Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2019 | Oct. 31, 2019 | |
Document and Entity Information [Abstract] | ||
Entity Registrant Name | PDS Biotechnology Corp | |
Entity Central Index Key | 0001472091 | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Shell Company | false | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Entity Common Stock, Shares Outstanding | 5,778,850 | |
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2019 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q3 | |
Entity Address, State or Province | NJ |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) | Sep. 30, 2019 | Dec. 31, 2018 | |
Current assets: | |||
Cash and cash equivalents | $ 17,406,608 | $ 103,695 | |
Prepaid expenses and other | 726,959 | 156,628 | |
Total current assets | 18,133,567 | 260,323 | |
Property and equipment, net | 26,929 | 29,508 | |
Intangible assets, net | 1,223,000 | 41,692 | |
Other assets | 0 | 12,800 | |
Total assets | 19,383,496 | 344,323 | |
Current liabilities: | |||
Accounts payable | 1,488,961 | 1,412,951 | |
Accrued expenses | 1,296,606 | 601,889 | |
Restructuring reserve | 858,332 | [1] | 0 |
Total current liabilities | 3,643,899 | 2,014,840 | |
Noncurrent liability: | |||
Deferred tax liability | 157,000 | 0 | |
Convertible promissory notes payable | 0 | 30,000 | |
STOCKHOLDERS' EQUITY (DEFICIT) | |||
Preferred stock, 5,000,000 shares authorized at September 30, 2019 and December 31, 2018, 0 outstanding | 0 | 0 | |
Common stock, $0.00033 par value, 75,000,000 shares authorized at September 30, 2019 and December 31, 2018, 5,278,850 shares and 3,417,187 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively | 1,742 | 1,128 | |
Additional paid-in capital | 39,414,792 | 19,311,529 | |
Accumulated deficit | (23,833,937) | (21,013,174) | |
Total stockholders' equity (deficit) | 15,582,597 | (1,700,517) | |
Total liabilities and stockholders' equity (deficit) | $ 19,383,496 | $ 344,323 | |
[1] | Restructuring reserve relates to the severance costs incurred by Edge Therapeutics prior to the merger transaction and assumed by the Company as part of the purchase accounting, but not yet paid. The severance costs continue through September 2020. For the nine months ended September 30, 2019, the Company paid $1,211,939 of restructuring expense which was previously recorded on Edge Therapeutics financials. |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Sep. 30, 2019 | Dec. 31, 2018 |
STOCKHOLDERS' EQUITY (DEFICIT) | ||
Preferred stock, shares authorized (in shares) | 5,000,000 | 5,000,000 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.00033 | $ 0.00033 |
Common stock, shares authorized (in shares) | 75,000,000 | 75,000,000 |
Common stock, shares issued (in shares) | 5,278,850 | 3,417,187 |
Common stock, shares outstanding (in shares) | 5,278,850 | 3,417,187 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (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 expenses | $ 1,834,371 | $ 194,068 | $ 4,751,308 | $ 563,812 |
General and administrative expenses | 3,068,581 | 516,202 | 9,358,429 | 1,450,429 |
Lease termination costs | 944,445 | 0 | 944,445 | 0 |
Total operating expenses | 5,847,397 | 710,270 | 15,054,182 | 2,014,241 |
Loss from operations | (5,847,397) | (710,270) | (15,054,182) | (2,014,241) |
Other income (expense): | ||||
Gain on bargain purchase upon merger | 0 | 0 | 11,939,331 | 0 |
Interest income | 95,787 | 4 | 294,694 | 14 |
Interest expense | 0 | (942) | (606) | (2,705) |
Net loss | (5,751,610) | (711,208) | (2,820,763) | (2,016,932) |
Comprehensive loss | $ (5,751,610) | $ (711,208) | $ (2,820,763) | $ (2,016,932) |
Net loss per share, basic and diluted (in dollars per share) | $ (1.10) | $ (0.21) | $ (0.60) | $ (0.62) |
Weighted average common shares outstanding, basic and diluted (in shares) | 5,246,829 | 3,346,237 | 4,729,153 | 3,253,085 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Changes in Stockholders' Equity (Deficit) (Unaudited) - USD ($) | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] | Total |
Balance at Dec. 31, 2017 | $ 1,007 | $ 17,492,083 | $ (18,102,618) | $ (609,528) |
Balance (in shares) at Dec. 31, 2017 | 3,051,538 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Stock-based compensation expense | $ 0 | 49,336 | 0 | 49,336 |
Capitalized offering costs | 0 | (46,000) | 0 | (46,000) |
Issuance of common stock, net of issuance costs | $ 102 | 1,076,792 | 0 | 1,076,894 |
Issuance of common stock, net of issuance costs (in shares) | 307,547 | |||
Issuance of common stock for warrant exercise | $ 3 | 99,960 | 0 | 99,963 |
Issuance of common stock for warrant exercise (in shares) | 7,673 | |||
Issuance of common stock for stock option exercise | $ 2 | 25,405 | 0 | 25,407 |
Issuance of common stock for stock option exercise (in shares) | 3,702 | |||
Issuance of warrants | $ 0 | 342,105 | 0 | 342,105 |
Net loss | 0 | 0 | (2,016,932) | (2,016,932) |
Balance at Sep. 30, 2018 | $ 1,114 | 19,039,681 | (20,119,550) | (1,078,755) |
Balance (in shares) at Sep. 30, 2018 | 3,370,460 | |||
Balance at Jun. 30, 2018 | $ 1,103 | 18,599,631 | (19,408,342) | (807,608) |
Balance (in shares) at Jun. 30, 2018 | 3,341,143 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Stock-based compensation expense | $ 0 | 41,691 | 0 | 41,691 |
Capitalized offering costs | 0 | (2,000) | 0 | (2,000) |
Issuance of common stock, net of issuance costs | $ 6 | 274,994 | 0 | 275,000 |
Issuance of common stock, net of issuance costs (in shares) | 17,942 | |||
Issuance of common stock for warrant exercise | $ 3 | 99,960 | 0 | 99,963 |
Issuance of common stock for warrant exercise (in shares) | 7,673 | |||
Issuance of common stock for stock option exercise | $ 2 | 25,405 | 0 | 25,407 |
Issuance of common stock for stock option exercise (in shares) | 3,702 | |||
Net loss | $ 0 | 0 | (711,208) | (711,208) |
Balance at Sep. 30, 2018 | $ 1,114 | 19,039,681 | (20,119,550) | (1,078,755) |
Balance (in shares) at Sep. 30, 2018 | 3,370,460 | |||
Balance at Dec. 31, 2018 | $ 1,128 | 19,311,529 | (21,013,174) | (1,700,517) |
Balance (in shares) at Dec. 31, 2018 | 3,417,187 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Stock-based compensation expense | $ 0 | 2,893,658 | 0 | 2,893,658 |
Issuance of common stock, net of issuance costs | $ 16 | 749,984 | 0 | 750,000 |
Issuance of common stock, net of issuance costs (in shares) | 48,930 | |||
Issuance of common stock for antidilution | $ 32 | (32) | 0 | 0 |
Issuance of common stock for antidilution (in shares) | 97,960 | |||
Issuance of common stock for convertible debt | $ 3 | 32,950 | 0 | 32,953 |
Issuance of common stock for convertible debt (in shares) | 9,683 | |||
Issuance of common stock from 401K match | $ 2 | 29,702 | 0 | 29,704 |
Issuance of common stock from 401K match (in shares) | 5,258 | |||
Issuance of common stock from equity transaction | $ 33 | 603,891 | 0 | 603,924 |
Issuance of common stock from equity transaction (in shares) | 100,654 | |||
Equity from merger transaction | $ 528 | 15,793,110 | 0 | 15,793,638 |
Equity from merger transaction (in shares) | 1,599,178 | |||
Net loss | $ 0 | 0 | (2,820,763) | (2,820,763) |
Balance at Sep. 30, 2019 | $ 1,742 | 39,414,792 | (23,833,937) | 15,582,597 |
Balance (in shares) at Sep. 30, 2019 | 5,278,850 | |||
Balance at Jun. 30, 2019 | $ 1,709 | 38,686,233 | (18,082,327) | 20,605,615 |
Balance (in shares) at Jun. 30, 2019 | 5,177,487 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Stock-based compensation expense | $ 0 | 120,207 | 0 | 120,207 |
Issuance of common stock from 401K match | $ 0 | 4,461 | 0 | 4,461 |
Issuance of common stock from 401K match (in shares) | 709 | |||
Issuance of common stock from equity transaction | $ 33 | 603,891 | 0 | 603,924 |
Issuance of common stock from equity transaction (in shares) | 100,654 | |||
Net loss | $ 0 | 0 | (5,751,610) | (5,751,610) |
Balance at Sep. 30, 2019 | $ 1,742 | $ 39,414,792 | $ (23,833,937) | $ 15,582,597 |
Balance (in shares) at Sep. 30, 2019 | 5,278,850 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Cash flows from operating activities: | ||
Net loss | $ (2,820,763) | $ (2,016,932) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 2,893,658 | 49,336 |
Stock-based consulting expense | 603,924 | 268,999 |
Stock-based 401K company common match | 29,705 | 0 |
Depreciation expense | 93,814 | 21,415 |
Loss on disposal of fixed assets related to lease termination | 310,951 | 0 |
Bargain purchase gain from merger | (11,939,331) | 0 |
Changes in assets and liabilities: | ||
Prepaid expenses and other assets | 1,908,520 | 34,366 |
Accounts payable | (1,521,516) | 244,305 |
Accrued expenses | (900,622) | 146,562 |
Restructuring reserve | (1,211,939) | 0 |
Net cash used in operating activities | (12,553,599) | (1,251,949) |
Cash flows from investing activities: | ||
Cash received in reverse merger transaction | 29,106,512 | 0 |
Net cash provided by investing activities | 29,106,512 | 0 |
Cash flows from financing activities: | ||
Payments for capital lease obligation | 0 | (10,636) |
Proceeds from issuance of common stock, net of issuance costs | 750,000 | 1,229,370 |
Net cash provided by financing activities | 750,000 | 1,218,734 |
Net increase (decrease) in cash and cash equivalents | 17,302,913 | (33,215) |
Cash and cash equivalents at beginning of period | 103,695 | 175,884 |
Cash and cash equivalents at end of period | 17,406,608 | 142,669 |
Cash paid for: | ||
Interest | 606 | 1,022 |
Supplemental cash flow information: | ||
Conversion of convertible notes and accrued interest into common stock | 32,953 | 0 |
Consideration in connection with reverse merger transaction | $ 15,793,638 | $ 0 |
Nature of Operations
Nature of Operations | 9 Months Ended |
Sep. 30, 2019 | |
Nature of Operations [Abstract] | |
Nature of Operations | Note 1 – PDS Biotechnology Corporation, a Delaware corporation (the “Company,” “PDS” or the “combined company”), is a clinical stage immuno-oncology company with a growing pipeline of clinical-stage immunotherapies to treat cancer at various stages, including head and neck cancer, prostate cancer, breast cancer, cervical cancer, anal cancer, and other cancers. All of PDS’s products are based on the proprietary Versamune ® platform technology, which activates and directs the human immune system to unleash a powerful and targeted attack against cancer cells. The Versamune ® -based immunotherapies may be used as monotherapies or in combination with other agents. PDS is initially prioritizing the development of the Versamune ® -based products as combination therapies to be administered with other potentially synergistic agents such as FDA-approved therapeutic or immunotherapeutic agents and promising therapeutic agents still in clinical development. On March 15, 2019, the Company, then operating as Edge Therapeutics, Inc. (“Edge”), completed its reverse merger with privately held PDS Biotechnology Corporation (“Private PDS”), pursuant to and in accordance with the terms of the Agreement and Plan of Merger, dated as of November 23, 2018, as amended on January 24, 2019, by and among the Company, Echos Merger Sub, a wholly-owned subsidiary of the Company (“Merger Sub”), and Private PDS, whereby Private PDS merged with and into Merger Sub, with Private PDS surviving as the Company’s wholly-owned subsidiary (the “Merger”). For accounting purposes, the Merger is treated as a “reverse acquisition” under generally accepted accounting principles in the United States (“U.S. GAAP”) and Private PDS is considered the accounting acquirer. Accordingly, upon consummation of the Merger, the historical financial statements of Private PDS became the Company's historical financial statements, and the historical financial statements of Private PDS are included in the comparative prior periods. See “Note 4 – Reverse Merger” for more information on the Merger. From the Company's inception, it has devoted substantially all of its efforts to business planning, engaging regulatory, manufacturing and other technical consultants, acquiring operating assets, planning and executing clinical trials and raising capital. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2019 | |
