6 Months Ended |
Jun. 30, 2015 | |
Text Block [Abstract] | |
Warrants | 5. Warrants A summary of warrant activity for the year ended December 31, 2014 and the six months ended June 30, 2015 is as follows: Warrants Weighted Average Price Balance - December 31, 2013 2,747,094 $ 1.91 Granted — — Exercised (210,000 ) 1.50 Expired (5,000 ) (10.00 ) Balance - December 31, 2014 2,532,094 1.93 Granted — — Exercised — — Expired (2,170,925 ) (2.00 ) Balance – June 30, 2015 361,169 $ 1.50 On March 23, 2015, warrants to acquire 2,170,925 shares of the Company’s common stock at a price of $2.00 per share expired. The warrants outstanding as of June 30, 2015 are as follows: Exercise Price Warrants Outstanding Expiration Dates $1.50 361,169 7/31/17 361,169 |
Short-Term Notes Payable
Short-Term Notes Payable | 6 Months Ended |
Jun. 30, 2015 | |
Debt Disclosure [Abstract] | |
Short-Term Notes Payable | 6. Short-Term Notes Payable As of June 30, 2015 and December 31, 2014, the Company had $34,767 and $64,840, respectively, in short-term notes payable for the financing of various insurance policies. On March 10, 2014, the Company entered into a short-term note payable for $50,694 bearing interest at 6.57% to finance the product liability insurance. Principal and interest payments on this note began April 10, 2014 and are made evenly based on a straight line amortization over a 10-month period with the final payment being made on January 10, 2015. On March 16, 2015, we entered into a short-term note payable for $49,395 bearing interest at 5.68% per annum to finance the product liability insurance. Principal and interest payments on this note began April 16, 2015 and are made evenly based on a straight line amortization over a 10-month period with the final payment due on January 16, 2016. On July 24, 2014, the Company entered into a short-term note payable for $108,306 bearing interest at 4.647% to finance a portion of the directors’ and officers’ liability insurance and employment practices liability insurance premiums. Principal and interest payments on this note began August 24, 2014 and are made evenly based on a straight line amortization over an 11-month period with the final payment made on June 22, 2015. |
Convertible Note Payable To Sha
Convertible Note Payable To Shareholder | 6 Months Ended |
Jun. 30, 2015 | |
Text Block [Abstract] | |
Convertible Note Payable To Shareholder | 7. Convertible Note Payable To Shareholder On June 9, 2015, the Company entered into an unsecured short-term Convertible Promissory Note in the principal amount of $5,000,000 bearing interest at 3.00% as consideration for the Technology Access Fees associated with the Oral Mucositis ECC (discussed below) entered into with Intrexon. The Convertible Promissory Note is payable, at the Company’s option, in cash or shares of the Company’s common stock. Principal and accrued interest is due on December 31, 2015. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2015 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 8. Commitments and Contingencies The University of Florida Research Foundation (UFRF) Licenses UFRF-MU1140 and Replacement Therapy Licenses. The Company is required to make minimum annual maintenance payments to the UFRF for the term of the amended license agreements in the amount of $10,000 for each license agreement and $20,000 in aggregate. The aggregate minimum annual payments are required to be paid in advance on a quarterly basis (i.e. $5,000 per quarter) for both licenses. The Company must also pay all patent costs and expenses incurred by the UFRF for the preparation, filing, prosecution, issuance and maintenance of the patents. The terms of the UFRF amended license agreements expire upon the earlier of (i) the date that no patents covered by the amended license agreements remain enforceable or (ii) the payment of earned royalties under the amended license agreements, once begun, ceases for more than three calendar quarters. The Company may voluntarily terminate the license agreement upon 90 days written notice to UFRF. UFRF may terminate the amended license agreements if the Company breaches its obligations to timely pay any amounts due under the amended license agreements, to submit development reports as required under the amended license agreements or commit any other breach of any other covenants contained in the amended license agreements and the Company fails to remedy such breach within 90 days after written notice of such breach by UFRF. The patent the Company exclusively licensed from UFRF for its Replacement Therapy expired in June 2015. The Company is currently evaluating its options with respect to the SMaRT Replacement Therapy technology. Texas A&M License Agreement Under the terms of the Texas A&M license agreement, the Company made an initial payment of five thousand dollars ($5,000) to Texas A&M. The Company must also pay to Texas A&M a royalty of five percent (5%) of net sales of products that include the licensed technology, subject to royalty stacking provisions with a two percent (2%) minimum royalty. Additionally, in order to maintain the exclusive license, commencing in 2014 and each year thereafter prior to the calendar year of the first sale of products using the licensed technology, the Company must pay Texas A&M $15,000 as minimum consideration for the continuation of the license agreement. Once the Company commences the sale of products that include the technology the Company licenses from Texas A&M, the Company must pay a minimum annual amount of $100,000 to Texas A&M and every year thereafter through the expiration of the Agreement. However, once sales begin, any royalty payments the Company makes on net sales will be credited against the $100,000 required maintenance payment. The Company must also pay all patent costs and expenses for the preparation, filing, prosecution, issuance and maintenance of the patent rights. Sales by sublicensees are subject to the royalty rate above, and the Company is responsible for certain payments to Texas A&M for any other consideration received that is not in the form of a royalty. Pursuant to the Texas A&M license agreement, the Company is obligated to meet the following milestones and make milestone payments: (i) enrollment of first patient in a Phase I clinical trial using the licensed technology, to occur on or before June 1, 2015, with a milestone achievement payment of $50,000, (ii) completion of Phase II clinical