Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2022 | Nov. 09, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Sep. 30, 2022 | |
Entity File Number | 001-37526 | |
Entity Registrant Name | Zynerba Pharmaceuticals, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 26-0389433 | |
Entity Address, Address Line One | 80 W. Lancaster Avenue | |
Entity Address, Address Line Two | Suite 300 | |
Entity Address, City or Town | Devon | |
Entity Address, State or Province | PA | |
Entity Address, Postal Zip Code | 19333 | |
City Area Code | 484 | |
Local Phone Number | 581-7505 | |
Title of 12(b) Security | Common Stock, $0.001 par value per share | |
Trading Symbol | ZYNE | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 47,062,711 | |
Entity Central Index Key | 0001621443 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 55,934,491 | $ 67,808,000 |
Incentive and tax receivables | 1,378,738 | 9,580,468 |
Prepaid expenses and other current assets | 3,487,626 | 2,831,392 |
Total current assets | 60,800,855 | 80,219,860 |
Property and equipment, net | 419,863 | 385,833 |
Incentive and tax receivables | 751,815 | |
Right-of-use assets | 394,205 | 565,814 |
Total assets | 62,366,738 | 81,171,507 |
Current liabilities: | ||
Accounts payable | 1,619,697 | 1,798,813 |
Accrued expenses | 7,598,187 | 7,896,598 |
Lease liabilities | 213,428 | 209,068 |
Total current liabilities | 9,431,312 | 9,904,479 |
Lease liabilities, long-term | 178,672 | 353,694 |
Total liabilities | 9,609,984 | 10,258,173 |
Stockholders' equity: | ||
Preferred stock, $0.001 par value; 10,000,000 shares authorized; no shares issued or outstanding | ||
Common stock, $0.001 par value; 200,000,000 shares authorized; 47,062,711 shares issued and outstanding at September 30, 2022 and 41,217,537 shares issued and outstanding at December 31, 2021 | 47,063 | 41,218 |
Additional paid-in capital | 319,210,944 | 310,353,595 |
Accumulated deficit | (266,501,253) | (239,481,479) |
Total stockholders' equity | 52,756,754 | 70,913,334 |
Total liabilities and stockholders' equity | $ 62,366,738 | $ 81,171,507 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2022 | Dec. 31, 2021 |
CONSOLIDATED BALANCE SHEETS | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 47,062,711 | 41,217,537 |
Common stock, shares outstanding | 47,062,711 | 41,217,537 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Operating expenses: | ||||
Research and development | $ 5,039,228 | $ 6,341,171 | $ 15,632,150 | $ 16,402,129 |
General and administrative | 3,453,648 | 3,869,481 | 10,933,411 | 11,531,824 |
Total operating expenses | 8,492,876 | 10,210,652 | 26,565,561 | 27,933,953 |
Loss from operations | (8,492,876) | (10,210,652) | (26,565,561) | (27,933,953) |
Other income (expense): | ||||
Interest income | 251,855 | 5,038 | 439,590 | 16,614 |
Foreign exchange loss | (435,128) | (376,637) | (893,803) | (576,619) |
Total other income (expense) | (183,273) | (371,599) | (454,213) | (560,005) |
Net loss | $ (8,676,149) | $ (10,582,251) | $ (27,019,774) | $ (28,493,958) |
Net loss per share basic | $ (0.20) | $ (0.26) | $ (0.65) | $ (0.73) |
Net loss per share diluted | $ (0.20) | $ (0.26) | $ (0.65) | $ (0.73) |
Basic weighted average shares outstanding | 43,746,878 | 40,092,128 | 41,831,998 | 38,933,209 |
Diluted weighted average shares outstanding | 43,746,878 | 40,092,128 | 41,831,998 | 38,933,209 |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY - USD ($) | Common stock | Additional paid-capital | Accumulated deficit | Total |
Balance at Dec. 31, 2020 | $ 29,975 | $ 262,286,008 | $ (202,172,455) | $ 60,143,528 |
Balance (in shares) at Dec. 31, 2020 | 29,975,264 | |||
Increase (Decrease) in Stockholders' Equity (Deficit) | ||||
Issuance of common stock, net of issuance costs | $ 10,245 | 42,210,099 | 42,220,344 | |
Issuance of common stock, net of issuance costs (in shares) | 10,244,326 | |||
Issuance of restricted stock | $ 1,019 | (1,019) | ||
Issuance of restricted stock (in shares) | 1,018,822 | |||
Exercise of stock options | $ 13 | 47,893 | 47,906 | |
Exercise of stock options (in shares) | 13,125 | |||
Stock-based compensation expense | 1,264,837 | 1,264,837 | ||
Net loss | (7,961,628) | (7,961,628) | ||
Balance at Mar. 31, 2021 | $ 41,252 | 305,807,818 | (210,134,083) | 95,714,987 |
Balance (in shares) at Mar. 31, 2021 | 41,251,537 | |||
Increase (Decrease) in Stockholders' Equity (Deficit) | ||||
Stock-based compensation expense | 1,934,349 | 1,934,349 | ||
Net loss | (9,950,079) | (9,950,079) | ||
Balance at Jun. 30, 2021 | $ 41,252 | 307,742,167 | (220,084,162) | 87,699,257 |
Balance (in shares) at Jun. 30, 2021 | 41,251,537 | |||
Increase (Decrease) in Stockholders' Equity (Deficit) | ||||
Issuance of restricted stock | $ 30 | (30) | ||
Issuance of restricted stock (in shares) | 30,000 | |||
Stock-based compensation expense | 1,569,993 | 1,569,993 | ||
Net loss | (10,582,251) | (10,582,251) | ||
Balance at Sep. 30, 2021 | $ 41,282 | 309,312,130 | (230,666,413) | 78,686,999 |
Balance (in shares) at Sep. 30, 2021 | 41,281,537 | |||
Balance at Dec. 31, 2021 | $ 41,218 | 310,353,595 | (239,481,479) | 70,913,334 |
Balance (in shares) at Dec. 31, 2021 | 41,217,537 | |||
Increase (Decrease) in Stockholders' Equity (Deficit) | ||||
Issuance of common stock, net of issuance costs | $ 857 | 1,582,916 | 1,583,773 | |
Issuance of common stock, net of issuance costs (in shares) | 857,060 | |||
Issuance of restricted stock | $ 1,249 | (1,249) | ||
Issuance of restricted stock (in shares) | 1,249,500 | |||
Stock-based compensation expense | 1,160,482 | 1,160,482 | ||
Net loss | (8,490,619) | (8,490,619) | ||
Balance at Mar. 31, 2022 | $ 43,324 | 313,095,744 | (247,972,098) | 65,166,970 |
Balance (in shares) at Mar. 31, 2022 | 43,324,097 | |||
Balance at Dec. 31, 2021 | $ 41,218 | 310,353,595 | (239,481,479) | 70,913,334 |
Balance (in shares) at Dec. 31, 2021 | 41,217,537 | |||
Balance at Sep. 30, 2022 | $ 47,063 | 319,210,944 | (266,501,253) | 52,756,754 |
Balance (in shares) at Sep. 30, 2022 | 47,062,711 | |||
Balance at Mar. 31, 2022 | $ 43,324 | 313,095,744 | (247,972,098) | 65,166,970 |
Balance (in shares) at Mar. 31, 2022 | 43,324,097 | |||
Increase (Decrease) in Stockholders' Equity (Deficit) | ||||
Issuance of common stock, net of issuance costs | $ 489 | 818,877 | 819,366 | |
Issuance of common stock, net of issuance costs (in shares) | 488,892 | |||
Issuance of restricted stock | $ 123 | (123) | ||
Issuance of restricted stock (in shares) | 123,154 | |||
Stock-based compensation expense | 1,108,543 | 1,108,543 | ||
Net loss | (9,853,006) | (9,853,006) | ||
Balance at Jun. 30, 2022 | $ 43,936 | 315,023,041 | (257,825,104) | 57,241,873 |
Balance (in shares) at Jun. 30, 2022 | 43,936,143 | |||
Increase (Decrease) in Stockholders' Equity (Deficit) | ||||
Issuance of common stock, net of issuance costs | $ 2,780 | 3,147,150 | 3,149,930 | |
Issuance of common stock, net of issuance costs (in shares) | 2,779,346 | |||
Commitment shares issued under an equity purchase agreement | $ 347 | (347) | ||
Commitment shares issued under an equity purchase agreement (in shares) | 347,222 | |||
Stock-based compensation expense | 1,041,100 | 1,041,100 | ||
Net loss | (8,676,149) | (8,676,149) | ||
Balance at Sep. 30, 2022 | $ 47,063 | $ 319,210,944 | $ (266,501,253) | $ 52,756,754 |
Balance (in shares) at Sep. 30, 2022 | 47,062,711 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Cash flows from operating activities: | ||
Net loss | $ (27,019,774) | $ (28,493,958) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 165,920 | 185,245 |
Stock-based compensation | 3,310,125 | 4,769,179 |
Changes in operating assets and liabilities: | ||
Incentive and tax receivables | 7,449,915 | (361,104) |
Prepaid expenses and other assets | (637,578) | 1,424,002 |
Right-of-use assets and liabilities | 947 | (7,858) |
Accounts payable | (256,554) | 113,634 |
Accrued expenses | (354,500) | (3,252,118) |
Net cash used in operating activities | (17,341,499) | (25,622,978) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (146,705) | (47,570) |
Net cash used in investing activities | (146,705) | (47,570) |
