Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2019 | Nov. 08, 2019 | |
Document And Entity Information | ||
Entity Registrant Name | ORAGENICS INC | |
Entity Central Index Key | 0001174940 | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2019 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 46,124,803 | |
Document Fiscal Period Focus | Q3 | |
Document Fiscal Year Focus | 2019 |
Balance Sheets
Balance Sheets - USD ($) | Sep. 30, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 22,291,924 | $ 20,208,301 |
Prepaid expenses and other current assets | 555,465 | 1,724,975 |
Total current assets | 22,847,389 | 21,933,276 |
Property and equipment, net | 89,651 | 116,276 |
Operating lease right-of-use assets | 714,925 | |
Total assets | 23,651,965 | 22,049,552 |
Current liabilities: | ||
Accounts payable and accrued expenses | 1,894,730 | 1,043,356 |
Short-term notes payable | 217,419 | 124,213 |
Operating lease liabilities | 135,120 | |
Total current liabilities | 2,247,269 | 1,167,569 |
Long-term liabilities: | ||
Operating lease liabilities | 586,170 | |
Total long-term liabilities | 586,170 | |
Shareholders' equity: | ||
Preferred stock, no par value; 50,000,000 shares authorized; 9,417,000 and 9,417,000 Series A shares, 6,600,000 and 6,600,000 Series B shares, 113.941 and 101.733 Series C shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively | 6,513,396 | 6,100,182 |
Common stock, $0.001 par value; 200,000,000 shares authorized; 46,124,803 and 29,433,135 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively | 46,125 | 29,433 |
Additional paid-in capital | 138,014,553 | 126,125,976 |
Accumulated deficit | (123,755,548) | (111,373,608) |
Total shareholders' equity | 20,818,526 | 20,881,983 |
Total liabilities and shareholders' equity | $ 23,651,965 | $ 22,049,552 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2019 | Dec. 31, 2018 |
Preferred stock, par value | ||
Preferred stock, shares authorized | 50,000,000 | 50,000,000 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 46,124,803 | 29,433,135 |
Common stock, shares outstanding | 46,124,803 | 29,433,135 |
Series A Preferred Stock [Member] | ||
Preferred stock, shares issued | 9,417,000 | 9,417,000 |
Preferred stock, shares outstanding | 9,417,000 | 9,417,000 |
Series B Preferred Stock [Member] | ||
Preferred stock, shares issued | 6,600,000 | 6,600,000 |
Preferred stock, shares outstanding | 6,600,000 | 6,600,000 |
Series C Preferred Stock [Member] | ||
Preferred stock, shares issued | 113.941 | 101.733 |
Preferred stock, shares outstanding | 113.941 | 101.733 |
Statements of Operations (Unaud
Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Operating expenses: | ||||
Research and development | $ 3,067,612 | $ 1,580,511 | $ 9,360,520 | $ 4,178,294 |
General and administrative | 852,841 | 1,183,830 | 2,858,997 | 2,991,300 |
Total operating expenses | 3,920,453 | 2,764,341 | 12,219,517 | 7,169,594 |
Loss from operations | (3,920,453) | (2,764,341) | (12,219,517) | (7,169,594) |
Other income (expense): | ||||
Interest income | 86,705 | 9,066 | 256,222 | 15,794 |
Interest expense | (2,501) | (2,142) | (4,531) | (3,643) |
Local business tax | (300) | (418) | (900) | (1,078) |
Total other income, net | 83,904 | 6,506 | 250,791 | 11,073 |
Loss before income taxes | (3,836,549) | (2,757,835) | (11,968,726) | (7,158,521) |
Income tax benefit | ||||
Net loss | (3,836,549) | (2,757,835) | (11,968,726) | (7,158,521) |
Deemed dividend of Series D preferred stock | (1,412,041) | (1,412,041) | ||
Net loss applicable to common shareholders | $ (3,836,549) | $ (4,169,876) | $ (11,968,726) | $ (8,570,562) |
Basic and diluted net loss per share | $ (0.08) | $ (0.35) | $ (0.29) | $ (1.12) |
Shares used to compute basic and diluted net loss per share | 46,124,803 | 11,937,624 | 40,989,592 | 7,656,670 |
Statements of Cash Flows (Unaud
Statements of Cash Flows (Unaudited) - USD ($) | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Cash flows from operating activities: | ||
Net loss | $ (11,968,726) | $ (7,158,521) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 44,344 | 18,393 |
Stock issued as compensation to non-employee directors | 24,320 | |
Stock-based compensation expense | 542,592 | 848,612 |
Stock issued in exchange for services | 12,001 | 6,001 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 1,442,087 | (389,191) |
Accounts payable and accrued expenses | 851,374 | 548,510 |
Net cash used in operating activities | (9,076,328) | (6,101,876) |
Cash flows from investing activities: | ||
Purchase of property and equipment | (11,354) | (60,242) |
Net cash used in investing activities | (11,354) | (60,242) |
Cash flows from financing activities: | ||
Payments on short-term notes payable | (179,371) | (134,561) |
Net proceeds from issuance of common stock and warrants | 11,350,676 | 1,510,327 |
Net proceeds from issuance of common stock, convertible preferred stock, and warrants | 12,431,627 | |
Net cash provided by financing activities | 11,171,305 | 13,807,393 |
Net increase in cash and cash equivalents | 2,083,623 | 7,645,275 |
Cash and cash equivalents at beginning of period | 20,208,301 | 6,166,143 |
Cash and cash equivalents at end of period | 22,291,924 | 13,811,418 |
Supplemental disclosure of cash flow information: | ||
Interest paid | 4,531 | 3,643 |
Non-cash investing and financing activities: | ||
Borrowings under short term notes payable for prepaid expense | 272,577 | 244,490 |
Par value of restricted stock issued | 16 | |
Stock dividend on Series C preferred stock | 413,215 | 58,670 |
Deemed dividend on Series D preferred stock | 1,412,041 | |
Par value of common stock issued in exchange for services | 25 | 13 |
Series A Preferred Stock [Member] | ||
Non-cash investing and financing activities: | ||
Par value of common stock issued in connection with stock conversion | 259 | |
Conversion of preferred stock into common stock | 268,096 | |
Series D Preferred Stock [Member] | ||
Non-cash investing and financing activities: | ||
Par value of common stock issued in connection with stock conversion | 7,868 | |
Conversion of preferred stock into common stock | $ 3,750,920 |
Organization
Organization | 9 Months Ended |
Sep. 30, 2019 | |
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. We are focused on becoming a leader in developing novel antibiotics against infectious disease and on developing effective treatments for oral mucositis. |
Basis of Presentation
Basis of Presentation | 9 Months Ended |
Sep. 30, 2019 | |
Accounting Policies [Abstract] | |
Basis of Presentation | 2. Basis of Presentation The accompanying unaudited interim financial statements as of September 30, 2019 and December 31, 2018 (audited) and three and nine months ended September 30, 2019 and 2018 have been prepared in accordance with accounting principles generally accepted in the United States of America (“US 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 US 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 ending September 30, 2019 are not necessarily indicative of the results that may be expected for the year ending December 31, 2019 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, 2018, which are included in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 29, 2019. 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 incurred a net loss of $11,968,726 and used cash of $9,076,328 in its operating activities during the nine months ended September 30, 2019. As of September 30, 2019, the Company had an accumulated deficit of $123,755,548. The Company expects to incur substantial expenditures to further develop each of its technologies. The Company believes the working capital at September 30, 2019 will be sufficient to meet the business objectives, as presently structured, through the fourth quarter of 2020. As such, there is substantial doubt that we can continue as a going concern beyond that date. 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, or other developments. Additional financing will be required to continue operations after the Company exhausts its current cash resources and to continue its long-term plans for clinical trials and new product development. 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 sublicensing arrangements, joint venturing or partnering, sales of rights to technology, government grants and public or private financings. 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 curtail its current development programs, cut operating costs, and forego future development and other opportunities. |
Significant Accounting Policies
Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2019 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies | 3. Significant Accounting Policies Recently Issued Accounting Pronouncements In July 2018, the Financial Accounting Standards Board issued Accounting Standards Updates 2018-10 Codification Improvements to Topic 842, Leases and 2018-11 Leases (Topic 842). Update 2018-10 Codification Improvements to Topic 842 represent changes to clarify the Codification, correct unintended application of guidance, or make minor improvements to the Codification that are not expected to have a significant effect on current accounting practice or create a significant administrative cost to most entities. Some of the amendments make the Codification easier to understand and easier to apply by eliminating inconsistencies, providing needed clarifications, and improving the presentation of guidance in the Codification. Update 2018-11 Leases (Topic 842) provides entities with an additional (and optional) transition method to adopt the new lease requirements by allowing entities to initially apply the requirements by recognizing a cumulative-effect adjustment transition method, which applies the provisions of the standard at the effective date without adjusting comparative periods presented. Consequently, an entity’s reporting for the comparative periods presented in the financial statements in which the entity adopts the new lease requirements would continue to be in accordance with current GAAP (Topic 840). An entity electing this additional (and optional) transition method must provide the required Topic 840 disclosures for all periods that continue to be in accordance with Topic 840. The amendments do not change the existing disclosure requirements in Topic 840. We implemented this standard on January 1, 2019 using the cumulative-effect adjustment transition method, which applies the provisions of the standard at the effective date without adjusting the comparative periods presented. The Company adopted the following practical expedients and