Summary of Significant Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Note 2 – Summary of Significant Accounting Policies (A) Unaudited interim financial statements: The interim balance sheet at September 30, 2019, the statements of operations and comprehensive loss and changes in stockholders' equity (deficit) for the three and nine months ended September 30, 2019 and 2018, and cash flows for the nine months ended September 30, 2019 and 2018 are unaudited. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. GAAP, and following the requirements of the Securities and Exchange Commission (“SEC”) for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by U.S. GAAP can be condensed or omitted. These condensed consolidated financial statements have been prepared on the same basis as the Company’s annual financial statements and, in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments that are necessary for a fair statement of its financial information. The results of operations for the three and nine months ended September 30, 2019 are not necessarily indicative of the results to be expected for the year ending December 31, 2019 or for any other future annual or interim period. The balance sheet as of December 31, 2018 included herein was derived from the audited condensed consolidated financial statements as of that date. These condensed consolidated financial statements should be read in conjunction with the Private PDS audited financial statements and notes thereto as of and for the year ended December 31, 2018, filed by the Company with the SEC in its Current Report on Form 8-K/A on April 30, 2019. (B) Use of estimates: The preparation of financial statements in conformity with U.S. 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 and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. (C) Significant risks and uncertainties: The Company's operations are subject to a number of factors that may affect its operating results and financial condition. Such factors include, but are not limited to: the clinical and regulatory development of its products, the Company’s review of strategic alternatives, the Company’s ability to preserve its cash resources, the Company’s ability to add product candidates to its pipeline, the Company's intellectual property, competition from products manufactured and sold or being developed by other companies, the price of, and demand for, Company products if approved for sale, the Company's ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products, and the Company's ability to raise capital. The Company currently has no commercially approved products. As such, there can be no assurance that the Company's future research and development programs will be successfully commercialized. Developing and commercializing a product requires significant time and capital and is subject to regulatory review and approval as well as competition from other biotechnology and pharmaceutical companies. The Company operates in an environment of rapid change and is dependent upon the continued services of its employees and consultants and obtaining and protecting its intellectual property. (D) Cash equivalents and concentration of cash balance: The Company considers all highly liquid securities with a maturity weighted average of less than three months to be cash equivalents. The Company's cash and cash equivalents in bank deposit accounts, at times, may exceed federally insured limits. (E) Research and development: Costs incurred in connection with research and development activities are expensed as incurred. These costs include licensing fees to use certain technology in the Company's research and development projects as well as fees paid to consultants and various entities that perform certain research and testing on behalf of the Company. Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using data, such as patient enrollment, clinical site activations or information provided by vendors on their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred. (F) Patent costs: The Company expenses patent costs as incurred and classifies such costs as general and administrative expenses in the accompanying statements of operations and comprehensive loss. (G) Intellectual property: PDS strives to protect and enhance the proprietary technology, inventions and improvements that are commercially important to its business, including seeking, maintaining, and defending patent rights. PDS has developed numerous patents and patent applications related to its Versamune ® Licensed patents Licensed Patent Families 1 and 2 cover the Versamune ® ® (H) Intangibles: The Company's intangible assets as of September 30, 2019 consist of in-process research and development ("IPR&D") intangible assets acquired as part of the reverse merger transaction on March 15, 2019. The fair value of IPR&D using a discounted cash flow method . In determining the value of IPR&D, management considers, among other factors, the stage of completion of the projects, the technological feasibility of the projects, whether the projects have an alternative future use, and the estimated residual cash flows that could be generated from the various projects and technologies over their respective projected economic lives. The discount rate used is determined at the time of acquisition and includes a rate of return which accounts for the time value of money, as well as risk factors reflecting the economic risk that the projected cash flows may not be realized. The Company reviews its IPR&D at least annually for possible impairment. IPR&D is reviewed for possible impairment between annual tests if an event occurs or circumstances change that would more likely than not reduce the fair value of the IPR&D below their carrying values. The Company will next test its IPR&D on December 1, 2019. The Company's IPR&D asset totaled $1.2 million at September 30, 2019. There were no trigger events during the three months and nine months ended September 30, 2019 to which an impairment analysis would be warranted. (I) Stock-based compensation: Pre merger, the Company measured and recognized share-based compensation expense, for both employee and director option awards, based on the grant date fair value of the awards. The Company recognized share-based compensation expense, net of estimated forfeitures, on a straight-line basis over the requisite service period of the awards, which is generally the vesting period. The Company determined the fair value of share-based awards granted to non-employees as either the fair value of the consideration received or the fair value of the equity instruments issued, whichever is more reliably measurable. All issuances of equity instruments issued to non-employees as consideration for goods or services received by the Company are accounted for based on the fair value of the equity instruments issued. These awards were recorded in expense and additional paid-in capital in shareholders’ equity (deficit) over the applicable service periods based on the fair value of the options at the end of each period. The Company classified share-based compensation expense in its condensed consolidated statements of operations in the same manner in which the award recipient’s payroll costs are classified or in which the award recipients’ service payments are classified. The Company estimated the fair value of employee and director share options as of the date of grant using the Black-Scholes option pricing model. The Company historically has been a private company and lacks company-specific historical and implied volatility information. Therefore, it estimated its expected share price volatility based on the historical volatility of a publicly traded set of peer companies. The expected term of the Company’s share options had been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options. The risk-free interest rate is determined by reference to the yield curve of a zero-coupon U.S. Treasury bond on the date of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield was based on the fact that the Company has never paid cash dividends on ordinary shares and does not expect to pay any cash dividends in the foreseeable future. The Company also estimated the fair value of consultant and non-employee share options using the Black-Scholes option pricing model reflecting the same assumptions as applied to employee and director options in each of the reporting periods, other than the expected life, which is assumed to be the remaining contractual life of the options. Prospectively, the Company will measure employee stock-based awards at grant-date fair value and recognize stock-based compensation expense on a straight-line basis over the vesting period of the award. Determining the appropriate fair value of stock-based awards will require the input of subjective assumptions, including, for stock options, the expected life of the option, and expected stock price volatility. The Company will use the Black-Scholes option pricing model to value its stock option awards. The assumptions used in calculating the fair value of stock-based awards represent management's best estimates and involve inherent uncertainties and the application of management's judgment. As a result, if factors change and management uses different assumptions, stock-based compensation expense could be materially different for future awards. The expected life of stock options will be estimated using the "simplified method," as the Company has limited historical information to develop reasonable expectations about future exercise patterns and employment duration for its stock options grants. The simplified method is based on the average of the vesting tranches and the contractual life of each grant. For stock price volatility, the Company will utilize comparable public companies and company specific as a basis for its expected volatility to calculate the fair value of options grants. The risk-free interest rate will be based on U.S. Treasury notes with a term approximating the expected life of the option. (J) Common stock warrants: The Company measures and recognizes warrants, for non-employees for the value or goods or services received or in conjunction with the issuance of a debt or equity financing issuance based on the grant date fair value of the warrant. The Company determines the fair value of warrants granted to non-employees or investors as either the fair value of the consideration received or the fair value of the debt or equity instruments issued, whichever is more reliably measurable. All issuances of debt and equity instruments issued to investors or non-employees as consideration for goods or services received by the Company are accounted for based on the fair value of the debt and equity instruments issued. Generally, if a warrant cannot be settled in cash by the holder or a stock settled transaction, the warrant is considered an equity transaction to the Company and has an offsetting debit to additional paid-in capital in shareholders’ (deficit) equity based on the fair value of the warrant at the issuance date. The Company estimates the fair value of warrants as of the date of grant using the Black-Scholes option pricing model as described in Stock-Based Compensation in the previous section. In February 2019, the Company issued 48,930 shares of common stock for proceeds of $750,000. In exchange for the financing, 34,192 of warrants were issued with an exercise price of $9.87 and an expiration date of December 31, 2023. (K) Net income (loss) per common share: Basic net income (loss) per share attributable to common stockholders is computed by dividing net income (loss) attributable to common stockholders by the weighted-average number of common shares outstanding during the period. All participating