Document And Entity Information
Document And Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Mar. 25, 2022 | Jun. 30, 2021 | |
Document Information Line Items | |||
Entity Registrant Name | ACTINIUM PHARMACEUTICALS, INC. | ||
Trading Symbol | ATNM | ||
Document Type | 10-K | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Common Stock, Shares Outstanding | 22,143,974 | ||
Entity Public Float | $ 138,622,140 | ||
Amendment Flag | false | ||
Entity Central Index Key | 0001388320 | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Well-known Seasoned Issuer | No | ||
Document Period End Date | Dec. 31, 2021 | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
ICFR Auditor Attestation Flag | false | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Entity File Number | 000-52446 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 74-2963609 | ||
Entity Address, Address Line One | 275 Madison Avenue, 7th Fl. | ||
Entity Address, City or Town | New York | ||
Entity Address, State or Province | NY | ||
Entity Address, Postal Zip Code | 10016 | ||
City Area Code | (646) | ||
Local Phone Number | 677-3870 | ||
Title of 12(b) Security | Common stock, par value $0.001 | ||
Security Exchange Name | NYSE | ||
Entity Interactive Data Current | Yes | ||
Auditor Name | Marcum llp | ||
Auditor Location | Houston, Texas | ||
Auditor Firm ID | 688 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Current Assets: | ||
Cash and cash equivalents | $ 77,829 | $ 63,560 |
Restricted cash – current | 392 | 48 |
Security deposit | 50 | |
Prepaid expenses and other current assets | 1,478 | 1,317 |
Total Current Assets | 79,749 | 64,925 |
Property and equipment, net of accumulated depreciation of $335 and $291 | 340 | 312 |
Operating lease right-of-use assets | 241 | 579 |
Finance leases right-of-use assets | 58 | 140 |
Security deposit | 50 | |
Restricted cash | 391 | |
Total Assets | 80,388 | 66,397 |
Current Liabilities: | ||
Accounts payable and accrued expenses | 5,535 | 4,340 |
Other liability | 998 | |
Operating leases current liability | 245 | 342 |
Finance leases current liability | 62 | 85 |
Total Current Liabilities | 6,840 | 4,767 |
Long-term operating lease obligations | 245 | |
Long-term finance lease obligations | 3 | 66 |
Total Liabilities | 6,843 | 5,078 |
Commitments and contingencies | ||
Stockholders’ Equity: | ||
Preferred stock, $0.001 par value; 50,000,000 shares authorized, 0 shares issued and outstanding | ||
Common stock, $0.001 par value; 1,000,000,000 and 600,000,000 shares authorized; 22,143,974 and 17,532,893 shares issued and outstanding | 22 | 18 |
Additional paid-in capital | 329,271 | 292,275 |
Accumulated deficit | (255,748) | (230,974) |
Total Stockholders’ Equity | 73,545 | 61,319 |
Total Liabilities and Stockholders’ Equity | $ 80,388 | $ 66,397 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Property and equipment, net of accumulated depreciation (in Dollars) | $ 335 | $ 291 |
Preferred stock par value (in Dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 50,000,000 | 50,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock par value (in Dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 1,000,000,000 | 600,000,000 |
Common stock, shares issued | 22,143,974 | 17,532,893 |
Common stock, shares outstanding | 22,143,974 | 17,532,893 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Revenue | ||
Revenue | ||
Other Revenue | 1,144 | |
Total revenue | 1,144 | |
Operating expenses: | ||
Research and development, net of reimbursements | 18,031 | 16,085 |
General and administrative | 8,077 | 6,308 |
Total operating expenses | 26,108 | 22,393 |
Loss from operations | (24,964) | (22,393) |
Other income: | ||
Interest income - net | 190 | 178 |
Total other income | 190 | 178 |
Net loss | (24,774) | (22,215) |
Deemed dividend for warrant down-round protection provision | (1) | |
Net loss applicable to common stockholders | $ (24,774) | $ (22,216) |
Net loss per common share - basic and diluted (in Dollars per share) | $ (1.2) | $ (1.83) |
Weighted average common shares outstanding - basic and diluted (in Shares) | 20,568,373 | 12,134,259 |
Consolidated Statement of Chang
Consolidated Statement of Changes in Stockholders’ Equity - USD ($) $ in Thousands | Common Stock | Additional Paid-In Capital | Accumulated Deficit | Total |
Balance at Dec. 31, 2019 | $ 5 | $ 214,397 | $ (208,758) | $ 5,644 |
Balance (in Shares) at Dec. 31, 2019 | 5,490,038 | |||
Stock-based compensation | 1,254 | 1,254 | ||
Stock-based compensation (in Shares) | 6,262 | |||
Sale of common stock and warrants, net of offering costs | $ 9 | 76,580 | 76,589 | |
Sale of common stock and warrants, net of offering costs (in Shares) | 8,575,051 | |||
Issuance of common stock from exercise of pre-funded warrants | $ 4 | 6 | 10 | |
Issuance of common stock from exercise of pre-funded warrants (in Shares) | 3,458,929 | |||
Issuance of common stock from exercise of warrants | 37 | 37 | ||
Issuance of common stock from exercise of warrants (in Shares) | 2,613 | |||
Deemed dividend for warrant down-round protection provision | 1 | (1) | ||
Net loss | (22,215) | (22,215) | ||
Balance at Dec. 31, 2020 | $ 18 | 292,275 | (230,974) | 61,319 |
Balance (in Shares) at Dec. 31, 2020 | 17,532,893 | |||
Stock-based compensation | 1,694 | 1,694 | ||
Stock-based compensation (in Shares) | 21,306 | |||
Sale of common stock, net of offering costs | $ 4 | 35,296 | 35,300 | |
Sale of common stock, net of offering costs (in Shares) | 4,588,875 | |||
Issuance of common stock from exercise of stock options | 6 | 6 | ||
Issuance of common stock from exercise of stock options (in Shares) | 900 | |||
Net loss | (24,774) | (24,774) | ||
Balance at Dec. 31, 2021 | $ 22 | $ 329,271 | $ (255,748) | $ 73,545 |
Balance (in Shares) at Dec. 31, 2021 | 22,143,974 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Cash Flows from Operating Activities: | ||
Net loss | $ (24,774) | $ (22,215) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 1,694 | 1,254 |
Depreciation and amortization expense | 524 | 447 |
Prepaid expenses and other current assets | (161) | (531) |
Increase (decrease) in: | ||
Accounts payable and accrued expenses | 1,195 | (257) |
Other liability | 998 | |
Operating lease liabilities | (342) | (315) |
Net Cash Used In Operating Activities | (20,866) | (21,617) |
Cash Flows from Investing Activities: | ||
Purchase of property and equipment | (133) | (253) |
Net Cash Used In Investing Activities | (133) | (253) |
Cash Flows from Financing Activities: | ||
Payments on note payable | (381) | |