elected the following accounting policies related to this standard: ● We did not reassess whether any expired or existing contracts are or contain leases. ● We did not reassess the lease classification for any expired or existing leases. ● We did not reassess initial direct costs for any existing leases. The standard did not have a material impact on our balance sheets or on our statements of operations. The most significant impact was the recognition of right of use (ROU) assets and lease liabilities for operating leases. We implemented internal controls to enable the preparation of financial information on adoption of the standard. Adoption of the lease standard had no impact to cash provided by or used in operating, financing, or investing activities in the cash flow statements. In June 2018, the Financial Accounting Standards Board issued Accounting Standards Update 2018-07 Compensation—Stock Compensation (Topic 718) Improvements to Nonemployee Share-Based Payment Accounting. The amendments in this Update expand the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. The requirements of Topic 718 should be applied to nonemployee awards except for specific guidance on inputs to an option pricing model and the attribution of cost (that is, the period of time over which share-based payment awards vest and the pattern of cost recognition over that period). The amendments specify that Topic 718 applies to all share-based payment transactions in which a grantor acquires goods or services to be used or consumed in a grantor’s own operations by issuing share-based payment awards. The amendments also clarify that Topic 718 does not apply to share-based payments used to effectively provide (1) financing to the issuer or (2) awards granted in conjunction with selling goods or services to customers as part of a contract accounted for under Topic 606, Revenue from Contracts with Customers. The amendments in this Update are effective for public business entities for fiscal years beginning after December 15, 2018, including interim periods within that fiscal year. The adoption of this guidance did not have a material impact on the Company’s results of operation, financial position or disclosures. There are no additional accounting pronouncements issued or effective during the three and nine months ended September 30, 2019 that have had, or are expected to have, a material impact on our financial statements. Use of Estimates The preparation of financial statements in conformity with US 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 expenses during the reporting period. Actual results could differ from those estimates. The principal areas of estimation reflected in the financial statements are stock based compensation, valuation of warrants, and income tax valuation allowance. 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 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 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 the Company. 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 US GAAP requires all stock-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 the Company, 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. In connection with adopting ASU 2016-09, the Company made an accounting policy election to account for forfeitures in compensation expense as they occur. Warrants The Company used the Black Scholes Option Pricing Model in calculating the relative fair value of any warrants that have been 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. 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. Concentrations 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 September 30, 2019 and December 31, 2018, the uninsured portion of this balance was $22,041,924 and $19,958,301, respectively. |
Stock-based Compensation
Stock-based Compensation | 9 Months Ended |
Sep. 30, 2019 | |
Share-based Payment Arrangement [Abstract] | |
Stock-based Compensation | 4. Stock-based Compensation The Company recognized stock-based compensation on all employee and non-employee awards as follows: For the Three Months Ended September 30, 2019 For the Three Months Ended September 30, 2018 For the Nine Months Ended September 30, 2019 For the Nine Months Ended September 30, 2018 Research and development $ 20,416 $ 73,463 $ 92,503 $ 91,511 General and administrative 211,759 574,839 450,089 781,421 Total Stock-based compensation $ 232,175 $ 648,302 $ 542,592 $ 872,932 At the Company’s Annual Meeting of Shareholders, held on June 20, 2019, the shareholders approved an amendment to the Company’s 2012 Equity Incentive Plan (the “Plan”) solely to increase the common shares available for awards thereunder by an additional 6,000,000 shares and ratified an amendment approved by shareholders at the prior year’s annual meeting to increase the shares available under the Plan by 1,500,000 shares. The aggregate number of shares of the Company’s common stock currently authorized pursuant to its Plan, as amended, is 8,250,000 and the Company’s Plan, as amended continues to provide that the maximum number of shares that may be subject to stock options and stock appreciation rights granted to any individual in a calendar year is 1,000,000 shares. The Plan also provides that the maximum number of shares that may be subject to awards (other than stock options and stock appreciation rights) intended to qualify as “performance-based compensation” under Section 162(m) of the Internal Revenue Code that may be granted to any individual in one calendar year is 1,000,000 shares (however, the exception for “performance-based compensation” under Code Section 162(m) was repealed in the Tax Cuts and Jobs Act of 2017, unless the awards intended to qualify for such exception were granted before November 2, 2017). As of September 30, 2019, an aggregate of 2,488,293 shares of common stock are covered by outstanding option awards and 5,520,957 shares of common stock are available for future awards under the Plan. The Company granted -0- and 676,160 stock options under its Plan, with a weighted-average grant date fair value of $-0- and $0.49 per share, during the three and nine months ended September 30, 2019, respectively. The Company granted 1,425,000 and 1,533,000 stock options under its Plan, with a weighted-average grant date fair value of $0.72 and $0.79 per share, during the three and nine months ended September 30, 2018, respectively. During the nine months ended September 30, 2019, 609,406 stock options previously granted under the Plan vested, no stock options were forfeited, and no stock options were exercised. Each executive officer and non-employee director receiving equity-based awards is 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 Plan which requirements are intended to align the ability to sell shares with the performance of the Company’s stock price. The executive officer recipients 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 Plan. Also, the non-employee directors are each 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 Plan. |
Warrants
Warrants | 9 Months Ended |
Sep. 30, 2019 | |
Warrants and Rights Note Disclosure [Abstract] | |
Warrants | 5. Warrants On March 25, 2019, the Company announced the closing of an underwritten public offering for gross proceeds of approximately $12.5 million, which included the partial exercise of the underwriter’s over-allotment option to purchase additional shares and warrants, prior to deducting underwriting discounts and commissions and offering expenses payable by the Company. The offering was comprised of 16,666,668 shares of common stock, together with short-term warrants to purchase up to 8,333,334 shares of common stock, and long-term warrants to purchase up to 8,333,334 shares of common stock, at a price to the public of $0.75. The Company granted the underwriter a 30-day option to purchase up to 2,500,000 additional shares of common stock and/or short-term warrants to purchase 1,250,000 shares of common stock and long-term warrants to purchase 1,250,000 shares of common stock of the Company at the public offering price, less underwriting discounts and commissions. The underwriter exercised its option to purchase the short-term warrants to purchase 1,250,000 shares of common stock and long-term warrants to purchase 1,250,000 shares of common stock effective as of the closing. Each short-term warrant has an exercise price of $0.75 per share of common stock, is immediately exercisable, and will expire on the earlier of (1) the eighteen-month anniversary of the date of issuance and (2) twenty-one trading days following the Company’s release of top-line data related to its Phase 2 double blind, placebo controlled clinical trial of AG013. Each long-term warrant has an exercise price of $0.90 per share of common stock, is immediately exercisable and will expire five years following the date of issuance. A summary of warrant activity for the year ended December 31, 2018 and the nine months ended September 30, 2019 is as follows: Warrants Weighted Average Price Balance - December 31, 2017 2,177,425 $ 3.10 Granted 14,700,000 1.00 Exercised (9,505,500 ) 1.00 Expired — — Balance - December 31, 2018 7,371,925 1.74 Granted 19,166,668 0.83 Exercised — — Expired — — Balance - September 30, 2019 26,538,593 $ 1.08 The warrants outstanding as of September 30, 2019 are as follows: Exercise Price Warrants Outstanding Expiration Date $ 3.10 48,387 9/19/2022 $ 2.00 900,000 4/10/2023 $ 3.10 462,106 5/10/2024 $ 3.10 602,414 7/25/2024 $ 3.10 1,064,518 11/8/2024 $ 1.00 4,294,500 7/17/2025 $ 0.75 9,583,334 9/25/2020 * $ 0.90 9,583,334 3/25/2024 26,538,593 * Subject to termination prior to the indicated date following the Company’s release of top-line data related to its Phase 2 double blind, placebo controlled clinical trial of AG013 plus twenty-one (21) trading days. All outstanding warrants are included in shareholders’ equity on the Company’s Balance Sheets. |
Short-Term Notes Payable
Short-Term Notes Payable | 9 Months Ended |
Sep. 30, 2019 | |
Debt Disclosure [Abstract] | |