Cash flows from financing activities: | ||
Proceeds from the issuance of common stock | 6,059,511 | 43,193,660 |
Payment of financing fees and expenses | (444,816) | (1,085,707) |
Proceeds from the exercise of stock options | 47,906 | |
Net cash provided by financing activities | 5,614,695 | 42,155,859 |
Net (decrease) increase in cash and cash equivalents | (11,873,509) | 16,485,311 |
Cash and cash equivalents at beginning of period | 67,808,000 | 59,157,187 |
Cash and cash equivalents at end of period | 55,934,491 | 75,642,498 |
Supplemental disclosures of cash flow information: | ||
Financing costs included in accounts payable and accrued expenses at end of period | 122,782 | $ 42,500 |
Property and equipment acquired but unpaid at end of period | $ 53,245 |
Nature of Business and Liquidit
Nature of Business and Liquidity | 9 Months Ended |
Sep. 30, 2022 | |
Nature of Business and Liquidity | |
Nature of Business and Liquidity | (1) Nature of Business and Liquidity Zynerba Pharmaceuticals, Inc., together with its subsidiary, Zynerba Pharmaceuticals Pty Ltd (collectively, “Zynerba,” the “Company,” or “we”), is a clinical stage specialty pharmaceutical company focused on the development of pharmaceutically-produced transdermal cannabinoid therapies for orphan neuropsychiatric disorders, including Fragile X syndrome (“FXS”) and chromosome 22q11.2 deletion syndrome (“22q”). We have been granted orphan drug designations from the United States Food and Drug Administration (“FDA”) and the European Commission for the use of cannabidiol for the treatment of FXS. We have also been granted orphan drug designation from the FDA for the treatment of 22q. In addition, we have received Fast Track designation from the FDA for treatment of behavioral symptoms associated with FXS. The Company has decided to prioritize its resources on FXS and 22q, both of which have no approved products. While the data from the Company’s autism spectrum disorder (“ASD”) clinical development program to date are compelling, given the difficult financial market, the Company has decided to defer the start of the Phase 3 development program in ASD that was previously planned for the second half of 2022. The Company has incurred losses and negative cash flows from operations since inception and has an accumulated deficit of $266.5 million as of September 30, 2022. The Company anticipates incurring additional losses until such time, if ever, that it can generate significant revenue from its product candidates currently in development. The Company's primary source of liquidity has been the issuance of equity securities. Management believes that the Company’s cash and cash equivalents as of September 30, 2022 are sufficient to fund operations and capital requirements into the first quarter of 2024. Top-line results from the confirmatory pivotal Phase 3 RECONNECT trial of Zygel in patients with FXS are expected in the second half of 2023. Substantial additional financings will be needed by the Company to fund its operations, and to complete clinical development of and to commercially develop its product candidates. The Company’s ability to raise sufficient additional financing depends on many factors beyond its control, including the current and ongoing volatility in the capital markets as a result of, among other factors, the COVID-19 pandemic and geopolitical tensions or the outbreak of hostilities or war. There is no assurance that such financing will be available when needed or on acceptable terms. The Company is subject to those risks associated with any clinical stage pharmaceutical company that has substantial expenditures for research and development. There can be no assurance that the Company's research and development projects will be successful, that products developed will obtain necessary regulatory approval, or that any approved product will be commercially viable. In addition, the Company operates in an environment of rapid technological change and is largely dependent on the services of its employees and consultants. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2022 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | (2) Summary of Significant Accounting Policies a. Basis of Presentation The accompanying unaudited interim consolidated financial statements of the Company have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. The interim unaudited consolidated financial statements have been prepared on the same basis as the consolidated financial statements as of and for the year ended December 31, 2021 included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 (the “2021 Annual Report”), filed with the Securities and Exchange Commission (the “SEC”). In the opinion of management, the accompanying consolidated financial statements of the Company include all normal and recurring adjustments (which consist primarily of accruals, estimates and assumptions that impact the consolidated financial statements) considered necessary to present fairly the Company's financial position as of September 30, 2022, its results of operations for the three and nine months ended September 30, 2022 and 2021 and cash flows for the nine months ended September 30, 2022 and 2021. Operating results for any interim period are not necessarily indicative of results for any future interim period or for the entire year. The accompanying unaudited interim consolidated financial statements should be read in conjunction with the consolidated financial statements and related notes included in the 2021 Annual Report. b. Use of Estimates The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial c. Incentive and Tax Receivables The Company’s subsidiary, Zynerba Pharmaceuticals Pty Ltd (the “Subsidiary”), is incorporated in Australia. The Subsidiary is eligible to participate in an Australian research and development tax incentive program. As part of this program, the Subsidiary is eligible to receive a cash refund from the Australian Taxation Office (“ATO”) for a percentage of the research and development costs expended by the Subsidiary in Australia. The cash refund is available to eligible companies with an annual aggregate revenue of less than $20.0 million (Australian) during the reimbursable period. The Company estimates the amount of cash refund it expects to receive related to the Australian research and development tax incentive program and records the incentives when it is probable (1) the Company will comply with relevant conditions of the program and (2) the incentive will be received. The Company evaluates its eligibility under tax incentive programs as of each balance sheet date based on the most current and relevant data available. If the Company is deemed to be ineligible or unable to receive the Australian research and development tax credit, or the Australian government significantly reduces or eliminates the tax credit, the actual cash refund the Company receives may materially differ from its estimates. In December 2018, the Company submitted an Advance Overseas Finding (“AOF”) application to a division of the Australian Government’s Department of Industry, Innovation and Science (“AusIndustry”), for a portion of the Company’s research and development activities incurred outside of Australia, which was approved by AusIndustry in July 2019. During the year ended December 31, 2019, the Company recorded $8.3 million as an incentive and tax receivable and recorded a corresponding credit During the three months ended March 31, 2022, the Company concluded its conversations with the ATO on these matters and made the decision to no longer pursue the AOF claim, resulting in the write off of both the AOF receivable and the corresponding reserve during the period. During the three months ended March 31, 2022, the Company received a payment of $8.0 million from the ATO for the non-AOF research and development incentive for the years ended December 31, 2018, 2019 and 2020. The Subsidiary incurs Goods and Services Tax (“GST”) on services provided by Australian vendors. As an Australian entity, the Subsidiary