Payments on finance leases | (85) | (79) |
Proceeds from sales of shares of common stock and warrants, net of offering costs | 35,300 | 76,589 |
Proceeds from the exercise of stock options | 6 | |
Proceeds from the exercise of warrants | 47 | |
Net Cash Provided By Financing Activities | 35,221 | 76,176 |
Net change in cash, cash equivalents and restricted cash | 14,222 | 54,306 |
Cash, cash equivalents and restricted cash at beginning of year | 63,999 | 9,693 |
Cash, cash equivalents and restricted cash at end of year | 78,221 | 63,999 |
Supplemental disclosures of cash flow information: | ||
Cash paid for interest | 8 | |
Cash paid for taxes | ||
Supplemental disclosure of non-cash investing and financing activities: | ||
Deemed dividend for warrant down-round protection provision | $ 1 |
Description of Business and Sum
Description of Business and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Description of Business and Summary of Significant Accounting Policies | Note 1 - Description of Business and Summary of Significant Accounting Policies Nature of Business - Principles of Consolidation - Use of Estimates in Financial Statement Presentation - Impact of COVID–19 Pandemic on Financial Statements - Many countries around the world have continued to impose quarantines and restrictions on travel and mass gatherings to slow the spread of the virus. Accordingly, the Company’s ability to continue to operate its business may also be limited. Such events may result in a period of business, supply and drug product manufacturing disruption, and in reduced operations, any of which could materially affect the Company’s business, financial condition and results of operations. In response to COVID-19, the Company implemented remote working and thus far, has not experienced a significant disruption or delay in its operations as it relates to the clinical development or drug production of our drug candidates. A continuation or worsening of the levels of market disruption and volatility seen in the recent past could have an adverse effect on the Company’s ability to access capital, which could in the future negatively affect the Company’s liquidity. In addition, a recession or market correction resulting from the spread of COVID-19 could materially affect the Company’s business and the value of the Company’s common stock. Additionally, COVID-19 may result in delays in receiving approvals from local and foreign regulatory authorities, delays in necessary interactions with IRB’s or Institutional Review Boards, local and foreign regulators, ethics committees and other important agencies and contractors due to limitations in employee resources or forced furlough of government employees. To date, COVID-19 has not had a financial impact on the Company. The Company continues to monitor the impacts of COVID-19 on the global economy and on its business operations. However, at this time, it is difficult to predict how long the potential operational impacts of COVID-19 will last or to what degree further disruption might impact the Company’s operations and financial results. Cash and Cash Equivalents and Restricted Cash- Following is a summary of cash, cash equivalents and restricted cash at December 31, 2021 and December 31, 2020: (in thousands) December 31, December 31, Cash and cash equivalents $ 77,829 $ 63,560 Restricted cash – current 392 48 Restricted cash – long-term - 391 Cash, cash equivalents and restricted cash $ 78,221 $ 63,999 Current restricted cash of $392 thousand at December 31, 2021 relates to a certificate of deposit held as collateral for a letter of credit issued in connection with the Company’s lease for corporate office space. This restricted cash was classified as long-term restricted cash at December 31, 2020. Current restricted cash of $48 thousand at December 31, 2020 related to a credit card account. Property and Equipment - Leases Fair Value of Financial Instruments - Revenue Recognition Revenue From Contracts With Customers At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses whether the promised goods or services promised within each contract are distinct and, therefore, represent a separate performance obligation. Goods and services that are determined not to be distinct are combined with other promised goods and services until a distinct bundle is identified. In determining whether goods or services are distinct, the Company evaluates certain criteria, including whether (i) the customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer (capable of being distinct) and (ii) the good or service is separately identifiable from other goods or services in the contract (distinct in the context of the contract). The Company then determines the transaction price, which is the amount of consideration it expects to be entitled from a customer in exchange for the promised goods or services for each performance obligation and recognizes the associated revenue as each performance obligation is satisfied. The Company’s estimate of the transaction price for each contract includes all variable consideration to which it expects to be entitled. Variable consideration includes payments in the form of collaboration milestone payments. If an arrangement includes collaboration milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. ASC 606 requires the Company to allocate the arrangement consideration on a relative standalone selling price basis for each performance obligation after determining the transaction price of the contract and identifying the performance obligations to which that amount should be allocated. The relative standalone selling price is defined in the revenue standard as the price at which an entity would sell a promised good or service separately to a customer. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation as each performance obligation is satisfied, either at a point in time or over time, and if over time, recognition is based on the use of an output or input method. Collaborative Arrangements - The Company follows the accounting guidance for collaboration agreements with third parties, which requires that certain transactions between the Company and collaborators be recorded in its consolidated statements of operations on either a gross basis or net basis, depending on the characteristics of the collaborative relationship, and requires enhanced disclosure of collaborative relationships. The Company evaluates its collaboration agreements for proper classification in its consolidated statements of operations based on the nature of the underlying activity. When the Company has concluded that it has a customer relationship with one of its collaborators, the Company follows the guidance of ASC 606 . Grant Revenue – Research and Development Costs - Share-Based Payments - Income Taxes - FASB ASC 740 prescribes guidance for the financial statement recognition, measurement and disclosure of uncertain tax positions. Tax positions must meet a “more-likely-than-not” recognition threshold to be recognized. There were no tax positions for which it is considered reasonably possible that the total amounts of unrecognized tax benefits will significantly increase or decrease within the next year. The Company recognizes interest related to unrecognized tax benefits in interest expense and penalties in operating expenses Net Loss Per Common Share For the years ended December 31, 2021 and 2020, the Company’s potentially dilutive shares, which include outstanding common stock options and warrants have not been included in the computation of diluted net loss per share as the result would have been anti-dilutive. (in thousands) December 31, December 31, Options 1,362 815 Warrants 2,112 2,113 Total 3,474 2,928 Subsequent Events Accounting Standards Recently Adopted Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity Accounting Standards Recently Issued– Earnings Per Share (topic 260), Debt — Modifications and Extinguishments (Subtopic 470-50), Compensation – Stock Compensation (Topic 718) and Derivatives and Hedging – Contracts in an Entity’s Own Equity (Subtopic 815-40) – Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options In October 2021, FASB issued ASU 2021-08, Business Combinations (Topic 805), Account for Contract Assets and Contract Liabilities from Contracts with Customers In November 2021, the FASB issued ASU 2021-10, Government Assistance (Topic 832), Disclosures by Business Entities about Government Assistance |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 12 Months Ended |
Dec. 31, 2021 | |
Disclosure Text Block Supplement [Abstract] | |
Prepaid Expenses and Other Current Assets | Note 2 - Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consisted of the following at December 31, 2021 and 2020: December 31, December 31, 2021 2020 Prepaid insurance $ 874 $ 792 Prepaid clinical trial expenses 543 457 Other prepaid expenses and other current assets 61 68 Total prepaid expenses and other current assets $ 1,478 $ 1,317 |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Note 3 - Property and Equipment Property and equipment consisted of the following at December 31, 2021 and 2020: December 31, December 31, (in thousands) Lives 2021 2020 Lab equipment 5 years $ 476 $ 378 Office equipment and furniture 3 - 7 years 199 225 Less: accumulated depreciation (335 ) (291 ) Property and equipment, net $ 340 $ 312 Depreciation expense consisted of the following for the years ended December 31, 2021 and 2020, respectively: December 31, December 31, (in thousands) 2021 2020 Research and development $ 88 $ 36 General administrative 17 18 Total Depreciation expense $ 105 $ 54 |
Leases
Leases | 12 Months Ended |
Dec. 31, 2021 | |
Leases [Abstract] | |
Leases | Note 4 - Leases The Company determines if an arrangement is a lease at inception. This determination generally depends on whether the arrangement conveys to the Company the right to control the use of a fixed asset for a period of time in exchange for consideration. Control of an underlying asset is conveyed to the Company if the Company obtains the rights to direct the use of and to obtain substantially all of the economic benefits from using the underlying asset. The Company has lease agreements which include lease and non-lease components, which the Company has elected to account for as a single lease component for all classes of underlying assets. Lease expense for variable lease components are recognized when the obligation is probable. The Company made an accounting policy election to exclude from balance sheet reporting those leases with initial terms of 12 months or less. Right-of-use assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. ASC 842 requires a lessee to discount its unpaid lease payments using the interest rate implicit in the lease or, if that rate cannot be readily determined, its incremental borrowing rate. As an implicit interest rate was not readily determinable in the Company’s leases, the incremental borrowing rate was used based on the information available at commencement date in determining the present value of lease payments. The lease term for all of the Company’s leases includes the non-cancellable period of the lease plus any additional periods covered by either a Company option to extend (or not to terminate) the lease that the Company is reasonably certain to exercise, or an option to extend (or not to terminate) the lease controlled by the lessor. Options for lease renewals have been excluded from the lease term (and lease liability) for the majority of the Company’s leases as the reasonably certain threshold is not met. At December 31, 2021, the Company has an operating lease for corporate office space and two finance leases for office equipment and furniture located in the corporate office space. In addition, the Company has auxiliary corporate office space that it rents on a month-to-month basis; this rental is accounted for as an operating lease with the same term as the Company’s main office in the same building. The components of lease expense are as follows: (in thousands) Year ended Year ended Operating lease expense $ 372 $ 372 Finance lease cost Amortization of right-to-use assets $ 81 $ 81 Interest on lease liabilities $ 9 $ 16 Total finance lease cost 90 $ 97 Supplemental cash flow information related to leases are as follows: Year ended (in thousands) December 31, December 31, Cash flow information: Cash paid for amounts included in the measurement of lease liabilities: Operating cash flow use from operating leases $ 377 $ 375 Operating cash flow use from finance leases $ 9 $ 16 Financing cash flow use from finance leases $ 85 $ 78 Non-cash activity: Right-of-use assets obtained in exchange for lease obligations: Operating leases $ - $ 83 Finance Leases $ - $ - Weighted average remaining lease terms are as follows at December 31, 2021: Weighted average remaining lease term: Operating leases 0.6 years Finance Leases 0.8 years As the interest rate implicit in the leases was not readily determinable at the time that the leases were evaluated, the Company used its incremental borrowing rate based on the information available in determining the present value of lease payments. The Company’s incremental borrowing rate was based on the term of the lease, the economic environment of the lease and reflect the rate the Company would have had to pay to borrow on a secured basis. Below is information on the weighted average discount rates used at the time that the leases were evaluated: Weighted average discount rates: Operating leases 8 % Finance Leases 8 % Maturities of lease liabilities are as follows: Year ending December 31, Operating Finance 2022 252 64 2023 - 4 Total lease payments $ 252 $ 68 Less imputed interest (7 ) (3 ) Present value of lease liabilities $ 245 $ 65 |