Short-Term Notes Payable | 6. Short-Term Notes Payable As of September 30, 2019 and December 31, 2018, the Company had $217,419 and $124,213, respectively, in short-term notes payable for the financing of various insurance policies. Products Liability Insurance On March 10, 2019, the Company entered into a short-term note payable for $17,688 bearing interest at 5.69% per annum to finance the product liability insurance. Principal and interest payments on this note began April 10, 2019 and are made evenly based on a straight-line amortization over an 11-month period with the final payment being due on February 10, 2020. On March 10, 2018, the Company entered into a short-term note payable for $28,915 bearing interest at 5.09% per annum to finance the product liability insurance. Principal and interest payments on this note began April 10, 2018 and are made evenly based on a straight-line amortization over an 11-month period with the final payment being made on February 12, 2019. Directors’ and Officers’ Insurance On August 7, 2019 the Company entered into a short-term note payable for $254,889 bearing interest at 5.74% 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, 2019 and are made evenly based on a straight-line amortization over an 11-month period with the final payment being due on June 24, 2020. On July 24, 2018, the Company entered into a short-term note payable for $215,575 bearing interest at 5.24% 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, 2018 and were made evenly based on a straight-line amortization over an 11-month period with the final payment being made on June 27, 2019. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 7. Commitments and Contingencies In June 2012, we entered into an Exclusive Channel Collaboration Agreement with Intrexon Corporation (“Intrexon”) for the development and commercialization of the native strain of MU1140 and related homologs using Intrexon’s advanced transgene and cell engineering platforms (the “Lantibiotic ECC”). In June of 2015, we also entered into an Exclusive Channel Collaboration Agreement with Intrexon and Intrexon Actobiotics NV, (a wholly-owned subsidiary of Intrexon), for the continued development and commercialization of AG013, for use in the treatment of oral mucositis in humans through the administration of an effector via genetically modified bacteria, but, in any case, excluding the delivery of anti-cancer effectors for the purpose of treatment or prophylaxis of cancer which was assigned by Intrexon to its wholly owned subsidiary, ActoBio Therapeutics, Inc. (the “Oral Mucositis ECC”). Intrexon Corporation together with its wholly owned subsidiaries are hereinafter collectively referred to as “Intrexon.” 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. In November of 2017 the Lantibiotic ECC was amended to: (I) consolidate the development milestone payments into one payment of $25,000,000, being due six months after receiving FDA approval of a New Drug Application, (ii) reduce the sublicense revenue percentage we would have had to pay from 50% to 25% of sublicensing revenue, (iii) reduce the royalty rate from 25% of Product Profit to 10% of Net Sales, (iv) revise the form of milestone payments from being share based or cash at the Company’s election to only cash, and (v) commit that Diligent Efforts (as defined in the Lantibiotic ECC) in pursuing the Lantibiotic Program would be deemed satisfied in 2018 provided that at least $1,200,000 was budgeted for the advancement of the Lantibiotic Program. In November of 2017, the Stock Issuance Agreement was also amended. Under the terms of the amendment, the Company has agreed to make certain payments, in cash, to Intrexon upon our achievement of designated milestones. The milestone events and amounts payable are as follows: (a) a one-time payment of twenty-five million United States dollars ($25,000,000) within six (6) months of the achievement of the Regulatory Approval Milestone Event meaning receiving approval from the FDA of a New Product Application for an Oragenics Product (or equivalent regulatory action in a foreign jurisdiction); (ii) a one-time payment of five million United States dollars ($5,000,000) within six (6) months of the achievement of the New Indication Milestone Event meaning receiving approval from the FDA of a Supplemental FDA Application (or an equivalent filing with another equivalent regulatory agency) which Supplemental FDA Application sought approval of an indication for use of the Oragenics Product other than the current regulatory-approved indication; and (iii) a one-time payment of five million United States dollars ($5,000,000) within six (6) months of the achievement of the New Product Milestone Event meaning receiving approval from the FDA of a New Product Application that is deemed to be a different drug product that the first Oragenics Product that was clinically pursued under the Lantibiotics Program. Pursuant to the terms of the amendment, we will also pay Intrexon on a quarterly basis 10% of Net Sales derived in that quarter from the sale of products developed from the Lantibiotic ECC, calculated on an Oragenics Product-by-Oragenics Product basis and we will pay Intrexon on a quarterly basis 25% of revenue obtained in that quarter from a sublicensor in the event of a sublicensing arrangement. On July 21, 2016, the Lantibiotics ECC was amended to revise the definition of Field in view of a provisional patent application filing between Intrexon and Oragenics and to further clarify Oragenics’ rights under the Lantibiotic ECC to genetically modified Streptococcus mutans None of the Lantibiotic ECC milestones had been achieved as of September 30, 2019. The Oral Mucositis ECC Under the Oral Mucositis 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. In November of 2017, the Company amended the Oral Mucositis ECC to: (i) consolidate the development milestone payments into one payment of $27,500,000 being due within six months after receiving FDA approval of a New Product Application; (ii) reduce the sublicense revenue percentage from 50% to 25% of sublicensing revenue; and (iii) revise the field in which the Company has exclusive rights to its Oral Mucositis product candidate for the treatment of Oral Mucositis to clarify that the Company has an exclusive for the treatment of Oral Mucositis in humans regardless of etiology. Pursuant to the terms of the Oral Mucositis ECC, as amended, we are obligated to pay Intrexon on a quarterly basis 12% of the net sales derived from the sale of products developed from the exclusive channel collaboration. We are also obligated to pay Intrexon on a quarterly basis, 25% of revenue obtained in that quarter from a sublicensor in the event of a sublicensing arrangement. In November of 2017, the Stock Issuance Agreement and Oral Mucositis ECC were amended. Under the terms of the amendment, the Company has agreed to make certain payments to Intrexon upon our achievement of designated milestones in the form of shares of our 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 our financial statements with Intrexon’s financial statements, or at our option make a cash payment to Intrexon. The milestone events and amounts payable are as follows: (i) a one-time payment of twenty-seven million five hundred thousand United States dollars ($27,500,000) within six (6) months of the achievement of the Regulatory Approval Milestone Event meaning receiving approval from the FDA of a New Product Application for an Oragenics Product (or equivalent regulatory action in a foreign jurisdiction); (ii) a one-time payment of five million United States dollars ($5,000,000) within six (6) months of the achievement of the New Indication Milestone Event meaning receiving approval from the FDA of a Supplemental FDA Application (or an equivalent filing with another equivalent regulatory agency) which Supplemental FDA Application sought approval of an indication for use of the Oragenics Product other than the current regulatory-approved indication; and (iii) a one-time payment of five million United States dollars ($5,000,000) within six (6) months of the achievement of the New Product Milestone Event meaning receiving approval from the FDA of a New Product Application that is deemed to be a different drug product that the first Oragenics Product that was clinically pursued under the Program. None of the Oral Mucositis ECC milestones had been achieved as of September 30, 2019. The Oral Mucositis ECC provides that in the event (i) Oragenics is required to make a milestone payment in cash as an issuance of shares would cause Intrexon to consolidate the Company’s financial statements with Intrexon’s financial statements, and (ii) Oragenics reasonably concludes that a cash milestone payment would have an adverse effect on its working capital needs over the next twelve (12) months, then such cash payment shall be in the form of an interest bearing promissory note with a maturity date of less than twelve (12) months and include other conventional market terms that would not be expected to unreasonably have an adverse effect on Oragenics working capital needs over such twelve (12) month period. Leases The Company’s Alachua facility is being leased from a real estate developer for a term of five years beginning in December 2014. Under the lease agreement, the rental payments range from $9,641 per month to $10,851 per month. In June of 2019, the Company entered into an amendment for the Alachua facility for a term of five years beginning in December of 2019. Under the amended lease agreement, the rental payments range from $12,870 per month to $13,338 per month. The lease may be terminated prior to its stated expiration date upon the payment of nine-months rent. In November of 2016, the Company entered into an amendment for the leased office space for corporate personnel located in Tampa, FL. The amended lease is for approximately 2,207 square feet. The lease period for the office space is for thirty-six months commencing on March 1, 2017. Lease payments range from $4,138 per month to $4,392 per month inclusive of insurance, taxes and utilities. The lease expires on February 29, 2020. Supplemental balance sheet information related to leases is as follows: September 30, 2019 Operating lease right-of-use assets $ 714,925 Operating lease liabilities - Short term $ 135,120 Operating lease liabilities - Long term 586,170 Total operating lease liabilities $ 721,290 Weighted Average Remaining Lease Term In Years Operating leases 3.97 Weighted Average Discount Rate Operating leases 5.67 % Maturities of operating lease liabilities are as follows: Year ended December 31: 2019 $ 47,747 2020 163,224 2021 154,908 2022 160,056 2023 160,056 2024 146,718 Total $ 832,709 Less: Imputed interest (111,419 ) Present value of lease liabilities $ 721,290 The cost component of operating leases is as follows: For the Nine Months Ended September 30, 2019 Operating lease cost $ 157,556 Short-term lease cost 1,719 Total lease cost $ 159,275 Supplemental cash flow information related to operating leases is as follows: For the Nine Months Ended September 30, 2019 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases $ 149,101 |