is entitled to a refund of the GST paid. The Company’s estimate of the amount of cash refund it expects to receive related to GST incurred is included in “Incentive and tax receivables” in the accompanying consolidated balance sheets. As of September 30, 2022, incentive and tax receivables included $0.3 million for refundable GST on expenses incurred with Australian vendors during the three months ended September 30, 2022. Current incentive and tax receivables consisted of the following as of September 30, 2022 and December 31, 2021: September 30, December 31, 2022 2021 Research and development incentive (non-AOF) for the period 1/1/18 - 12/31/18 $ — $ 3,144,152 Research and development incentive (non-AOF) for the period 1/1/19 - 12/31/19 — 2,914,931 Research and development incentive (non-AOF) for the period 1/1/20 - 12/31/20 — 1,993,038 Research and development incentive (non-AOF) for the period 1/1/21 - 12/31/21 1,095,535 1,226,688 Research and development incentive (AOF) for the period 1/1/18 - 12/31/19 — 8,566,843 Goods and services tax 283,203 301,659 Total incentive and tax receivables before reserve for AOF 1,378,738 18,147,311 Reserve for research and development incentive (AOF) for the period 1/1/18 - 12/31/19 — (8,566,843) Total incentive and tax receivables - current assets $ 1,378,738 $ 9,580,468 As of September 30, 2022, the Company’s estimate of the amount of cash refund it expects to receive for 2021 eligible spending as part of this incentive program was $1.1 million and was recorded as a current asset. In October 2022, the Company received payment from the ATO for the non-AOF research and development incentive for the year ended December 31, 2021 included in the table above. The Company’s estimate of the amount of cash refund it expects to receive for 2022 eligible spending through September 30, 2022 was $0.8 million and was recorded as a non-current asset. d. Research and Development Research and development costs are expensed as incurred and are primarily comprised of external research and development expenses incurred under arrangements with third parties, such as contract research organizations, contract manufacturing organizations, consultants and employee-related expenses including salaries and benefits. At the end of each reporting period, the Company compares the payments made to each service provider to the estimated progress towards completion of the related project. Factors that the Company considers in preparing these estimates include the number of patients enrolled in studies, milestones achieved and other criteria related to the efforts of its vendors. These estimates will be subject to change as additional information becomes available. Depending on the timing of payments to vendors and estimated services provided, the Company will record net prepaid or accrued expenses related to these costs. Research and development expenses are recorded net of expected refunds of eligible research and development costs paid pursuant to the Australian research and development tax incentive program and GST incurred on services provided by Australian vendors. The following table summarizes research and development expenses for the nine months ended September 30, 2022 and 2021: Nine months ended September 30, 2022 2021 Research and development expenses - before R&D incentive $ 16,450,619 $ 17,304,684 Research and development incentive (818,469) (902,555) Total research and development expenses $ 15,632,150 $ 16,402,129 e . Basic net loss per share is determined using the weighted average number of shares of common stock outstanding during each period. Diluted net income per share includes the effect, if any, from the potential exercise or conversion of securities, such as restricted stock and stock options, which would result in the issuance of incremental shares of common stock. Basic and dilutive computations of net loss per share are the same in periods in which a net loss exists as the dilutive effects of restricted stock and stock options would be anti-dilutive. The following potentially dilutive securities outstanding as of September 30, 2022 and 2021 have been excluded from the computation of diluted weighted average shares outstanding, as their effects on net loss per share for the periods presented would be anti-dilutive: September 30, 2022 2021 Stock options 6,276,016 5,300,538 Unvested restricted stock 2,119,512 1,053,822 8,395,528 6,354,360 f. Recent Accounting Pronouncements The Company does not expect any recently issued accounting pronouncements to have a significant impact on its future results of operations, financial position or cash flow. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Measurements | |
Fair Value Measurements | (3) Fair Value Measurements The Company measures certain assets and liabilities at fair value in accordance with Accounting Standards Codification (“ASC 820”), Fair Value Measurements and Disclosures Level 1 — Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities. Level 2 — Valuations based on observable inputs and quoted prices in active markets for similar assets and liabilities. Level 3 — Valuations based on unobservable inputs and models that are supported by little or no market activity. In accordance with the fair value hierarchy described above, the following table sets forth the Company's financial assets measured at fair value on a recurring basis as of September 30, 2022 and December 31, 2021: Fair Value Measurement Carrying amount as of September 30, 2022 as of September 30, 2022 Level 1 Level 2 Level 3 Cash equivalents (money market accounts) $ 50,368,948 $ 50,368,948 $ — $ — $ 50,368,948 $ 50,368,948 $ — $ — Fair Value Measurement Carrying amount as of December 31, 2021 as of December 31, 2021 Level 1 Level 2 Level 3 Cash equivalents (money market accounts) $ 67,709,279 $ 67,709,279 $ — $ — $ 67,709,279 $ 67,709,279 $ — $ — |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 9 Months Ended |
Sep. 30, 2022 | |
Prepaid Expenses and Other Current Assets | |
Prepaid Expenses and Other Current Assets | (4) Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consisted of the following as of September 30, 2022 and December 31, 2021: September 30, December 31, 2022 2021 Prepaid development expenses $ 634,106 $ 543,897 Prepaid insurance 2,186,026 1,952,867 Deferred financing costs 156,271 137,615 Other current assets 511,223 197,013 Total prepaid expenses and other current assets $ 3,487,626 $ 2,831,392 |
Property and Equipment
Property and Equipment | 9 Months Ended |
Sep. 30, 2022 | |
Property and Equipment | |
Property and Equipment | (5) Property and Equipment Property and equipment consisted of the following as of September 30, 2022 and December 31, 2021: Estimated useful life September 30, December 31, (in years) 2022 2021 Equipment 2-5 $ 740,543 $ 740,543 Computer equipment 3-5 30,319 30,319 Furniture and fixtures 3-5 311,356 311,356 Leasehold improvements various 68,881 68,881 Construction in process 279,292 79,342 Total cost 1,430,391 1,230,441 Less accumulated depreciation (1,010,528) (844,608) Property and equipment, net $ 419,863 $ 385,833 Depreciation expense was $165,920 and $185,245 for the nine months ended September 30, 2022 and 2021 respectively. |
Accrued Expenses
Accrued Expenses | 9 Months Ended |
Sep. 30, 2022 | |
Accrued Expenses | |
Accrued Expenses | (6) Accrued Expenses Accrued expenses consisted of the following as of September 30, 2022 and December 31, 2021: September 30, December 31, 2022 2021 Accrued compensation $ 2,006,537 $ 2,412,291 Accrued research and development 4,731,308 5,125,010 Other 860,342 359,297 Total accrued expenses $ 7,598,187 $ 7,896,598 |
Common Stock
Common Stock | 9 Months Ended |
Sep. 30, 2022 | |
Common Stock | |