Other revenue
Other revenue | 12 Months Ended |
Dec. 31, 2021 | |
Other Revenue [Abstract] | |
Other revenue | Note 5 - Other revenue The Company has a grant from a government-sponsored entity for research and development related activities that provide for payments for reimbursed costs, which includes overhead and general and administrative costs as well as an administrative fee. The Company recognizes revenue from grants as it performs services under this arrangement. Associated expenses are recognized when incurred as research and development expense. Revenue of $0.2 million was recognized during year ended December 31, 2021. The Company determined that certain collaborations with a third-party are within the scope of ASC 606. The collaboration agreement is made up of multiple modules related to various research activities. The Company identified a single performance obligation to provide research services within each module for which the Company receives monetary consideration. The third-party can choose to proceed with each module or can terminate the agreement at any time. The Company recognizes revenue for each module on a straight-line basis over the expected module period. Revenue for succeeding modules is not recognized until all contingencies are resolved, inclusive of the third-party’s ability to terminate the module. The consideration is recognized to revenue over each module and revenue recognized during the year ended December 31, 2021 was $0.9 million. Other liability consists of $1.0 million of deferred other revenue that is expected to be recognized during 2022. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 6 - Commitments and Contingencies On June 15, 2012, the Company entered into a license and sponsored research agreement with Fred Hutchinson Cancer Research Center (“FHCRC”) to build upon previous and ongoing clinical trials with apamistamab (licensed antibody). FHCRC has completed both a Phase 1 and Phase 2 clinical trial with apamistamab. The Company has been granted exclusive rights to the antibody and related master cell bank developed by FHCRC. A milestone payment of $1 million will be due to FHCRC upon FDA approval of the first drug utilizing the licensed antibody. Upon commercial sale of the drug, royalty payments of 2% of net sales will be due to FHCRC. |
Equity
Equity | 12 Months Ended |
Dec. 31, 2021 | |
Stockholders' Equity Note [Abstract] | |
Equity | Note 7 - Equity On April 24, 2020, the Company issued and sold 4.3 million shares of common stock and 2.8 million pre-funded warrants to purchase shares of common stock. The price to the public in this offering for each share of common stock was $4.50 and for each pre-funded warrant was $4.497. Each pre-funded warrant had an exercise price of $0.003 per share and was exercisable immediately upon issuance. Gross proceeds from this offering were $31.6 million, before deducting underwriting discounts and commissions and other offering expenses payable by the Company. Net proceeds from this offering were $29.1 million. During the year ended December 31, 2020, holders of all of the 2.8 million pre-funded April 2020 warrants exercised their warrants at $0.003 per share and received 2.8 million shares of common stock. On June 19, 2020, the Company issued and sold 1.9 million shares of common stock and 0.7 million pre-funded warrants to purchase shares of common stock. The price to the public in this offering for each share of common stock was $9.75 and for each pre-funded warrant was $9.747. Each pre-funded warrant had an exercise price of $0.003 per share and was exercisable immediately upon issuance. Gross proceeds from this offering were $25.0 million, before deducting underwriting discounts and commissions and other offering expenses payable by the Company. Net proceeds from this offering were $23.0 million. During the year ended December 31, 2020, holders of all of the 0.7 million pre-funded June 2020 warrants exercised their warrants at $0.003 per share and received 0.7 million shares of common stock. In August 2020, the Company entered into the Capital on Demand™ Sales Agreement with JonesTrading Institutional Services LLC (“JonesTrading”), pursuant to which the Company may sell, from time to time, through or to JonesTrading, up to an aggregate of $200 million of its common stock. Shares of common stock are offered pursuant to the Company’s shelf registration statement on Form S-3 filed with the SEC on August 7, 2020. As of December 31, 2020, the Company had sold 2.1 million shares of common stock, resulting in gross proceeds of $22.6 million and net proceeds of $21.7 million. For the year ended December 31, 2021, the Company sold 4.6 million shares of common stock, resulting in gross proceeds of $36.5 million and net proceeds of $35.3 million. 2019 Amended and Restated Stock Plan In December 2019, the Company’s 2019 Stock Plan was established. The expiration date of the plan is October 18, 2029 and the total number of shares of the Company’s common stock available for grant to employees, directors and consultants of the Company was 333,333 shares. At the Company’s Annual Meeting of Stockholders held on November 18, 2020, its stockholders authorized an increase in the number of shares authorized under the plan, resulting in the number of shares authorized in the plan to be 3,083,333 shares. At the Company’s Annual Meeting of Stockholders held on November 9, 2021, its stockholders authorized an increase in the number of shares authorized under the plan, resulting in the number of shares authorized in the plan to be 5,833,333 shares. 2013 Amended and Restated Stock Plan In September 2013, the Company’s 2013 Stock Plan was established. The expiration date of the plan is September 9, 2023 and at the time of approval, the total number of shares of the Company’s common stock available for grant to employees, directors and consultants of the Company under the plan was 91,666 shares. After a number of amendments approved by stockholders, the number of shares authorized under the plan is 758,333 shares. 