securities are excluded from basic weighted-average common shares outstanding. In computing both basic net income (loss) per share attributable to common stockholders and diluted net income (loss) per share attributable to common stockholders, undistributed earnings are re-allocated to reflect the potential impact of dilutive securities, including stock options and warrants. Diluted net income (loss) per share attributable to common stockholders is computed by dividing net income (loss) attributable to common stockholders by the weighted-average number of common equivalent shares outstanding for the period. Diluted net income (loss) per share attributable to common stockholders includes any dilutive effect from outstanding stock options and warrants using the treasury stock method. The common stock issuable upon the conversion or exercise of the following dilutive securities as of September 30, 2019 and as of September 30, 2018 have been excluded from the diluted net loss per share attributable to common stockholders calculation because their effect would have been antidilutive for the period presented: As of September 30, 2019 2018 Stock options to purchase Common Stock 1,405,902 513,534 Convertible promissory note - 9,216 Warrants to purchase Common Stock 262,758 115,860 Total 1,668,660 638,610 The following is a reconciliation of the numerator (net income or loss) and the denominator (number of shares) used in the calculation of basic and diluted net income (loss) per share attributable to common stockholders: Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Numerator Basic and diluted net loss $ (5,751,610 ) $ (711,208 ) $ (2,820,763 ) $ (2,016,932 ) Denominator Shares used in computing basic net loss per share 5,246,829 3,346,237 4,729,153 3,253,085 Net loss per share, basic and diluted $ (1.10 ) $ (0.21 ) $ (0.60 ) $ (0.62 ) (L) Accounting standards not yet adopted: In August 2018, the Financial Accounting Standards Board (“FASB”) issued No. 2018-13, Fair Value Measurement (Topic 820) (“ASU 2018-13”). ASU 2018-13 modifies disclosure requirements related to fair value measurement and is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. Implementation on a prospective or retrospective basis varies by specific disclosure requirement. Early adoption is permitted. ASU 2018-13 also allows for early adoption of any removed or modified disclosures upon issuance of ASU 2018-13 while delaying adoption of the additional disclosures until their effective date. The Company is currently evaluating the In August 2018, the FASB issued No. 2018-15, Intangibles-Goodwill and Other-Internal-Use Software (Subtopic 350-40) (“ASU 2018-15”). ASU 2018-15 reduces complexity for the accounting for costs of implementing a cloud computing service arrangement and aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software (and hosting arrangements that include an internal use software license). ASU 2018-15 is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019, with early adoption permitted. The Company is currently evaluating the . (M) Accounting standards adopted: In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) ("ASU 2016-02"), which sets out the principles for the recognition, measurement, The new lease standard also provides practical expedients for an entity's ongoing accounting. The Company elected the short-term lease recognition exemption under which the Company will not recognize right-of-use (“ROU”) assets or lease liabilities, and this includes not recognizing ROU assets or lease liabilities for existing short-term leases. The Company elected the practical expedient to not separate lease and non-lease components for certain classes of assets (office building). The Company determines if an arrangement is a lease at inception. Operating lease ROU assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term. Operating lease expense is recognized on a straight-line basis over the lease term, subject to any changes in the lease or expectations regarding the terms. Variable lease costs such as operating costs and property taxes are expensed as incurred. ASU 2018-07, Improvements to Nonemployee Share Based Payment Accounting, eliminates the separate accounting model for nonemployee share-based payment awards and generally requires companies to account for share-based payment transactions with nonemployees in the same way as share-based payment transactions with employees. PDS adopted this ASU on January 1, 2019 and there was not a material impact requiring the retrospective adjustment to retained earnings on transition. |
Liquidity
Liquidity | 9 Months Ended |
Sep. 30, 2019 | |
Liquidity [Abstract] | |
Liquidity | Note 3 – Liquidity As of September 30, 2019, the Company had $17.4 million of cash and cash equivalents, primarily provided by $29.1 million of pre-existing cash on Edge’s balance sheets that the Company obtained as a result of the Merger. The Company's primary uses of cash are to fund operating expenses, primarily research and development expenditures. Cash used to fund operating expenses is impacted by the timing of when the Company pays these expenses, as reflected in the change to the Company's outstanding accounts payable and accrued expenses. On July 29, 2019, the Company entered into a common stock purchase agreement (the “Aspire Purchase Agreement”) pursuant to which, the Company has the right, in its sole discretion, to present Aspire Capital Fund, LLC (“Aspire Capital”) with a purchase notice, directing Aspire Capital (as principal) to purchase up to 100,000 shares of the Company’s common stock per business day, in an aggregate amount of up to $20.0 million of the Company's common stock (the “Purchase Shares”) over the term of the Aspire Purchase Agreement at a per share price equal to the lesser of the lowest sale price of the Company’s common stock on the purchase date or the arithmetic average of the three lowest closing sale prices for the Company’s common stock during the ten consecutive trading days ending on the trading day immediately preceding the purchase date. The Company may sell an aggregate of 1,034,979 shares of its common stock (which represented 19.99% of the Company’s outstanding shares of common stock on the date of the Aspire Purchase Agreement) without stockholder approval. The Company may sell additional shares of its common stock above the 19.99% limit provided that (i) it obtains stockholder approval or (ii) stockholder approval has not been obtained at any time the 1,034,979 share limitation is reached and at all times thereafter the average price paid for all shares issued under the Aspire Purchase Agreement, is equal to or greater than $5.76, which was the consolidated closing bid price of the Company’s common stock on July 26, 2019. The minimum price at which the Company sell shares under the Aspire Purchase Agreement is $0.50. On July 29, 2019, the Company issued 100,654 shares of common stock to Aspire Capital as consideration for entering into the Aspire Purchase Agreement . under The Company evaluated whether there are any conditions and events, considered in the aggregate, that raise substantial doubt about its ability to continue as a going concern within one year beyond the filing of this Quarterly Report on Form 10-Q. Based on such evaluation and the Company's current plans, which are subject to change, management believes that the Company's existing cash and cash equivalents as of September 30, 2019 and proceeds expected to become available through government funding programs will be sufficient to satisfy its operating cash needs for at least one year after the filing of this Quarterly Report on Form 10-Q. The Company plans to continue to fund the Company's operations and capital funding needs through equity and/or debt financings. The Company may also enter into government funding programs and consider selectively partnering for clinical development and commercialization. The sale of additional equity would result in additional dilution to the Company's stockholders. Incurring debt financing would result in debt service obligations, and the instruments governing such debt could provide for operating and financing covenants that would restrict the Company's operations. If the Company's was unable to raise additional capital in sufficient amounts or on acceptable terms, the Company may be required to delay, limit, reduce, or terminate the Company's product development or future commercialization efforts or grant rights to develop and market immunotherapies that the Company would otherwise prefer to develop and market ourselves. Any of these actions could harm the Company's business, results of operations and prospects. |
Reverse Merger
Reverse Merger | 9 Months Ended |
Sep. 30, 2019 | |
Reverse Merger [Abstract] | |
Reverse Merger | Note 4 – Reverse Merger On March 15, 2019, the Company (then operating as Edge), Merger Sub and Private PDS completed the Merger in accordance with the Plan of Merger and Reorganization, dated as of November 23, 2018, as amended on January 24, 2019, pursuant to and in accordance with which Merger Sub merged with and into Private PDS, with Private PDS surviving as the Company’s wholly-owned subsidiary. Immediately following completion of the Merger, the Company effected the Reverse Stock Split at a ratio of one new share for every twenty shares of its common stock then-outstanding, and changed its corporate name from Edge Therapeutics, Inc. to PDS Biotechnology Corporation, and Private PDS, now the Company’s wholly-owned subsidiary, changed its name to PDS Operating Corporation. The Merger is intended to qualify for federal income tax purposes as a tax-free reorganization under the provisions of Section 368(a) of the Internal Revenue Code of 1986, as amended. In connection with the Merger, each share of Private PDS’s common stock outstanding immediately prior to the Merger was converted into 0.3262 shares (on a post-Reverse Stock Split basis) of the Company’s common stock. As a result, the Company issued 3,573,760 shares of its common stock to the stockholders of Private PDS in exchange for all of the outstanding shares of common stock of Private PDS. For accounting purposes, Private PDS is considered to be the accounting acquirer in the Merger because Private PDS’s stockholders owned approximately 70% of the combined company’s common stock immediately following the closing of the Merger. As the accounting acquirer, Private PDS’s assets and liabilities continue to be recorded at their historical carrying amounts and the historical operations that will be reflected in the Company’s financial statements will be those of Private PDS. All references in the unaudited interim condensed consolidated financial statements to the number of shares and per share amounts of the Company’s common stock have been retroactively restated to reflect completion of the Merger and the Reverse Stock Split. Purchase Price Pursuant to the Plan of Merger and Reorganization Agreement, as amended, Edge issued to Private PDS's stockholders a number of shares of Edge’s common stock representing approximately 70% of the outstanding shares of common stock of the combined company. The purchase price, which represents the consideration transferred to Edge’s stockholders in the Merger is calculated based on the number of shares of common stock of the combined company that Edge’s stockholders owned as of the closing of the Merger on March 15, 2019, which consists of the following: Number of shares of the combined company to be owned by Edge security holders (1) 1,600,166 Multiplied by the price per share of Edge's common stock as of March 15, 2019 $ 9.87 Purchase price (in thousands) $ 15,794 (1) The amount includes 1,576,916 shares of Edge’s common stock outstanding as of March 15, 2019 plus 23,250 stock options of Edge that were in the money and vested immediately upon closing of the Merger. At closing, 753 of in-the-money options and 235 fractional shares paid out in cash