trial using the licensed technology to occur on or before June 1, 2019, with a milestone achievement payment of $100,000, (iii) completion of Phase III clinical trial of the licensed technology to occur on or before June 1, 2022, with a milestone achievement payment of $150,000, and (iv) first sale of the licensed technology to occur on or before June 1, 2025 with a milestone achievement payment of $400,000. If we fail to accomplish the milestones or fail to achieve net sales of products including the licensed technology for two consecutive calendar years, Texas A&M at its sole option may waive the requirement, negotiate the missed milestones or terminate the license agreement. None of the Texas A&M milestones had been achieved as of June 30, 2015. The Company plans to seek an extension of the first enrollment of a patient milestone referred to above prior to the due date. On July 11, 2012 the Texas A&M license agreement was amended to add references to replacement therapy in the defined terms “Licensed Technology” and “Patent Rights”. All other terms of the Texas A&M license agreement remain unchanged. On May 18, 2015, the Texas A&M license agreement was amended to extend the enrollment of first patient in a Phase I clinical trial using the licensed technology, from on or before June 1, 2015, to on or before June 30, 2016. All other terms of the Texas A&M license agreement as amended remained unchanged. The term of the Texas A&M license agreement expires upon (i) the expiration of the applicable patent rights covered by the license agreement, (ii) the failure of any patent filed pursuant to the license agreement to issue, or (iii) the final and unappealable determination by a court that the patent rights are invalid. The Company may voluntarily terminate the license agreement upon 90 days written notice to Texas A&M. Texas A&M can terminate the license agreement if the Company materially breaches the license agreement and does not cure such breach within 60 days of receiving notice of such breach from Texas A&M. The Lantibiotic ECC Under the Lantibiotic ECC, and subject to certain exceptions, the Company is responsible for, among other things, funding the further anticipated development of lantibiotics toward the goal of commercialization, conducting nonclinical and clinical development of candidate lantibiotics, as well as for other aspects of manufacturing and the commercialization of the product(s). Among other things, Intrexon is responsible for technology discovery efforts, cell-engineering development, certain aspects of the manufacturing process, and costs of filing, prosecution and maintenance of Intrexon’s patents. Subject to certain expense allocations and other offsets provided in the Lantibiotic ECC, the Company will pay Intrexon, on a quarterly basis, 25% of gross quarterly profits derived in that quarter from the sale of products developed from the Lantibiotic ECC, calculated on an Oragenics Product-by-Oragenics Product basis. The Company has likewise agreed to pay Intrexon, on a quarterly basis, 50% of revenue obtained in that quarter from a sublicensor in the event of a sublicensing arrangement. In addition, in partial consideration for each party’s execution and delivery of the Lantibiotic ECC, the Company entered into a Stock Issuance Agreement with Intrexon (“SPIA”). Pursuant to the Stock Issuance Agreement, the Company issued to Intrexon 4,392,425 shares of the Company’s common stock as an initial technology access fee, in consideration for the execution and delivery of the Lantibiotic ECC and granted Intrexon certain equity participation rights and registration rights. Under the Stock Issuance Agreement and as part of the Lantibiotic ECC, the Company has also agreed to make certain payments to Intrexon upon the Company’s achievement of designated milestones in the form of shares of Company common stock or, at the Company’s option, make a cash payment to Intrexon (based upon the fair market value of the shares otherwise required to be issued). The milestone events and amounts payable are as follows: (i) upon filing of the first Investigational New Drug application with the U.S. Food and Drug Administration (“FDA”) for an Oragenics Product, that number of shares equal to the number of shares of common stock comprising 1.0% of the Base Shares (as defined below); (ii) upon the dosing of the first patient in the first Phase 2 clinical study with an Oragenics Product, that number of shares equal to the number of shares of common stock comprising 1.5% of the Base Shares; (iii) upon the dosing of the first patient in the first Phase 3 clinical study with an Oragenics Product, that number of shares equal to the number of shares of common stock comprising 2% of the Base Shares; (iv) upon the filing of the first New Drug Application (“NDA”) or Biologics License Application (“BLA”) with the FDA for an Oragenics Product, or alternatively the filing of the first equivalent regulatory filing with a foreign regulatory agency, that number of shares equal to the number of shares of Common Stock comprising 2.5% of the Base Shares; and (v) upon the granting of the first regulatory approval of an Oragenics Product, that number of shares equal to the number of shares of Common Stock comprising 3% of the Base Shares. Base Shares is defined in the Stock Issuance Agreement to mean (i) the number of shares of Company common stock together with any securities or instruments convertible or exercisable for shares of common stock issued and outstanding at the time of the applicable milestone event, (ii) minus any shares issuable upon conversion of Capital Inducement Securities. Capital Inducement Securities is defined in the Stock Issuance Agreement to mean warrants or other convertible securities of the Company issued to investors in connection with a debt or equity investment in the Company that are issued in addition to the primary investment securities and in an amount not to exceed 10% of the overall number of shares issued in the investment (on an as-converted to common stock basis). None of the Lantibiotic ECC milestones had been achieved as of June 30, 2015. Intrexon may terminate the Lantibiotic ECC if we fail to use diligent efforts to develop and commercialize Oragenics Products or if we elect not to pursue the development of a Lantibiotics Program identified by Intrexon that is a “Superior Therapy” as defined in the Lantibiotic ECC. We may voluntarily