Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2021 | Nov. 03, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2021 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q3 | |
Document Transition Report | false | |
Entity File Number | 001-37568 | |
Entity Registrant Name | PDS Biotechnology Corp | |
Entity Central Index Key | 0001472091 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 26-4231384 | |
Entity Address, Address Line One | 25B Vreeland Road, | |
Entity Address, Address Line Two | Suite 300 | |
Entity Address, City or Town | Florham Park, | |
Entity Address, State or Province | NJ | |
Entity Address, Postal Zip Code | 07932 | |
City Area Code | 800 | |
Local Phone Number | 208-3343 | |
Title of 12(b) Security | Common Stock, par value $0.00033 per share | |
Trading Symbol | PDSB | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 28,435,067 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Sep. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 69,744,004 | $ 28,839,565 |
Prepaid expenses and other | 1,596,810 | 1,497,665 |
Total current assets | 71,340,814 | 30,337,230 |
Property and equipment, net | 1,037 | 5,443 |
Operating lease right-to-use asset | 406,171 | 547,706 |
Total assets | 71,748,022 | 30,890,379 |
Current liabilities: | ||
Accounts payable | 1,445,585 | 1,415,224 |
Accrued expenses | 1,923,846 | 1,735,322 |
Operating lease obligation-short term | 207,717 | 119,904 |
Total current liabilities | 3,577,148 | 3,270,450 |
Noncurrent liability: | ||
Operating lease obligation-long term | 313,976 | 490,353 |
Total Liabilities | 3,891,124 | 3,760,803 |
STOCKHOLDERS' EQUITY | ||
Common stock, $0.00033 par value, 75,000,000 shares authorized at September 30, 2021 and December 31, 2020, 28,435,067 shares and 22,261,619 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively | 9,383 | 7,346 |
Additional paid-in capital | 122,231,115 | 70,907,315 |
Accumulated deficit | (54,383,600) | (43,785,085) |
Total stockholders' equity | 67,856,898 | 27,129,576 |
Total liabilities and stockholders' equity | $ 71,748,022 | $ 30,890,379 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2021 | Dec. 31, 2020 |
STOCKHOLDERS' EQUITY | ||
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) | 28,435,067 | 22,261,619 |
Common stock shares outstanding (in shares) | 28,435,067 | 22,261,619 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Operating expenses: | ||||
Research and development expenses | $ 3,687,999 | $ 2,060,815 | $ 7,865,249 | $ 5,446,718 |
General and administrative expenses | 3,274,325 | 1,846,214 | 7,252,371 | 5,428,098 |
Total operating expenses | 6,962,324 | 3,907,029 | 15,117,620 | 10,874,816 |
Loss from operations | (6,962,324) | (3,907,029) | (15,117,620) | (10,874,816) |
Other income: | ||||
Interest income | 1,358 | 1,207 | 2,617 | 54,242 |
Loss before income taxes | (6,960,966) | (3,905,822) | (15,115,003) | (10,820,574) |
Benefit from income taxes | 0 | 0 | 4,516,488 | 0 |
Net loss | (6,960,966) | (3,905,822) | (10,598,515) | (10,820,574) |
Comprehensive loss | $ (6,960,966) | $ (3,905,822) | $ (10,598,515) | $ (10,820,574) |
Per share information: | ||||
Net loss per share, basic (in dollars per share) | $ (0.24) | $ (0.21) | $ (0.43) | $ (0.73) |
Net loss per share, diluted (in dollars per share) | $ (0.24) | $ (0.21) | $ (0.43) | $ (0.73) |
Weighted average common shares outstanding, basic (in shares) | 28,425,850 | 18,961,619 | 24,639,299 | 14,892,764 |
Weighted average common shares outstanding, diluted (in shares) | 28,425,850 | 18,961,619 | 24,639,299 | 14,892,764 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Changes in Stockholders' Equity - USD ($) | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] | Total |
Balance at Dec. 31, 2019 | $ 1,742 | $ 40,633,670 | $ (28,937,705) | $ 11,697,707 |
Balance (in shares) at Dec. 31, 2019 | 5,281,237 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Stock-based compensation expense | $ 0 | 300,898 | 0 | 300,898 |
Issuance of common stock, net of issuance costs | $ 5,581 | 29,750,921 | 0 | 29,756,502 |
Issuance of common stock, net of issuance costs (in shares) | 16,900,000 | |||
Issuance of warrant exercise | $ 22 | 70,437 | 0 | 70,459 |
Issuance of warrant exercise (in shares) | 65,240 | |||
Issuance of common stock from 401K match | $ 1 | 19,966 | 0 | 19,967 |
Issuance of common stock from 401K match (in shares) | 15,142 | |||
Net loss | $ 0 | 0 | (10,820,574) | (10,820,574) |
Balance at Sep. 30, 2020 | $ 7,346 | 70,775,892 | (39,758,279) | 31,024,959 |
Balance (in shares) at Sep. 30, 2020 | 22,261,619 | |||
Balance at Jun. 30, 2020 | $ 5,064 | 52,861,882 | (35,852,457) | 17,014,489 |
Balance (in shares) at Jun. 30, 2020 | 15,361,619 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Stock-based compensation expense | $ 0 | 129,792 | 0 | 129,792 |
Issuance of common stock from equity transaction | $ 2,282 | 17,784,218 | 0 | 17,786,500 |
Issuance of common stock from equity transaction (in shares) | 6,900,000 | |||
Net loss | $ 0 | 0 | (3,905,822) | (3,905,822) |
Balance at Sep. 30, 2020 | $ 7,346 | 70,775,892 | (39,758,279) | 31,024,959 |
Balance (in shares) at Sep. 30, 2020 | 22,261,619 | |||
Balance at Dec. 31, 2020 | $ 7,346 | 70,907,315 | (43,785,085) | 27,129,576 |
Balance (in shares) at Dec. 31, 2020 | 22,261,619 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Stock-based compensation expense | $ 0 | 2,400,980 | 0 | 2,400,980 |
Issuance of common stock, net of issuance costs | $ 2,009 | 48,542,989 | 0 | 48,544,998 |
Issuance of common stock, net of issuance costs (in shares) | 6,088,235 | |||
Issuances of common stock, from exercise of stock options | $ 23 | 344,089 | 0 | 344,112 |
Issuances of common stock, from exercise of stock options (in shares) | 68,571 | |||
Issuance of common stock from 401K match | $ 5 | 35,742 | 0 | 35,747 |
Issuance of common stock from 401K match (in shares) | 16,642 | |||
Net loss | $ 0 | 0 | (10,598,515) | (10,598,515) |
Balance at Sep. 30, 2021 | $ 9,383 | 122,231,115 | (54,383,600) | 67,856,898 |
Balance (in shares) at Sep. 30, 2021 | 28,435,067 | |||
Balance at Jun. 30, 2021 | $ 9,377 | 120,405,851 | (47,422,634) | 72,992,594 |
Balance (in shares) at Jun. 30, 2021 | 28,417,909 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Stock-based compensation expense | $ 0 | 1,701,763 | 0 | 1,701,763 |
Issuances of common stock, from exercise of stock options | $ 6 | 123,501 | 0 | 123,507 |
Issuances of common stock, from exercise of stock options (in shares) | 17,158 | |||
Net loss | $ 0 | 0 | (6,960,966) | (6,960,966) |
Balance at Sep. 30, 2021 | $ 9,383 | $ 122,231,115 | $ (54,383,600) | $ 67,856,898 |