to shareholders were not issued as common stock, resulting in 1,599,178 common shares issued. Preliminary Purchase Price Allocation The preliminary purchase price was allocated to the net assets acquired of Edge based upon their preliminary estimated fair values as of March 15, 2019. The in-process research and development asset (“IPR&D”) that is recognized relates to Edge’s NEWTON 2 clinical trial for EG-1962 . The allocation of the preliminary purchase price to the net assets of Edge, based on the fair values as of March 15, 2019, is as follows: Cash and cash equivalents $ 29,106,513 Prepaid expense and other assets (1) 1,716,732 Right to use asset 1,384,810 Intangible assets-IPR&D 1,223,000 Total identifiable assets acquired 33,431,055 Accounts payable, accrued expenses, other liabilities (4,595,934 ) Lease liability (945,152 ) Deferred tax liability (157,000 ) Total liabilities assumed (5,698,086 ) Net identifiable assets acquired 27,732,969 Bargain purchase gain (11,939,331 ) Purchase price $ 15,793,638 (1) The valuation of equipment held for sale was believed to be $0 at the date of acquisition based on recent sales interest. Subsequent to the acquisition date, there was an offer on the equipment for a price of $275,000, as such the Company deemed this would have been the value of the equipment if this sales offer would been available at the date of acquisition. The fair value of the IPR&D was determined using the discounted cash flow method based on probability- adjusted cash flow success scenarios to develop EG-1962 into a commercial product, estimating the revenue and costs. The rates utilized to discount the net cash flows to the present value are commensurate with the stage of development of the projects and uncertainties in the economic estimates used in the projections. Pro Forma Financial Information The following pro forma consolidated results of net loss for the three months ended September 30, 2019 and 2018 assume the Merger was completed as of January 1, 2018: Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Pro forma operating expenses $ 15,964,969 $ 5,162,697 $ 25,171,754 $ 39,067,927 Pro forma net loss (16,552,729 ) (4,976,379 ) (13,621,882 ) (39,799,838 ) Pro forma basic and diluted net loss per share $ (3.15 ) $ (1.01 ) $ (2.88 ) $ (8.28 ) The September 30, 2019 pro forma net loss excludes the bargain purchase gain that resulted from the Merger. |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 9 Months Ended |
Sep. 30, 2019 | |
Fair Value of Financial Instruments [Abstract] | |
Fair Value of Financial Instruments | Note 5 – Fair Value of Financial Instruments There were no transfers among Levels 1, 2, or 3 during 2019 or 2018. Fair Value Measurements at Reporting Date Using Total Quoted Prices in Active Markets (Level 1) Quoted Prices in Inactive Markets (Level 2) Significant Unobservable Inputs (Level 3) As of September 30, 2019: (unaudited) Cash and cash equivalents $ 17,406,608 $ 17,406,608 $ – $ – As of December 31, 2018: Cash and cash equivalents $ 103,695 $ 103,695 $ – $ – |
Intangible Assets
Intangible Assets | 9 Months Ended |
Sep. 30, 2019 | |
Intangible Assets [Abstract] | |
Intangible Assets | Note 6 – Intangible Assets As of September 30, 2019, $1,223,000 was for IPR&D resulting from the Merger's preliminary purchase price allocation. This asset is not amortized. As of December 31, 2018, the balance of $41,692 consisted of NIH licensing fees. This balance was expensed into research and development costs during the three months ended March 31, 2019. |
Leases
Leases | 9 Months Ended |
Sep. 30, 2019 | |
Leases [Abstract] | |
Leases | Note 7 – Leases The Company adopted Accounting Standards Codification (ASC) Topic 842 on the date of the Merger and recognized an operating right-of-use (ROU) asset of $1.4 million and operating lease liabilities of $1.4 million at upon acquiring the lease in the reverse merger. The Company leases office space in Berkeley Heights, New Jersey that was expected to expire on November 15, 2021 under an operating lease. The Company has the option to renew the lease for five years. The Company evaluated the renewal option at the lease commencement date and determined that it will not excise the option to renew. The lease provides for an initial monthly base amount plus annual escalations through the term of the lease. In addition to the monthly base amount in the lease agreement, the Company is required to pay its proportionate share of real estate taxes and operating expenses during the lease term which are expensed as incurred. The discount rate implicit within the lease is not determinable, therefore on the date of the Merger The discount rate used to measure the operating lease liability as of September 30, 2019 was 10.15%. For the three and nine months ended September 30, 2019, the Company’s operating lease expense was $98,648 and $271,283 respectively. On July 8, 2019, the Company entered into a lease termination agreement for its office space located at 300 Connell Drive, Suite 4000, Berkeley Heights, NJ 07922 effective August 31, 2019 (the “Lease Termination Agreement”). Pursuant to the Lease Termination Agreement, the Company is required to pay 50 percent of the remaining lease payments of $665,802 over three installments on September 1, 2019, December 1, 2019 and March 1, 2020, which was recorded as lease termination costs. The Company maintains a month-to-month lease for its research facilities at the Princeton Innovation Center BioLabs located at 303A College Road E, Princeton NJ 08540. The Company entered into a temporary month-to-month lease as of September 1, 2019 for office space located at 830 Morris Turnpike, Short Hills NJ 07078 until the Company enters into a new lease for permanent office space. On August 31, 2019, the right-of-use asset of $1.2 million and operating lease liability of $1.2 million was written off. Leasehold improvements amounting to approximately $0.3 million were also written off and are included in lease termination costs. |
Accrued Expenses and Restructur
Accrued Expenses and Restructuring Reserve | 9 Months Ended |
Sep. 30, 2019 | |
Accrued Expenses and Restructuring Reserve [Abstract] | |
Accrued Expenses and Restructuring Reserve | Note 8 – Accrued Expenses and Restructuring Reserve Accrued expenses and other liabilities consist of the following: As of September 30, 2019 As of December 31, 2018 Accrued research and development costs $ 132,538 $ 71,329 Accrued professional fees 230,337 421,617 Accrued compensation 489,863 54,269 Accrued other – 46,674 Accrued rent termination 443,868 8,000 Total $ 1,296,606 $ 601,889 Restructuring Reserve As of September 30, 2019 As of December 31, 2018 Restructuring reserve (1) $ 858,332 $ – Total $ 858,332 $ – (1) Restructuring reserve relates to the severance costs incurred by Edge Therapeutics prior to the merger transaction and assumed by the Company as part of the purchase accounting, but not yet paid. The severance costs continue through September 2020. For the nine months ended September 30, 2019, the Company paid $1,211,939 of restructuring expense which was previously recorded on Edge Therapeutics financials. |
Convertible Promissory Note
Convertible Promissory Note | 9 Months Ended |
Sep. 30, 2019 | |
Convertible Promissory Note [Abstract] | |
Convertible Promissory Note | Note 9 – Convertible Promissory Note In November 2017, the Company received $30,000 from an investor in exchange for a convertible promissory note bearing interest at 7.50% per annum. The original terms of the promissory note was amended in December 2018 and states that in the event the Company consummates a sale of the Company prior to the conversion or repayment in full of this Note, the outstanding principal amount and all accrued but unpaid interest due shall automatically convert into the numbers of shares of the Company’s common stock equal to (a) the principal amount plus all accrued but unpaid interest thereon, divided by (b) $3.40, which shall be automatically issued to Holder as of immediately prior to the consummation of such Sale of the Company. This event occurred on March 15, 2019, the date of the Merger, on which 9,683 shares of common stock were issued. |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2019 | |
Stock-Based Compensation [Abstract] | |
Stock-Based Compensation | Note 10 – Stock-Based Compensation The Company has five equity compensation plans: the 2009 Amended Stock Plan, the 2010 Equity Incentive Plan, the 2012 Equity Incentive Plan, 2014 Equity Incentive Plan and the 2018 Stock Incentive Plan (the "Plans"). Originally, the Company was able to grant up to 27,410 and 54,820 shares of Common Stock as both incentive stock options ("ISOs") and nonqualified stock options ("NQs") under the 2010 Equity Incentive Plan and the 2012 Equity Incentive Plan, respectively. In 2013, the Company's stockholders approved an increase to 63,957 shares authorized for issuance under the 2010 Equity Incentive Plan. In 2014, the Board of Directors of the Company (the "Board") approved an increase to 67,520 shares authorized for issuance under the 2010 Equity Incentive Plan. In 2014, the Company's stockholders approved the 2014 Equity Incentive Plan pursuant to which the Company may grant up to 91,367 shares as ISOs, NQs and restricted stock units ("RSUs"), subject to increases as hereafter described (the "Plan Limit"). In addition, on January 1, 2015 and each January 1 thereafter prior to the termination of the 2014 Equity Incentive Plan, pursuant to the terms of the 2014 Equity Incentive Plan, the Plan Limit was and shall be increased by the lesser of (x) 4% of the number of shares of Common Stock outstanding as of the immediately preceding December 31 and (y) such lesser number as the Board of Directors may determine in its discretion. On January 1, 2016, 2017, 2018 and 2019 the Plan Limit was increased to 152,366 shares, 210,203 shares, 271,941 shares and 323,529 shares, respectively. In March 2019, the Plan was amended and restated which removed the annual increase component and was limited to 826,292 shares. In 2018, the Company's stockholders approved the 2018 Stock Incentive Plan pursuant to which the Company may grant up to 558,071 shares as Stock Options, (ii) Stock Appreciation Rights, (iii) Restricted Stock, (iv) Deferred Stock, (v) Stock Reload Options and/or (vi) Other Stock-Based Awards. Pursuant to the terms of the Plans, ISOs have a term of ten years from the date of grant or such shorter term as may be provided in the option agreement. Unless specified otherwise in an individual option agreement, ISOs generally vest over a four year term and NQs generally vest over a one to five year terms. Unless terminated by the Board, the Plans shall continue to remain effective for a term of ten years or until such time as no further awards may be granted and all awards granted under the Plans are no longer outstanding. On June 17, 2019, the Board adopted the 2019 Inducement Plan. The 2019 Inducement Plan provides for the grant of non-qualified stock options. The 2019 Inducement Plan was recommended for approval by the Compensation Committee of the Board and subsequently approved and adopted by the Board without stockholder approval pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules. The Board has reserved 200,000 shares of the Company's common stock for issuance pursuant to non-qualified stock options granted under the 2019 Inducement Plan, and the 2019 Inducement Plan will be administered by the Compensation Committee of the Board. In accordance with Rule 5635(c)(4) of the Nasdaq Listing Rules, non-qualified stock options under the 2019 Inducement Plan may only be made to an employee who has not previously been an employee or member of the Board (or any parent or subsidiary of the Company), or following a bona fide period of non-employment by the Company (or a parent or subsidiary of the Company), if he or she is granted such non-qualified stock options in connection with his