terminate the Lantibiotic ECC at any time upon 90 days written notice to Intrexon. Upon termination of the Lantibiotic ECC, the Company may continue to develop and commercialize any Oragenics Product that has been, at the time of termination: • commercialized by the Company; • approved by regulatory authorities; • a subject of an application for regulatory approval that is pending before the applicable regulatory authority; or • the subject of at least an ongoing Phase 1, Phase 2 or Phase 3 clinical trial in the Field (in the case of a termination by Intrexon due to an uncured material breach by the Company or a voluntary termination by the Company). The Company’s obligation to pay 25% of gross profits or revenue and milestone payments described above with respect to these “retained” products as well as to use diligent efforts to develop and commercialize these “retained” Oragenics Products will survive termination of the Lantibiotic ECC. The Live Biotherapeutic Products (“LBPs”) ECC Under the LBPs ECC, and subject to certain exceptions, the Company is responsible for, among other things, funding the further anticipated development of probiotics toward the goal of commercialization, conducting nonclinical and clinical development of candidate probiotics, as well as for other aspects of manufacturing and the commercialization of the product(s). Among other things, Intrexon is responsible for technology discovery efforts, cell-engineering development, certain aspects of the manufacturing process, and costs of filing, prosecution and maintenance of Intrexon’s patents. The Company will pay Intrexon 10% of the net sales derived from the sale of products developed from the exclusive channel collaboration relating to the LBPs Program. The Company has likewise agreed to pay Intrexon a percentage of revenue obtained from a sublicensee in the event of a sublicensing arrangement. The percentage of the revenue to be paid will be determined at the time that a sublicense agreement is negotiated. Under the SPIA and as part of the LBPs ECC, the Company has also agreed to make certain payments to Intrexon upon the Company’s achievement of designated milestones. The milestone payments are each payable to Intrexon, at the Company’s election (subject to an election right of Intrexon if the milestone is achieved by a sublicensee), either in cash or in shares of Company common stock (using the fair market value of the shares to calculate the number of shares to be issued to Intrexon in lieu of cash). The Commercialization Milestone Events and amounts payable are as follows: • $2,000,000 within thirty (30) days of the dosing of a patient by or on behalf of the Company, or an Affiliate (as that term is defined in the LBPs ECC) or permitted sublicensee of the Company, in a phase II clinical trial, whether such occurs in the United States of America under the jurisdiction of the FDA or elsewhere under the jurisdiction of a foreign regulatory agency, for a Company Product; • $5,000,000 within thirty (30) days of the first meeting of the primary endpoint by or on behalf of the Company, or an Affiliate or permitted sublicensee of the Company, in a phase III clinical trial, whether such occurs in the United States of America under the jurisdiction of the FDA or elsewhere under the jurisdiction of a foreign regulatory agency, for a Company Product; • $10,000,000 within thirty (30) days of the first to occur of (a) the First Commercial Sale (as that term is defined in the LBPs ECC) of a Company Product, or (b) the approval of a NDA (as that term is defined in the LBPs ECC) for a Company Product by the FDA or equivalent regulatory action in a foreign jurisdiction. None of the LBPs ECC milestones had been achieved as of June 30, 2015. The Company may voluntarily terminate the LBPs ECC upon 90 days written notice to Intrexon. Intrexon may also terminate the LBPs ECC if the Company breaches the LBPs ECC and fails to cure the breach within 60 days or the Company does not pursue development of the Superior Therapy under the probiotics identified by Intrexon that is a “Superior Therapy” as defined in the LBPs ECC. Upon termination of the LBPs ECC, the Company may continue to develop and commercialize any Company Product that, at the time of termination, satisfies at least one of the following criteria: • commercialized by the Company; • approved by regulatory authorities; • a subject of an application for regulatory approval that is pending before the applicable regulatory authority; or • the subject of at least an ongoing Phase 1, Phase 2 or Phase 3 clinical trial in the field of the LBPs Program. The Company’s obligation to pay 10% of net sales and the milestone payments described above with respect to these “retained” products as well as to use diligent efforts to develop and commercialize these “retained” Company Products will survive termination of the LBPs ECC. The Oral Mucositis ECC Under the ECC, and subject to certain exceptions, the Company is responsible for, among other things, funding the further anticipated development of products toward the goal of commercialization, conducting preclinical and clinical development of candidate products, as well as for other aspects of manufacturing and the commercialization of the product(s). Among other things, Intrexon is responsible for technology discovery efforts, cell-engineering development, and certain aspects of the manufacturing process. The Company will pay Intrexon on a quarterly basis 12% of the net sales derived from the sale of products developed from the exclusive channel collaboration. The Company has likewise agreed to pay Intrexon on a quarterly basis 50% of revenue obtained in that quarter from a sublicensor in the event of a sublicensing arrangement. The Company has also agreed to make certain payments to Intrexon upon the Company’s achievement of designated milestones in the form of shares of Company Common Stock (based upon the fair market value of the shares otherwise required to be issued) unless the issuance of such shares would reasonably likely cause Intrexon to consolidate the Company’s financial statements with Intrexon’s financial statements, or at the Company’s option make a cash payment to Intrexon. The Commercialization Milestone Events and amounts payable are as follows: (i) two million United States dollars ($2,000,000) within thirty (30) days of the first instance of the achievement of the Phase II Milestone Event