Related Party Transactions
Related Party Transactions | 9 Months Ended |
Sep. 30, 2019 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 8. Related Party Transactions During the three and nine months ended September 30, 2019, we paid $134,635 and $251,946, respectively; and during the three and nine months ended September 30, 2018, we paid $134,883 and $294,116, respectively, to Intrexon under the Oral Mucositis ECC and Lantibiotic ECC agreements (See Note 7). Included in accounts payable and accrued expenses at September 30, 2019 and December 31, 2018 was $55,771 and $39,607, respectively, related to unpaid invoices received from Intrexon relating to work performed under the ECC Agreements. As of September 30, 2019 and 2018 Intrexon beneficially owned approximately 3.36% and 8.3% of our outstanding common stock excluding Intrexon’s ownership of our Series C Preferred which has no voting rights. In addition, during the first quarter of 2019, we paid a dividend on Series C Preferred Stock in the form of Series C Preferred Stock, to Intrexon as the sole holder of such preferred stock, pursuant to the terms of such Series C Preferred Stock (See Note 9 Shareholders’ Equity—Preferred Stock). Dr. Frederick Telling, Chairman and Director, and Dr. Alan Joslyn, Chief Executive Officer and President, participated in the Company’s, March 25, 2019, underwritten public offering, (See Note 9 Shareholders’ Equity—Common Stock), through the purchase of 100,000 shares and 66,667 shares, respectively, of the Company’s common stock and short-term warrants to purchase 50,000 shares and 33,333 shares, and long-term warrants to purchase 50,000 shares and 33,333 shares respectively, of the Company’s common stock. Dr. Telling’s and Dr. Joslyn’s participation in the offering was approved by the Company’s Audit Committee. |
Shareholders' Equity
Shareholders' Equity | 9 Months Ended |
Sep. 30, 2019 | |
Equity [Abstract] | |
Shareholders' Equity | 9. Shareholders’ Equity Common Stock Closing of Underwritten Public Offering On March 25, 2019, the Company announced the closing of an underwritten public offering for gross proceeds of approximately $12.5 million, which included the partial exercise of the underwriter’s over-allotment option to purchase additional shares and warrants, prior to deducting underwriting discounts and commissions and offering expenses payable by the Company. The offering was comprised of 16,666,668 shares of common stock, together with short-term warrants to purchase up to 8,333,334 shares of common stock, and long-term warrants to purchase up to 8,333,334 shares of common stock, at a price to the public of $0.75. The Company granted the underwriter a 30-day option to purchase up to 2,500,000 additional shares of common stock and/or short-term warrants to purchase 1,250,000 shares of common stock and long-term warrants to purchase 1,250,000 shares of common stock of the Company at the public offering price, less underwriting discounts and commissions. The underwriter did not exercise its option to purchase additional shares of common stock, however the underwriter Each short-term warrant has an exercise price of $0.75 per share of common stock, is immediately exercisable, and will expire on the earlier of (1) the eighteen-month anniversary of the date of issuance and (2) twenty-one trading days following the Company’s release of top-line data related to its Phase 2 double blind, placebo controlled clinical trial of AG013. Each long-term warrant has an exercise price of $0.90 per share of common stock, is immediately exercisable and will expire five years following the date of issuance. The Company intends to use the net proceeds of the offering to fund its AG013 research, clinical trials, pre-clinical development of the lantibiotics program, and for working capital and general corporate purposes. Other Share Issuance On February 1, 2019, and May 1, 2019, respectively, the Company issued 12,500 shares of its common stock as partial consideration for the acquisition of certain services. Preferred Stock The Series A Non-Voting, Convertible Preferred Stock Financing On May 10, 2017 we entered into a securities purchase agreement with three accredited investors, to purchase up to $3,000,000 of Series A Convertible Preferred Stock (the “Series A Preferred Stock Financing”). The full $3,000,000 of Preferred Stock, and after giving effect to the reverse stock split and the conversion of 2,583,000 shares of the Series A Preferred Stock into 258,300 shares of the Company’s common stock, is convertible into nine hundred and forty one thousand seven hundred and one shares of our Common Stock, based on a fixed conversion price of $2.50 per share on an as-converted basis.. Except as otherwise required by law, the Series A Preferred Stock shall have no voting rights. However, as long as any shares of Series A Preferred Stock are outstanding, we shall not, without the affirmative vote of the holders of a majority of the then outstanding shares of the Series A Preferred Stock, (a) alter or change adversely the powers, preferences or rights given to the Series A Preferred Stock or alter or amend the Certificate of Designation, (b) amend its articles of incorporation or other charter documents in any manner that adversely affects any rights of the holders of Series A Preferred Stock, (c) increase the number of authorized shares of Series A Preferred Stock, or (d) enter into any agreement with respect to any of the foregoing. Upon any liquidation, dissolution or winding-up by us, whether voluntary or involuntary that is not a Fundamental Transaction (as defined in the Certificate of Designation), the holders of Series A Preferred Stock shall be entitled to receive out of the assets, the greater of (i) the product of the number of shares of Series A Preferred Stock then held by such holder, multiplied by the Original Issue Price; and (ii) the amount that would be payable to such holder in the Liquidation in respect of Common Stock issuable upon conversion of such shares of Series A Preferred Stock if all outstanding shares of Series A Preferred Stock were converted into Common Stock immediately prior to the Liquidation. The Series A Preferred Stock is classified as permanent equity. The Series B Non-Voting, Convertible Preferred Stock Financing On November 8, 2017, we completed a private placement of $3,300,000 of Series B Non-Voting, Convertible Preferred Stock (the “Series B Convertible Preferred Stock”) pursuant to a Securities Purchase Agreement with four existing shareholders who are accredited investors including an entity affiliated with a director of the Company (the “Series B Preferred Stock Financing”). The full $3,300,000 of Series B Convertible Preferred Stock is convertible, after giving effect to the reverse stock split into one million three hundred and twenty thousand shares of our Common Stock, based on a conversion of one share of Series B Preferred Stock into two shares of Common Stock. Except as otherwise required by law, the Series B Preferred Stock shall have no voting rights. However, as long as any shares of Series B Preferred Stock are outstanding, we shall not, without the affirmative vote of the holders of a majority of the then outstanding shares of the Series B Preferred Stock, (a) alter or change adversely the powers, preferences or rights given to the Series B Preferred Stock or alter or amend the Certificate of Designation, (b) amend its articles of incorporation or other charter documents in any manner that adversely affects any rights of the holders of Series B Preferred Stock, (c) increase the number of authorized shares of Series B Preferred Stock, or (d) enter into any agreement with respect to any of the foregoing. The Series B Preferred Stock shall rank (i) on par with the Common Stock and Series A Preferred Stock and junior to Series C Preferred Stock as to dividend rights and (ii) junior to Series C Preferred Stock, on par with Series A Preferred Stock and senior to the Common Stock as to distribution of assets upon liquidation, dissolution or winding-up by us, whether voluntary or involuntary. Upon any liquidation, dissolution or winding-up by us, whether voluntary or involuntary, the holders of Series B Preferred Stock shall be entitled to receive out of the assets, after payment to the holders of Series C Preferred Stock but on par with the holders of Series A Preferred Stock and in preference to the holders of the Common Stock, an amount of cash equal to the greater of (i) the product of the number of shares of Series B Preferred Stock then held by such holder, multiplied by the Original Issue Price; and (ii) the amount that would be payable to such holder in the Liquidation in respect of Common Stock issuable upon conversion of such shares of Series B Preferred Stock if all outstanding shares of Series B Preferred Stock were converted into Common Stock immediately prior to the Liquidation. The Series B Preferred Stock is classified as permanent equity. Series C Non-Voting, Non- Convertible Preferred Stock Financing Intrexon Debt Conversion Each issued and outstanding share of Series C Preferred Stock entitled the holder of record, Intrexon, to receive dividends at the annual rate of twelve percent (12%) (the “Initial Rate”) of its Stated Value, payable by issuing additional shares of Series C Preferred Stock within thirty days after the end of each calendar year pro-rata for partial years. The Initial Rate was automatically increased to twenty percent (20%) after May 10, 2019. In January of 2019 we issued 12.208 shares of the Company’s Series C Preferred Stock as a dividend to Intrexon, as the holder of the Series C Preferred Stock. Changes In Shareholders’ Equity A summary of the changes in shareholders’ equity for the three and nine months ended September 30, 2019 and 2018 is as follows: Additional Total Common Stock Preferred Stock Paid In Accumulated Shareholders’ Shares Amount Shares Amount Capital Deficit Equity Balances at December 31, 2018 29,433,135 $ 29,433 16,017,101.733 $ 6,100,182 $ 126,125,976 $ (111,373,608 ) $ 20,881,983 Compensation expense relating to option issuances — — — — 145,829 — 145,829 Issuance of common stock - shelf takedown, net of expenses 16,666,668 16,667 — — 11,399,009 — 11,415,676 Issuance of common stock in exchange for services 12,500 12 — — 5,988 — 6,000 Series C dividend — — 12.208 413,214 — (413,214 ) — Net loss — — — — — (3,325,717 ) (3,325,717 ) Balances at March 31, 2019 46,112,303 $ 46,112 16,017,113.941 $ 6,513,396 $ 137,676,802 $ (115,112,539 ) $ 29,123,771 Compensation expense relating to option issuances — — — — 