or her commencement of employment with the Company or a subsidiary and such grant is an inducement material to his or her entering into employment with the Company or such subsidiary. The Company’s stock-based compensation expense related to stock options was recognized in operating expense as follows: Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 (unaudited) (unaudited) Stock-Based Compensation Research and development $ 49,748 $ 21,582 $ 499,835 $ 24,801 General and administrative 70,458 20,109 2,393,823 24,535 Total $ 120,206 $ 41,691 $ 2,893,658 $ 49,336 The fair value of options granted during the three and nine months ended September 30, 2019 and 2018 was estimated using the Black-Scholes option valuation model utilizing the following assumptions. For , 2018, the Company granted a total of 95,300 options on July 6 Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Weighted Average Weighted Average Weighted Average Weighted Average (unaudited) (unaudited) Volatility 92.22 % 83.60 % 89.88 % 83.60 % Risk-Free Interest Rate 1.49 % 2.75 % 2.33 % 2.75 % Expected Term in Years 6.08 6.25 6.14 6.25 Dividend Rate 0.00 % 0.00 % 0.00 % 0.00 % Fair Value of Option on Grant Date $ 3.50 $ 12.91 $ 5.30 $ 12.91 The following table summarizes the number of options outstanding and the weighted average exercise price: Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life in Years Aggregate Intrinsic Value Options outstanding at December 31, 2018 541,117 $ 7.20 Assumed in connection with Merger 347,697 121.52 Granted 806,137 7.55 Exercised – – Forfeited (289,049 ) 97.80 Options outstanding at September 30, 2019 1,405,902 $ 17.05 7.20 $ – Vested and expected to vest at September 30, 2019 1,405,902 $ 17.05 7.20 $ – Exercisable at September 30, 2019 1,006,972 $ 21.37 6.19 $ – At September 30, 2019 there was approximately $1,753,155 of unamortized stock option compensation expense, which is expected to be recognized over a remaining average vesting period of 3.61 years. |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2019 | |
Income Taxes [Abstract] | |
Income Taxes | Note 11 – Income Taxes In assessing the realizability of the net deferred tax assets, the Company considers all relevant positive and negative evidence to determine whether it is more likely than not that some portion or all of the deferred income tax assets will not be realized. The realization of the gross deferred tax assets is dependent on several factors, including the generation of sufficient taxable income prior to the expiration of the net operating loss carryforwards. The Company expects to have a loss for 2019 and there will be no current income tax expense. Additionally, there was a full valuation allowance against the net deferred tax assets as of September 30, 2019 and December 31, 2018. the Company recorded no income tax benefit due to realization uncertainties. The Company’s U.S. statutory rate is 21%. The primary factor impacting the effective tax rate for the three and nine months ended September 30, 2019 is the anticipated full year operating loss which will require full valuation allowances against any associated net deferred tax assets. Entities are also required to evaluate, measure, recognize and disclose any uncertain income tax provisions taken on their income tax returns. The Company has analyzed its tax positions and has concluded that as of September 30, 2019, there were no uncertain positions. The Company's U.S. federal and state net operating losses have occurred since its inception and as such, tax years subject to potential tax examination could apply from that date because the utilization of net operating losses from prior years opens the relevant year to audit by the IRS and/or state taxing authorities. The Company did not have any unrecognized tax benefits and has not accrued any interest or penalties for the three and nine months ended September 30, 2019 and for the year ended December 31, 2018. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2019 | |
Commitments and Contingencies [Abstract] | |
Commitments and Contingencies | Note 12 – Commitments and Contingencies Retainer/Advisory and Finders’ Fee Agreements The Company entered into several consultant agreements beginning in May 2016 for retainer fees, advisory fees and finders’ fees. The fees were settled either with cash or issuance of common stock. Expenses recorded for the three and nine months period ended September 30, 2018 were $181,500 and $299,000 respectively. There were no fees paid in the three and nine months period ended September 30, 2019. Employment Matters The Company has entered into employment agreements or offer letters with each of its executive officers. The employment agreements generally provide for, among other things, salary, bonus and severance payments. The employment agreements generally provide for between 12 months and 24 months of severance benefits to be paid to an executive (as well as certain potential bonus, COBRA and equity award benefits), subject to the effectiveness of a general release of claims, if the executive terminates his or her employment for good reason or if the Company terminates the executive's employment without cause. Such severance payments may be provided for as long as 24 months in connection with a termination following a change of control. The continued provision of severance benefits is conditioned on each executive's compliance with the terms of the Company's confidentiality and invention and assignment agreement as well as his or her release of claims. Rent For the three and nine months ended September 30, 2019 and 2018, rent was $38,365 and $58,665 and $15,644 and $46,931, respectively |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2019 | |
Subsequent Events [Abstract] | |
Subsequent Events | Note 13 – Subsequent Events Subsequent events have been evaluated through the date these financial statements were issued. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2019 | |
Summary of Significant Accounting Policies [Abstract] | |
Unaudited Interim Financial Statements | (A) Unaudited interim financial statements: The interim balance sheet at September 30, 2019, the statements of operations and comprehensive loss and changes in stockholders' equity (deficit) for the three and nine months ended September 30, 2019 and 2018, and cash flows for the nine months ended September 30, 2019 and 2018 are unaudited. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. GAAP, and following the requirements of the Securities and Exchange Commission (“SEC”) for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by U.S. GAAP can be condensed or omitted. These condensed consolidated financial statements have been prepared on the same basis as the Company’s annual financial statements and, in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments that are necessary for a fair statement of its financial information. The results of operations for the three and nine months ended September 30, 2019 are not necessarily indicative of the results to be expected for the year ending December 31, 2019 or for any other future annual or interim period. The balance sheet as of December 31, 2018 included herein was derived from the audited condensed consolidated financial statements as of that date. These condensed consolidated financial statements should be read in conjunction with the Private PDS audited financial statements and notes thereto as of and for the year ended December 31, 2018, filed by the Company with the SEC in its Current Report on Form 8-K/A on April 30, 2019. |
Use of Estimates | (B) Use of estimates: The preparation of financial statements in conformity with U.S. 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 and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. |
Significant Risks and Uncertainties | (C) Significant risks and uncertainties: The Company's operations are subject to a number of factors that may affect its operating results and financial condition. Such factors include, but are not limited to: the clinical and regulatory development of its products, the Company’s review of strategic alternatives, the Company’s ability to preserve its cash resources, the Company’s ability to add product candidates to its pipeline, the Company's intellectual property, competition from products manufactured and sold or being developed by other companies, the price of, and demand for, Company products if approved for sale, the Company's ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products, and the Company's ability to raise capital. The Company currently has no commercially approved products. As such, there can be no assurance that the Company's future research and development programs will be successfully commercialized. Developing and commercializing a product requires significant time and capital and is subject to regulatory review and approval as well as competition from other biotechnology and pharmaceutical companies. The Company operates in an environment of rapid change and is dependent upon the continued services of its employees and consultants and obtaining and protecting its intellectual property. |
Cash Equivalents and Concentration of Cash Balance | (D) Cash equivalents and concentration of cash balance: The Company considers all highly liquid securities with a maturity weighted average of less than three months to be cash equivalents. The Company's cash and cash equivalents in bank deposit accounts, at times, may exceed federally insured limits. |
Research and Development | (E) Research and development: Costs incurred in connection with research and development activities are expensed as incurred. These costs include licensing fees to use certain technology in the Company's research and development projects as well as fees paid to consultants and various entities that perform certain research and testing on behalf of the Company. Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using data, such as patient enrollment, clinical site activations or information provided by vendors on their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred. |
Patent Costs | (F) Patent costs: The Company expenses patent costs as incurred and classifies such costs as general and administrative expenses in the accompanying statements of operations and comprehensive loss. |
Intellectual Property | (G) Intellectual property: PDS strives to protect and enhance the proprietary technology, inventions and improvements that are commercially important to its business, including seeking, maintaining, and defending patent rights. PDS has developed numerous patents and patent applications related to its Versamune ® Licensed patents Licensed Patent Families 1 and 2 cover the Versamune ® ® |
Intangibles | (H) Intangibles: The Company's intangible assets as of September 30, 2019 consist of in-process research and development ("IPR&D") intangible assets acquired as part of the reverse merger transaction on March 15, 2019. The fair value of IPR&D using a discounted cash flow method . In determining the value of IPR&D, management considers, among other factors, the stage of completion of the projects, the technological feasibility of the projects, whether the projects have an alternative future use, and the estimated residual cash flows that could be generated from the various projects and technologies over their respective projected economic lives. The discount rate used is determined at the time of acquisition and includes a rate of return which accounts for the time value of money, as well as risk factors reflecting the economic risk that the projected cash flows may not be realized. The Company reviews its IPR&D at least annually for possible impairment. IPR&D is reviewed for possible impairment between annual tests if an event occurs or circumstances change that would more likely than not reduce the fair value of the IPR&D below their carrying values. The Company will next test its IPR&D on December 1, 2019. The Company's IPR&D asset totaled $1.2 million at September 30, 2019. There were no trigger events during the three months and nine months ended September 30, 2019 to which an impairment analysis would be warranted. |