Common Stock | (7) Common Stock a. At The Market Financing On May 11, 2021, the Company entered into a Controlled Equity Offering SM In August 2019, the Company entered into a Controlled Equity Offering SM b. Equity Purchase Agreement On July 21, 2022 (the “Effective Date”), the Company entered into a Purchase Agreement (the “Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”) pursuant to which Lincoln Park committed to purchase up to $20.0 million of the Company’s common stock. Under the terms and subject to the conditions of the Purchase Agreement, the Company has the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase up to $20.0 million of the Company’s common stock. Such sales of common stock will be subject to certain limitations, and may occur from time to time, at the Company’s sole discretion, over the 36-month period commencing on the Effective Date. The number of shares the Company may sell to Lincoln Park on any single business day in a regular purchase is 150,000, but that amount may be increased up to 300,000 shares, depending upon the market price of the Company’s common stock at the time of sale and subject to a maximum limit of $2.0 million per regular purchase. The purchase price per share for each such regular purchase will be based on prevailing market prices of the Company’s common stock immediately preceding the time of sale as computed under the Purchase Agreement. In addition to regular purchases, the Company may also direct Lincoln Park to purchase other amounts as accelerated purchases or as additional accelerated purchases. Pursuant to the terms of the Purchase Agreement, the Company issued 347,222 shares of its common stock to Lincoln Park as consideration for its commitment to purchase shares of the Company’s common stock under the Purchase Agreement. During the three months ended September 30, 2022, the Company sold and issued 200,000 shares of common stock under the Purchase Agreement at a weighted average selling price of $1.15 per share, resulting in gross of $0.2 million and net proceeds, after deducting offering expenses, of $0.1 million. |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2022 | |
Stock-Based Compensation | |
Stock-Based Compensation | (8) Stock-Based Compensation The Company maintains the Amended and Restated 2014 Omnibus Incentive Compensation Plan, as amended (the “2014 Plan”), which allows for the granting of incentive stock options, nonqualified stock options, stock appreciation rights, stock awards, stock units, performance units and other stock-based awards to employees, officers, non-employee directors, consultants, and advisors. In addition, the 2014 Plan provides selected executive employees with the opportunity to receive bonus awards that are considered qualified performance-based compensation. The 2014 Plan is subject to automatic annual increases in the number of shares authorized for issuance under the 2014 Plan on the first trading day of January each year equal to the lesser of 1.5 million shares or 10% of the number of shares of common stock outstanding on the last trading day of December of the preceding year. As of January 1, 2022, the number of shares of common stock that may be issued under the 2014 Plan was automatically increased by 1.5 million shares, increasing the total number of shares of common stock available for issuance under the 2014 Plan to 10,804,869 shares. As of September 30, 2022, 1,442,876 shares were available for future issuance under the 2014 Plan. Options issued under the 2014 Plan have a contractual life of 10 years and may be exercisable in cash or as otherwise determined by the board of directors. The Company has granted options to employees and non-employee directors. Stock options granted to employees primarily vest 25% upon the first anniversary of the grant date and the balance of unvested options vests in quarterly installments over the remaining three years. Stock options granted annually to non-employee directors vest on the earlier of the one-year anniversary of the grant date, or the date of the Company’s next annual stockholders’ meeting that occurs after the grant date. The Company’s non-employee director compensation policy enables directors to receive stock options in lieu of quarterly cash payments. Any option granted to the directors in lieu of cash compensation vests in full on the grant date. The Company records forfeitures as they occur. Stock-based compensation expense for performance-based grants are recorded when management estimates that the vesting of these shares is probable based on the status of the Company’s research and development programs and other relevant factors, which were established by the Company’s board of directors. The Company’s board of directors determines if the performance conditions have been met. During the nine months ended September 30, 2021, the Company granted 506,911 time-based restricted stock awards to employees with two-year cliff vesting of which 469,911 restricted stock awards remained outstanding as of September 30, 2022. In addition, during the nine months ended September 30, 2021, the Company granted 506,911 performance-based restricted stock awards to employees of which 187,964 restricted stock awards have fully vested and 281,947 restricted stock awards remained outstanding as of September 30, 2022. The performance-based conditions for these performance-based grants were deemed probable of achievement during the six months ended June 30, 2021 and, as of September 30, 2022, the Company has recorded $1.6 million in stock-based compensation expense related to these grants. As of September 30, 2022, there was $40,696 of unrecognized stock-based compensation expense related to these performance-based awards, which will be expensed over the estimated service period related to each performance condition. During the nine months ended September 30, 2022, the Company granted 841,654 time-based restricted stock awards to employees, non-employee directors and consultants of which 804,654 restricted stock awards remained outstanding as of September 30, 2022. In addition, during the nine months ended September 30, 2022, the Company granted 556,500 performance-based restricted stock awards to employees of which 548,000 restricted stock awards remained outstanding as of September 30, 2022. As of September 30, 2022, satisfaction of the related performance conditions has not been deemed probable of being achieved and there was $1.1 million of unrecognized stock-based compensation expense related to these performance-based awards, which will be expensed over the estimated service period related to each performance condition once the performance conditions have been deemed probable. For the nine months ended September 30, 2022 and 2021, the Company recorded stock-based compensation expense related to its stock option grants and restricted stock awards, as follows: Stock Option Grants Restricted stock awards Total 2022 2021 2022 2021 2022 2021 Research and development $ 776,809 $ 1,198,492 $ 723,638 $ 1,245,175 $ 1,500,447 $ 2,443,667 General and administrative 941,321 1,307,844 868,357 1,017,668 1,809,678 2,325,512 $ 1,718,130 $ 2,506,336 $ 1,591,995 $ 2,262,843 $ 3,310,125 $ 4,769,179 The following table summarizes the Company’s stock option activity for the nine months ended September 30, 2022: Weighted- Weighted- Average Average Aggregate Number Exercise Contractual Intrinsic of Shares Price Life (in Years) Value Outstanding as of December 31, 2021 5,224,913 $ 8.74 Granted 1,136,728 2.17 Forfeited (85,625) 10.97 Outstanding as of September 30, 2022 6,276,016 7.52 6.17 $ — Exercisable as of September 30, 2022 4,303,603 9.58 5.00 $ — Vested and expected to vest as of September 30, 2022 6,276,016 $ 7.52 The weighted-average grant date fair values of options granted during the nine months ended September 30, 2022 and 2021 were $1.74 and $2.84, respectively. The fair values of stock options granted were calculated using the Black-Scholes option pricing model with the following weighted-average assumptions: Nine months ended September 30, 2022 2021 Weighted-average risk-free interest rate 2.02% 0.37% Expected term of options (in years) 6.11 6.21 Expected stock price volatility 100.23% 95.60% Expected dividend yield 0% 0% As of September 30, 2022, there was $3.9 million of unrecognized stock-based compensation expense related to stock options, which is expected to be recognized over a weighted-average period of 2.40 years. During the nine months ended September 30, 2021, the Company received $47,906 in cash from the exercise of employee stock options. The following table summarizes the Company’s restricted stock award activity under the 2014 Plan for the nine months ended September 30, 2022: Weighted Average Aggregate Grant Date Intrinsic Shares Fair Value Value Unvested as of December 31, 2021 989,822 $ 3.62 Granted 1,398,154 2.17 Forfeited (25,500) 2.41 Vested (242,964) 3.60 Unvested as of September 30, 2022 2,119,512 $ 2.86 $ 1,551,483 Expected to vest as of September 30, 2022 1,566,512 $ 2.85 $ 1,146,687 As of September 30, 2022, excluding performance-based restricted stock awards that have not been deemed probable, there was $1.5 million of unrecognized stock-based compensation expense related to unvested restricted stock awards, which is expected to be recognized over a weighted-average period of 0.62 years. |