2013 Equity Incentive Plan In September 2013, the Company’s 2013 Equity Incentive Plan was established. The expiration date of the plan is September 9, 2023 and the total number of shares of the Company’s common stock available for grant to employees, directors and consultants of the Company under the plan was 15,000 shares. In December 2013, the shareholders of the Company approved the plan and increased the number of shares authorized under the plan to 33,333 shares. Stock Options Following is a summary of stock option activity for the years ended December 31, 2021 and 2020: (in thousands, except for per-share amount) Number of Weighted Weighted Aggregate Outstanding, January 1, 2020 380 35.10 7.88 155 Granted 458 9.99 Cancelled (23 ) 16.84 Outstanding, December 31, 2020 815 21.53 8.51 120 Granted 881 6.43 Exercised (1 ) 6.69 Cancelled (333 ) 18.78 Outstanding, December 31, 2021 1,362 12.45 8.69 - Exercisable, December 31, 2021 354 27.04 6.92 - During 2021, the Company granted its employees and members of the Board of Directors options to purchase 881 thousand shares of common stock with an exercise price ranging from $6.02 to $9.25 per share, a term of 10 years, and a vesting period from 4 to 4.2 years. The options have an aggregated fair value of $3.9 million that was calculated using the Black-Scholes option-pricing model. Variables used in the Black-Scholes option-pricing model include: (1) discount rate range from 0.65% to 1.28% (2) expected life of 6 years, (3) expected volatility range from 79.8% to 85.1%, and (4) zero expected dividends. During 2020, the Company granted its employees and members of the Board of Directors options to purchase 458 thousand shares of common stock with an exercise price ranging from $6.63 to $12.41 per share, a term of 10 years, and a vesting period from 4 to 4.2 years. The options have an aggregated fair value of $3.2 million that was calculated using the Black-Scholes option-pricing model. Variables used in the Black-Scholes option-pricing model include: (1) discount rate range from 0.34% to 0.56% (2) expected life of 6 years, (3) expected volatility range from 83.6% to 85.5%, and (4) zero expected dividends. During the years ended December 31, 2021 and 2020, options to purchase 333 thousand and 23 thousand common shares were cancelled, respectively, upon the termination of employment. During 2021, 1 thousand options were exercised for shares of common stock. There were no exercises of options during 2020. The fair values of all options issued and outstanding are being amortized over their respective vesting periods. The unrecognized compensation expense at December 31, 2021 was $4.9 million related to unvested options, which is expected to be expensed over a weighted average of 3.3 years. During 2021 and 2020, the Company recorded total option expense of $1.5 million and $1.2 million, respectively. Pre-funded Warrants As part of the April 2020 offering and the June 2020 offering, the Company issued pre-funded warrants. Each pre-funded warrant had an exercise price of $0.003 per share and was exercisable immediately upon issuance. The pre-funded warrants did not have an expiration date. During 2020 all the pre-funded warrants were exercised for shares of common stock. Warrants Following is a summary of warrant activities for the years ended December 31, 2021 and 2020: (in thousands, except for per-share amounts) Number of Weighted Weighted Aggregate Outstanding, January 1, 2020 2,871 20.71 2.95 301 Granted - - Exercised (2 ) 15.00 Cancelled (756 ) 20.99 Outstanding, December 31, 2020 2,113 20.55 2.76 362 Granted 1 8.30 Exercised - - Cancelled (2 ) 50.17 Outstanding, December 31, 2021 2,112 20.52 1.76 276 Exercisable, December 31, 2021 2,108 20.12 1.76 276 The Company has an outstanding warrant to purchase 1,907 shares of common stock, issued on March 14, 2017 to Sandesh Seth, the Company’s Chairman and Chief Executive Officer. The warrant included down-round protection up until it was amended on August 11, 2020. For warrants with down-round protection, a deemed dividend is recorded for the change in fair value of the warrants when the down-round provision is triggered. As a result of the April 2020 offering and June 2020 offering, the exercise price of the warrant was reset from $26.40 per share to $15.62 per share. The down-round protection provision in the above warrants created a deemed dividend to common stockholders of $1 thousand in the year ended December 31, 2020 which is reflected in the accompanying consolidated statement of operations and consolidated statement of changes in stockholders’ equity. On August 11, 2020, the Company and Mr. Seth agreed to amend the warrant to remove the anti-dilution provision that had been in the warrant. Accordingly, pursuant to the amendment, as of August 11, 2020, the exercise price of the warrant will no longer be subject to a proportional adjustment if and when the Company issues any shares of its common stock for a consideration less than the exercise price of the warrant. All other terms of the warrant remained the same. During the years ended December 31, 2021 and 2020, the Company recorded stock-based compensation expense related to warrants of $16 thousand and $13 thousand, respectively. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Note 8 - Income Taxes Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company’s deferred tax assets and liabilities at December 31, 2021 and 2020 are as follows: (in thousands) 2021 2020 Deferred tax assets: Net operating losses carry forward $ 36,405 $ 33,955 Share-based compensation 1,213 1,689 Research and development/orphan drug credits 14,536 12,638 Intangibles 10,426 7,873 Others 19 19 Less: valuation allowance (62,599 ) (56,174 ) Deferred tax assets, net $ - $ - The Company has recorded a valuation allowance of $62.6 million and $56.2 million against its deferred tax assets at December 31, 2021 and 2020 respectively, because management determined that it is not more-likely-than not that those assets will be realized. For federal income tax purposes, the Company has $163.0 million of unused net operating losses (“NOLs”) at December 31, 2021 available for carry forward to future years. NOLs of $120.8 million generated prior to 2018 will begin to expire if unused in 2022. NOLs generated in 2018 and later years of $42.2 million have an indefinite life, but will be limited to 80% of their value if used in a tax year ending after January 