Stock-Based Compensation | (I) Stock-based compensation: Pre merger, the Company measured and recognized share-based compensation expense, for both employee and director option awards, based on the grant date fair value of the awards. The Company recognized share-based compensation expense, net of estimated forfeitures, on a straight-line basis over the requisite service period of the awards, which is generally the vesting period. The Company determined the fair value of share-based awards granted to non-employees as either the fair value of the consideration received or the fair value of the equity instruments issued, whichever is more reliably measurable. All issuances of equity instruments issued to non-employees as consideration for goods or services received by the Company are accounted for based on the fair value of the equity instruments issued. These awards were recorded in expense and additional paid-in capital in shareholders’ equity (deficit) over the applicable service periods based on the fair value of the options at the end of each period. The Company classified share-based compensation expense in its condensed consolidated statements of operations in the same manner in which the award recipient’s payroll costs are classified or in which the award recipients’ service payments are classified. The Company estimated the fair value of employee and director share options as of the date of grant using the Black-Scholes option pricing model. The Company historically has been a private company and lacks company-specific historical and implied volatility information. Therefore, it estimated its expected share price volatility based on the historical volatility of a publicly traded set of peer companies. The expected term of the Company’s share options had been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options. The risk-free interest rate is determined by reference to the yield curve of a zero-coupon U.S. Treasury bond on the date of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield was based on the fact that the Company has never paid cash dividends on ordinary shares and does not expect to pay any cash dividends in the foreseeable future. The Company also estimated the fair value of consultant and non-employee share options using the Black-Scholes option pricing model reflecting the same assumptions as applied to employee and director options in each of the reporting periods, other than the expected life, which is assumed to be the remaining contractual life of the options. Prospectively, the Company will measure employee stock-based awards at grant-date fair value and recognize stock-based compensation expense on a straight-line basis over the vesting period of the award. Determining the appropriate fair value of stock-based awards will require the input of subjective assumptions, including, for stock options, the expected life of the option, and expected stock price volatility. The Company will use the Black-Scholes option pricing model to value its stock option awards. The assumptions used in calculating the fair value of stock-based awards represent management's best estimates and involve inherent uncertainties and the application of management's judgment. As a result, if factors change and management uses different assumptions, stock-based compensation expense could be materially different for future awards. The expected life of stock options will be estimated using the "simplified method," as the Company has limited historical information to develop reasonable expectations about future exercise patterns and employment duration for its stock options grants. The simplified method is based on the average of the vesting tranches and the contractual life of each grant. For stock price volatility, the Company will utilize comparable public companies and company specific as a basis for its expected volatility to calculate the fair value of options grants. The risk-free interest rate will be based on U.S. Treasury notes with a term approximating the expected life of the option. |
Common Stock Warrants | (J) Common stock warrants: The Company measures and recognizes warrants, for non-employees for the value or goods or services received or in conjunction with the issuance of a debt or equity financing issuance based on the grant date fair value of the warrant. The Company determines the fair value of warrants granted to non-employees or investors as either the fair value of the consideration received or the fair value of the debt or equity instruments issued, whichever is more reliably measurable. All issuances of debt and equity instruments issued to investors or non-employees as consideration for goods or services received by the Company are accounted for based on the fair value of the debt and equity instruments issued. Generally, if a warrant cannot be settled in cash by the holder or a stock settled transaction, the warrant is considered an equity transaction to the Company and has an offsetting debit to additional paid-in capital in shareholders’ (deficit) equity based on the fair value of the warrant at the issuance date. The Company estimates the fair value of warrants as of the date of grant using the Black-Scholes option pricing model as described in Stock-Based Compensation in the previous section. In February 2019, the Company issued 48,930 shares of common stock for proceeds of $750,000. In exchange for the financing, 34,192 of warrants were issued with an exercise price of $9.87 and an expiration date of December 31, 2023. |
Net Income (Loss) per Common Share | (K) Net income (loss) per common share: Basic net income (loss) per share attributable to common stockholders is computed by dividing net income (loss) attributable to common stockholders by the weighted-average number of common shares outstanding during the period. All participating securities are excluded from basic weighted-average common shares outstanding. In computing both basic net income (loss) per share attributable to common stockholders and diluted net income (loss) per share attributable to common stockholders, undistributed earnings are re-allocated to reflect the potential impact of dilutive securities, including stock options and warrants. Diluted net income (loss) per share attributable to common stockholders is computed by dividing net income (loss) attributable to common stockholders by the weighted-average number of common equivalent shares outstanding for the period. Diluted net income (loss) per share attributable to common stockholders includes any dilutive effect from outstanding stock options and warrants using the treasury stock method. The common stock issuable upon the conversion or exercise of the following dilutive securities as of September 30, 2019 and as of September 30, 2018 have been excluded from the diluted net loss per share attributable to common stockholders calculation because their effect would have been antidilutive for the period presented: As of September 30, 2019 2018 Stock options to purchase Common Stock 1,405,902 513,534 Convertible promissory note - 9,216 Warrants to purchase Common Stock 262,758 115,860 Total 1,668,660 638,610 The following is a reconciliation of the numerator (net income or loss) and the denominator (number of shares) used in the calculation of basic and diluted net income (loss) per share attributable to common stockholders: Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Numerator Basic and diluted net loss $ (5,751,610 ) $ (711,208 ) $ (2,820,763 ) $ (2,016,932 ) Denominator Shares used in computing basic net loss per share 5,246,829 3,346,237 4,729,153 3,253,085 Net loss per share, basic and diluted $ (1.10 ) $ (0.21 ) $ (0.60 ) $ (0.62 ) |
Accounting Standards Not Yet Adopted | (L) Accounting standards not yet adopted: In August 2018, the Financial Accounting Standards Board (“FASB”) issued No. 2018-13, Fair Value Measurement (Topic 820) (“ASU 2018-13”). ASU 2018-13 modifies disclosure requirements related to fair value measurement and is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. Implementation on a prospective or retrospective basis varies by specific disclosure requirement. Early adoption is permitted. ASU 2018-13 also allows for early adoption of any removed or modified disclosures upon issuance of ASU 2018-13 while delaying adoption of the additional disclosures until their effective date. The Company is currently evaluating the In August 2018, the FASB issued No. 2018-15, Intangibles-Goodwill and Other-Internal-Use Software (Subtopic 350-40) (“ASU 2018-15”). ASU 2018-15 reduces complexity for the accounting for costs of implementing a cloud computing service arrangement and aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software (and hosting arrangements that include an internal use software license). ASU 2018-15 is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019, with early adoption permitted. The Company is currently evaluating the . |
Accounting Standards Adopted | (M) Accounting standards adopted: In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) ("ASU 2016-02"), which sets out the principles for the recognition, measurement, The new lease standard also provides practical expedients for an entity's ongoing accounting. The Company elected the short-term lease recognition exemption under which the Company will not recognize right-of-use (“ROU”) assets or lease liabilities, and this includes not recognizing ROU assets or lease liabilities for existing short-term leases. The Company elected the practical expedient to not separate lease and non-lease components for certain classes of assets (office building). The Company determines if an arrangement is a lease at inception. Operating lease ROU assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term. Operating lease expense is recognized on a straight-line basis over the lease term, subject to any changes in the lease or expectations regarding the terms. Variable lease costs such as operating costs and property taxes are expensed as incurred. ASU 2018-07, Improvements to Nonemployee Share Based Payment Accounting, eliminates the separate accounting model for nonemployee share-based payment awards and generally requires companies to account for share-based payment transactions with nonemployees in the same way as share-based payment transactions with employees. PDS adopted this ASU on January 1, 2019 and there was not a material impact requiring the retrospective adjustment to retained earnings on transition. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Summary of Significant Accounting Policies [Abstract] | |
Antidilutive Securities | The common stock issuable upon the conversion or exercise of the following dilutive securities as of September 30, 2019 and as of September 30, 2018 have been excluded from the diluted net loss per share attributable to common stockholders calculation because their effect would have been antidilutive for the period presented: As of September 30, 2019 2018 Stock options to purchase Common Stock 1,405,902 513,534 Convertible promissory note - 9,216 Warrants to purchase Common Stock 262,758 115,860 Total 1,668,660 638,610 |
Calculation of Basic and Diluted Net Income (Loss) per Share Attributable to Common Stockholders | The following is a reconciliation of the numerator (net income or loss) and the denominator (number of shares) used in the calculation of basic and diluted net income (loss) per share attributable to common stockholders: Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Numerator Basic and diluted net loss $ (5,751,610 ) $ (711,208 ) $ (2,820,763 ) $ (2,016,932 ) Denominator Shares used in computing basic net loss per share 5,246,829 3,346,237 4,729,153 3,253,085 Net loss per share, basic and diluted $ (1.10 ) $ (0.21 ) $ (0.60 ) $ (0.62 ) |