Operating Lease Obligations
Operating Lease Obligations | 9 Months Ended |
Sep. 30, 2022 | |
Operating Lease Obligations | |
Operating Lease Obligations | (9) Operating Lease Obligations The Company adopted Accounting Standards Update No. 2016-02, Leases (Topic 842), Accounting Standards Codification 842 The Company leases its headquarters where it occupies 10,877 square feet of office space. On March 1, 2021, the Company extended its lease for three As of March 1, 2021, the effective date of the lease modification, the Company remeasured the lease liability for the remaining portion of the lease and adjusted the lease liability to $755,085 and right-of-use assets to $752,391, which was recorded net of a deferred rent liability of $2,694. As of September 30, 2022, the Company’s right-of-use asset, net of amortization, was $394,205. Other operating lease information as of September 30, 2022: Weighted-average remaining lease term - operating leases 1.7 years Weighted-average discount rate - operating leases 2.76 % The following is a maturity analysis of the annual undiscounted cash flows of the operating lease liabilities as of September 30, 2022: September 30, Year ending: 2022 December 31, 2022 $ 60,105 December 31, 2023 240,421 December 31, 2024 100,175 Total minimum lease payments 400,701 Less: imputed lease interest (8,601) Total lease liabilities $ 392,100 Lease expense for the nine months ended September 30, 2022 was comprised of the following: Nine months ended September 30, 2022 2021 Operating lease expense $ 181,262 $ 183,788 Variable lease expense 46,951 46,190 Total lease expense $ 228,213 $ 229,978 Total cash payments related to leases were $227,266 and $237,835 for the nine months ended September 30, 2022 and 2021, respectively. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | a. Basis of Presentation The accompanying unaudited interim consolidated financial statements of the Company have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. The interim unaudited consolidated financial statements have been prepared on the same basis as the consolidated financial statements as of and for the year ended December 31, 2021 included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 (the “2021 Annual Report”), filed with the Securities and Exchange Commission (the “SEC”). In the opinion of management, the accompanying consolidated financial statements of the Company include all normal and recurring adjustments (which consist primarily of accruals, estimates and assumptions that impact the consolidated financial statements) considered necessary to present fairly the Company's financial position as of September 30, 2022, its results of operations for the three and nine months ended September 30, 2022 and 2021 and cash flows for the nine months ended September 30, 2022 and 2021. Operating results for any interim period are not necessarily indicative of results for any future interim period or for the entire year. The accompanying unaudited interim consolidated financial statements should be read in conjunction with the consolidated financial statements and related notes included in the 2021 Annual Report. |
Use of Estimates | b. Use of Estimates The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial |
Incentive and Tax Receivables | c. Incentive and Tax Receivables The Company’s subsidiary, Zynerba Pharmaceuticals Pty Ltd (the “Subsidiary”), is incorporated in Australia. The Subsidiary is eligible to participate in an Australian research and development tax incentive program. As part of this program, the Subsidiary is eligible to receive a cash refund from the Australian Taxation Office (“ATO”) for a percentage of the research and development costs expended by the Subsidiary in Australia. The cash refund is available to eligible companies with an annual aggregate revenue of less than $20.0 million (Australian) during the reimbursable period. The Company estimates the amount of cash refund it expects to receive related to the Australian research and development tax incentive program and records the incentives when it is probable (1) the Company will comply with relevant conditions of the program and (2) the incentive will be received. The Company evaluates its eligibility under tax incentive programs as of each balance sheet date based on the most current and relevant data available. If the Company is deemed to be ineligible or unable to receive the Australian research and development tax credit, or the Australian government significantly reduces or eliminates the tax credit, the actual cash refund the Company receives may materially differ from its estimates. In December 2018, the Company submitted an Advance Overseas Finding (“AOF”) application to a division of the Australian Government’s Department of Industry, Innovation and Science (“AusIndustry”), for a portion of the Company’s research and development activities incurred outside of Australia, which was approved by AusIndustry in July 2019. During the year ended December 31, 2019, the Company recorded $8.3 million as an incentive and tax receivable and recorded a corresponding credit During the three months ended March 31, 2022, the Company concluded its conversations with the ATO on these matters and made the decision to no longer pursue the AOF claim, resulting in the write off of both the AOF receivable and the corresponding reserve during the period. During the three months ended March 31, 2022, the Company received a payment of $8.0 million from the ATO for the non-AOF research and development incentive for the years ended December 31, 2018, 2019 and 2020. The Subsidiary incurs Goods and Services Tax (“GST”) on services provided by Australian vendors. As an Australian entity, the Subsidiary is entitled to a refund of the GST paid. The Company’s estimate of the amount of cash refund it expects to receive related to GST incurred is included in “Incentive and tax receivables” in the accompanying consolidated balance sheets. As of September 30, 2022, incentive and tax receivables included $0.3 million for refundable GST on expenses incurred with Australian vendors during the three months ended September 30, 2022. Current incentive and tax receivables consisted of the following as of September 30, 2022 and December 31, 2021: September 30, December 31, 2022 2021 Research and development incentive (non-AOF) for the period 1/1/18 - 12/31/18 $ — $ 3,144,152 Research and development incentive (non-AOF) for the period 1/1/19 - 12/31/19 — 2,914,931 Research and development incentive (non-AOF) for the period 1/1/20 - 12/31/20 — 1,993,038 Research and development incentive (non-AOF) for the period 1/1/21 - 12/31/21 1,095,535 1,226,688 Research and development incentive (AOF) for the period 1/1/18 - 12/31/19 — 8,566,843 Goods and services tax 283,203 301,659 Total incentive and tax receivables before reserve for AOF 1,378,738 18,147,311 Reserve for research and development incentive (AOF) for the period 1/1/18 - 12/31/19 — (8,566,843) Total incentive and tax receivables - current assets $ 1,378,738 $ 9,580,468 As of September 30, 2022, the Company’s estimate of the amount of cash refund it expects to receive for 2021 eligible spending as part of this incentive program was $1.1 million and was recorded as a current asset. In October 2022, the Company received payment from the ATO for the non-AOF research and development incentive for the year ended December 31, 2021 included in the table above. The Company’s estimate of the amount of cash refund it expects to receive for 2022 eligible spending through September 30, 2022 was $0.8 million and was recorded as a non-current asset. |