Balance (in shares) at Sep. 30, 2021 | 28,435,067 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Cash flows from operating activities: | ||
Net loss | $ (10,598,515) | $ (10,820,574) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 2,400,980 | 300,898 |
Stock-based 401K company common match | 35,747 | 19,967 |
Depreciation expense | 4,406 | 11,706 |
Operating lease expense | 180,775 | 106,949 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | (99,145) | 1,935,067 |
Accounts payable | 30,361 | 361,871 |
Accrued expenses | 188,524 | 125,133 |
Restructuring reserve | 0 | (498,185) |
Operating lease liabilities | (127,804) | (62,597) |
Net cash used in operating activities | (7,984,671) | (8,519,765) |
Cash flows from financing activities: | ||
Proceeds from exercise of warrants | 0 | 70,459 |
Proceeds from exercise of stock options | 344,112 | 0 |
Proceeds from issuances of common stock, net of issuance costs | 48,544,998 | 29,756,502 |
Net cash provided by financing activities | 48,889,110 | 29,826,961 |
Net increase in cash and cash equivalents | 40,904,439 | 21,307,196 |
Cash and cash equivalents at beginning of period | 28,839,565 | 12,161,739 |
Cash and cash equivalents at end of period | $ 69,744,004 | $ 33,468,935 |
Nature of Operations
Nature of Operations | 9 Months Ended |
Sep. 30, 2021 | |
Nature of Operations [Abstract] | |
Nature of Operations | Note 1 – Nature of Operations PDS Biotechnology Corporation, a Delaware corporation (the “Company” or “PDS”), is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies and infectious disease vaccines designed to overcome the well-established limitations of current immunotherapy technologies. PDS owns Versamune®, a proprietary T-cell activating platform designed to train the immune system to better attack and destroy disease. When paired with an antigen, which is a disease-related protein that is recognizable by the immune system, Versamune® has been shown to induce, in vivo, The Company’s immuno-oncology products can potentially be used as a component of combination products with other leading technologies to provide effective treatments across a range of advanced cancer types. Currently, the Company believes its product candidates are of interest for potential combination treatments in relation to Human Papillomavirus (HPV)-associated cancers, melanoma, colorectal, lung, breast and prostate cancers and potentially as monotherapies in early-stage cancers. In addition, PDS is working to progress its infectious disease development program, which includes novel vaccines for COVID-19 and universal influenza. From the Company’s inception, it has devoted substantially all of its efforts to drug development, business planning, engaging regulatory, manufacturing and other technical consultants, acquiring operating assets, planning and executing clinical trials and raising capital. In December 2019, a novel (new) coronavirus known as SARS-CoV-2 was first detected in Wuhan, Hubei Province, People’s Republic of China, causing outbreaks of the coronavirus disease, known as COVID-19, that has now spread globally. On January 30, 2020, the World Health Organization (WHO) declared COVID-19 a public health emergency. The Secretary of Health and Human Services declared a public health emergency on January 31, 2020, under section 319 of the Public Health Service Act (42 U.S.C. 247d), in response to the COVID-19 outbreak. On March 11, 2020, the WHO declared COVID-19 a pandemic and on March 13 the President declared a national emergency in response to the pandemic. PDS continues to learn more about the full impact of the COVID-19 pandemic which has continued to evolve due to the emergence of variants of concern, resulting in new waves of infection regionally and globally. The COVID-19 pandemic has and could continue to negatively affect the Company’s liquidity and operations. To date, the start of two of the three initiated PDS0101 clinical trials were delayed, specifically as a result of the adverse impact the COVID-19 pandemic has had on clinical trial operations for cancer indications in the United States. The FDA has continued to update its guidance assisting sponsors in assuring the safety of trial participants, maintaining compliance with Good Clinical Practice (GCP) and minimizing risks to trial integrity. Clinical trial sites have implemented institution-specific measures securing the safety of patients and staff to ensure the integrity of the trials in the face of the ongoing pandemic. All three studies have since been initiated despite the pandemic challenges; however, the evolving COVID-19 pandemic has impacted the pace of enrollment in clinical trials in general and the Company may be negatively affected with its trials. COVID-19 related travel and other restrictions may also impact the potential for on-site monitoring visiting and audits and inspections by Company personnel, third parties, and government regulators. There may be shortages of site personnel and equipment necessary for the timely completion of the clinical trials. The Company is providing support to address these challenges, but these mitigation measures may not overcome the obstacles that the pandemic has wrought which continue to impede progress of clinical trials. Although there is uncertainty related to the anticipated impact of the COVID-19 pandemic on the Company’s future results, management believes the Company’s current cash reserves leave us well-positioned to manage the business through this crisis as it continues to unfold. However, the impacts of the COVID-19 pandemic and its variants are broad-reaching and continuing and the financial impacts associated with the COVID-19 pandemic are still uncertain. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2021 | |