meaning the first dosing of a patient by or on behalf of Oragenics, or an Affiliate or permitted sublicensee of Oragenics, in a phase II clinical trial, whether such occurs in the United States of America under the jurisdiction of the FDA or elsewhere under the jurisdiction of a foreign regulatory agency, for each different Oragenics Product; (ii) five million United States dollars ($5,000,000) within thirty (30) days of the first instance of the achievement of the Phase IIb/III Milestone Event meaning meeting of the primary endpoint by or on behalf of Oragenics, or an Affiliate or permitted sublicensee of Oragenics, in a phase III clinical trial, whether such occurs in the United States of America under the jurisdiction of the FDA or elsewhere under the jurisdiction of a foreign regulatory agency, for each different Oragenics Product; (iii) five million United States dollars ($5,000,000) within thirty (30) days of the first instance of the achievement of the Regulatory Approval Application Milestone Event for each different Oragenics Product which Regulatory Approval Application Milestone Event meaning for a given Oragenics Product, the first to occur of (a) the filing by Oragenics, an Affiliate thereof, or a permitted sublicensee thereof, of a FDA New Drug Application or a Biologics License Application with the FDA seeking approval of such Oragenics Product, or (b) the filing of an equivalent approval or marketing application for such Oragenics Product with an equivalent regulatory authority in a foreign jurisdiction; (iv) ten million United States dollars ($10,000,000) within thirty (30) days of the first instance of the achievement of the Approval Milestone Event for each different Oragenics Product which Approval Milestone Event meaning the first to occur of (a) the First Commercial Sale of an Oragenics Product anywhere in the Territory, or (b) 90th day after the approval of a FDA New Drug Application for an Oragenics Product by the FDA or equivalent regulatory action in a foreign jurisdiction; (v) Oragenics shall pay Intrexon a milestone payment of five million United States dollars ($5,000,000) within thirty (30) days of the first instance of the achievement of the New Indication Milestone Event meaning the filing by or on behalf of Oragenics, an Affiliate of Oragenics, or a permitted sublicensee of Oragenics a Supplemental FDA Application with the FDA or with another equivalent regulatory agency seeking approval of an indication for use of the product AG013 other than the current regulatory-approved indication; and (vi) Oragenics shall pay Intrexon a milestone payment of five million United States dollars ($5,000,000) within thirty (30) days of the first instance of the achievement of the New Product Milestone Event meaning the filing of a regulatory package filed with the FDA or with another equivalent regulatory agency by or on behalf of Oragenics, an Affiliate of Oragenics, or a permitted sublicensee of Oragenics, that is deemed (according to relevant FDA guideline) to be a different drug product than AG013. None of the Oral Mucositis ECC milestones had been achieved as of June 30, 2015. The Company may voluntarily terminate the Oral Mucositis ECC upon 90 days written notice to Intrexon. Intrexon may also terminate the ECC if the Company breaches and fails to cure the breach within 60 days or the Company does not pursue development of the Superior Therapy under the probiotics identified by Intrexon that is a “Superior Therapy” as defined in the ECC. Upon termination of the ECC, the Company may continue to develop and commercialize any Company Product that, at the time of termination that satisfies at least one of the following criteria: (i) the particular Company Product is being sold by the Company triggering profit sharing payments under the ECC to Intrexon; (ii) the particular Company Product has received regulatory approval; (iii) the particular Company Product is a subject of an application for regulatory approval in the Field covered by the ECC that is pending before the applicable regulatory authority; (iv) the particular Company Product is AG013, and such Company Product has been the subject of at least one completed phase II clinical trial (as such is defined by relevant FDA guidelines) during the Term; or (v) the particular Company Product other than AGO13 and such Oragenics Product is the subject of at least an ongoing Phase 1, Phase 2 or Phase 3 clinical trial in the Field. |
Related Party Transactions
Related Party Transactions | 6 Months Ended |
Jun. 30, 2015 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 9. Related Party Transactions During the three and six months ended June 30, 2015 and 2014, we paid $31,927 and $361,294; $45,755 and $901,319, respectively, to Intrexon under the ECC agreements (See Note 8). Included in accounts payable and accrued expenses at June 30, 2015 and 2014 was $38,932 and $7,605, respectively, related to unpaid invoices received from Intrexon relating to work performed under the ECC Agreements. As of June 30, 2015 and 2014 Intrexon owned approximately 24% of our outstanding common stock. |
Common Stock
Common Stock | 6 Months Ended |
Jun. 30, 2015 | |
Equity [Abstract] | |
Common Stock | 10. Common Stock On March 16, 2015, in connection with and in furtherance of the new equity based award program (see Note 4), the Board approved the award of 40,000 restricted shares of Company common stock to each of the Company’s non-employee directors, Frederick Telling, Charles Pope, Alan Dunton, Christine Koski and Robert Koski under the Company’s 2012 Plan of which a total of 20,000 restricted shares have vested on June 30, 2105 for each non-employee director and the remainder will vest at the end of each calendar quarter in 2015 provided the recipient remains a director through the vesting date. The awards are considered issued and outstanding as of the date of the grant and are eligible to be voted by the recipient. The Company has $132,000 in unrecognized compensation expense relating to these awards that will be recognized pro-rata through the remainder of 2015. |
Subsequent Event
Subsequent Event | 6 Months Ended |
Jun. 30, 2015 | |
Subsequent Events [Abstract] | |
Subsequent Event | 11. Subsequent Event On August 3, 2015, Griffin Securities Inc. exercised 185,585 of their previously issued warrants resulting in the issuance of 98,592 shares of our common stock |
Significant Accounting Polici17
Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2015 | |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements In May 2014, the FASB issued guidance on Revenue from Contracts with Customers, to clarify the principles used to recognize revenue for all entities. The core principle of the new guidance is that an entity will recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods and services. The standard provides a five-step analysis of transactions to determine when and how revenue is recognized. Additionally, the guidance requires disaggregated disclosures related to the nature, amount, timing, and uncertainty of revenue that is recognized. The guidance is effective for annual and interim periods beginning after December 15, 2016. The FASB has subsequently delayed this standard by one year. Early adoption is permitted as of the original effective date. The Company is currently evaluating the effects, if any, the adoption of this guidance will have on the Company’s financial statements. There are no additional accounting pronouncements issued or effective during the six months ended June 30, 2015 that have had or are expected to have an impact on our financial statements. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. The principal areas of estimation reflected in the financial statements are anticipated milestone payments, stock based compensation, valuation of warrants, income tax valuation allowance, inventory obsolescence reserve, sales returns and allowances and the allowance for doubtful accounts. |
Guaranteed Rights of Return | Guaranteed Rights of Return The Company has granted guaranteed rights of return to two dental distributors. The Company defers recognition of revenue on these accounts until either the distributor provides notification to the Company that the product has been sold to the end consumer or the guaranteed right of return period expires. Once notification has been received and verified, the Company records revenue in that accounting period. The Company had $17,855 and $21,222 of revenue deferred under guaranteed rights of return arrangements included in deferred revenue in the balance sheets as of June 30, 2015 and December 31, 2014, respectively. |
Inventory | Inventory Inventory is stated at the lower of cost or market. Cost, which includes material, labor and overhead, is determined on a first-in, first-out basis. On a quarterly basis, we analyze our inventory levels and reserve for inventory that is expected to expire prior to being sold, inventory that has a cost basis in excess of its expected net realizable value, inventory in excess of expected sales requirements, or inventory that fails to meet commercial sale specifications. Expired inventory is disposed of and the related costs are written off to the reserve for inventory obsolescence. The inventory reserve was approximately $68,200 and $50,100 as of June 30, 2015 and December 31, 2014, respectively. |
Stock-Based Payment Arrangements | Stock-Based Payment Arrangements Generally, all forms of stock-based payments, including stock option grants, warrants, and restricted stock grants are measured at their fair value on the awards’ grant date typically using a Black-Scholes pricing model. Stock-based compensation awards issued to non-employees for services rendered are recorded at the fair value of the stock-based payment. The expense resulting from stock-based payments are recorded in research and development expense or selling, general and administrative expense in the statement of operations, depending on the nature of the services provided. Stock-based payment expense is recorded over the requisite service period in which the grantee provides services to us, to the extent the stock option grants, warrants, or restricted stock grants do not vest at the grant date they are subject to forfeiture. |
Stock-Based Compensation | Stock-Based Compensation GAAP requires all share-based payments to employees, including grants of employee stock options, to be recognized in the financial statements based on their fair values as of the grant date. Stock-based compensation expense is recorded over the requisite service period in which the grantee provides services to us, to the extent the options do not vest at the grant date and are subject to forfeiture. For performance-based awards that do not include market-based conditions, we record share-based compensation expense only when the performance-based milestone is deemed probable of achievement. We utilize both quantitative and qualitative criteria to judge whether milestones are probable of achievement. For awards with market-based performance conditions, we recognize the grant-date fair value of the award over the derived service period regardless of whether the underlying performance condition is met. |
Net Loss Per Share | Net Loss Per Share During all periods presented, the Company had securities outstanding that could potentially dilute basic earnings per share in the future, but were excluded from the computation of diluted net loss per share, as their effect would have been antidilutive. Because the Company reported a net loss for all periods presented, shares associated with the stock options and warrants are not included because they are antidilutive. Basic and diluted net loss per share amounts are the same for the periods presented. Net loss per share is computed using the weighted average number of shares of common stock outstanding. |
Revenue Recognition | Revenue Recognition The Company recognizes revenues from the sales of product when title and risk of loss pass to the customer, which is generally when the product is shipped. The Company records allowances for discounts and product returns at the time of sale as a reduction of revenues as such allowances can be reliably estimated based on historical experience or known trends. The Company maintains a return policy that allows customers to return product within a specified period of time prior to and subsequent to the expiration date of the product. The estimate of the provision for returns is analyzed quarterly and is based upon many factors, including industry data of product return rates, historical experience of actual returns, analysis of the level of inventory in the distribution channel, if any, and reorder rates. If the history or product returns changes, the reserve will be adjusted. While the Company believes that the reserves it has established are reasonable and appropriate based upon current facts and circumstances, applying different judgments to the same facts and circumstances would result in the estimated amounts for sales returns and chargebacks to vary. Because the ProBiora3 products have only had limited distribution, the Company could experience different circumstances in the future and these differences could be material. The Company has granted guaranteed rights of return at various times to certain customers. At this time there are two dental distributors with guaranteed rights of return. Orders are processed and shipped on these accounts, however, the Company defers recognition of revenue until the customer provides notification to the Company that the product has sold to the end consumer. Once notification has been received and verified, the Company will record revenue in that accounting period. |