Research and Development | d. Research and Development Research and development costs are expensed as incurred and are primarily comprised of external research and development expenses incurred under arrangements with third parties, such as contract research organizations, contract manufacturing organizations, consultants and employee-related expenses including salaries and benefits. At the end of each reporting period, the Company compares the payments made to each service provider to the estimated progress towards completion of the related project. Factors that the Company considers in preparing these estimates include the number of patients enrolled in studies, milestones achieved and other criteria related to the efforts of its vendors. These estimates will be subject to change as additional information becomes available. Depending on the timing of payments to vendors and estimated services provided, the Company will record net prepaid or accrued expenses related to these costs. Research and development expenses are recorded net of expected refunds of eligible research and development costs paid pursuant to the Australian research and development tax incentive program and GST incurred on services provided by Australian vendors. The following table summarizes research and development expenses for the nine months ended September 30, 2022 and 2021: Nine months ended September 30, 2022 2021 Research and development expenses - before R&D incentive $ 16,450,619 $ 17,304,684 Research and development incentive (818,469) (902,555) Total research and development expenses $ 15,632,150 $ 16,402,129 |
Net Loss Per Share | e . Basic net loss per share is determined using the weighted average number of shares of common stock outstanding during each period. Diluted net income per share includes the effect, if any, from the potential exercise or conversion of securities, such as restricted stock and stock options, which would result in the issuance of incremental shares of common stock. Basic and dilutive computations of net loss per share are the same in periods in which a net loss exists as the dilutive effects of restricted stock and stock options would be anti-dilutive. The following potentially dilutive securities outstanding as of September 30, 2022 and 2021 have been excluded from the computation of diluted weighted average shares outstanding, as their effects on net loss per share for the periods presented would be anti-dilutive: September 30, 2022 2021 Stock options 6,276,016 5,300,538 Unvested restricted stock 2,119,512 1,053,822 8,395,528 6,354,360 |
Recent Accounting Pronouncements | f. Recent Accounting Pronouncements The Company does not expect any recently issued accounting pronouncements to have a significant impact on its future results of operations, financial position or cash flow. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Summary of Significant Accounting Policies | |
Schedule of incentive and tax receivables | September 30, December 31, 2022 2021 Research and development incentive (non-AOF) for the period 1/1/18 - 12/31/18 $ — $ 3,144,152 Research and development incentive (non-AOF) for the period 1/1/19 - 12/31/19 — 2,914,931 Research and development incentive (non-AOF) for the period 1/1/20 - 12/31/20 — 1,993,038 Research and development incentive (non-AOF) for the period 1/1/21 - 12/31/21 1,095,535 1,226,688 Research and development incentive (AOF) for the period 1/1/18 - 12/31/19 — 8,566,843 Goods and services tax 283,203 301,659 Total incentive and tax receivables before reserve for AOF 1,378,738 18,147,311 Reserve for research and development incentive (AOF) for the period 1/1/18 - 12/31/19 — (8,566,843) Total incentive and tax receivables - current assets $ 1,378,738 $ 9,580,468 |
Schedule of research and development expenses | Nine months ended September 30, 2022 2021 Research and development expenses - before R&D incentive $ 16,450,619 $ 17,304,684 Research and development incentive (818,469) (902,555) Total research and development expenses $ 15,632,150 $ 16,402,129 |
Summary of potentially dilutive securities excluded from the computation of diluted weighted average shares outstanding | September 30, 2022 2021 Stock options 6,276,016 5,300,538 Unvested restricted stock 2,119,512 1,053,822 8,395,528 6,354,360 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Measurements | |
Summary of financial assets measured at fair value on a recurring basis | Fair Value Measurement Carrying amount as of September 30, 2022 as of September 30, 2022 Level 1 Level 2 Level 3 Cash equivalents (money market accounts) $ 50,368,948 $ 50,368,948 $ — $ — $ 50,368,948 $ 50,368,948 $ — $ — Fair Value Measurement Carrying amount as of December 31, 2021 as of December 31, 2021 Level 1 Level 2 Level 3 Cash equivalents (money market accounts) $ 67,709,279 $ 67,709,279 $ — $ — $ 67,709,279 $ 67,709,279 $ — $ — |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Prepaid Expenses and Other Current Assets | |
Schedule of prepaid expenses and other current assets | September 30, December 31, 2022 2021 Prepaid development expenses $ 634,106 $ 543,897 Prepaid insurance 2,186,026 1,952,867 Deferred financing costs 156,271 137,615 Other current assets 511,223 197,013 Total prepaid expenses and other current assets $ 3,487,626 $ 2,831,392 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Property and Equipment | |
Schedule of property and equipment | Estimated useful life September 30, December 31, (in years) 2022 2021 Equipment 2-5 $ 740,543 $ 740,543 Computer equipment 3-5 30,319 30,319 Furniture and fixtures 3-5 311,356 311,356 Leasehold improvements various 68,881 68,881 Construction in process 279,292 79,342 Total cost 1,430,391 1,230,441 Less accumulated depreciation (1,010,528) (844,608) Property and equipment, net $ 419,863 $ 385,833 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Accrued Expenses | |
Schedule of accrued expenses | September 30, December 31, 2022 2021 Accrued compensation $ 2,006,537 $ 2,412,291 Accrued research and development 4,731,308 5,125,010 Other 860,342 359,297 Total accrued expenses $ 7,598,187 $ 7,896,598 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Stock-Based Compensation | |
Schedule of stock-based compensation expense | Stock Option Grants Restricted stock awards Total 2022 2021 2022 2021 2022 2021 Research and development $ 776,809 $ 1,198,492 $ 723,638 $ 1,245,175 $ 1,500,447 $ 2,443,667 General and administrative 941,321 1,307,844 868,357 1,017,668 1,809,678 2,325,512 $ 1,718,130 $ 2,506,336 $ 1,591,995 $ 2,262,843 $ 3,310,125 $ 4,769,179 |
Summary of stock option activity | Weighted- Weighted- Average Average Aggregate Number Exercise Contractual Intrinsic of Shares Price Life (in Years) Value Outstanding as of December 31, 2021 5,224,913 $ 8.74 Granted 1,136,728 2.17 Forfeited (85,625) 10.97 Outstanding as of September 30, 2022 6,276,016 7.52 6.17 $ — Exercisable as of September 30, 2022 4,303,603 9.58 5.00 $ — Vested and expected to vest as of September 30, 2022 6,276,016 $ 7.52 |
Schedule of weighted-average assumptions used to calculate fair values of stock options | Nine months ended September 30, 2022 2021 Weighted-average risk-free interest rate 2.02% 0.37% Expected term of options (in years) 6.11 6.21 Expected stock price volatility 100.23% 95.60% Expected dividend yield 0% 0% |
Summary of restricted stock activity | Weighted Average Aggregate Grant Date Intrinsic Shares Fair Value Value Unvested as of December 31, 2021 989,822 $ 3.62 Granted 1,398,154 2.17 Forfeited (25,500) 2.41 Vested (242,964) 3.60 Unvested as of September 30, 2022 2,119,512 $ 2.86 $ 1,551,483 Expected to vest as of September 30, 2022 1,566,512 $ 2.85 $ 1,146,687 |