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, 2021, the statements of operations and comprehensive loss and changes in stockholders’ equity for the three and nine months ended September 30, 2021 and 2020, and cash flows for the nine months ended September 30, 2021 and 2020 are unaudited. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. GAAP, in accordance with 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, 2021 are not necessarily indicative of the results to be expected for the year ending December 31, 2021 or for any other future annual or interim period. The balance sheet as of December 31, 2020 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 Company’s audited consolidated financial statements and notes thereto as of and for the year ended December 31, 2020, filed by the Company with the SEC in its Annual Report on Form 10-K on March 18, 2021. (B) Use of estimates: The preparation of condensed consolidated 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 the reported amounts of expenses at the date of the consolidated financial statements and during the reporting periods, and to disclose contingent assets and liabilities at the date of the consolidated financial statements. 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 ability to preserve its cash resources, the Company’s review of strategic alternatives, the Company’s ability to add product candidates to its pipeline, the Company’s intellectual property, the ability to efficiently and effectively conduct its clinical trials, 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, the Company’s ability to raise capital, and the effects of health epidemics, pandemics, or outbreaks of infectious diseases, including the recent COVID-19 pandemic and its variants. 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 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) Stock-based compensation: The Company accounts for its stock-based compensation in accordance with ASC Topic 718, Compensation—Stock Compensation (“ASC 718”). ASC 718 requires all stock-based payments to employees, directors and non-employees to be recognized as expense in the consolidated statements of operations and comprehensive loss based on their grant date fair values. In order to determine the fair value of stock options on the date of grant, the Company uses the Black-Scholes option-pricing model. Inherent in this model are assumptions related to expected stock-price volatility, option term, risk-free interest rate and dividend yield. While the risk-free interest rate and dividend yield are less subjective assumptions that are based on factual data derived from public sources, the expected stock-price volatility and option term assumptions require a greater level of judgment. The Company expenses the fair value of its stock-based compensation awards to employees and directors on a straight-line basis over the requisite service period, which is generally the vesting period. The Company recognizes forfeitures as they occur. (H) Net loss per common share: Basic and diluted net loss per common share is determined by dividing net loss attributable to common stockholders by the weighted average common shares outstanding during the period. For all periods presented, the common shares underlying the stock options and warrants have been excluded from the calculation because their effect would be anti-dilutive. Therefore, the weighted average shares outstanding used to calculate both basic and diluted loss per common share are the same. The potentially dilutive securities excluded from the determination of diluted loss per share as their effect is antidilutive, are as follows: As of September 30, 2021 2020 Stock options to purchase Common Stock 2,951,852 1,639,753 Warrants to purchase Common Stock 197,518 197,518 Total 3,149,370 1,837,271 |
Liquidity
Liquidity | 9 Months Ended |
Sep. 30, 2021 | |
Liquidity [Abstract] | |
Liquidity | Note 3 – Liquidity As of September 30, 2021, the Company had $69.7 million of cash and cash equivalents. 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, or the Aspire Purchase Agreement, with Aspire Capital pursuant to which, the Company has the right, in its sole discretion, to present Aspire Capital Fund, LLC, or 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 its common stock, or the Purchased Shares, over the term of the Aspire Purchase Agreement. The Company may sell an aggregate of 1,034,979 shares of its common stock (which represented 19.99% of its 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) the Company 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 can sell shares under the Aspire Purchase Agreement is $0.50. On July 29, 2019, the Company issued 100,654 shares of its common stock to Aspire Capital, as consideration for entering into the Aspire Purchase Agreement, which the Company refers to as the Commitment Shares. The Company recorded the fair value of the shares at July 29, 2019 of $603,924 as an expense in the third quarter of 2019. Concurrently with the Aspire Purchase Agreement, the Company entered into a registration rights agreement with Aspire Capital, or the Registration Rights Agreement. In accordance with the Registration Rights Agreement, on August 20, 2019, the Company filed a Registration Statement on Form S-1 (File No. 333-232988) to cover the resale of the Commitment Shares and any Purchased Shares issuable to Aspire Capital under the Aspire Purchase Agreement. There is market uncertainty regarding the utilization of financing associated from the Aspire Purchase Agreement. As of September 30, 2021, no Purchase Shares have been sold to Aspire Capital under the Aspire Purchase Agreement. In February 2020, the Company completed an underwritten public offering, in which it sold 10,000,000 shares of common stock at a public offering price of $1.30 per share. The shares sold included 769,230 shares issued upon the exercise by the underwriter of its option to purchase additional shares at the public offering price, minus underwriting discounts and commissions. The Company received gross proceeds of approximately $13 million and net proceeds of approximately $11.9 million after deducting underwriting discounts and commissions. In July 2020, the Company filed a shelf registration statement, or the 2020 Shelf Registration Statement, with the SEC, for the issuance of common stock, preferred stock, warrants, rights, debt securities and units, which the Company refers to collectively as the Shelf Securities, up to an aggregate amount of $100 million. The 2020 Shelf Registration Statement was declared effective on July 31, 2020. In August 2020, the Company sold 6,900,000 shares of its common stock at a public offering price of $2.75 per share pursuant to the 2020 Shelf Registration Statement, which includes 900,000 shares issued upon the exercise by the underwriter of its option to purchase additional shares at the public offering price, minus underwriting discounts and commissions. The Company received gross proceeds of approximately $19.0 million and net proceeds of approximately $17.1 million, after deducting underwriting discounts and offering expenses. In May 2021, the Company received approximately $4.5 million from the net sale of tax benefits through 2019 to an unrelated, profitable New Jersey corporation pursuant the Company’s participation in the New Jersey Technology Business Tax Certificate Transfer Net Operating Loss (NOL) program for State Fiscal Year 2020. In June 2021, the Company completed an underwritten public offering in which it sold 6,088,235 shares of common stock at a public offering price of $8.50 per share pursuant to the 2020 Shelf Registration Statement, which includes 794,117 shares issued upon the exercise by the underwriter of its option to purchase additional shares at the public offering price, minus underwriting discounts and commissions. the Company received gross proceeds of approximately $51.7 million and net proceeds of approximately $48.5 million, after deducting underwriting discounts and offering expenses. Approximately $29,300,000 of Shelf Securities remain available for future sale under the 2020 Shelf Registration Statement. 