1, 2022. For state income tax purposes, the Company has $87.9 million of unused NOLs at December 31, 2021 available for carry forward to future years. These NOLs will begin to expire in 2034 if unused. The Company has federal research and development tax credits of $2.9 million at December 31, 2021 which will begin to expire in 2034 if unused and orphan drug credits of $11.6 million which will begin to expire in 2028 if unused. Federal and state tax laws impose limitations on the utilization of net operating losses and credit carryforwards in the event of an ownership change for tax purposes, as defined in Section 382 of the Internal Revenue Code. Accordingly, the Company’s ability to utilize these carryforwards may be limited as a result of an ownership change which may have already happened or may happen in the future. Such an ownership change could result in a limitation in the use of the net operating losses in future years and possibly a reduction of the net operating losses available. The difference between the income tax provision and the amount that would result if the U.S. Federal statutory rates were applied to pre-tax losses for the year ended December 31, 2021 and 2020 are as follows: (in thousands) December 31, December 31, Federal statutory income taxes $ (5,202 ) (21.0 )% $ (4,665 ) (21.0 )% State income taxes (373 ) (1.5 )% 56 0.3 % Deferred true-up 562 2.3 % (64 ) (0.3 )% Research and development/orphan drug tax credit (1,898 ) (7.7 )% (1,766 ) (8.0 )% Other 486 2.0 % 202 0.9 % Change in valuation allowance 6,425 25.9 % 6,237 28.1 % Provision for income tax $ - - $ - - |
Accounting Policies, by Policy
Accounting Policies, by Policy (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Nature of Business | Nature of Business - |
Principles of Consolidation | Principles of Consolidation - |
Use of Estimates in Financial Statement Presentation | Use of Estimates in Financial Statement Presentation - |
Impact of COVID–19 Pandemic on Financial Statements | Impact of COVID–19 Pandemic on Financial Statements - Many countries around the world have continued to impose quarantines and restrictions on travel and mass gatherings to slow the spread of the virus. Accordingly, the Company’s ability to continue to operate its business may also be limited. Such events may result in a period of business, supply and drug product manufacturing disruption, and in reduced operations, any of which could materially affect the Company’s business, financial condition and results of operations. In response to COVID-19, the Company implemented remote working and thus far, has not experienced a significant disruption or delay in its operations as it relates to the clinical development or drug production of our drug candidates. A continuation or worsening of the levels of market disruption and volatility seen in the recent past could have an adverse effect on the Company’s ability to access capital, which could in the future negatively affect the Company’s liquidity. In addition, a recession or market correction resulting from the spread of COVID-19 could materially affect the Company’s business and the value of the Company’s common stock. Additionally, COVID-19 may result in delays in receiving approvals from local and foreign regulatory authorities, delays in necessary interactions with IRB’s or Institutional Review Boards, local and foreign regulators, ethics committees and other important agencies and contractors due to limitations in employee resources or forced furlough of government employees. To date, COVID-19 has not had a financial impact on the Company. The Company continues to monitor the impacts of COVID-19 on the global economy and on its business operations. However, at this time, it is difficult to predict how long the potential operational impacts of COVID-19 will last or to what degree further disruption might impact the Company’s operations and financial results. |
Cash and Cash Equivalents and Restricted Cash | Cash and Cash Equivalents and Restricted Cash- Following is a summary of cash, cash equivalents and restricted cash at December 31, 2021 and December 31, 2020: (in thousands) December 31, December 31, Cash and cash equivalents $ 77,829 $ 63,560 Restricted cash – current 392 48 Restricted cash – long-term - 391 Cash, cash equivalents and restricted cash $ 78,221 $ 63,999 Current restricted cash of $392 thousand at December 31, 2021 relates to a certificate of deposit held as collateral for a letter of credit issued in connection with the Company’s lease for corporate office space. This restricted cash was classified as long-term restricted cash at December 31, 2020. Current restricted cash of $48 thousand at December 31, 2020 related to a credit card account. |
Property and Equipment | Property and Equipment - |
Leases | Leases |
Fair Value of Financial Instruments | Fair Value of Financial Instruments - |
Revenue Recognition | Revenue Recognition Revenue From Contracts With Customers At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses whether the promised goods or services promised within each contract are distinct and, therefore, represent a separate performance obligation. Goods and services that are determined not to be distinct are combined with other promised goods and services until a distinct bundle is identified. In determining whether goods or services are distinct, the Company evaluates certain criteria, including whether (i) the customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer (capable of being distinct) and (ii) the good or service is separately identifiable from other goods or services in the contract (distinct in the context of the contract). The Company then determines the transaction price, which is the amount of consideration it expects to be entitled from a customer in exchange for the promised goods or services for each performance obligation and recognizes the associated revenue as each performance obligation is satisfied. The Company’s estimate of the transaction price for each contract includes all variable consideration to which it expects to be entitled. Variable consideration includes payments in the form of collaboration milestone payments. If an arrangement includes collaboration milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. ASC 606 requires the Company to allocate the arrangement consideration on a relative standalone selling price basis for each performance obligation after determining the transaction price of the contract and identifying the performance obligations to which that amount should be allocated. The relative standalone selling price is defined in the revenue standard as the price at which an entity would sell a promised good or service separately to a customer. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation as each performance obligation is satisfied, either at a point in time or over time, and if over time, recognition is based on the use of an output or input method. |