Concentrations | Concentrations The Company is dependent on key suppliers to provide probiotics, blending, warehousing and packaging of its EvoraPlus, EvoraKids, EvoraPro, EvoraPet, and Teddy’s Pride products. The Company had four key suppliers during the three and six months ended June 30, 2015. The majority of the Company’s cost of revenues is from these key suppliers during the three and six months ended June 30, 2015 and 2014. Accounts payable and accrued expenses for these vendors totaled approximately $60,643 and $189,120 as of June 30, 2015 and December 31, 2014, respectively. Financial instruments which potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents. The Company maintains cash accounts in commercial banks, which may, at times, exceed federally insured limits. The Company has not experienced any losses in such accounts. The Company believes it is not exposed to any significant credit risk on cash and cash equivalents. As of June 30, 2015, the uninsured portion of this balance was $7,793,503. As of December 31, 2014, the uninsured portion of this balance was $10,198,921. |
Warrant [Member] | |
Warrants | Warrants The Company used the Black-Scholes Option Pricing Model in calculating the relative fair value of any warrants that are issued. |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-based Compensation Expense Recognized | The Company recognized stock-based compensation on all employee and non-employee awards as follows: Three Months Ended Three Months Ended Six Months Ended Six Months Ended Research and development $ 82,953 $ 127,730 $ 103,870 $ 137,767 Selling, general and administrative 191,187 123,446 282,410 118,954 Total Stock based compensation $ 274,140 $ 251,176 $ 386,280 $ 256,721 |
Warrants (Tables)
Warrants (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
Text Block [Abstract] | |
Summary of Warrant Activity | A summary of warrant activity for the year ended December 31, 2014 and the six months ended June 30, 2015 is as follows: Warrants Weighted Average Price Balance - December 31, 2013 2,747,094 $ 1.91 Granted — — Exercised (210,000 ) 1.50 Expired (5,000 ) (10.00 ) Balance - December 31, 2014 2,532,094 1.93 Granted — — Exercised — — Expired (2,170,925 ) (2.00 ) Balance – June 30, 2015 361,169 $ 1.50 |
Summary of Warrants Outstanding | The warrants outstanding as of June 30, 2015 are as follows: Exercise Price Warrants Outstanding Expiration Dates $1.50 361,169 7/31/17 361,169 |
Basis of Presentation - Additio
Basis of Presentation - Additional Information (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | Dec. 31, 2013 | Dec. 31, 2014 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||||
Revenues generated by company | $ 242,038 | $ 303,752 | $ 605,812 | $ 518,412 | ||
Net loss | 6,335,471 | $ 1,895,519 | 7,628,248 | 3,536,403 | ||
Cash used in operations | 2,232,061 | $ 3,280,502 | ||||
Accumulated deficit | $ 83,572,883 | $ 83,572,883 | $ 75,944,635 | |||
Gross proceeds from issuance of common stock | $ 3,900,000 | |||||
Net proceeds through underwritten public offering | $ 9,904,996 |
Significant Accounting Polici21
Significant Accounting Policies - Additional Information (Detail) | 3 Months Ended | 6 Months Ended | |
Jun. 30, 2015USD ($)Supplier | Jun. 30, 2015USD ($)CustomerSupplier | Dec. 31, 2014USD ($) | |
Basis Of Presentation And Summary Of Significant Accounting Policies [Line Items] | |||
Number of dental distributor with guaranteed rights of returns | Customer | 2 | ||
Revenue deferred under guaranteed rights of return arrangements | $ 17,855 | $ 17,855 | $ 21,222 |
Inventory reserve | 68,200 | 68,200 | 50,100 |
Accounts payable and accrued expenses for key suppliers | 548,686 | 548,686 | 710,210 |
Uninsured portion of cash balance | $ 7,793,503 | $ 7,793,503 | 10,198,921 |
Supplier Concentration Risk [Member] | |||
Basis Of Presentation And Summary Of Significant Accounting Policies [Line Items] | |||
Number of key suppliers | Supplier | 4 | 4 | |
Accounts payable and accrued expenses for key suppliers | $ 60,643 | $ 60,643 | 189,120 |
Guaranteed Rights of Return [Member] | |||
Basis Of Presentation And Summary Of Significant Accounting Policies [Line Items] | |||
Revenue deferred under guaranteed rights of return arrangements | $ 17,855 | $ 17,855 | $ 21,222 |
Stock-based Compensation - Stoc
Stock-based Compensation - Stock-based Compensation Expense Recognized (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Total Stock based compensation | $ 274,140 | $ 251,176 | $ 386,280 | $ 256,721 |
Research and Development [Member] | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Total Stock based compensation | 82,953 | 127,730 | 103,870 | 137,767 |
Selling, General and Administrative [Member] | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Total Stock based compensation | $ 191,187 | $ 123,446 | $ 282,410 | $ 118,954 |
Stock-based Compensation - Addi
Stock-based Compensation - Additional Information (Detail) - USD ($) | Mar. 16, 2015 | Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||||
Stock option awards | 10,000 | 100,000 | 910,000 | 100,000 | |
Weighted-average grant date fair value | $ 0.77 | $ 2.81 | $ 1.29 | $ 2.81 | |
Stock options vested | 28,333 | ||||
Stock options forfeited | 278,334 | ||||
Number of stock options, exercised | 0 | ||||
Non- employee Directors [Member] | |||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||||
Annual retainer amount for the threshold of stock precluded from selling | $ 270,000 | ||||
2012 Equity Incentive Plan [Member] | Chief Financial Officer [Member] | |||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||||