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 in its outstanding accounts payable and accrued expenses. 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. The Company’s budgeted cash requirements in 2021 and beyond include expenses related to continuing development and clinical studies. Based on its available cash resources and cash flow projections as of the date the consolidated financial statements were available for issuance, management believes there are sufficient funds to continue operations and research and development programs for at least 12 months from the date of this report. The Company plans to continue to fund its operations and capital funding needs through equity and/or debt financings. However, the Company cannot be certain that additional financing will be available when needed or that, if available, financing will be obtained on terms favorable to the Company or its existing stockholders. 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 its operations. If the Company is unable to raise additional capital in sufficient amounts or on acceptable terms, we may be required to delay, limit, reduce, or terminate its product development or future commercialization efforts or grant rights to develop and market immunotherapies that the Company would otherwise prefer to develop and market itself. Any of these actions could harm its business, results of operations and prospects. Failure to obtain adequate financing also may adversely affect the Company’s ability to operate as a going concern. |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 9 Months Ended |
Sep. 30, 2021 | |
Fair Value of Financial Instruments [Abstract] | |
Fair Value of Financial Instruments | Note 4 – Fair Value of Financial Instruments There were no transfers among Levels 1, 2, or 3 during 2021 or 2020. 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 2021 Cash and cash equivalents $ 69,744,004 $ 69,744,004 $ – $ – As of December 31, 2020 Cash and cash equivalents $ 28,839,565 $ 28,839,565 $ – $ – |
Leases
Leases | 9 Months Ended |
Sep. 30, 2021 | |
Leases [Abstract] | |
Leases | Note 5 – Leases 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 was 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 in the third quarter of 2019. 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 entered into a new lease for permanent office space. This lease was terminated on May 31, 2020. Effective March 5, 2020, the Company entered into a sublease for approximately 11,200 square feet of office space located at 25B Vreeland Road, Suite 300, Florham Park, NJ. The sublease commenced on May 1, 2020 and will continue for a term of forty (40) months with an option to renew through October 31, 2027. As of September 30, 2021, there are twenty-three (23) months remaining in the lease term. Upon inception of the lease, the Company recognized approximately $0.7 million of a ROU asset and operating lease liabilities. The discount rate used to measure the operating lease liability as of May 1, 2020 was 9.15%. Throughout the period described above the Company has maintained, and continues to maintain, a month-to-month lease for its research facilities at the Princeton Innovation Center BioLabs located at 303A College Road E, Princeton NJ, 08540. Supplemental cash flow information related to operating leases is as follows: As of September 30, 2021 2020 Cash paid for operating lease liabilities $ 127,804 $ 62,597 Right-of use assets recorded in exchange for lease obligations $ – $ 638,831 Maturity of the Company’s operating lease liability is as follows: Year ended December 31, 2021 (remaining three months) $ 43,035 2022 294,986 2023 239,469 2024 – 2025 and after – Total future minimum lease payments 577,490 Less imputed interest (55,797 ) $ 521,693 |
Accrued Expenses
Accrued Expenses | 9 Months Ended |
Sep. 30, 2021 | |
Accrued Expenses [Abstract] | |
Accrued Expenses | Note 6 – Accrued Expenses Accrued expenses and other liabilities consist of the following: As of September 30, 2021 As of December 31, 2020 Accrued research and development costs $ 19,500 $ 204,780 Accrued professional fees 277,555 219,822 Accrued compensation 1,626,791 1,310,720 Total $ 1,923,846 $ 1,735,322 |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2021 | |
Stock-Based Compensation [Abstract] | |
Stock-Based Compensation | Note 7 – Stock-Based Compensation The Company has three equity compensation plans: the 2009 Stock Option Plan, 2014 Equity Incentive Plan and the 2018 Stock Incentive Plan (the “Plans”). 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 and 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. In March 2019, the Plan was amended and restated which removed the annual increase component and was limited to 826,292 shares. As previously disclosed, on December 8, 2020, the Board of Directors of the Company adopted, subject to stockholder approval, the Second Amended and Restated PDS Biotechnology Corporation 2014 Equity Inventive Plan (the “Restated Plan”), which would amend and restate the Amended and Restated PDS Biotechnology Corporation 2014 Equity Incentive Plan (the “Current Plan”). The Company held its annual meeting of stockholders on June 17, 2021 (the “Annual Meeting”). The stockholders voted to approve the Restated Plan at the Annual Meeting. The Restated Plan is identical to the Current Plan in all material respects, except as follows: (a) the number of shares of Common Stock authorized for issuance under the Restated Plan will increase from 826,292 shares to 3,339,243 shares, plus the total number of shares that remained available for issuance, that are not covered by outstanding awards issued under the Current Plan, immediately prior to December 8, 2020; and (b) the Restated Plan will terminate on December 7, 2030, unless earlier terminated. Please reference the disclosure in Note 9. 