164,588 — 164,588 Issuance of common stock - shelf takedown, net of expenses — — — — (65,000 ) — (65,000 ) Issuance of common stock in exchange for services 12,500 13 — — 5,988 — 6,001 Net loss — — — — — (4,806,460 ) (4,806,460 ) Balances at June 30, 2019 46,124,803 $ 46,125 16,017,113.941 $ 6,513,396 $ 137,782,378 $ (119,918,999 ) $ 24,422,900 Compensation expense relating to option issuances — — — — 232,175 — 232,175 Net loss — — — — — (3,836,549 ) (3,836,549 ) Balances at September 30, 2019 46,124,803 $ 46,125 16,017,113.941 $ 6,513,396 $ 138,014,553 $ (123,755,548 ) $ 20,818,526 Additional Total Common Stock Preferred Stock Paid In Accumulated Shareholders’ Shares Amount Shares Amount Capital Deficit Equity Balances at December 31, 2017 4,928,335 $ 4,928 18,600,100.000 $ 6,309,608 $ 101,402,570 $ (101,400,797 ) $ 6,316,309 Compensation expense relating to option issuances — — — — 118,324 — 118,324 Conversion of Series A preferred stock to common stock 258,300 259 (2,583,000 ) (268,096 ) 267,837 — — Series C dividend — — 1.733 58,670 — (58,670 ) — Net loss — — — — — (2,119,397 ) (2,119,397 ) Balances at March 31, 2018 5,186,635 $ 5,187 16,017,101.7330 $ 6,100,182 $ 101,788,731 $ (103,578,864 ) $ 4,315,236 Compensation expense relating to option issuances — — — — 81,986 — 81,986 Issuance of common stock - shelf takedown, net of expenses 900,000 900 — — 1,509,427 — 1,510,327 Issuance of restricted common stock 16,000 16 — — 24,304 — 24,320 Net loss — — — — — (2,281,289 ) (2,281,289 ) Balances at June 30, 2018 6,102,635 $ 6,103 16,017,101.733 $ 6,100,182 $ 103,404,448 $ (105,860,153 ) $ 3,650,580 Compensation expense relating to option issuances — — — — 648,302 — 648,302 Issuance of common stock, Series D preferred stock, and warrants, net of expenses 4,436,000 4,436 9,364,000 4,464,107 7,963,085 — 12,431,628 Conversion of Series D preferred stock to common stock 7,868,000 7,868 (7,868,000 ) (3,750,920 ) 3,743,052 — — Issuance of common stock in exchange for services 12,500 12 — — 5,988 — 6,000 Net loss — — — — — (2,757,835 ) (2,757,835 ) Balances at September 30, 2018 18,419,135 $ 18,419 17,513,101.733 $ 6,813,369 $ 115,764,875 $ (108,617,988 ) $ 13,978,675 |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2019 | |
Accounting Policies [Abstract] | |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements In July 2018, the Financial Accounting Standards Board issued Accounting Standards Updates 2018-10 Codification Improvements to Topic 842, Leases and 2018-11 Leases (Topic 842). Update 2018-10 Codification Improvements to Topic 842 represent changes to clarify the Codification, correct unintended application of guidance, or make minor improvements to the Codification that are not expected to have a significant effect on current accounting practice or create a significant administrative cost to most entities. Some of the amendments make the Codification easier to understand and easier to apply by eliminating inconsistencies, providing needed clarifications, and improving the presentation of guidance in the Codification. Update 2018-11 Leases (Topic 842) provides entities with an additional (and optional) transition method to adopt the new lease requirements by allowing entities to initially apply the requirements by recognizing a cumulative-effect adjustment transition method, which applies the provisions of the standard at the effective date without adjusting comparative periods presented. Consequently, an entity’s reporting for the comparative periods presented in the financial statements in which the entity adopts the new lease requirements would continue to be in accordance with current GAAP (Topic 840). An entity electing this additional (and optional) transition method must provide the required Topic 840 disclosures for all periods that continue to be in accordance with Topic 840. The amendments do not change the existing disclosure requirements in Topic 840. We implemented this standard on January 1, 2019 using the cumulative-effect adjustment transition method, which applies the provisions of the standard at the effective date without adjusting the comparative periods presented. The Company adopted the following practical expedients and elected the following accounting policies related to this standard: ● We did not reassess whether any expired or existing contracts are or contain leases. ● We did not reassess the lease classification for any expired or existing leases. ● We did not reassess initial direct costs for any existing leases. The standard did not have a material impact on our balance sheets or on our statements of operations. The most significant impact was the recognition of right of use (ROU) assets and lease liabilities for operating leases. We implemented internal controls to enable the preparation of financial information on adoption of the standard. Adoption of the lease standard had no impact to cash provided by or used in operating, financing, or investing activities in the cash flow statements. In June 2018, the Financial Accounting Standards Board issued Accounting Standards Update 2018-07 Compensation—Stock Compensation (Topic 718) Improvements to Nonemployee Share-Based Payment Accounting. The amendments in this Update expand the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. The requirements of Topic 718 should be applied to nonemployee awards except for specific guidance on inputs to an option pricing model and the attribution of cost (that is, the period of time over which share-based payment awards vest and the pattern of cost recognition over that period). The amendments specify that Topic 718 applies to all share-based payment transactions in which a grantor acquires goods or services to be used or consumed in a grantor’s own operations by issuing share-based payment awards. The amendments also clarify that Topic 718 does not apply to share-based payments used to effectively provide (1) financing to the issuer or (2) awards granted in conjunction with selling goods or services to customers as part of a contract accounted for under Topic 606, Revenue from Contracts with Customers. The amendments in this Update are effective for public business entities for fiscal years beginning after December 15, 2018, including interim periods within that fiscal year. The adoption of this guidance did not have a material impact on the Company’s results of operation, financial position or disclosures. There are no additional accounting pronouncements issued or effective during the three and nine months ended September 30, 2019 that have had, or are expected to have, a material impact on our financial statements. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with US 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 expenses during the reporting period. Actual results could differ from those estimates. The principal areas of estimation reflected in the financial statements are stock based compensation, valuation of warrants, and income tax valuation allowance. |
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 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 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 the Company. 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 US GAAP requires all stock-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 the Company, 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. In connection with adopting ASU 2016-09, the Company made an accounting policy election to account for forfeitures in compensation expense as they occur. |
Warrants | Warrants The Company used the Black Scholes Option Pricing Model in calculating the relative fair value of any warrants that have been issued. |
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. 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. |
Concentrations | Concentrations 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 September 30, 2019 and December 31, 2018, the uninsured portion of this balance was $22,041,924 and $19,958,301, respectively. |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of Recognized Stock-based Compensation Expense | The Company recognized stock-based compensation on all employee and non-employee awards as follows: For the Three Months Ended September 30, 2019 For the Three Months Ended September 30, 2018 For the Nine Months Ended September 30, 2019 For the Nine Months Ended September 30, 2018 Research and development $ 20,416 $ 73,463 $ 92,503 $ 91,511 General and administrative 211,759 574,839 450,089 781,421 Total Stock-based compensation $ 232,175 $ 648,302 $ 542,592 $ 872,932 |
Warrants (Tables)
Warrants (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Warrants and Rights Note Disclosure [Abstract] | |
Summary of Warrant Activity | A summary of warrant activity for the year ended December 31, 2018 and the nine months ended September 30, 2019 is as follows: Warrants Weighted Average Price Balance - December 31, 2017 2,177,425 $ 3.10 Granted 14,700,000 1.00 Exercised (9,505,500 ) 1.00 Expired — — Balance - December 31, 2018 7,371,925 1.74 Granted 19,166,668 0.83 Exercised — — Expired — — Balance - September 30, 2019 26,538,593 $ 1.08 |
Schedule of Warrants Outstanding | The warrants outstanding as of September 30, 2019 are as follows: Exercise Price Warrants Outstanding Expiration Date $ 3.10 48,387 9/19/2022 $ 2.00 900,000 4/10/2023 $ 3.10 462,106 5/10/2024 $ 3.10 602,414 7/25/2024 $ 3.10 1,064,518 11/8/2024 $ 1.00 4,294,500 7/17/2025 $ 0.75 9,583,334 9/25/2020 * $ 0.90 9,583,334 3/25/2024 26,538,593 * Subject to termination prior to the indicated date following the Company’s release of top-line data related to its Phase 2 double blind, placebo controlled clinical trial of AG013 plus twenty-one (21) trading days. |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Supplemental Balance Sheet Information Related to Leases | Supplemental balance sheet information related to leases is as follows: September 30, 2019 Operating lease right-of-use assets $ 714,925 Operating lease liabilities - Short term $ 135,120 Operating lease liabilities - Long term 586,170 Total operating lease liabilities $ 721,290 Weighted Average Remaining Lease Term In Years Operating leases 3.97 Weighted Average Discount Rate Operating leases 5.67 % |
Schedule of Maturities of Operating Lease Liabilities | Maturities of operating lease liabilities are as follows: Year ended December 31: 2019 $ 47,747 2020 163,224 2021 154,908 2022 160,056 2023 160,056 2024 146,718 Total $ 832,709 Less: Imputed interest (111,419 ) Present value of lease liabilities $ 721,290 |