Stock option awards | 200,000 | ||||
Exercise price of plan | $ 1.32 | ||||
Vesting period | 3 years | ||||
2012 Equity Incentive Plan [Member] | Non- employee Directors [Member] | |||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||||
Stock option awards | 80,000 | ||||
Exercise price of plan | $ 1.32 | ||||
2012 Equity Incentive Plan [Member] | Non- employee Directors [Member] | Restricted Stock [Member] | |||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||||
Restricted shares awarded | 40,000 | ||||
Restricted shares ending date | Under the Company's 2012 Plan, of which 10,000 restricted shares vest at the end of each calendar quarter in 2015, provided the recipient remains a director through the vesting date. | ||||
Restricted shares vest in each quarter end | 10,000 | 20,000 | |||
Operations Or Product Development [Member] | 2012 Equity Incentive Plan [Member] | Senior Vice President [Member] | |||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||||
Stock option awards | 150,000 | ||||
Exercise price of plan | $ 1.32 | ||||
Vesting period | 3 years | ||||
Discovery Research [Member] | 2012 Equity Incentive Plan [Member] | Senior Vice President [Member] | |||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||||
Stock option awards | 150,000 | ||||
Exercise price of plan | $ 1.32 | ||||
Vesting period | 3 years |
Warrants - Summary of Warrant A
Warrants - Summary of Warrant Activity (Detail) - $ / shares | Mar. 23, 2015 | Jun. 30, 2015 | Dec. 31, 2014 |
Equity [Abstract] | |||
Warrants, Beginning balance | 2,532,094 | 2,747,094 | |
Warrants, Granted | 0 | 0 | |
Warrants, Exercised | (210,000) | ||
Warrants, Expired | (2,170,925) | (2,170,925) | (5,000) |
Warrants, Ending balance | 361,169 | 2,532,094 | |
Weighted Average Price, Beginning balance | $ 1.93 | $ 1.91 | |
Weighted Average Price, Granted | 0 | 0 | |
Weighted Average Price, Exercised | 1.50 | ||
Weighted Average Price, Expired | $ (2) | (2) | (10) |
Weighted Average Price, Ending balance | $ 1.50 | $ 1.93 |
Warrants - Additional Informati
Warrants - Additional Information (Detail) - $ / shares | Mar. 23, 2015 | Jun. 30, 2015 | Dec. 31, 2014 |
Equity [Abstract] | |||
Shares underlying warrant outstanding | 2,170,925 | 2,170,925 | 5,000 |
Warrants exercisable price per share | $ 2 | $ 2 | $ 10 |
Warrants - Summary of Warrants
Warrants - Summary of Warrants Outstanding (Detail) - $ / shares | 6 Months Ended | ||
Jun. 30, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Class of Warrant or Right [Line Items] | |||
Exercise Price | $ 1.50 | $ 1.93 | $ 1.91 |
Warrants Outstanding | 361,169 | 2,532,094 | 2,747,094 |
Exercise Price 1.50 [Member] | |||
Class of Warrant or Right [Line Items] | |||
Exercise Price | $ 1.50 | ||
Warrants Outstanding | 361,169 | ||
Expiration Dates | Jul. 31, 2017 |
Short-Term Notes Payable - Addi
Short-Term Notes Payable - Additional Information (Detail) - USD ($) | Mar. 16, 2015 | Jul. 24, 2014 | Mar. 10, 2014 | Jun. 30, 2015 | Dec. 31, 2014 |
Short-term Debt [Line Items] | |||||
Short term notes payable for financing insurance policies | $ 34,767 | $ 64,840 | |||
Product Liability Insurance Financings One [Member] | Short Term Note Payable [Member] | |||||
Short-term Debt [Line Items] | |||||
Short-term note payable | $ 50,694 | ||||
Interest rate on short-term note | 6.57% | ||||
Debt instrument issuance date | Apr. 10, 2014 | ||||
Short-term notes payable amortization period | 10 months | ||||
Final payment date of short-term note payable | Jan. 10, 2015 | ||||
Directors And Officers Liability Insurance Financings [Member] | Short Term Note Payable [Member] | |||||
Short-term Debt [Line Items] | |||||
Short-term note payable | $ 108,306 | ||||
Interest rate on short-term note | 4.647% | ||||
Debt instrument issuance date | Aug. 24, 2014 | ||||
Short-term notes payable amortization period | 11 months | ||||
Final payment date of short-term note payable | Jun. 22, 2015 | ||||
Product Liability Insurance Financings Two [Member] | Short Term Note Payable [Member] | |||||
Short-term Debt [Line Items] | |||||
Short-term note payable | $ 49,395 | ||||
Interest rate on short-term note | 5.68% | ||||
Debt instrument issuance date | Apr. 16, 2015 | ||||
Short-term notes payable amortization period | 10 months | ||||
Final payment date of short-term note payable | Jan. 16, 2016 |
Convertible Note Payable To S28
Convertible Note Payable To Shareholder - Additional Information (Detail) - Jun. 09, 2015 - Convertible Promissory Note [Member] - USD ($) | Total |
Short-term Debt [Line Items] | |
Principal amount of short-term notes | $ 5,000,000 |
Interest rate on short-term note | 3.00% |
Principal and accrued interest due date | Dec. 31, 2015 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - Jun. 30, 2015 | USD ($)Milestoneshares |
UFRF License Agreements [Member] | |
Commitment And Contingencies [Line Items] | |
Company's obligation to pay from percentage of selling price of product | 5.00% |
Company's obligation to pay from all revenue received from sublicenses | 22.00% |
One-time commercialization fee monthly amount for calculation | $ 5,000 |
Post-commercialization minimum royalty payments | 50,000 |
One-time additional royalty payment would be due when total cumulative royalties paid to UFRF exceed amount | $ 2,000,000 |
One-time additional payment to UFRF as a percentage of total royalties due to UFRF | 10.00% |
Minimum annual maintenance payment per license agreement | $ 10,000 |
Aggregate minimum annual maintenance payment | 20,000 |
Quarterly maintenance payment to UFRF under installment plan | $ 5,000 |
Termination notice period | 90 days |
Texas A and M University License [Member] | |
Commitment And Contingencies [Line Items] | |
Company's obligation to pay from percentage of selling price of product | 5.00% |
Post-commercialization minimum royalty payments | $ 100,000 |
Initial payment to Texas A&M | 5,000 |
Minimum consideration for the continuation of the license agreement | 15,000 |
Annual maintenance payment under licensing agreement with Texas A&M | $ 100,000 |
Number of milestones achieved | Milestone | 0 |
Maximum period to cure the breach | 60 days |
Texas A and M University License [Member] | Phase II Clinical Trial [Member | |
Commitment And Contingencies [Line Items] | |
Date of milestone achievement under licensing agreement with Texas A&M | Jun. 1, 2019 |
Milestone payment under licensing agreement | $ 100,000 |