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 (i) Stock Options, (ii) Stock Appreciation Rights, (iii) Restricted Stock, (iv) Preferred Stock, (v) Stock Reload Options and/or (vi) Other Stock-Based Awards. one On December 9, 2020, the Company amended the Inducement Plan solely to increase the total number of shares of Common Stock reserved for issuance under the Inducement Plan from 200,000 shares to 500,000 shares. The 2019 Inducement Plan is 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. As of September 30, 2021, there were 362,700 shares available for grant under the 2019 Inducement Plan. The Company’s stock-based compensation expense related to stock options was recognized in operating expense as follows: Three Months September 30, 2021 Nine Months Ended September 30, 2021 2020 2021 2020 (unaudited) (unaudited) Stock-Based Compensation Research and development $ 596,762 $ 61,557 $ 824,580 $ 168,083 General and administrative 1,105,000 68,235 1,576,401 132,815 Total $ 1,701,763 $ 129,792 $ 2,400,980 $ 300,898 The fair value of options granted during the three and nine months ended September 30, 2021 and the three and nine months ended September 30, 2020 was estimated using the Black-Scholes option valuation model utilizing the following assumptions . Three Months September 30, 2021 Nine Months Ended September 30, 2021 2020 2021 2020 Weighted Average Weighted Average Weighted Average Weighted Average (unaudited) (unaudited) Volatility 100.16 % – % 100.58 % 97.00 % Risk-Free Interest Rate 0.77 % – % 55.88 % 0.38 % Expected Term in Years 6.08 – 6.28 6.07 Dividend Rate – – – – Fair Value of Option on Grant Date $ 11.81 $ – $ 7.43 $ 1.10 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, 2020 1,650,897 $ 11.87 7.03 $ 226,731 Granted 1,722,730 3.34 9.28 $ 8,803,138 Exercised (95,737 ) 7.24 – $ – Forfeited (326,038 ) 29.71 – $ – Options outstanding at September 30, 2021 2,951,852 $ 5.07 7.99 $ 29,754,366 Vested and expected to vest at September 30, 2021 2,951,852 $ 5.07 7.99 $ 29,754,366 Exercisable at September 30, 2021 1,130,039 $ 7.66 5.81 $ 8,914,003 At September 30, 2021 there was approximately $11,300,108 of unamortized stock option compensation expense, which is expected to be recognized over a remaining average vesting period of 2.97 years. |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2021 | |
Income Taxes [Abstract] | |
Income Taxes | Note 8 – 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 2021 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, 2021 and December 31, 2020. In May 2021, in accordance with the State of New Jersey’s Technology Business Tax Certificate Program, which allowed certain high technology and biotechnology companies to sell unused NOL carryforwards to other New Jersey-based corporate taxpayers, the Company sold New Jersey NOL carryforwards, resulting in the recognition of $4.5 million of income tax benefit, net of transaction costs. The Company’s U.S. statutory rate is 21%. The effective tax rate, excluding the benefit of the sale of any New Jersey net operating losses, for the three and nine months ended September 30, 2021 is 0%. The primary factor impacting the effective tax rate is the anticipated full year operating loss which will require a full valuation allowance against any associate deferred tax asset. 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, 2021, 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, 2021 and for the year ended December 31, 2020. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2021 | |
Commitments and Contingencies [Abstract] | |
Commitments and Contingencies | Note 9 – Commitments and Contingencies Rent For month-to-month arrangements not impacted by the adoption of ASC 842, rent for the three and nine months ended September 30, 2021 was $52,000 and $130,493, respectively, compared to the three and nine months ended September 30, 2020 of $35,700 and $140,678. Legal Proceedings On July 23, 2021, David R. Rosener, a purported stockholder of the Company, filed a putative class action and shareholder derivative complaint in the Court of Chancery of the State of Delaware (C.A. No. 2021-0644 JRS) against the Company and all of its directors and certain of its executive officers. The plaintiff named all current directors of PDS as defendants as well as PDS’s Chief Scientific Officer and PDS’s Chief Medical Officer and also named PDS as a nominal defendant. The plaintiff claims PDS’s bylaws required tabulation of broker non-votes on Proposal 3 at the Company’s 2021 annual stockholder meeting on June 17, 2021, which sought shareholder approval of the Second Amended and Restated PDS Biotechnology Corporation 2014 Equity Incentive Plan (the “Restated Plan”). The complaint asserts claims for breach of fiduciary duties, declaratory judgment, waste of corporate assets and unjust enrichment in connection with the Restated Plan and the granting of an aggregate award of 1,040,700 stock options to certain executive officers pursuant to the Restated Plan. The plaintiff seeks unspecified monetary damages, seeks to have the Restated Plan declared void, and seeks recission of the grant of stock options as ultra vires. Given the early stage of this lawsuit, PDS is unable to reasonably estimate the costs associated with the lawsuit or predict the outcome. Each of the Company, its directors and the named executives intend to defend this action vigorously. There can be no guarantee as to the timing of any resolution. |
Retirement Plan
Retirement Plan | 9 Months Ended |
Sep. 30, 2021 | |
Retirement Plan [Abstract] | |
Retirement Plan | Note 10 – Retirement Plan The Company has a 401(k) defined contribution plan for the benefit of all employees and permits voluntary contributions by employees subject to IRS-imposed limitations. The 401(k) employer contributions were $25,803 and $71,214 for the three and nine months ended September 30, 2021, respectively, compared to $11,809 and $35,293 for the three and nine months ended September 30, 2020, |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2021 | |
Subsequent Events [Abstract] | |
Subsequent Events | Note 11– Subsequent Events On October 18, 2021, the Company granted an option to purchase 202,800 shares of common stock to its incoming Chief Financial Officer and 25,400 to other incoming employees with a strike price of $12.03 vesting over a four-year period with one quarter first Effective as November 5, 2021, the Company entered into a Patent License Agreement (the “Patent License Agreement”) with the U.S. Department of Health and Human Services, as represented by National Cancer Institute (“NCI”) of the National Institutes of Health (“NIH”). Pursuant to the License Agreement, the Company obtained a nonexclusive license to the patent rights for NCI’s T-cell receptor gamma alternate reading frame protein (“TARP”) to develop and commercialize TARP peptide-based therapies in combination with the Company’s Versamune ® |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2021 | |