Schedule of Cost Component of Operating Leases | The cost component of operating leases is as follows: For the Nine Months Ended September 30, 2019 Operating lease cost $ 157,556 Short-term lease cost 1,719 Total lease cost $ 159,275 |
Schedule of Supplemental Cash Flow Information Related to Operating Leases | Supplemental cash flow information related to operating leases is as follows: For the Nine Months Ended September 30, 2019 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases $ 149,101 |
Shareholders' Equity (Tables)
Shareholders' Equity (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Equity [Abstract] | |
Summary of Changes in Shareholders' Equity | A summary of the changes in shareholders’ equity for the three and nine months ended September 30, 2019 and 2018 is as follows: Additional Total Common Stock Preferred Stock Paid In Accumulated Shareholders’ Shares Amount Shares Amount Capital Deficit Equity Balances at December 31, 2018 29,433,135 $ 29,433 16,017,101.733 $ 6,100,182 $ 126,125,976 $ (111,373,608 ) $ 20,881,983 Compensation expense relating to option issuances — — — — 145,829 — 145,829 Issuance of common stock - shelf takedown, net of expenses 16,666,668 16,667 — — 11,399,009 — 11,415,676 Issuance of common stock in exchange for services 12,500 12 — — 5,988 — 6,000 Series C dividend — — 12.208 413,214 — (413,214 ) — Net loss — — — — — (3,325,717 ) (3,325,717 ) Balances at March 31, 2019 46,112,303 $ 46,112 16,017,113.941 $ 6,513,396 $ 137,676,802 $ (115,112,539 ) $ 29,123,771 Compensation expense relating to option issuances — — — — 164,588 — 164,588 Issuance of common stock - shelf takedown, net of expenses — — — — (65,000 ) — (65,000 ) Issuance of common stock in exchange for services 12,500 13 — — 5,988 — 6,001 Net loss — — — — — (4,806,460 ) (4,806,460 ) Balances at June 30, 2019 46,124,803 $ 46,125 16,017,113.941 $ 6,513,396 $ 137,782,378 $ (119,918,999 ) $ 24,422,900 Compensation expense relating to option issuances — — — — 232,175 — 232,175 Net loss — — — — — (3,836,549 ) (3,836,549 ) Balances at September 30, 2019 46,124,803 $ 46,125 16,017,113.941 $ 6,513,396 $ 138,014,553 $ (123,755,548 ) $ 20,818,526 Additional Total Common Stock Preferred Stock Paid In Accumulated Shareholders’ Shares Amount Shares Amount Capital Deficit Equity Balances at December 31, 2017 4,928,335 $ 4,928 18,600,100.000 $ 6,309,608 $ 101,402,570 $ (101,400,797 ) $ 6,316,309 Compensation expense relating to option issuances — — — — 118,324 — 118,324 Conversion of Series A preferred stock to common stock 258,300 259 (2,583,000 ) (268,096 ) 267,837 — — Series C dividend — — 1.733 58,670 — (58,670 ) — Net loss — — — — — (2,119,397 ) (2,119,397 ) Balances at March 31, 2018 5,186,635 $ 5,187 16,017,101.7330 $ 6,100,182 $ 101,788,731 $ (103,578,864 ) $ 4,315,236 Compensation expense relating to option issuances — — — — 81,986 — 81,986 Issuance of common stock - shelf takedown, net of expenses 900,000 900 — — 1,509,427 — 1,510,327 Issuance of restricted common stock 16,000 16 — — 24,304 — 24,320 Net loss — — — — — (2,281,289 ) (2,281,289 ) Balances at June 30, 2018 6,102,635 $ 6,103 16,017,101.733 $ 6,100,182 $ 103,404,448 $ (105,860,153 ) $ 3,650,580 Compensation expense relating to option issuances — — — — 648,302 — 648,302 Issuance of common stock, Series D preferred stock, and warrants, net of expenses 4,436,000 4,436 9,364,000 4,464,107 7,963,085 — 12,431,628 Conversion of Series D preferred stock to common stock 7,868,000 7,868 (7,868,000 ) (3,750,920 ) 3,743,052 — — Issuance of common stock in exchange for services 12,500 12 — — 5,988 — 6,000 Net loss — — — — — (2,757,835 ) (2,757,835 ) Balances at September 30, 2018 18,419,135 $ 18,419 17,513,101.733 $ 6,813,369 $ 115,764,875 $ (108,617,988 ) $ 13,978,675 |
Basis of Presentation (Details
Basis of Presentation (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | |||||||
Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||||||||
Net loss | $ (3,836,549) | $ (4,806,460) | $ (3,325,717) | $ (2,757,835) | $ (2,281,289) | $ (2,119,397) | $ (11,968,726) | $ (7,158,521) | |
Cash used in operations | (9,076,328) | $ (6,101,876) | |||||||
Accumulated deficit | $ (123,755,548) | $ (123,755,548) | $ (111,373,608) |
Significant Accounting Polici_3
Significant Accounting Policies (Details Narrative) - USD ($) | Sep. 30, 2019 | Dec. 31, 2018 |
Accounting Policies [Abstract] | ||
Uninsured portion of cash balance | $ 22,041,924 | $ 19,958,301 |
Stock-based Compensation (Detai
Stock-based Compensation (Details Narrative) - 2012 Equity Incentive Plan [Member] - USD ($) | Jun. 20, 2019 | Jun. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 |
Number of additional shares authorized for issuance under an established share-based compensation plan | 6,000,000 | 1,500,000 | ||||
Shares authorized under the incentive plan | 8,250,000 | |||||
Maximum number of shares to individual | 1,000,000 | |||||
Number of stock options outstanding | 2,488,293 | 2,488,293 | ||||
Stock option awards for future grant | 5,520,957 | 5,520,957 | ||||
Stock option awards | 0 | 1,425,000 | 676,160 | 1,533,000 | ||
Weighted-average grant date fair value | $ 0 | $ 0.72 | $ 0.49 | $ 0.79 | ||
Number of stock options, vested | 609,406 | |||||
Number of stock options, forfeited | 0 | |||||
Number of stock options, exercised | 0 | |||||
Non Employee Directors [Member] | ||||||
Annual retainer amount for the threshold of stock | $ 270,000 |
Stock-based Compensation - Sche
Stock-based Compensation - Schedule Of Recognized Stock-based Compensation Expense (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Total Stock-based compensation | $ 232,175 | $ 648,302 | $ 542,592 | $ 848,612 |
Research And Development [Member] | ||||
Total Stock-based compensation | 20,416 | 73,463 | 92,503 | 91,511 |
General And Administrative [Member] | ||||
Total Stock-based compensation | $ 211,759 | $ 574,839 | $ 450,089 | $ 781,421 |
Warrants (Details Narrative)
Warrants (Details Narrative) | Mar. 25, 2019USD ($)Integer$ / sharesshares | Mar. 25, 2019USD ($)Integer$ / sharesshares | Sep. 30, 2019Integer$ / shares | Dec. 31, 2018$ / shares | Dec. 31, 2017$ / shares |
Trading days | Integer | 21 | ||||
Warrants exercise price per share | $ / shares | $ 1.08 | $ 1.74 | $ 3.10 | ||
Underwritten Public Offering [Member] | |||||
Proceeds from public offering | $ | $ 12,500,000 | $ 12,500,000 | |||
Warrants share price per unit | $ / shares | $ 0.75 | $ 0.75 | |||
Common Stock [Member] | Underwritten Public Offering [Member] | |||||
Number of common stock issued in offering | 16,666,668 | 16,666,668 | |||
Common Stock [Member] | Over Allotment Option [Member] | |||||
Maximum number of shares available to be purchased by underwriters | 2,500,000 | ||||
Short Term Warrants [Member] | Underwritten Public Offering [Member] | |||||
Exercisable term of warrants | 18 months | 18 months | |||
Trading days | Integer | 21 | 21 | |||
Warrants exercise price per share | $ / shares | $ 0.75 | $ 0.75 | |||
Short Term Warrants [Member] | Over Allotment Option [Member] | |||||
Number of warrants available for purchase | 1,250,000 | 1,250,000 | |||
Short Term Warrants [Member] | Underwriter [Member] | |||||
Number of warrants purchased during period | 1,250,000 | 1,250,000 | |||
Long Term Warrants [Member] | Underwritten Public Offering [Member] | |||||
Warrants exercise price per share | $ / shares | $ 0.90 | $ 0.90 | |||
Warrant term | 5 years | 5 years | |||
Long Term Warrants [Member] | Over Allotment Option [Member] | |||||
Number of warrants available for purchase | 1,250,000 | 1,250,000 | |||
Long Term Warrants [Member] | Underwriter [Member] | |||||
Number of warrants purchased during period | 1,250,000 | 1,250,000 | |||
Maximum [Member] | Short Term Warrants [Member] | Underwritten Public Offering [Member] | |||||
Shares of common stock callable by warrants issued | 8,333,334 | 8,333,334 | |||
Maximum [Member] | Long Term Warrants [Member] | Underwritten Public Offering [Member] | |||||
Shares of common stock callable by warrants issued | 8,333,334 | 8,333,334 |
Warrants - Summary of Warrant A
Warrants - Summary of Warrant Activity (Details) - $ / shares | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Warrants and Rights Note Disclosure [Abstract] | ||
Warrants Outstanding, Beginning Balance | 7,371,925 | 2,177,425 |
Warrants Outstanding, Granted | 19,166,668 | 14,700,000 |
Warrants Outstanding, Exercised | (9,505,500) | |
Warrants Outstanding, Expired | ||
Warrants Outstanding, Ending Balance | 26,538,593 | 7,371,925 |
Warrants Outstanding Weighted Average Price, Beginning Balance | $ 1.74 | $ 3.10 |
Warrants Outstanding Weighted Average Price, Granted | 0.83 | 1 |
Warrants Outstanding Weighted Average Price, Exercised | 1 | |
Warrants Outstanding Weighted Average Price, Expired | ||
Warrants Outstanding Weighted Average Price, Ending Balance | $ 1.08 | $ 1.74 |
Warrants - Schedule of Warrants
Warrants - Schedule of Warrants Outstanding (Details) - $ / shares | 9 Months Ended | |||
Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | ||
Warrant Outstanding Exercise Price | $ 1.08 | $ 1.74 | $ 3.10 | |
Warrants Outstanding | 26,538,593 | 7,371,925 | 2,177,425 | |
Range One [Member] | ||||
Warrant Outstanding Exercise Price | $ 3.10 | |||
Warrants Outstanding | 48,387 | |||
Expiration Date | Sep. 19, 2022 | |||
Range Two [Member] | ||||
Warrant Outstanding Exercise Price | $ 2 | |||
Warrants Outstanding | 900,000 | |||
Expiration Date | Apr. 10, 2023 | |||
Range Three [Member] | ||||
Warrant Outstanding Exercise Price | $ 3.10 | |||
Warrants Outstanding | 462,106 | |||
Expiration Date | May 10, 2024 | |||
Range Four [Member] | ||||
Warrant Outstanding Exercise Price | $ 3.10 | |||
Warrants Outstanding | 602,414 | |||
Expiration Date | Jul. 25, 2024 | |||
Range Five [Member] | ||||
Warrant Outstanding Exercise Price | $ 3.10 | |||
Warrants Outstanding | 1,064,518 | |||
Expiration Date | Nov. 8, 2024 | |||
Range Six [Member] | ||||
Warrant Outstanding Exercise Price | $ 1 | |||
Warrants Outstanding | 4,294,500 | |||
Expiration Date | Jul. 17, 2025 | |||
Range Seven [Member] | ||||
Warrant Outstanding Exercise Price | $ 0.75 | |||
Warrants Outstanding | 9,583,334 | |||
Expiration Date | [1] | Sep. 25, 2020 | ||
Range Eight [Member] | ||||
Warrant Outstanding Exercise Price | $ 0.90 | |||
Warrants Outstanding | 9,583,334 | |||
Expiration Date | Mar. 25, 2024 | |||
[1] | Subject to termination prior to the indicated date following the Company's release of top-line data related to its Phase 2 double blind, placebo controlled clinical trial of AG013 plus twenty-one (21) trading days. |
Warrants - Schedule of Warran_2
Warrants - Schedule of Warrants Outstanding (Details) (Parenthetical) | 9 Months Ended |