Collaborative Arrangements | Collaborative Arrangements - The Company follows the accounting guidance for collaboration agreements with third parties, which requires that certain transactions between the Company and collaborators be recorded in its consolidated statements of operations on either a gross basis or net basis, depending on the characteristics of the collaborative relationship, and requires enhanced disclosure of collaborative relationships. The Company evaluates its collaboration agreements for proper classification in its consolidated statements of operations based on the nature of the underlying activity. When the Company has concluded that it has a customer relationship with one of its collaborators, the Company follows the guidance of ASC 606 . |
Grant Revenue | Grant Revenue – |
Research and Development Costs | Research and Development Costs - |
Share-Based Payments | Share-Based Payments - |
Income Taxes | Income Taxes - FASB ASC 740 prescribes guidance for the financial statement recognition, measurement and disclosure of uncertain tax positions. Tax positions must meet a “more-likely-than-not” recognition threshold to be recognized. There were no tax positions for which it is considered reasonably possible that the total amounts of unrecognized tax benefits will significantly increase or decrease within the next year. The Company recognizes interest related to unrecognized tax benefits in interest expense and penalties in operating expenses |
Net Loss Per Common Share | Net Loss Per Common Share For the years ended December 31, 2021 and 2020, the Company’s potentially dilutive shares, which include outstanding common stock options and warrants have not been included in the computation of diluted net loss per share as the result would have been anti-dilutive. (in thousands) December 31, December 31, Options 1,362 815 Warrants 2,112 2,113 Total 3,474 2,928 |
Subsequent Events | Subsequent Events |
Accounting Standards Recently Adopted | Accounting Standards Recently Adopted Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity |
Accounting Standards Recently Issued | Accounting Standards Recently Issued– Earnings Per Share (topic 260), Debt — Modifications and Extinguishments (Subtopic 470-50), Compensation – Stock Compensation (Topic 718) and Derivatives and Hedging – Contracts in an Entity’s Own Equity (Subtopic 815-40) – Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options In October 2021, FASB issued ASU 2021-08, Business Combinations (Topic 805), Account for Contract Assets and Contract Liabilities from Contracts with Customers In November 2021, the FASB issued ASU 2021-10, Government Assistance (Topic 832), Disclosures by Business Entities about Government Assistance |
Description of Business and S_2
Description of Business and Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Schedule of cash and cash equivalent and restricted cash | (in thousands) December 31, December 31, Cash and cash equivalents $ 77,829 $ 63,560 Restricted cash – current 392 48 Restricted cash – long-term - 391 Cash, cash equivalents and restricted cash $ 78,221 $ 63,999 |
Schedule of antidilutive securities excluded from computation of diluted net loss per share | (in thousands) December 31, December 31, Options 1,362 815 Warrants 2,112 2,113 Total 3,474 2,928 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Disclosure Text Block Supplement [Abstract] | |
Schedule of prepaid expenses and other current assets | December 31, December 31, 2021 2020 Prepaid insurance $ 874 $ 792 Prepaid clinical trial expenses 543 457 Other prepaid expenses and other current assets 61 68 Total prepaid expenses and other current assets $ 1,478 $ 1,317 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
Schedule of property and equipment | December 31, December 31, (in thousands) Lives 2021 2020 Lab equipment 5 years $ 476 $ 378 Office equipment and furniture 3 - 7 years 199 225 Less: accumulated depreciation (335 ) (291 ) Property and equipment, net $ 340 $ 312 |
Schedule of depreciation expense | December 31, December 31, (in thousands) 2021 2020 Research and development $ 88 $ 36 General administrative 17 18 Total Depreciation expense $ 105 $ 54 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Leases [Abstract] | |
Schedule of components of lease expense | (in thousands) Year ended Year ended Operating lease expense $ 372 $ 372 Finance lease cost Amortization of right-to-use assets $ 81 $ 81 Interest on lease liabilities $ 9 $ 16 Total finance lease cost 90 $ 97 |
Schedule of supplemental cash flow information related to leases | Year ended (in thousands) December 31, December 31, Cash flow information: Cash paid for amounts included in the measurement of lease liabilities: Operating cash flow use from operating leases $ 377 $ 375 Operating cash flow use from finance leases $ 9 $ 16 Financing cash flow use from finance leases $ 85 $ 78 Non-cash activity: Right-of-use assets obtained in exchange for lease obligations: Operating leases $ - $ 83 Finance Leases $ - $ - |
Schedule of weighted average remaining lease terms | Weighted average remaining lease term: Operating leases 0.6 years Finance Leases 0.8 years |
Schedule of weighted average discount rates | Weighted average discount rates: Operating leases 8 % Finance Leases 8 % |
Schedule of maturities of lease liabilities | Year ending December 31, Operating Finance 2022 252 64 2023 - 4 Total lease payments $ 252 $ 68 Less imputed interest (7 ) (3 ) Present value of lease liabilities $ 245 $ 65 |
Equity (Tables)
Equity (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Stockholders' Equity Note [Abstract] | |
Schedule of stock option activity | (in thousands, except for per-share amount) Number of Weighted Weighted Aggregate Outstanding, January 1, 2020 380 35.10 7.88 155 Granted 458 9.99 Cancelled (23 ) 16.84 Outstanding, December 31, 2020 815 21.53 8.51 120 Granted 881 6.43 Exercised (1 ) 6.69 Cancelled (333 ) 18.78 Outstanding, December 31, 2021 1,362 12.45 8.69 - Exercisable, December 31, 2021 354 27.04 6.92 - |