Operating Lease Obligations (Ta
Operating Lease Obligations (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Operating Lease Obligations | |
Schedule of other operating lease information | Weighted-average remaining lease term - operating leases 1.7 years Weighted-average discount rate - operating leases 2.76 % |
Schedule of operating lease liabilities maturity analysis | September 30, Year ending: 2022 December 31, 2022 $ 60,105 December 31, 2023 240,421 December 31, 2024 100,175 Total minimum lease payments 400,701 Less: imputed lease interest (8,601) Total lease liabilities $ 392,100 |
Schedule of lease expense | Nine months ended September 30, 2022 2021 Operating lease expense $ 181,262 $ 183,788 Variable lease expense 46,951 46,190 Total lease expense $ 228,213 $ 229,978 |
Nature of Business and Liquid_2
Nature of Business and Liquidity (Details) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Nature of Business and Liquidity | ||
Accumulated deficit | $ 266,501,253 | $ 239,481,479 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Incentive and Tax Receivable (Details) - Australian Taxation Office - USD ($) $ in Millions | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2022 | Dec. 31, 2019 | Sep. 30, 2022 | |
Incentive and Tax Receivable | |||
Aggregate revenue maximum to be eligible to receive a cash refund | $ 20 | ||
Research and development incentive and tax receivable | $ 8.3 | ||
Research and development incentive tax credit | $ 8.3 | ||
Research and development incentive | $ 8 | ||
Incentive And Tax Receivables Current | |||
Incentive and Tax Receivable | |||
Estimated GST receivable | $ 0.3 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Current incentive and Tax Receivable (Details) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Incentive and Tax Receivable | ||
Total incentive and tax receivables - current assets | $ 1,378,738 | $ 9,580,468 |
Australian Taxation Office | ||
Incentive and Tax Receivable | ||
Research and development incentive (non-AOF) for the period 1/1/18 - 12/31/18 | 3,144,152 | |
Research and development incentive (non-AOF) for the period 1/1/19 - 12/31/19 | 2,914,931 | |
Research and development incentive (non-AOF) for the period 1/1/20 - 12/31/20 | 1,993,038 | |
Research and development incentive (non-AOF) for the period 1/1/21 - 12/31/21 | 1,095,535 | 1,226,688 |
Research and development incentive (AOF) for the period 1/1/18 - 12/31/19 | 8,566,843 | |
Goods and services tax | 283,203 | 301,659 |
Total incentive and tax receivables before reserve for AOF | 1,378,738 | 18,147,311 |
Reserve for research and development incentive (AOF) for the period 1/1/18 - 12/31/19 | (8,566,843) | |
Total incentive and tax receivables - current assets | 1,378,738 | $ 9,580,468 |
Australian Taxation Office | Incentive And Tax Receivables Current | ||
Incentive and Tax Receivable | ||
Cash refund from research and development incentive program | 1,100,000 | |
Australian Taxation Office | Incentive And Tax Receivables Noncurrent. | ||
Incentive and Tax Receivable | ||
Cash refund from research and development incentive program | $ 800,000 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Research and Development (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Research and Development | ||||
Research and development expenses - before R&D incentive | $ 16,450,619 | $ 17,304,684 | ||
Research and development incentive | (818,469) | (902,555) | ||
Total research and development expense | $ 5,039,228 | $ 6,341,171 | $ 15,632,150 | $ 16,402,129 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Anti-dilutive securities (Details) - shares | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share | ||
Anti-dilutive securities | 8,395,528 | 6,354,360 |
Stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share | ||
Anti-dilutive securities | 6,276,016 | 5,300,538 |
Restricted stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share | ||
Anti-dilutive securities | 2,119,512 | 1,053,822 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Carrying value | ||
Fair value on a recurring basis | ||
Cash equivalents (money market accounts) | $ 50,368,948 | $ 67,709,279 |
Total | 50,368,948 | 67,709,279 |
Recurring | Fair Value Measurement | Level 1 | ||
Fair value on a recurring basis | ||
Cash equivalents (money market accounts) | 50,368,948 | 67,709,279 |
Total | $ 50,368,948 | $ 67,709,279 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets (Details) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Prepaid Expenses and Other Current Assets | ||
Prepaid development expenses | $ 634,106 | $ 543,897 |
Prepaid insurance | 2,186,026 | 1,952,867 |
Deferred financing costs | 156,271 | 137,615 |
Other current assets | 511,223 | 197,013 |
Total prepaid expenses and other current assets | $ 3,487,626 | $ 2,831,392 |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Property, Plant and Equipment | |||
Total cost | $ 1,430,391 | $ 1,230,441 | |
Less accumulated depreciation | (1,010,528) | (844,608) | |
Property and equipment, net | 419,863 | 385,833 | |
Depreciation expense | 165,920 | $ 185,245 | |
Equipment | |||
Property, Plant and Equipment | |||
Total cost | $ 740,543 | $ 740,543 | |
Equipment | Minimum | |||
Property, Plant and Equipment | |||
Estimated useful life | 2 years | 2 years | |
Equipment | Maximum | |||
Property, Plant and Equipment | |||
Estimated useful life | 5 years | 5 years | |
Computer equipment | |||
Property, Plant and Equipment | |||
Total cost | $ 30,319 | $ 30,319 | |
Computer equipment | Minimum | |||
Property, Plant and Equipment | |||
Estimated useful life | 3 years | 3 years | |
Computer equipment | Maximum | |||
Property, Plant and Equipment | |||
Estimated useful life | 5 years | 5 years | |
Furniture and fixtures | |||
Property, Plant and Equipment | |||
Total cost | $ 311,356 | $ 311,356 | |
Furniture and fixtures | Minimum | |||
Property, Plant and Equipment | |||
Estimated useful life | 3 years | 3 years | |
Furniture and fixtures | Maximum | |||
Property, Plant and Equipment | |||
Estimated useful life | 5 years | 5 years | |
Leasehold improvements | |||
Property, Plant and Equipment | |||
Estimated useful life (in years) | various | various | |
Total cost | $ 68,881 | $ 68,881 | |
Construction in process | |||
Property, Plant and Equipment | |||
Total cost | $ 279,292 | $ 79,342 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Accrued Expenses | ||
Accrued compensation | $ 2,006,537 | $ 2,412,291 |
Accrued research and development | 4,731,308 | 5,125,010 |
Other | 860,342 | 359,297 |
Total accrued expenses | $ 7,598,187 | $ 7,896,598 |
Common Stock (Details)
Common Stock (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 18 Months Ended | |||||
Jul. 21, 2022 | Sep. 30, 2022 | Mar. 31, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Feb. 09, 2021 | May 11, 2021 | Aug. 31, 2019 | |
Sales of Stock | ||||||||
Proceeds from the issuance of common stock | $ 6,059,511 | $ 43,193,660 | ||||||
2021 Sales Agreement | ||||||||
Sales of Stock | ||||||||
Maximum aggregate value of common stock available for offering | $ 75,000,000 | |||||||
Shares issued | 3,925,298 | |||||||
Weighted average selling price per share | $ 1.49 | |||||||
Proceeds from the issuance of common stock | $ 5,800,000 | |||||||
Net proceeds from the issuance of common stock | $ 5,400,000 | |||||||
2019 Sales Agreement. | ||||||||
Sales of Stock | ||||||||
Maximum aggregate value of common stock available for offering | $ 75,000,000 | |||||||
Shares issued | 10,244,326 | |||||||
Weighted average selling price per share | $ 4.22 | |||||||
Proceeds from the issuance of common stock | $ 43,200,000 | $ 75,000,000 | ||||||
Net proceeds from the issuance of common stock | $ 42,200,000 | |||||||
Equity Purchase Agreement | ||||||||
Sales of Stock | ||||||||
Maximum aggregate value of common stock available for offering | $ 20,000,000 | |||||||
Shares issued | 200,000 | 347,222 | ||||||
Weighted average selling price per share | $ 1.15 | |||||||
Proceeds from the issuance of common stock | $ 200,000 | |||||||