Texas A and M University License [Member] | Phase III Clinical Trial [Member] | |
Commitment And Contingencies [Line Items] | |
Date of milestone achievement under licensing agreement with Texas A&M | Jun. 1, 2022 |
Milestone payment under licensing agreement | $ 150,000 |
Texas A and M University License [Member] | Phase I Clinical Trial [Member] | |
Commitment And Contingencies [Line Items] | |
Date of milestone achievement under licensing agreement with Texas A&M | Jun. 1, 2015 |
Milestone payment under licensing agreement | $ 50,000 |
Texas A and M University License [Member] | Sale Of Licensed Technology [Member] | |
Commitment And Contingencies [Line Items] | |
Date of milestone achievement under licensing agreement with Texas A&M | Jun. 1, 2025 |
Milestone payment under licensing agreement | $ 400,000 |
Texas A and M University License [Member] | Minimum [Member] | |
Commitment And Contingencies [Line Items] | |
Company's obligation to pay from percentage of selling price of product | 2.00% |
Lantibiotic ECC [Member] | |
Commitment And Contingencies [Line Items] | |
Company's obligation to pay from percentage of selling price of product | 25.00% |
Company's obligation to pay from all revenue received from sublicenses | 50.00% |
Termination notice period | 90 days |
Number of milestones achieved | Milestone | 0 |
Number of shares issued | shares | 4,392,425 |
Maximum percentage of primary investment securities to investment of shares issued | 10.00% |
Lantibiotic ECC [Member] | Investigational New Drug Application [Member] | |
Commitment And Contingencies [Line Items] | |
Percentage of number of shares of common stock equal to Base Shares | 1.00% |
Lantibiotic ECC [Member] | Phase II Clinical Trial [Member | |
Commitment And Contingencies [Line Items] | |
Percentage of number of shares of common stock equal to Base Shares | 1.50% |
Lantibiotic ECC [Member] | Phase III Clinical Trial [Member] | |
Commitment And Contingencies [Line Items] | |
Percentage of number of shares of common stock equal to Base Shares | 2.00% |
Lantibiotic ECC [Member] | New Drug Application or Biologics License Application [Member] | |
Commitment And Contingencies [Line Items] | |
Percentage of number of shares of common stock equal to Base Shares | 2.50% |
Lantibiotic ECC [Member] | First Regulatory Approval of Oragenics Product [Member] | |
Commitment And Contingencies [Line Items] | |
Percentage of number of shares of common stock equal to Base Shares | 3.00% |
Live Biotherapeutic Products ECC [Member] | |
Commitment And Contingencies [Line Items] | |
Company's obligation to pay from percentage of selling price of product | 10.00% |
Termination notice period | 90 days |
Number of milestones achieved | Milestone | 0 |
Maximum period to cure the breach | 60 days |
Live Biotherapeutic Products ECC [Member] | Phase II Clinical Trial [Member | |
Commitment And Contingencies [Line Items] | |
Milestone payment under licensing agreement | $ 2,000,000 |
Milestone measurement period | 30 days |
Live Biotherapeutic Products ECC [Member] | Phase III Clinical Trial [Member] | |
Commitment And Contingencies [Line Items] | |
Milestone payment under licensing agreement | $ 5,000,000 |
Milestone measurement period | 30 days |
Live Biotherapeutic Products ECC [Member] | Sale Of Licensed Technology [Member] | |
Commitment And Contingencies [Line Items] | |
Milestone payment under licensing agreement | $ 10,000,000 |
Milestone measurement period | 30 days |
Oral Mucositis ECC [Member] | |
Commitment And Contingencies [Line Items] | |
Company's obligation to pay from percentage of selling price of product | 12.00% |
Company's obligation to pay from all revenue received from sublicenses | 50.00% |
Termination notice period | 90 days |
Number of milestones achieved | Milestone | 0 |
Maximum period to cure the breach | 60 days |
Oral Mucositis ECC [Member] | Phase II Milestone Event [Member] | |
Commitment And Contingencies [Line Items] | |
Milestone payment under licensing agreement | $ 2,000,000 |
Milestone measurement period | 30 days |
Oral Mucositis ECC [Member] | Phase IIb/III Milestone Event [Member] | |
Commitment And Contingencies [Line Items] | |
Milestone payment under licensing agreement | $ 5,000,000 |
Milestone measurement period | 30 days |
Oral Mucositis ECC [Member] | Regulatory Approval Application Milestone Event [Member] | |
Commitment And Contingencies [Line Items] | |
Milestone payment under licensing agreement | $ 5,000,000 |
Milestone measurement period | 30 days |
Oral Mucositis ECC [Member] | Approval Milestone Event [Member] | |
Commitment And Contingencies [Line Items] | |
Milestone payment under licensing agreement | $ 10,000,000 |
Milestone measurement period | 30 days |
Oral Mucositis ECC [Member] | New Indication Milestone Event [Member] | |
Commitment And Contingencies [Line Items] | |
Milestone payment under licensing agreement | $ 5,000,000 |
Milestone measurement period | 30 days |
Oral Mucositis ECC [Member] | New Product Milestone Event [Member] | |
Commitment And Contingencies [Line Items] | |
Milestone payment under licensing agreement | $ 5,000,000 |
Milestone measurement period | 30 days |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Detail) - Principal Owner [Member] - Lantibiotic ECC [Member] - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | |
Related Party Transaction [Line Items] | ||||
Cash paid to Intrexon Corporation | $ 31,927 | $ 45,755 | $ 361,294 | $ 901,319 |
Accounts payable and accrued expenses | $ 38,932 | $ 7,605 | $ 38,932 | $ 7,605 |
Percentage of outstanding common stock | 24.00% | 24.00% | 24.00% | 24.00% |
Common Stock - Additional Infor
Common Stock - Additional Information (Detail) - Non- employee Directors [Member] - 2012 Equity Incentive Plan [Member] - Restricted Stock [Member] - USD ($) | Mar. 16, 2015 | Jun. 30, 2015 | Jun. 30, 2015 |
Class of Stock [Line Items] | |||
Restricted shares awarded | 40,000 | ||
Restricted shares vest in each quarter end | 10,000 | 20,000 | |
Unrecognized compensation expense | $ 132,000 |
Subsequent Event - Additional I
Subsequent Event - Additional Information (Detail) - shares | Aug. 03, 2015 | Dec. 31, 2014 |
Subsequent Event [Line Items] | ||
Warrants, exercised | 210,000 | |
Subsequent Event [Member] | Griffin Securities Inc. [Member] | ||
Subsequent Event [Line Items] | ||
Warrants, exercised | 185,585 | |
Shares of common stock issued upon exercise of warrants | 98,592 |