Summary of Significant Accounting Policies [Abstract] | |
Unaudited Interim Financial Statements | (A) Unaudited interim financial statements: The interim balance sheet at September 30, 2021, the statements of operations and comprehensive loss and changes in stockholders’ equity for the three and nine months ended September 30, 2021 and 2020, and cash flows for the nine months ended September 30, 2021 and 2020 are unaudited. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. GAAP, in accordance with 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, 2021 are not necessarily indicative of the results to be expected for the year ending December 31, 2021 or for any other future annual or interim period. The balance sheet as of December 31, 2020 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 Company’s audited consolidated financial statements and notes thereto as of and for the year ended December 31, 2020, filed by the Company with the SEC in its Annual Report on Form 10-K on March 18, 2021. |
Use of Estimates | (B) Use of estimates: The preparation of condensed consolidated 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 the reported amounts of expenses at the date of the consolidated financial statements and during the reporting periods, and to disclose contingent assets and liabilities at the date of the consolidated financial statements. 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 ability to preserve its cash resources, the Company’s review of strategic alternatives, the Company’s ability to add product candidates to its pipeline, the Company’s intellectual property, the ability to efficiently and effectively conduct its clinical trials, 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, the Company’s ability to raise capital, and the effects of health epidemics, pandemics, or outbreaks of infectious diseases, including the recent COVID-19 pandemic and its variants. 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 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. |
Stock-Based Compensation | (G) Stock-based compensation: The Company accounts for its stock-based compensation in accordance with ASC Topic 718, Compensation—Stock Compensation (“ASC 718”). ASC 718 requires all stock-based payments to employees, directors and non-employees to be recognized as expense in the consolidated statements of operations and comprehensive loss based on their grant date fair values. In order to determine the fair value of stock options on the date of grant, the Company uses the Black-Scholes option-pricing model. Inherent in this model are assumptions related to expected stock-price volatility, option term, risk-free interest rate and dividend yield. While the risk-free interest rate and dividend yield are less subjective assumptions that are based on factual data derived from public sources, the expected stock-price volatility and option term assumptions require a greater level of judgment. The Company expenses the fair value of its stock-based compensation awards to employees and directors on a straight-line basis over the requisite service period, which is generally the vesting period. The Company recognizes forfeitures as they occur. |
Net Loss per Common Share | (H) Net loss per common share: Basic and diluted net loss per common share is determined by dividing net loss attributable to common stockholders by the weighted average common shares outstanding during the period. For all periods presented, the common shares underlying the stock options and warrants have been excluded from the calculation because their effect would be anti-dilutive. Therefore, the weighted average shares outstanding used to calculate both basic and diluted loss per common share are the same. The potentially dilutive securities excluded from the determination of diluted loss per share as their effect is antidilutive, are as follows: As of September 30, 2021 2020 Stock options to purchase Common Stock 2,951,852 1,639,753 Warrants to purchase Common Stock 197,518 197,518 Total 3,149,370 1,837,271 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Summary of Significant Accounting Policies [Abstract] | |
Antidilutive Securities | The potentially dilutive securities excluded from the determination of diluted loss per share as their effect is antidilutive, are as follows: As of September 30, 2021 2020 Stock options to purchase Common Stock 2,951,852 1,639,753 Warrants to purchase Common Stock 197,518 197,518 Total 3,149,370 1,837,271 |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Fair Value of Financial Instruments [Abstract] | |
Fair Value of Financial Instruments | There were no transfers among Levels 1, 2, or 3 during 2021 or 2020. 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 2021 Cash and cash equivalents $ 69,744,004 $ 69,744,004 $ – $ – As of December 31, 2020 Cash and cash equivalents $ 28,839,565 $ 28,839,565 $ – $ – |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Leases [Abstract] | |
Supplemental Cash Flow Information Related to Operating Leases | Supplemental cash flow information related to operating leases is as follows: As of September 30, 2021 2020 Cash paid for operating lease liabilities $ 127,804 $ 62,597 Right-of use assets recorded in exchange for lease obligations $ – $ 638,831 |
Future Payments for Operating Lease Liabilities | Maturity of the Company’s operating lease liability is as follows: Year ended December 31, 2021 (remaining three months) $ 43,035 2022 294,986 2023 239,469 2024 – 2025 and after – Total future minimum lease payments 577,490 Less imputed interest (55,797 ) $ 521,693 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Accrued Expenses [Abstract] | |
Accrued Expenses and Other Liabilities | Accrued expenses and other liabilities consist of the following: As of September 30, 2021 As of December 31, 2020 Accrued research and development costs $ 19,500 $ 204,780 Accrued professional fees 277,555 219,822 Accrued compensation 1,626,791 1,310,720 Total $ 1,923,846 $ 1,735,322 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
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 September 30, 2021 Nine Months Ended September 30, 2021 2020 2021 2020 (unaudited) (unaudited) Stock-Based Compensation Research and development $ 596,762 $ 61,557 $ 824,580 $ 168,083 General and administrative 1,105,000 68,235 1,576,401 132,815 Total $ 1,701,763 $ 129,792 $ 2,400,980 $ 300,898 |