Sep. 30, 2019Integer | |
Warrants and Rights Note Disclosure [Abstract] | |
Trading days | 21 |
Short-Term Notes Payable (Detai
Short-Term Notes Payable (Details Narrative) - USD ($) | Aug. 07, 2019 | Mar. 10, 2019 | Jul. 24, 2018 | Mar. 10, 2018 | Sep. 30, 2019 | Dec. 31, 2018 |
Short-term notes payable for financing | $ 217,419 | $ 124,213 | ||||
Product Liability Insurance Financing [Member] | Short-term Note Payable [Member] | ||||||
Debt instrument amount | $ 17,688 | $ 28,915 | ||||
Debt instrument interest rate | 5.69% | 5.09% | ||||
Principal and interest payment date | Apr. 10, 2019 | Apr. 10, 2018 | ||||
Short-term notes payable amortization period | 11 months | 11 months | ||||
Debt instrument maturity date | Feb. 10, 2020 | Feb. 12, 2019 | ||||
Directors and Officers Liability Insurance [Member] | Short-term Note Payable [Member] | ||||||
Debt instrument amount | $ 254,889 | $ 215,575 | ||||
Debt instrument interest rate | 5.74% | 5.24% | ||||
Principal and interest payment date | Aug. 24, 2019 | Aug. 24, 2018 | ||||
Short-term notes payable amortization period | 11 months | 11 months | ||||
Debt instrument maturity date | Jun. 24, 2020 | Jun. 27, 2019 |
Commitments and Contingencies_2
Commitments and Contingencies (Details Narrative) | 1 Months Ended | 9 Months Ended | |
Nov. 30, 2017USD ($) | Nov. 30, 2016USD ($)ft² | Sep. 30, 2019USD ($) | |
Monthly lease payments | $ 149,101 | ||
Alachua Facility [Member] | |||
Period of lease | 5 years | ||
Amendment Alachua Facility [Member] | |||
Period of lease | 5 years | ||
Tampa Facility [Member] | |||
Period of lease | 36 months | ||
Area of office space leased | ft² | 2,207 | ||
Lease expiry date | Feb. 29, 2020 | ||
Maximum [Member] | Alachua Facility [Member] | |||
Monthly lease payments | $ 10,851 | ||
Maximum [Member] | Amendment Alachua Facility [Member] | |||
Monthly lease payments | 13,338 | ||
Maximum [Member] | Tampa Facility [Member] | |||
Monthly lease payments | $ 4,392 | ||
Minimum [Member] | Alachua Facility [Member] | |||
Monthly lease payments | 9,641 | ||
Minimum [Member] | Amendment Alachua Facility [Member] | |||
Monthly lease payments | $ 12,870 | ||
Minimum [Member] | Tampa Facility [Member] | |||
Monthly lease payments | $ 4,138 | ||
Lantibiotic Exclusive Channel Collaboration [Member] | Intrexon [Member] | Cost Of Revenue [Member] | |||
Royalty payment percentage | 25.00% | ||
Lantibiotic Exclusive Channel Collaboration [Member] | Prior to Amendment [Member] | |||
Royalty payment of sublicenses percentage | 50.00% | ||
Lantibiotic Exclusive Channel Collaboration [Member] | Prior to Amendment [Member] | Product Profit [Member] | |||
Reduction in royalty rate percentage | 25.00% | ||
Lantibiotic Exclusive Channel Collaboration [Member] | Subsequent to Amendment [Member] | |||
Royalty payment of sublicenses percentage | 25.00% | ||
Amount required to expended for advancement of lantibiotic program | $ 1,200,000 | ||
Lantibiotic Exclusive Channel Collaboration [Member] | Subsequent to Amendment [Member] | Net Sales [Member] | |||
Reduction in royalty rate percentage | 10.00% | ||
Lantibiotic Exclusive Channel Collaboration [Member] | Amendment [Member] | Intrexon [Member] | Net Sales [Member] | |||
Royalty payment percentage | 10.00% | ||
Lantibiotic Exclusive Channel Collaboration [Member] | New Drug Application [Member] | |||
Milestone payment under licensing agreement | $ 25,000,000 | ||
Milestone measurement period | 6 years | ||
Lantibiotic Exclusive Channel Collaboration [Member] | Regulatory Approval Milestone Event [Member] | |||
Milestone payment under licensing agreement | $ 25,000,000 | ||
Milestone measurement period | 6 months | ||
Lantibiotic Exclusive Channel Collaboration [Member] | New Indication Milestone Event [Member] | |||
Milestone payment under licensing agreement | $ 5,000,000 | ||
Milestone measurement period | 6 months | ||
Lantibiotic Exclusive Channel Collaboration [Member] | New Product Milestone Event [Member] | |||
Milestone payment under licensing agreement | $ 5,000,000 | ||
Milestone measurement period | 6 months | ||
Oral Mucositis Exclusive Channel Collaboration [Member] | Maximum [Member] | |||
Royalty payment of sublicenses percentage | 50.00% | ||
Maturity of interest bearing promissory note | 12 months | ||
Oral Mucositis Exclusive Channel Collaboration [Member] | Minimum [Member] | |||
Royalty payment of sublicenses percentage | 25.00% | ||
Oral Mucositis Exclusive Channel Collaboration [Member] | Intrexon [Member] | Net Sales [Member] | |||
Royalty payment percentage | 12.00% | ||
Oral Mucositis Exclusive Channel Collaboration [Member] | Intrexon [Member] | Cost Of Revenue [Member] | |||
Royalty payment percentage | 25.00% | ||
Oral Mucositis Exclusive Channel Collaboration [Member] | Regulatory Approval Milestone Event [Member] | |||
Milestone payment under licensing agreement | $ 27,500,000 | ||
Milestone measurement period | 6 months | ||
Oral Mucositis Exclusive Channel Collaboration [Member] | New Indication Milestone Event [Member] | |||
Milestone payment under licensing agreement | $ 5,000,000 | ||
Milestone measurement period | 6 months | ||
Oral Mucositis Exclusive Channel Collaboration [Member] | New Product Milestone Event [Member] | |||
Milestone payment under licensing agreement | $ 5,000,000 | ||
Milestone measurement period | 6 months | ||
Oral Mucositis Exclusive Channel Collaboration [Member] | New Product Application [Member] | |||
Milestone payment under licensing agreement | $ 27,500,000 | ||
Milestone measurement period | 6 years |
Commitments and Contingencies -
Commitments and Contingencies - Schedule of Supplemental Balance Sheet Information Related to Leases (Details) - USD ($) | Sep. 30, 2019 | Dec. 31, 2018 |
Commitments and Contingencies Disclosure [Abstract] | ||
Operating lease right-of-use assets | $ 714,925 | |
Operating lease liabilities - Short term | 135,120 | |
Operating lease liabilities - Long term | 586,170 | |
Total operating lease liabilities | $ 721,290 | |
Weighted Average Remaining Lease Term In Years, Operating leases | 3 years 11 months 19 days | |
Weighted Average Discount Rate, Operating leases | 5.67% |
Commitments and Contingencies_3
Commitments and Contingencies - Schedule of Maturities of Operating Lease Liabilities (Details) | Sep. 30, 2019USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2019 | $ 47,747 |
2020 | 163,224 |
2021 | 154,908 |
2022 | 160,056 |
2023 | 160,056 |
2024 | 146,718 |
Total | 832,709 |
Less: Imputed interest | (111,419) |
Present value of lease liabilities | $ 721,290 |
Commitments and Contingencies_4
Commitments and Contingencies - Schedule of Cost Component of Operating Leases (Details) | 9 Months Ended |
Sep. 30, 2019USD ($) | |
Commitments and Contingencies Disclosure [Abstract] | |
Operating lease cost | $ 157,556 |
Short-term lease cost | 1,719 |
Total lease cost | $ 159,275 |
Commitments and Contingencies_5
Commitments and Contingencies - Schedule of Supplemental Cash Flow Information Related to Operating Leases (Details) | 9 Months Ended |
Sep. 30, 2019USD ($) | |
Commitments and Contingencies Disclosure [Abstract] | |
Operating cash flows from operating leases | $ 149,101 |
Related Party Transactions (Det
Related Party Transactions (Details Narrative) - USD ($) | Mar. 25, 2019 | Mar. 25, 2019 | Mar. 25, 2019 | Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 |
Common Stock [Member] | Underwritten Public Offering [Member] | ||||||||
Number of common stock issued in offering | 16,666,668 | 16,666,668 | ||||||
Common Stock [Member] | Underwritten Public Offering [Member] | Dr. Frederick Telling [Member] | ||||||||
Number of common stock issued in offering | 100,000 | |||||||
Common Stock [Member] | Underwritten Public Offering [Member] | Dr. Alan Joslyn [Member] | ||||||||
Number of common stock issued in offering | 66,667 | |||||||
Short Term Warrants [Member] | Underwritten Public Offering [Member] | Dr. Frederick Telling [Member] | ||||||||
Number of warrants purchased | 50,000 | 50,000 | 50,000 | |||||
Short Term Warrants [Member] | Underwritten Public Offering [Member] | Dr. Alan Joslyn [Member] | ||||||||
Number of warrants purchased | 33,333 | 33,333 | 33,333 | |||||
Long Term Warrants [Member] | Underwritten Public Offering [Member] | Dr. Frederick Telling [Member] | ||||||||
Number of warrants purchased | 50,000 | 50,000 | 50,000 | |||||
Long Term Warrants [Member] | Underwritten Public Offering [Member] | Dr. Alan Joslyn [Member] | ||||||||
Number of warrants purchased | 33,333 | 33,333 | 33,333 | |||||
Intrexon [Member] | ||||||||
Accounts payable and accrued expenses | $ 55,771 | $ 55,771 | $ 39,607 | |||||
Percentage of outstanding common stock | 3.36% | 8.30% | 3.36% | 8.30% | ||||
Intrexon [Member] | Oral Mucositis and Lantibiotic Exclusive Channel Collaboration Agreements [Member] | ||||||||
Cash paid to related parties | $ 134,635 | $ 134,883 | $ 251,946 | $ 294,116 |
Shareholders' Equity (Details N
Shareholders' Equity (Details Narrative) | May 01, 2019shares | Mar. 25, 2019USD ($)Integer$ / sharesshares | Mar. 25, 2019USD ($)Integer$ / sharesshares | Feb. 01, 2019shares | Nov. 08, 2017USD ($)Investors | May 10, 2017USD ($)Investors$ / sharesshares | Jan. 31, 2019shares | Jun. 30, 2019shares | Mar. 31, 2019shares | Sep. 30, 2018shares | Mar. 31, 2018shares | Sep. 30, 2019Integer$ / shares | Dec. 31, 2018$ / shares | Dec. 31, 2017$ / shares |
Class of Stock [Line Items] | ||||||||||||||
Warrants exercise price per share | $ / shares | $ 1.08 | $ 1.74 | $ 3.10 | |||||||||||
Trading days | Integer | 21 | |||||||||||||
Issuance of stock as partial consideration for acquisition of certain services | ||||||||||||||
Series A Preferred Stock [Member] | Securities Purchase Agreement [Member] | ||||||||||||||
Class of Stock [Line Items] | ||||||||||||||
Maximum amount of shares agreed to be purchased | $ | $ 3,000,000 | |||||||||||||
Description on preferred stock, conversion basis | The full $3,000,000 of Preferred Stock, and after giving effect to the reverse stock split and the conversion of 2,583,000 shares of the Series A Preferred Stock into 258,300 shares of the Company's common stock, is convertible into nine hundred and forty one thousand seven hundred and one shares of our Common Stock, based on a fixed conversion price of $2.50 per share on an as-converted basis. | |||||||||||||
Number of preferred stock converted | 2,583,000 | |||||||||||||
Number of shares issued upon conversion, convertible preferred stock | 258,300 | |||||||||||||
Fixed conversion price per share | $ / shares | $ 2.50 | |||||||||||||