Net proceeds from the issuance of common stock | $ 100,000 | |||||||
Maximum time period for right to sell shares from the effective date | 36 months | |||||||
Maximum number of shares that may sell per day in regular purchase | 150,000 | |||||||
Maximum number of shares that may sell per day depending upon closing price | 300,000 | |||||||
Maximum value limit per regular purchase | $ 2,000,000 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock Based Compensation Narrative (Details) - 2014 Plan - USD ($) | 9 Months Ended | ||
Jan. 01, 2022 | Sep. 30, 2022 | Sep. 30, 2021 | |
Stock-Based Compensation | |||
Annual threshold increase of authorized shares for issuance | 1,500,000 | ||
Annual threshold increase of authorized shares for issuance (as a percent) | 10% | ||
Additional number of shares authorized for issuance | 1,500,000 | ||
Shares reserved for issuance | 10,804,869 | ||
Shares available for issuance | 1,442,876 | ||
Share based compensation expense | $ 3,310,125 | $ 4,769,179 | |
Stock options | |||
Stock-Based Compensation | |||
Contractual life (in years) | 10 years | ||
Share based compensation expense | $ 1,718,130 | $ 2,506,336 | |
Stock options | Employees | |||
Stock-Based Compensation | |||
Vesting percentage | 25% | ||
Vesting period | 3 years | ||
Stock options | Board of Directors | |||
Stock-Based Compensation | |||
Vesting period | 1 year | ||
Time Based Restricted Stock | 2021 Award | |||
Stock-Based Compensation | |||
Shares granted | 506,911 | ||
Shares outstanding | 469,911 | ||
Vesting period | 2 years | ||
Time Based Restricted Stock | 2022 Award | |||
Stock-Based Compensation | |||
Shares granted | 841,654 | ||
Shares outstanding | 804,654 | ||
Performance-based awards | 2022 Award | |||
Stock-Based Compensation | |||
Unrecognized stock based compensation expense | $ 1,100,000 | ||
Performance Based Restricted Awards | 2021 Award | |||
Stock-Based Compensation | |||
Shares granted | 506,911 | ||
Shares outstanding | 281,947 | ||
Share based compensation expense | $ 1,600,000 | ||
Unrecognized stock based compensation expense | $ 40,696 | ||
Restricted stock vested | 187,964 | ||
Performance Based Restricted Awards | 2022 Award | |||
Stock-Based Compensation | |||
Shares granted | 556,500 | ||
Shares outstanding | 548,000 |
Stock-Based Compensation - St_2
Stock-Based Compensation - Stock-Based Compensation Expense (Details) - 2014 Plan - USD ($) | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Stock-Based Compensation | ||
Stock-based compensation | $ 3,310,125 | $ 4,769,179 |
Research and development | ||
Stock-Based Compensation | ||
Stock-based compensation | 1,500,447 | 2,443,667 |
General and administrative | ||
Stock-Based Compensation | ||
Stock-based compensation | 1,809,678 | 2,325,512 |
Stock options | ||
Stock-Based Compensation | ||
Stock-based compensation | 1,718,130 | 2,506,336 |
Stock options | Research and development | ||
Stock-Based Compensation | ||
Stock-based compensation | 776,809 | 1,198,492 |
Stock options | General and administrative | ||
Stock-Based Compensation | ||
Stock-based compensation | 941,321 | 1,307,844 |
Restricted stock | ||
Stock-Based Compensation | ||
Stock-based compensation | 1,591,995 | 2,262,843 |
Restricted stock | Research and development | ||
Stock-Based Compensation | ||
Stock-based compensation | 723,638 | 1,245,175 |
Restricted stock | General and administrative | ||
Stock-Based Compensation | ||
Stock-based compensation | $ 868,357 | $ 1,017,668 |
Stock-Based Compensation - Opti
Stock-Based Compensation - Options Activity, Unrecognized Costs, Valuation (Details) - USD ($) | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Additional disclosures | ||
Proceeds from the exercise of stock options | $ 47,906 | |
2014 Plan | Stock options | ||
Options | ||
Balance (in shares) | 5,224,913 | |
Granted (in shares) | 1,136,728 | |
Forfeited (in shares) | (85,625) | |
Balance (in shares) | 6,276,016 | |
Options exercisable (in shares) | 4,303,603 | |
Options vested and expected to vest (in shares) | 6,276,016 | |
Weighted average exercise price per share | ||
Balance (in dollars per shares) | $ 8.74 | |
Granted (in dollars per shares) | 2.17 | |
Forfeited (in dollars per share) | 10.97 | |
Balance (in dollars per shares) | 7.52 | |
Options exercisable (in dollars per shares) | 9.58 | |
Options vested and expected to vest (in dollars per share) | $ 7.52 | |
Additional disclosures | ||
Options Outstanding Weighted Average Contractual term | 6 years 2 months 1 day | |
Options Vested and Expected to Vest Weighted Average Contractual Life | 5 years | |
Expected stock based compensation expense | $ 3,900,000 | |
Recognition period for compensation costs | 2 years 4 months 24 days | |
Proceeds from the exercise of stock options | $ 47,906 | |
Weighted Average Grant Date Fair Value | ||
Granted (in dollars per share) | $ 1.74 | $ 2.84 |
Assumptions and Methodology | ||
Weighted average risk-free interest rate (as a percent) | 2.02% | 0.37% |
Expected term of options (in years) | 6 years 1 month 9 days | 6 years 2 months 15 days |
Expected stock price volatility (as a percent) | 100.23% | 95.60% |
Expected dividend yield (as a percent) | 0% | 0% |
Stock-Based Compensation - Rest
Stock-Based Compensation - Restricted Stock Activity, Unrecognized Costs (Details) - 2014 Plan - Restricted stock | 9 Months Ended |
Sep. 30, 2022 USD ($) $ / shares shares | |
Restricted stock award activity | |
Unvested balance (in shares) | shares | 989,822 |
Granted (in shares) | shares | 1,398,154 |
Forfeited (in shares) | shares | (25,500) |
Vested (in shares) | shares | (242,964) |
Unvested balance (in shares) | shares | 2,119,512 |
Weighted Average Grant Date Fair Value | |
Unvested balance (in dollars per share) | $ / shares | $ 3.62 |
Granted (in dollars per share) | $ / shares | 2.17 |
Forfeited (in dollars per share) | $ / shares | 2.41 |
Vested (in dollars per share) | $ / shares | 3.60 |
Unvested balance (in dollars per share) | $ / shares | $ 2.86 |
Aggregate intrinsic value | $ | $ 1,551,483 |
Unvested restricted stock awards expected to vest (in shares) | shares | 1,566,512 |
Vested and expected to vest - Weighted average grant date fair value | $ / shares | $ 2.85 |
Vested and expected to vest - Aggregate Intrinsic Value | $ | $ 1,146,687 |
Unrecognized compensation expense related to unvested awards | $ | $ 1,500,000 |
Recognition period for compensation costs | 7 months 13 days |
Operating Lease Obligations - N
Operating Lease Obligations - Narrative (Details) | 9 Months Ended | ||
Mar. 01, 2021 USD ($) | Sep. 30, 2022 USD ($) ft² | Dec. 31, 2021 USD ($) | |
Operating Lease Obligations | |||
Practical expedients - Package | true | ||
Practical expedients - Single lease component | true | ||
Area of leasable office space | ft² | 10,877 | ||
Extended term of lease | 3 years | ||
Operating lease liability | $ 755,085 | $ 392,100 | |
Right-of-use assets | 752,391 | $ 394,205 | $ 565,814 |
Deferred rent liability included in right-of-use assets | $ 2,694 |
Operating Lease Obligations - O
Operating Lease Obligations - Other Operating Lease Information (Details) | Sep. 30, 2022 |
Operating Lease Obligations | |
Weighted-average remaining lease term - operating leases | 1 year 8 months 12 days |
Weighted-average discount rate - operating leases | 2.76% |
Operating Lease Obligations - M
Operating Lease Obligations - Maturities (Details) - USD ($) | Sep. 30, 2022 | Mar. 01, 2021 |
Maturity Analysis of Operating Lease Liabilities | ||
December 31, 2022 | $ 60,105 | |
December 31, 2023 | 240,421 | |
December 31, 2024 | 100,175 | |
Total minimum lease payments | 400,701 | |
Less: imputed lease interest | (8,601) | |
Total lease liabilities | $ 392,100 | $ 755,085 |
Operating Lease Obligations - L
Operating Lease Obligations - Lease Expense and Payments (Details) - USD ($) | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Lease expense | ||
Operating lease expense | $ 181,262 | $ 183,788 |
Variable lease expense | 46,951 | 46,190 |
Total lease expense | 228,213 | 229,978 |
Cash payments related to leases | $ 227,266 | $ 237,835 |