Assumptions Used to Value Stock Options Granted | The fair value of options granted during the three and nine months ended September 30, 2021 and the three and nine months ended September 30, 2020 was estimated using the Black-Scholes option valuation model utilizing the following assumptions . Three Months September 30, 2021 Nine Months Ended September 30, 2021 2020 2021 2020 Weighted Average Weighted Average Weighted Average Weighted Average (unaudited) (unaudited) Volatility 100.16 % – % 100.58 % 97.00 % Risk-Free Interest Rate 0.77 % – % 55.88 % 0.38 % Expected Term in Years 6.08 – 6.28 6.07 Dividend Rate – – – – Fair Value of Option on Grant Date $ 11.81 $ – $ 7.43 $ 1.10 |
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, 2020 1,650,897 $ 11.87 7.03 $ 226,731 Granted 1,722,730 3.34 9.28 $ 8,803,138 Exercised (95,737 ) 7.24 – $ – Forfeited (326,038 ) 29.71 – $ – Options outstanding at September 30, 2021 2,951,852 $ 5.07 7.99 $ 29,754,366 Vested and expected to vest at September 30, 2021 2,951,852 $ 5.07 7.99 $ 29,754,366 Exercisable at September 30, 2021 1,130,039 $ 7.66 5.81 $ 8,914,003 |
Nature of Operations (Details)
Nature of Operations (Details) | Sep. 30, 2021ClinicalTrial |
Nature of Operations [Abstract] | |
Number of planned clinical trials delayed | 2 |
Number of planned clinical trials | 3 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details) - shares | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Net Loss per Common Share [Abstract] | ||
Antidilutive impact to EPS (in shares) | 3,149,370 | 1,837,271 |
Stock Options to Purchase Common Stock [Member] | ||
Net Loss per Common Share [Abstract] | ||
Antidilutive impact to EPS (in shares) | 2,951,852 | 1,639,753 |
Warrants to Purchase Common Stock [Member] | ||
Net Loss per Common Share [Abstract] | ||
Antidilutive impact to EPS (in shares) | 197,518 | 197,518 |
Liquidity (Details)
Liquidity (Details) - USD ($) | Jul. 29, 2019 | Jun. 30, 2021 | May 31, 2021 | Aug. 31, 2020 | Feb. 29, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | Jul. 31, 2020 | Jul. 26, 2019 |
Liquidity [Abstract] | ||||||||||
Cash and cash equivalents | $ 69,744,004 | $ 28,839,565 | ||||||||
Percentage of shares of common stock that can be sold without shareholder approval | 19.99% | |||||||||
Share price (in dollars per share) | $ 5.76 | |||||||||
Issuance of common stock from equity transaction (in shares) | 100,654 | |||||||||
Issuance of common stock from equity transaction | $ 603,924 | |||||||||
Shares sold under common stock purchase agreement (in shares) | 0 | |||||||||
Issuance of common stock (in shares) | 6,088,235 | 6,900,000 | 10,000,000 | |||||||
Sales price (in dollars per share) | $ 8.50 | $ 2.75 | $ 1.30 | |||||||
Proceeds from issuance of shares | $ 51,700,000 | $ 19,000,000 | $ 13,000,000 | $ 48,544,998 | $ 29,756,502 | |||||
Proceeds from issuance of shares, net of underwriting discounts and commissions | $ 48,500,000 | $ 17,100,000 | $ 11,900,000 | |||||||
Registered securities in Shelf Registration Statement available for future sale | $ 100,000,000 | |||||||||
Proceeds from sale of tax benefits | $ 4,500,000 | |||||||||
Shelf securities available for sale | $ 29,300,000 | |||||||||
Over-Allotment Option [Member] | ||||||||||
Liquidity [Abstract] | ||||||||||
Issuance of common stock (in shares) | 794,117 | 900,000 | 769,230 | |||||||
Minimum [Member] | ||||||||||
Liquidity [Abstract] | ||||||||||
Share price (in dollars per share) | $ 0.50 | |||||||||
Maximum [Member] | ||||||||||
Liquidity [Abstract] | ||||||||||
Shares of common stock to be purchased (in shares) | 100,000 | |||||||||
Common stock to be purchased under common stock purchase agreement | $ 20,000,000 | |||||||||
Shares of common stock that can be sold without shareholder approval (in shares) | 1,034,979 |
Fair Value of Financial Instr_3
Fair Value of Financial Instruments (Details) - USD ($) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
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 | 69,744,004 | 28,839,565 |
Quoted Prices in Active Markets (Level 1) [Member] | ||
Fair Value of Financial Instruments [Abstract] | ||
Cash and cash equivalents | 69,744,004 | 28,839,565 |
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 |
Leases, Operating Leases (Detai
Leases, Operating Leases (Details) | Sep. 30, 2021USD ($)ft² | Dec. 31, 2020USD ($) | May 01, 2020USD ($) | Jul. 08, 2019USD ($)Installment |
Leases [Abstract] | ||||
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 | |||
Area of office space under sub-lease | ft² | 11,200 | |||
Term of sub-lease agreement | 40 months | |||
Remaining lease term | 23 months | |||
Right-of-use asset | $ 406,171 | $ 547,706 | $ 700,000 | |
Operating lease liability | $ 521,693 | $ 700,000 | ||
Discount rate used to measure operating lease liability | 9.15% |
Leases, Supplemental Cash Flow
Leases, Supplemental Cash Flow Information Related to Operating Leases (Details) - USD ($) | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Supplemental Cash Flow Information Related to Operating Leases [Abstract] | ||
Cash paid for operating lease liabilities | $ 127,804 | $ 62,597 |
Right-of use assets recorded in exchange for lease obligations | $ 0 | $ 638,831 |
Leases, Future Payments for Ope
Leases, Future Payments for Operating Lease Liabilities (Details) - USD ($) | Sep. 30, 2021 | May 01, 2020 |
Future Payments for Operating Lease Liabilities [Abstract] | ||
2021 (remaining three months) | $ 43,035 | |
2022 | 294,986 | |
2023 | 239,469 | |
2024 | 0 | |
2025 and after | 0 | |
Total future minimum lease payments | 577,490 | |
Less imputed interest | (55,797) | |
Lease liability | $ 521,693 | $ 700,000 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) | Sep. 30, 2021 | Dec. 31, 2020 |
Accrued Expenses [Abstract] | ||
Accrued research and development costs | $ 19,500 | $ 204,780 |
Accrued professional fees | 277,555 | 219,822 |
Accrued compensation | 1,626,791 | 1,310,720 |
Total | $ 1,923,846 | $ 1,735,322 |
Stock-Based Compensation, Equit
Stock-Based Compensation, Equity Compensation Plans (Details) | 9 Months Ended | 12 Months Ended | |||||
Sep. 30, 2021Planshares | Dec. 31, 2014shares | Jun. 17, 2021shares | Dec. 09, 2020shares | Dec. 08, 2020shares | Mar. 31, 2019shares | Dec. 31, 2018shares | |
Stock Options [Abstract] | |||||||
Number of equity compensation plans | Plan | 3 | ||||||
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 | ||||||
2014 Equity Incentive Plan [Member] | |||||||
Stock Options [Abstract] | |||||||