Reverse Merger (Tables)
Reverse Merger (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Reverse Merger [Abstract] | |
Calculation and Allocation of Purchase Price | Pursuant to the Plan of Merger and Reorganization Agreement, as amended, Edge issued to Private PDS's stockholders a number of shares of Edge’s common stock representing approximately 70% of the outstanding shares of common stock of the combined company. The purchase price, which represents the consideration transferred to Edge’s stockholders in the Merger is calculated based on the number of shares of common stock of the combined company that Edge’s stockholders owned as of the closing of the Merger on March 15, 2019, which consists of the following: Number of shares of the combined company to be owned by Edge security holders (1) 1,600,166 Multiplied by the price per share of Edge's common stock as of March 15, 2019 $ 9.87 Purchase price (in thousands) $ 15,794 (1) The amount includes 1,576,916 shares of Edge’s common stock outstanding as of March 15, 2019 plus 23,250 stock options of Edge that were in the money and vested immediately upon closing of the Merger. At closing, 753 of in-the-money options and 235 fractional shares paid out in cash to shareholders were not issued as common stock, resulting in 1,599,178 common shares issued. The allocation of the preliminary purchase price to the net assets of Edge, based on the fair values as of March 15, 2019, is as follows: Cash and cash equivalents $ 29,106,513 Prepaid expense and other assets (1) 1,716,732 Right to use asset 1,384,810 Intangible assets-IPR&D 1,223,000 Total identifiable assets acquired 33,431,055 Accounts payable, accrued expenses, other liabilities (4,595,934 ) Lease liability (945,152 ) Deferred tax liability (157,000 ) Total liabilities assumed (5,698,086 ) Net identifiable assets acquired 27,732,969 Bargain purchase gain (11,939,331 ) Purchase price $ 15,793,638 (1) The valuation of equipment held for sale was believed to be $0 at the date of acquisition based on recent sales interest. Subsequent to the acquisition date, there was an offer on the equipment for a price of $275,000, as such the Company deemed this would have been the value of the equipment if this sales offer would been available at the date of acquisition. |
Pro Forma Consolidated Results | The following pro forma consolidated results of net loss for the three months ended September 30, 2019 and 2018 assume the Merger was completed as of January 1, 2018: Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Pro forma operating expenses $ 15,964,969 $ 5,162,697 $ 25,171,754 $ 39,067,927 Pro forma net loss (16,552,729 ) (4,976,379 ) (13,621,882 ) (39,799,838 ) Pro forma basic and diluted net loss per share $ (3.15 ) $ (1.01 ) $ (2.88 ) $ (8.28 ) |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Fair Value of Financial Instruments [Abstract] | |
Fair Value of Financial Instruments | Fair Value Measurements at Reporting Date Using Total Quoted Prices in Active Markets (Level 1) Quoted Prices in Inactive Markets (Level 2) Significant Unobservable Inputs (Level 3) As of September 30, 2019: (unaudited) Cash and cash equivalents $ 17,406,608 $ 17,406,608 $ – $ – As of December 31, 2018: Cash and cash equivalents $ 103,695 $ 103,695 $ – $ – |
Accrued Expenses and Restruct_2
Accrued Expenses and Restructuring Reserve (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Accrued Expenses and Restructuring Reserve [Abstract] | |
Accrued Expenses and Other Liabilities | Accrued expenses and other liabilities consist of the following: As of September 30, 2019 As of December 31, 2018 Accrued research and development costs $ 132,538 $ 71,329 Accrued professional fees 230,337 421,617 Accrued compensation 489,863 54,269 Accrued other – 46,674 Accrued rent termination 443,868 8,000 Total $ 1,296,606 $ 601,889 |
Restructuring Reserve | Restructuring Reserve As of September 30, 2019 As of December 31, 2018 Restructuring reserve (1) $ 858,332 $ – Total $ 858,332 $ – (1) Restructuring reserve relates to the severance costs incurred by Edge Therapeutics prior to the merger transaction and assumed by the Company as part of the purchase accounting, but not yet paid. The severance costs continue through September 2020. For the nine months ended September 30, 2019, the Company paid $1,211,939 of restructuring expense which was previously recorded on Edge Therapeutics financials. |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Stock-Based Compensation [Abstract] | |
Stock-Based Compensation Expense | The Company’s stock-based compensation expense related to stock options was recognized in operating expense as follows: Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 (unaudited) (unaudited) Stock-Based Compensation Research and development $ 49,748 $ 21,582 $ 499,835 $ 24,801 General and administrative 70,458 20,109 2,393,823 24,535 Total $ 120,206 $ 41,691 $ 2,893,658 $ 49,336 |
Assumptions Used to Value Stock Options Granted | The fair value of options granted during the three and nine months ended September 30, 2019 and 2018 was estimated using the Black-Scholes option valuation model utilizing the following assumptions. For , 2018, the Company granted a total of 95,300 options on July 6 Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Weighted Average Weighted Average Weighted Average Weighted Average (unaudited) (unaudited) Volatility 92.22 % 83.60 % 89.88 % 83.60 % Risk-Free Interest Rate 1.49 % 2.75 % 2.33 % 2.75 % Expected Term in Years 6.08 6.25 6.14 6.25 Dividend Rate 0.00 % 0.00 % 0.00 % 0.00 % Fair Value of Option on Grant Date $ 3.50 $ 12.91 $ 5.30 $ 12.91 |
Stock Option Activity | The following table summarizes the number of options outstanding and the weighted average exercise price: Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life in Years Aggregate Intrinsic Value Options outstanding at December 31, 2018 541,117 $ 7.20 Assumed in connection with Merger 347,697 121.52 Granted 806,137 7.55 Exercised – – Forfeited (289,049 ) 97.80 Options outstanding at September 30, 2019 1,405,902 $ 17.05 7.20 $ – Vested and expected to vest at September 30, 2019 1,405,902 $ 17.05 7.20 $ – Exercisable at September 30, 2019 1,006,972 $ 21.37 6.19 $ – |
Nature of Operations (Details)
Nature of Operations (Details) | Mar. 15, 2019 |
Nature of Operations [Abstract] | |
Reverse stock split ratio | 0.05 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||
Feb. 28, 2019USD ($)$ / sharesshares | Sep. 30, 2019USD ($)PatentApplication$ / sharesshares | Sep. 30, 2018USD ($)$ / sharesshares | Sep. 30, 2019USD ($)PatentApplication$ / sharesshares | Sep. 30, 2018USD ($)$ / sharesshares | Aug. 31, 2019USD ($) | Mar. 15, 2019USD ($) | Dec. 31, 2018USD ($) | |
Intangibles [Abstract] | ||||||||
IPR&D asset | $ | $ 1,223,000 | $ 1,223,000 | $ 41,692 | |||||
Common Stock Warrants [Abstract] | ||||||||
Issuance of common stock, shares (in shares) | shares | 48,930 | |||||||
Proceeds from issuance of common stock | $ | $ 750,000 | $ 750,000 | $ 1,229,370 | |||||
Warrants issued (in shares) | shares | 34,192 | |||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 9.87 | |||||||
Net Income (Loss) per Common Share [Abstract] | ||||||||
Antidilutive impact to EPS (in shares) | shares | 1,668,660 | 638,610 | ||||||
Numerator [Abstract] | ||||||||
Basic and diluted net loss | $ | $ (5,751,610) | $ (711,208) | $ (2,820,763) | $ (2,016,932) | ||||
Denominator [Abstract] | ||||||||
Shares used in computing basic net loss per share (in shares) | shares | 5,246,829 | 3,346,237 | 4,729,153 | 3,253,085 | ||||
Net loss per share, basic and diluted (in dollars per share) | $ / shares | $ (1.10) | $ (0.21) | $ (0.60) | $ (0.62) | ||||
Accounting Standards Adopted [Abstract] | ||||||||
Right to use asset | $ | $ 1,200,000 | $ 1,400,000 | ||||||
Lease liability | $ | $ 1,200,000 | 1,400,000 | ||||||
U.S. [Member] | ||||||||
Intellectual Property [Abstract] | ||||||||
Number of patents held | Patent | 4 | 4 | ||||||
Number of pending patent applications | Application | 6 | 6 | ||||||
Foreign [Member] | ||||||||
Intellectual Property [Abstract] | ||||||||
Number of patents held | Patent | 22 | 22 | ||||||
Number of pending patent applications | Application | 33 | 33 | ||||||
Stock Options to Purchase Common Stock [Member] | ||||||||
Net Income (Loss) per Common Share [Abstract] | ||||||||
Antidilutive impact to EPS (in shares) | shares | 1,405,902 | 513,534 | ||||||
Convertible Promissory Note [Member] | ||||||||
Net Income (Loss) per Common Share [Abstract] | ||||||||
Antidilutive impact to EPS (in shares) | shares | 0 | 9,216 | ||||||
Warrants to Purchase Common Stock [Member] | ||||||||
Net Income (Loss) per Common Share [Abstract] | ||||||||
Antidilutive impact to EPS (in shares) | shares | 262,758 | 115,860 | ||||||
ASU 2016-02 [Member] | ||||||||
Accounting Standards Adopted [Abstract] | ||||||||
Right to use asset | $ | 1,400,000 | |||||||
Lease liability | $ | $ 1,400,000 |
Liquidity (Details)
Liquidity (Details) | Jul. 29, 2019USD ($)shares | Sep. 30, 2019USD ($)Priceshares | Sep. 30, 2018USD ($) | Jul. 26, 2019$ / shares | Mar. 15, 2019USD ($) | Dec. 31, 2018USD ($) |
Liquidity [Abstract] | ||||||
Cash and cash equivalents | $ | $ 17,406,608 | $ 103,695 | ||||
Threshold closing sale prices | Price | 3 | |||||
Threshold consecutive trading days | 10 days | |||||
Percentage of shares of common stock that can be sold without shareholder approval | 19.99% | |||||
Share price (in dollars per share) | $ / shares | $ 5.76 | |||||
Issuance of common stock from equity transaction (in shares) | shares | 100,654 | |||||
Stock-based consulting expense | $ | $ 603,924 | $ 603,924 | $ 268,999 | |||
Shares sold (in shares) | shares | 0 | |||||
Maximum [Member] | ||||||
Liquidity [Abstract] | ||||||
Shares of common stock to be purchased (in shares) | shares | 100,000 | |||||
Common stock to be purchased | $ | $ 20,000,000 | |||||
Shares of common stock that can be sold without shareholder approval (in shares) | shares | 1,034,979 | |||||
Minimum [Member] | ||||||
Liquidity [Abstract] | ||||||
Share price (in dollars per share) | $ / shares | $ 0.50 | |||||
Edge [Member] | ||||||
Liquidity [Abstract] | ||||||
Pre-existing cash | $ | $ 29,106,513 |
Reverse Merger (Details)
Reverse Merger (Details) | Mar. 15, 2019shares |
Reverse Merger [Abstract] | |
Reverse stock split ratio | 0.05 |
Number of shares issued for each share of common stock in connection with Merger (in shares) | 0.3262 |
Number of shares issued in connection with Merger (in shares) | 3,573,760 |
Reverse Merger, Purchase Price
Reverse Merger, Purchase Price (Details) - USD ($) | Mar. 15, 2019 | Sep. 30, 2019 | Mar. 14, 2019 | Dec. 31, 2018 | |
Purchase Price [Abstract] | |||||
Common stock shares outstanding (in shares) | 5,278,850 | 3,417,187 | |||
Shares issued in Merger (in shares) | 1,599,178 | ||||
In-the-money shares paid out in cash (in shares) | 753 | ||||
Fractional shares paid out in cash (in shares) | 235 | ||||
Edge [Member] | |||||
Purchase Price [Abstract] | |||||
Number of shares of the combined company to be owned by Edge security holders (in shares) | [1] | 1,600,166 | |||
Multiplied by the price per share of Edge's common stock as of March 15, 2019 (in dollars per share) | $ 9.87 | ||||
Purchase price | $ 15,793,638 | ||||
Common stock shares outstanding (in shares) | 1,576,916 | ||||
Number of stock options vested (in shares) | 23,250 | ||||
[1] | The amount includes 1,576,916 shares of Edge's common stock outstanding as of March 15, 2019 plus 23,250 stock options of Edge that were in the money and vested immediately upon closing of the Merger. At closing, 753 of in-the-money options and 235 fractional shares paid out in cash to shareholders were not issued as common stock, resulting in 1,599,178 common shares issued. |
Reverse Merger, Allocation of P