Number of accredited investors | Investors | 3 | |||||||||||||
Series C Preferred Stock [Member] | ||||||||||||||
Class of Stock [Line Items] | ||||||||||||||
Preferred stock dividend rate | 12.00% | 20.00% | ||||||||||||
Preferred stock issued as dividend | 12.208 | |||||||||||||
Common Stock [Member] | ||||||||||||||
Class of Stock [Line Items] | ||||||||||||||
Issuance of stock as partial consideration for acquisition of certain services | 12,500 | 12,500 | 12,500 | 12,500 | 12,500 | |||||||||
Number of shares issued upon conversion, convertible preferred stock | 258,300 | |||||||||||||
Preferred stock issued as dividend | ||||||||||||||
Underwritten Public Offering [Member] | ||||||||||||||
Class of Stock [Line Items] | ||||||||||||||
Proceeds from public offering | $ | $ 12,500,000 | $ 12,500,000 | ||||||||||||
Share price per unit | $ / shares | $ 0.75 | $ 0.75 | ||||||||||||
Underwritten Public Offering [Member] | Common Stock [Member] | ||||||||||||||
Class of Stock [Line Items] | ||||||||||||||
Number of common stock issued in offering | 16,666,668 | 16,666,668 | ||||||||||||
Underwritten Public Offering [Member] | Long Term Warrants [Member] | ||||||||||||||
Class of Stock [Line Items] | ||||||||||||||
Warrants exercise price per share | $ / shares | $ 0.90 | $ 0.90 | ||||||||||||
Term of warrants | 5 years | 5 years | ||||||||||||
Underwritten Public Offering [Member] | Long Term Warrants [Member] | Maximum [Member] | ||||||||||||||
Class of Stock [Line Items] | ||||||||||||||
Number of warrants to purchase common stock | 8,333,334 | 8,333,334 | ||||||||||||
Underwritten Public Offering [Member] | Short Term Warrants [Member] | ||||||||||||||
Class of Stock [Line Items] | ||||||||||||||
Warrants exercise price per share | $ / shares | $ 0.75 | $ 0.75 | ||||||||||||
Exercisable term of warrants | 18 months | 18 months | ||||||||||||
Trading days | Integer | 21 | 21 | ||||||||||||
Underwritten Public Offering [Member] | Short Term Warrants [Member] | Maximum [Member] | ||||||||||||||
Class of Stock [Line Items] | ||||||||||||||
Number of warrants to purchase common stock | 8,333,334 | 8,333,334 | ||||||||||||
Over Allotment Option [Member] | Common Stock [Member] | Maximum [Member] | ||||||||||||||
Class of Stock [Line Items] | ||||||||||||||
Number of shares of stock available for purchase | 2,500,000 | |||||||||||||
Over Allotment Option [Member] | Long Term Warrants [Member] | ||||||||||||||
Class of Stock [Line Items] | ||||||||||||||
Number of warrants available for purchase | 1,250,000 | 1,250,000 | ||||||||||||
Over Allotment Option [Member] | Short Term Warrants [Member] | ||||||||||||||
Class of Stock [Line Items] | ||||||||||||||
Number of warrants available for purchase | 1,250,000 | 1,250,000 | ||||||||||||
Underwriter [Member] | Long Term Warrants [Member] | ||||||||||||||
Class of Stock [Line Items] | ||||||||||||||
Number of warrants purchased in period | 1,250,000 | 1,250,000 | ||||||||||||
Underwriter [Member] | Short Term Warrants [Member] | ||||||||||||||
Class of Stock [Line Items] | ||||||||||||||
Number of warrants purchased in period | 1,250,000 | 1,250,000 | ||||||||||||
Private Placement [Member] | Series B Preferred Stock [Member] | ||||||||||||||
Class of Stock [Line Items] | ||||||||||||||
Proceeds from issuance of private placement | $ | $ 3,300,000 | |||||||||||||
Number of accredited investors | Investors | 4 |
Shareholders' Equity - Summary
Shareholders' Equity - Summary of Changes in Shareholders' Equity (Details) - USD ($) | May 01, 2019 | Feb. 01, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Sep. 30, 2019 | Sep. 30, 2018 |
Shareholders Equity [Line Items] | ||||||||||
Beginning balances | $ 24,422,900 | $ 29,123,771 | $ 20,881,983 | $ 3,650,580 | $ 4,315,236 | $ 6,316,309 | $ 20,881,983 | $ 6,316,309 | ||
Compensation expense relating to option issuances | 232,175 | 164,588 | 145,829 | 648,302 | 81,986 | 118,324 | ||||
Issuance of common stock - shelf takedown, net of expenses | (65,000) | 11,415,676 | 1,510,327 | |||||||
Issuance of common stock in exchange for services | 6,001 | $ 6,000 | 6,000 | |||||||
Issuance of common stock in exchange for services, shares | ||||||||||
Series C dividend | 413,215 | 58,670 | ||||||||
Conversion of Series A preferred stock to common stock | ||||||||||
Issuance of restricted common stock | 24,320 | |||||||||
Issuance of common stock, Series D preferred stock, and warrants, net of expenses | 12,431,628 | |||||||||
Conversion of Series D preferred stock to common stock | ||||||||||
Net loss | (3,836,549) | (4,806,460) | (3,325,717) | (2,757,835) | (2,281,289) | (2,119,397) | (11,968,726) | (7,158,521) | ||
Ending balances | 20,818,526 | 24,422,900 | 29,123,771 | 13,978,675 | 3,650,580 | 4,315,236 | 20,818,526 | 13,978,675 | ||
Common Stock [Member] | ||||||||||
Shareholders Equity [Line Items] | ||||||||||
Beginning balances | $ 46,125 | $ 46,112 | $ 29,433 | $ 6,103 | $ 5,187 | $ 4,928 | $ 29,433 | $ 4,928 | ||
Beginning balances, shares | 46,124,803 | 46,112,303 | 29,433,135 | 6,102,635 | 5,186,635 | 4,928,335 | 29,433,135 | 4,928,335 | ||
Compensation expense relating to option issuances | ||||||||||
Issuance of common stock - shelf takedown, net of expenses | $ 16,667 | $ 900 | ||||||||
Issuance of common stock - shelf takedown, net of expenses, shares | 16,666,668 | 900,000 | ||||||||
Issuance of common stock in exchange for services | $ 13 | $ 12 | $ 12 | |||||||
Issuance of common stock in exchange for services, shares | 12,500 | 12,500 | 12,500 | 12,500 | 12,500 | |||||
Series C dividend | ||||||||||
Series C dividend, shares | ||||||||||
Conversion of Series A preferred stock to common stock | $ 259 | |||||||||
Conversion of Series A preferred stock to common stock | 258,300 | |||||||||
Issuance of restricted common stock | $ 16 | |||||||||
Issuance of restricted common stock, shares | 16,000 | |||||||||
Issuance of common stock, Series D preferred stock, and warrants, net of expenses | $ 4,436 | |||||||||
Issuance of common stock, Series D preferred stock, and warrants, net of expenses, shares | 4,436,000 | |||||||||
Conversion of Series D preferred stock to common stock | $ 7,868 | |||||||||
Conversion of Series D preferred stock to common stock, shares | 7,868,000 | |||||||||
Net loss | ||||||||||
Ending balances | $ 46,125 | $ 46,125 | $ 46,112 | $ 18,419 | $ 6,103 | $ 5,187 | $ 46,125 | $ 18,419 | ||
Ending balances, shares | 46,124,803 | 46,124,803 | 46,112,303 | 18,419,135 | 6,102,635 | 5,186,635 | 46,124,803 | 18,419,135 | ||
Preferred Stock [Member] | ||||||||||
Shareholders Equity [Line Items] | ||||||||||
Beginning balances | $ 6,513,396 | $ 6,513,396 | $ 6,100,182 | $ 6,100,182 | $ 6,100,182 | $ 6,309,608 | $ 6,100,182 | $ 6,309,608 | ||
Beginning balances, shares | 16,017,113.941 | 16,017,113.941 | 16,017,101.733 | 16,017,101.733 | 16,017,101.7330 | 18,600,100 | 16,017,101.733 | 18,600,100 | ||
Compensation expense relating to option issuances | ||||||||||
Issuance of common stock - shelf takedown, net of expenses | ||||||||||
Issuance of common stock - shelf takedown, net of expenses, shares | ||||||||||
Issuance of common stock in exchange for services | ||||||||||
Issuance of common stock in exchange for services, shares | ||||||||||
Series C dividend | $ 413,214 | $ 58,670 | ||||||||
Series C dividend, shares | 12.208 | 1.733 | ||||||||
Conversion of Series A preferred stock to common stock | $ (268,096) | |||||||||
Conversion of Series A preferred stock to common stock | (2,583,000) | |||||||||
Issuance of restricted common stock | ||||||||||
Issuance of common stock, Series D preferred stock, and warrants, net of expenses | $ 4,464,107 | |||||||||
Issuance of common stock, Series D preferred stock, and warrants, net of expenses, shares | 9,364,000 | |||||||||
Conversion of Series D preferred stock to common stock | $ (3,750,920) | |||||||||
Conversion of Series D preferred stock to common stock, shares | (7,868,000) | |||||||||
Net loss | ||||||||||
Ending balances | $ 6,513,396 | $ 6,513,396 | $ 6,513,396 | $ 6,813,369 | $ 6,100,182 | $ 6,100,182 | $ 6,513,396 | $ 6,813,369 | ||
Ending balances, shares | 16,017,113.941 | 16,017,113.941 | 16,017,113.941 | 17,513,101.733 | 16,017,101.733 | 16,017,101.7330 | 16,017,113.941 | 17,513,101.733 | ||
Additional Paid In Capital [Member] | ||||||||||
Shareholders Equity [Line Items] | ||||||||||
Beginning balances | $ 137,782,378 | $ 137,676,802 | $ 126,125,976 | $ 103,404,448 | $ 101,788,731 | $ 101,402,570 | $ 126,125,976 | $ 101,402,570 | ||
Compensation expense relating to option issuances | 232,175 | 164,588 | 145,829 | 648,302 | 81,986 | 118,324 | ||||
Issuance of common stock - shelf takedown, net of expenses | (65,000) | 11,399,009 | 1,509,427 | |||||||
Issuance of common stock in exchange for services | 5,988 | $ 5,988 | 5,988 | |||||||
Issuance of common stock in exchange for services, shares | ||||||||||
Series C dividend | ||||||||||
Series C dividend, shares | ||||||||||
Conversion of Series A preferred stock to common stock | $ 267,837 | |||||||||
Issuance of restricted common stock | 24,304 | |||||||||
Issuance of common stock, Series D preferred stock, and warrants, net of expenses | 7,963,085 | |||||||||
Conversion of Series D preferred stock to common stock | 3,743,052 | |||||||||
Net loss | ||||||||||
Ending balances | 138,014,553 | 137,782,378 | 137,676,802 | 115,764,875 | 103,404,448 | 101,788,731 | 138,014,553 | 115,764,875 | ||
Accumulated Deficit [Member] | ||||||||||
Shareholders Equity [Line Items] | ||||||||||
Beginning balances | (119,918,999) | (115,112,539) | $ (111,373,608) | (105,860,153) | (103,578,864) | (101,400,797) | $ (111,373,608) | (101,400,797) | ||
Beginning balances, shares | ||||||||||
Compensation expense relating to option issuances | ||||||||||
Issuance of common stock - shelf takedown, net of expenses | ||||||||||
Issuance of common stock - shelf takedown, net of expenses, shares | ||||||||||
Issuance of common stock in exchange for services | ||||||||||
Issuance of common stock in exchange for services, shares | ||||||||||
Series C dividend | $ (413,214) | (58,670) | ||||||||
Conversion of Series A preferred stock to common stock | ||||||||||
Issuance of restricted common stock | ||||||||||
Issuance of common stock, Series D preferred stock, and warrants, net of expenses | ||||||||||
Conversion of Series D preferred stock to common stock | ||||||||||
Net loss | (3,836,549) | (4,806,460) | (3,325,717) | (2,757,835) | (2,281,289) | (2,119,397) | ||||
Ending balances | $ (123,755,548) | $ (119,918,999) | $ (115,112,539) | $ (108,617,988) | $ (105,860,153) | $ (103,578,864) | $ (123,755,548) | $ (108,617,988) |