Number of shares authorized for issuance (in shares) | 91,367 | 3,339,243 | 826,292 | ||||
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 | ||||||
Shares available for grant (in shares) | 190,799 | ||||||
2019 Inducement Plan [Member] | |||||||
Stock Options [Abstract] | |||||||
Common stock reserved for issuance (in shares) | 500,000 | 200,000 | |||||
Shares available for grant (in shares) | 362,700 |
Stock-Based Compensation, Stock
Stock-Based Compensation, Stock-Based Compensation Expense Related to Stock Options (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Stock-Based Compensation [Abstract] | ||||
Stock-based compensation expense | $ 1,701,763 | $ 129,792 | $ 2,400,980 | $ 300,898 |
Research and Development [Member] | ||||
Stock-Based Compensation [Abstract] | ||||
Stock-based compensation expense | 596,762 | 61,557 | 824,580 | 168,083 |
General and Administrative [Member] | ||||
Stock-Based Compensation [Abstract] | ||||
Stock-based compensation expense | $ 1,105,000 | $ 68,235 | $ 1,576,401 | $ 132,815 |
Stock-Based Compensation, Assum
Stock-Based Compensation, Assumptions Used to Value Stock Options Granted (Details) - $ / shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Stock-Based Compensation [Abstract] | ||||
Options granted (in shares) | 63,800 | |||
Assumptions Used in Determining Fair Value of Stock Options Granted [Abstract] | ||||
Volatility | 100.16% | 0.00% | 100.58% | 97.00% |
Risk-free interest rate | 0.77% | 0.00% | 55.88% | 0.38% |
Expected term | 6 years 29 days | 6 years 3 months 10 days | 6 years 25 days | |
Dividend rate | 0.00% | 0.00% | 0.00% | 0.00% |
Fair value of option on grant date (in dollars per share) | $ 11.81 | $ 0 | $ 7.43 | $ 1.10 |
Stock-Based Compensation, Sto_2
Stock-Based Compensation, Stock Option Activity (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Sep. 30, 2021 | Dec. 31, 2020 | |
Number of Shares [Roll Forward] | |||
Granted (in shares) | 63,800 | ||
Stock Options [Member] | |||
Number of Shares [Roll Forward] | |||
Options outstanding, beginning balance (in shares) | 1,650,897 | ||
Granted (in shares) | 1,722,730 | ||
Exercised (in shares) | (95,737) | ||
Forfeited (in shares) | (326,038) | ||
Options outstanding, ending balance (in shares) | 2,951,852 | 2,951,852 | 1,650,897 |
Vested and expected to vest (in shares) | 2,951,852 | 2,951,852 | |
Exercisable (in shares) | 1,130,039 | 1,130,039 | |
Weighted Average Exercise Price [Roll Forward] | |||
Options outstanding, beginning balance (in dollars per share) | $ 11.87 | ||
Granted (in dollars per share) | 3.34 | ||
Exercised (in dollars per share) | 7.24 | ||
Forfeited (in dollars per share) | 29.71 | ||
Options outstanding, ending balance (in dollars per share) | $ 5.07 | 5.07 | $ 11.87 |
Vested and expected to vest (in dollars per share) | 5.07 | 5.07 | |
Exercisable (in dollars per share) | $ 7.66 | $ 7.66 | |
Weighted Average Remaining Contractual Life and Aggregate Intrinsic Value [Abstract] | |||
Options outstanding, weighted average remaining contractual life | 7 years 11 months 26 days | 7 years 10 days | |
Granted, weighted average remaining contractual life | 9 years 3 months 10 days | ||
Vested and expected to vest, weighted average remaining contractual life | 7 years 11 months 26 days | ||
Exercisable, weighted average remaining contractual life | 5 years 9 months 21 days | ||
Options outstanding, aggregate intrinsic value | $ 226,731 | ||
Granted, aggregate intrinsic value | 8,803,138 | ||
Exercised, aggregate intrinsic value | 0 | ||
Forfeited, aggregate intrinsic value | 0 | ||
Options outstanding, aggregate intrinsic value | $ 29,754,366 | 29,754,366 | $ 226,731 |
Vested and expected to vest, aggregate intrinsic value | 29,754,366 | 29,754,366 | |
Exercisable, aggregate intrinsic value | 8,914,003 | 8,914,003 | |
Unamortized Stock Compensation Expense [Abstract] | |||
Unamortized stock compensation expense | $ 11,300,108 | $ 11,300,108 | |
Period for recognition | 2 years 11 months 19 days |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||
May 31, 2021 | Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | |
Income Taxes [Abstract] | ||||||
Current income tax expense | $ 0 | |||||
Benefit from income taxes | $ (4,500,000) | $ 0 | $ 0 | $ (4,516,488) | $ 0 | |
Federal statutory rate | 21.00% | |||||
Effective tax rate | 0.00% | 0.00% | ||||
Uncertain tax positions | $ 0 | $ 0 | ||||
Unrecognized tax benefits | 0 | 0 | $ 0 | |||
Accrued interest and penalties | $ 0 | $ 0 | $ 0 |
Commitments and Contingencies (
Commitments and Contingencies (Details) - USD ($) | Dec. 08, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 |
Commitments and Contingencies [Abstract] | |||||
Rent expense | $ 52,000 | $ 35,700 | $ 130,493 | $ 140,678 | |
Legal Proceedings [Abstract] | |||||
Options granted (in shares) | 63,800 | ||||
Stock Options [Member] | |||||
Legal Proceedings [Abstract] | |||||
Options granted (in shares) | 1,722,730 | ||||
2014 Equity Incentive Plan [Member] | Stock Options [Member] | Frank Bedu-Addo, Gregory Conn, and Lauren Wood [Member] | |||||
Legal Proceedings [Abstract] | |||||
Options granted (in shares) | 1,040,700 |
Retirement Plan (Details)
Retirement Plan (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Retirement Plan [Abstract] | ||||
401(k) employer contributions | $ 25,803 | $ 11,809 | $ 71,214 | $ 35,293 |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) $ / shares in Units, $ in Millions | Oct. 18, 2021 | Sep. 30, 2021 | Sep. 30, 2021 |
Subsequent Events [Abstract] | |||
Options granted (in shares) | 63,800 | ||
Stock Options [Member] | |||
Subsequent Events [Abstract] | |||
Options granted (in shares) | 1,722,730 | ||
Exercise price (in dollars per share) | $ 3.34 | ||
Subsequent Event [Member] | Chief Financial Officer [Member] | |||
Subsequent Events [Abstract] | |||
Options granted (in shares) | 202,800 | ||
Subsequent Event [Member] | Other Employees [Member] | |||
Subsequent Events [Abstract] | |||
Options granted (in shares) | 25,400 | ||
Subsequent Event [Member] | Stock Options [Member] | |||
Subsequent Events [Abstract] | |||
Exercise price (in dollars per share) | $ 12.03 | ||
Vesting period | 4 years | ||
Expiration period | 10 years | ||
Aggregate fair value of options granted | $ 2.2 | ||
Subsequent Event [Member] | Stock Options [Member] | One Quarter of Options Granted [Member] | |||
Subsequent Events [Abstract] | |||
Vesting period | 1 year | ||
Percentage of options vesting | 25.00% | ||
Subsequent Event [Member] | Stock Options [Member] | Remaining Options Granted [Member] | |||
Subsequent Events [Abstract] | |||
Vesting period | 36 months |