Reverse Merger, Allocation of Preliminary Purchase Price (Details) | Mar. 15, 2019USD ($) | Sep. 30, 2019USD ($) | Jun. 30, 2019USD ($)Adjustment | Sep. 30, 2018USD ($) | Sep. 30, 2019USD ($) | Sep. 30, 2018USD ($) | |
Allocation of Preliminary Purchase Price [Abstract] | |||||||
Bargain purchase gain | $ 0 | $ 0 | $ (11,939,331) | $ 0 | |||
Edge [Member] | |||||||
Allocation of Preliminary Purchase Price [Abstract] | |||||||
Number of adjustments made to preliminary valuation | Adjustment | 2 | ||||||
Adjustment to preliminary valuation for equipment | $ 275,000 | ||||||
Equipment | $ 0 | ||||||
Adjustment to preliminary valuation for bonus plan | $ 65,551 | ||||||
Cash and cash equivalents | 29,106,513 | ||||||
Prepaid expense and other assets | [1] | 1,716,732 | |||||
Right to use asset | 1,384,810 | ||||||
Intangible assets-IPR&D | 1,223,000 | ||||||
Total identifiable assets acquired | 33,431,055 | ||||||
Accounts payable, accrued expenses, other liabilities | (4,595,934) | ||||||
Lease liability | (945,152) | ||||||
Deferred tax liability | (157,000) | ||||||
Total liabilities assumed | (5,698,086) | ||||||
Net identifiable assets acquired | 27,732,969 | ||||||
Bargain purchase gain | (11,939,331) | ||||||
Purchase price | $ 15,793,638 | ||||||
[1] | The valuation of equipment held for sale was believed to be $0 at the date of acquisition based on recent sales interest. Subsequent to the acquisition date, there was an offer on the equipment for a price of $275,000, as such the Company deemed this would have been the value of the equipment if this sales offer would been available at the date of acquisition. |
Reverse Merger, Pro Forma Finan
Reverse Merger, Pro Forma Financial Information (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Pro Forma Financial Information [Abstract] | ||||
Pro forma operating expenses | $ 15,964,969 | $ 5,162,697 | $ 25,171,754 | $ 39,067,927 |
Pro forma net loss | $ (16,552,729) | $ (4,976,379) | $ (13,621,882) | $ (39,799,838) |
Pro forma basic net loss per share (in dollars per share) | $ (3.15) | $ (1.01) | $ (2.88) | $ (8.28) |
Pro forma diluted net loss per share (in dollars per share) | $ (3.15) | $ (1.01) | $ (2.88) | $ (8.28) |
Fair Value of Financial Instr_3
Fair Value of Financial Instruments (Details) - USD ($) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Fair Value Transfers Between Levels [Abstract] | ||
Transfers from Level 1 to Level 2 | $ 0 | $ 0 |
Transfers from Level 2 to Level 1 | 0 | 0 |
Transfers into Level 3 | 0 | 0 |
Transfers out of Level 3 | 0 | 0 |
Fair Value of Financial Instruments [Abstract] | ||
Cash and cash equivalents | 17,406,608 | 103,695 |
Quoted Prices in Active Markets (Level 1) [Member] | ||
Fair Value of Financial Instruments [Abstract] | ||
Cash and cash equivalents | 17,406,608 | 103,695 |
Quoted Prices in Inactive Markets (Level 2) [Member] | ||
Fair Value of Financial Instruments [Abstract] | ||
Cash and cash equivalents | 0 | 0 |
Significant Unobservable Inputs (Level 3) [Member] | ||
Fair Value of Financial Instruments [Abstract] | ||
Cash and cash equivalents | $ 0 | $ 0 |
Intangible Assets (Details)
Intangible Assets (Details) - USD ($) | Sep. 30, 2019 | Dec. 31, 2018 |
Intangible Assets [Abstract] | ||
Intangible assets | $ 1,223,000 | $ 41,692 |
Leases (Details)
Leases (Details) | Aug. 31, 2019USD ($) | Sep. 30, 2019USD ($) | Sep. 30, 2019USD ($) | Sep. 30, 2018USD ($) | Jul. 08, 2019USD ($)Installment | Mar. 15, 2019USD ($) |
Leases [Abstract] | ||||||
Right-of-use asset | $ 1,200,000 | $ 1,400,000 | ||||
Operating leases liabilities | 1,200,000 | $ 1,400,000 | ||||
Renewal term | 5 years | 5 years | ||||
Discount rate - operating lease | 10.15% | 10.15% | ||||
Operating lease expense | $ 98,648 | $ 271,283 | ||||
Percentage of remaining payments required to be paid to terminate lease | 50.00% | |||||
Remaining lease payments | $ 665,802 | |||||
Number of installments for remaining lease payment | Installment | 3 | |||||
Write-off of leasehold improvements related to lease termination | $ (310,951) | $ (310,951) | $ 0 |
Accrued Expenses and Restruct_3
Accrued Expenses and Restructuring Reserve (Details) - USD ($) | 9 Months Ended | ||
Sep. 30, 2019 | Dec. 31, 2018 | ||
Accrued Expenses and Other Liabilities [Abstract] | |||
Accrued research and development costs | $ 132,538 | $ 71,329 | |
Accrued professional fees | 230,337 | 421,617 | |
Accrued compensation | 489,863 | 54,269 | |
Accrued other | 0 | 46,674 | |
Accrued rent termination | 443,868 | 8,000 | |
Total | 1,296,606 | 601,889 | |
Restructuring Reserve [Abstract] | |||
Restructuring reserve | 858,332 | [1] | 0 |
Total | 858,332 | $ 0 | |
Restructuring expense paid | $ 1,211,939 | ||
[1] | Restructuring reserve relates to the severance costs incurred by Edge Therapeutics prior to the merger transaction and assumed by the Company as part of the purchase accounting, but not yet paid. The severance costs continue through September 2020. For the nine months ended September 30, 2019, the Company paid $1,211,939 of restructuring expense which was previously recorded on Edge Therapeutics financials. |
Convertible Promissory Note (De
Convertible Promissory Note (Details) - USD ($) | Mar. 15, 2019 | Nov. 30, 2017 | Sep. 30, 2019 |
Common Stock [Member] | |||
Convertible Debt [Abstract] | |||
Issuance of common stock for convertible debt (in shares) | 9,683 | 9,683 | |
Convertible Promissory Note [Member] | |||
Convertible Debt [Abstract] | |||
Proceeds from issuance of note | $ 30,000 | ||
Interest rate | 7.50% | ||
Conversion price (in dollars per share) | $ 3.40 |
Stock-Based Compensation, Equit
Stock-Based Compensation, Equity Compensation Plans (Details) | 9 Months Ended | 12 Months Ended | |||||||||
Sep. 30, 2019Planshares | Dec. 31, 2014shares | Mar. 31, 2019shares | Jan. 02, 2019shares | Dec. 31, 2018shares | Jan. 02, 2018shares | Jan. 02, 2017shares | Jan. 02, 2016shares | Dec. 31, 2013shares | Dec. 31, 2012shares | Dec. 31, 2010shares | |
Stock Options [Abstract] | |||||||||||
Number of equity compensation plans | Plan | 5 | ||||||||||
The Plans [Member] | |||||||||||
Stock Options [Abstract] | |||||||||||
Term of plan | 10 years | ||||||||||
The Plans [Member] | Incentive Stock Options [Member] | |||||||||||
Stock Options [Abstract] | |||||||||||
Vesting period | 4 years | ||||||||||
The Plans [Member] | Incentive Stock Options [Member] | Maximum [Member] | |||||||||||
Stock Options [Abstract] | |||||||||||
Term of option | 10 years | ||||||||||
The Plans [Member] | Nonqualified Options [Member] | Minimum [Member] | |||||||||||
Stock Options [Abstract] | |||||||||||
Vesting period | 1 year | ||||||||||
The Plans [Member] | Nonqualified Options [Member] | Maximum [Member] | |||||||||||
Stock Options [Abstract] | |||||||||||
Vesting period | 5 years | ||||||||||
2010 Equity Incentive Plan [Member] | |||||||||||
Stock Options [Abstract] | |||||||||||
Number of shares authorized for issuance (in shares) | 67,520 | 63,957 | 27,410 | ||||||||
2012 Equity Incentive Plan [Member] | |||||||||||
Stock Options [Abstract] | |||||||||||
Number of shares authorized for issuance (in shares) | 54,820 | ||||||||||
2014 Equity Incentive Plan [Member] | |||||||||||
Stock Options [Abstract] | |||||||||||
Number of shares authorized for issuance (in shares) | 91,367 | 826,292 | 323,529 | 271,941 | 210,203 | 152,366 | |||||
Percentage of Common Stock outstanding used to determine annual increase in the plan limit | 4.00% | ||||||||||
2018 Equity Incentive Plan [Member] | |||||||||||
Stock Options [Abstract] | |||||||||||
Number of shares authorized for issuance (in shares) | 558,071 | ||||||||||
2019 Inducement Plan [Member] | |||||||||||
Stock Options [Abstract] | |||||||||||
Common stock reserved for issuance (in shares) | 200,000 |
Stock-Based Compensation, Stock
Stock-Based Compensation, Stock-Based Compensation Expense (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Stock-Based Compensation [Abstract] | ||||
Stock-based compensation expense | $ 120,206 | $ 41,691 | $ 2,893,658 | $ 49,336 |
Research and Development [Member] | ||||
Stock-Based Compensation [Abstract] | ||||
Stock-based compensation expense | 49,748 | 21,582 | 499,835 | 24,801 |
General and Administrative [Member] | ||||
Stock-Based Compensation [Abstract] | ||||
Stock-based compensation expense | $ 70,458 | $ 20,109 | $ 2,393,823 | $ 24,535 |
Stock-Based Compensation, Assum
Stock-Based Compensation, Assumptions Used to Value Stock Options Granted (Details) - $ / shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Assumptions Used in Determining Fair Value of Stock Options Granted [Abstract] | ||||
Volatility | 92.22% | 83.60% | 89.88% | 83.60% |
Risk-free interest rate | 1.49% | 2.75% | 2.33% | 2.75% |
Expected term | 6 years 29 days | 6 years 3 months | 6 years 1 month 20 days | 6 years 3 months |
Dividend rate | 0.00% | 0.00% | 0.00% | 0.00% |
Fair value of option on grant date (in dollars per share) | $ 3.50 | $ 12.91 | $ 5.30 | $ 12.91 |
Stock-Based Compensation, Sto_2
Stock-Based Compensation, Stock Option Activity (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Unamortized Stock Compensation Expense [Abstract] | |||
Unamortized stock compensation expense | $ 1,753,155 | ||
Stock Options [Member] | |||
Number of Shares [Roll Forward] | |||
Options outstanding, beginning balance (in shares) | 541,117 | ||
Assumed in connection with Merger (in shares) | 347,697 | ||
Granted (in shares) | 806,137 | ||
Exercised (in shares) | 0 | ||
Forfeited (in shares) | (289,049) | ||
Options outstanding, ending balance (in shares) | 1,405,902 | ||
Vested and expected to vest (in shares) | 1,405,902 | ||
Exercisable (in shares) | 1,006,972 | ||
Weighted Average Exercise Price [Roll Forward] | |||
Options outstanding, beginning balance (in dollars per share) | $ 7.20 | ||
Assumed in connection with merger (in dollars per share) | 121.52 | ||
Granted (in dollars per share) | 7.55 | ||
Exercised (in dollars per share) | 0 | ||
Forfeited (in dollars per share) | 97.80 | ||
Options outstanding, ending balance (in dollars per share) | 17.05 | ||
Vested and expected to vest (in dollars per share) | 17.05 | ||
Exercisable (in dollars per share) | $ 21.37 | ||
Weighted Average Remaining Contractual Life and Aggregate Intrinsic Value [Abstract] | |||
Options outstanding, weighted average remaining contractual life | 7 years 2 months 12 days | ||
Vested and expected to vest, weighted average remaining contractual life | 7 years 2 months 12 days | ||
Exercisable, weighted average remaining contractual life | 6 years 2 months 8 days | ||
Options outstanding, aggregate intrinsic value | $ 0 | ||
Vested and expected to vest, aggregate intrinsic value | 0 | ||
Exercisable, aggregate intrinsic value | $ 0 | ||
Unamortized Stock Compensation Expense [Abstract] | |||
Period for recognition | 3 years 7 months 10 days | ||
Stock Options [Member] | July 6, 2018 [Member] | |||
Number of Shares [Roll Forward] | |||
Granted (in shares) | 95,300 | 95,300 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | 9 Months Ended | |
Sep. 30, 2019 | Dec. 31, 2018 | |
Income Taxes [Abstract] | ||
Current income tax expense | $ 0 | |
Income tax benefit | $ 0 | |
Federal statutory rate | 21.00% | |
Uncertain tax positions | $ 0 | |
Unrecognized tax benefits | 0 | $ 0 |
Accrued interest and penalties | $ 0 | $ 0 |
Commitments and Contingencies (
Commitments and Contingencies (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Commitments and Contingencies [Abstract] | ||||
Consultant agreements expenses | $ 0 | $ 181,500 | $ 0 | $ 299,000 |
Rent expense | $ 38,365 | $ 15,644 | $ 58,665 | $ 46,931 |
Employment Agreements [Member] | ||||
Commitments and Contingencies [Abstract] | ||||
Term for payment of severance benefits | 24 months | |||
Employment Agreements [Member] | Minimum [Member] | ||||
Commitments and Contingencies [Abstract] | ||||
Term for payment of severance benefits | 12 months | |||
Employment Agreements [Member] | Maximum [Member] | ||||
Commitments and Contingencies [Abstract] | ||||
Term for payment of severance benefits | 24 months |