Schedule of warrant activities | (in thousands, except for per-share amounts) Number of Weighted Weighted Aggregate Outstanding, January 1, 2020 2,871 20.71 2.95 301 Granted - - Exercised (2 ) 15.00 Cancelled (756 ) 20.99 Outstanding, December 31, 2020 2,113 20.55 2.76 362 Granted 1 8.30 Exercised - - Cancelled (2 ) 50.17 Outstanding, December 31, 2021 2,112 20.52 1.76 276 Exercisable, December 31, 2021 2,108 20.12 1.76 276 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Schedule of deferred tax assets and liabilities | (in thousands) 2021 2020 Deferred tax assets: Net operating losses carry forward $ 36,405 $ 33,955 Share-based compensation 1,213 1,689 Research and development/orphan drug credits 14,536 12,638 Intangibles 10,426 7,873 Others 19 19 Less: valuation allowance (62,599 ) (56,174 ) Deferred tax assets, net $ - $ - |
Schedule of difference between income tax provision and U.S federal statutory rates | (in thousands) December 31, December 31, Federal statutory income taxes $ (5,202 ) (21.0 )% $ (4,665 ) (21.0 )% State income taxes (373 ) (1.5 )% 56 0.3 % Deferred true-up 562 2.3 % (64 ) (0.3 )% Research and development/orphan drug tax credit (1,898 ) (7.7 )% (1,766 ) (8.0 )% Other 486 2.0 % 202 0.9 % Change in valuation allowance 6,425 25.9 % 6,237 28.1 % Provision for income tax $ - - $ - - |
Description of Business and S_3
Description of Business and Summary of Significant Accounting Policies (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Accounting Policies [Abstract] | ||
Current restricted cash | $ 392 | $ 48 |
Description of Business and S_4
Description of Business and Summary of Significant Accounting Policies (Details) - Schedule of cash and cash equivalent and restricted cash - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Schedule of cash and cash equivalent and restricted cash [Abstract] | ||
Cash and cash equivalents | $ 77,829 | $ 63,560 |
Restricted cash – current | 392 | 48 |
Restricted cash – long-term | 391 | |
Cash, cash equivalents and restricted cash | $ 78,221 | $ 63,999 |
Description of Business and S_5
Description of Business and Summary of Significant Accounting Policies (Details) - Schedule of antidilutive securities excluded from computation of diluted net loss per share - shares shares in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 3,474 | 2,928 |
Options [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 1,362 | 815 |
Warrants [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 2,112 | 2,113 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets (Details) - Schedule of prepaid expenses and other current assets - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Schedule of prepaid expenses and other current assets [Abstract] | ||
Prepaid insurance | $ 874 | $ 792 |
Prepaid clinical trial expenses | 543 | 457 |
Other prepaid expenses and other current assets | 61 | 68 |
Total prepaid expenses and other current assets | $ 1,478 | $ 1,317 |
Property and Equipment (Details
Property and Equipment (Details) - Schedule of property and equipment - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Property, Plant and Equipment [Line Items] | ||
Less: accumulated depreciation | $ (335) | $ (291) |
Property and equipment, net | $ 340 | 312 |
Lab equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Useful lives | 5 years | |
Property and equipment, gross | $ 476 | 378 |
Office equipment and furniture [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 199 | $ 225 |
Minimum [Member] | Office equipment and furniture [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Useful lives | 3 years | |
Maximum [Member] | Office equipment and furniture [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Useful lives | 7 years |
Property and Equipment (Detai_2
Property and Equipment (Details) - Schedule of depreciation expense - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Property and Equipment (Details) - Schedule of depreciation expense [Line Items] | ||
Total Depreciation expense | $ 105 | $ 54 |
Research and development [Member] | ||
Property and Equipment (Details) - Schedule of depreciation expense [Line Items] | ||
Total Depreciation expense | 88 | 36 |
General administrative [Member] | ||
Property and Equipment (Details) - Schedule of depreciation expense [Line Items] | ||
Total Depreciation expense | $ 17 | $ 18 |
Leases (Details) - Schedule of
Leases (Details) - Schedule of components of lease expense - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Schedule of components of lease expense [Abstract] | ||
Operating lease expense | $ 372 | $ 372 |
Finance lease cost | ||
Amortization of right-to-use assets | 81 | 81 |
Interest on lease liabilities | 9 | 16 |
Total finance lease cost | $ 90 | $ 97 |
Leases (Details) - Schedule o_2
Leases (Details) - Schedule of supplemental cash flow information related to leases - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Cash paid for amounts included in the measurement of lease liabilities: | ||
Operating cash flow use from operating leases | $ 377 | $ 375 |
Operating cash flow use from finance leases | 9 | 16 |
Financing cash flow use from finance leases | 85 | 78 |
Right-of-use assets obtained in exchange for lease obligations: | ||
Operating leases | 83 | |
Finance Leases |
Leases (Details) - Schedule o_3
Leases (Details) - Schedule of weighted average remaining lease terms | Dec. 31, 2021 |
Weighted average remaining lease term: | |
Operating leases | 7 months 6 days |
Finance Leases | 9 months 18 days |
Leases (Details) - Schedule o_4
Leases (Details) - Schedule of weighted average discount rates | Dec. 31, 2021 |
Weighted average discount rates: | |
Operating leases | 8.00% |
Finance Leases | 8.00% |
Leases (Details) - Schedule o_5
Leases (Details) - Schedule of maturities of lease liabilities $ in Thousands | Dec. 31, 2021USD ($) |
Operating Leases [Member] | |
Leases (Details) - Schedule of maturities of lease liabilities [Line Items] | |
2022 | $ 252 |
2023 | |
Total lease payments | 252 |
Less imputed interest | (7) |
Present value of lease liabilities | 245 |
Finance Leases [Member] | |
Leases (Details) - Schedule of maturities of lease liabilities [Line Items] | |
2022 | 64 |
2023 | 4 |
Total lease payments | 68 |
Less imputed interest | (3) |
Present value of lease liabilities | $ 65 |
Other revenue (Details)
Other revenue (Details) $ in Millions | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Other Revenue [Abstract] | |
Revenue | $ 0.2 |
Recognized to revenue | 0.9 |
Deferred revenue | $ 1 |
Commitments and Contingencies (
Commitments and Contingencies (Details) $ in Millions | 1 Months Ended |
Jun. 15, 2012USD ($) | |
Commitments and Contingencies Disclosure [Abstract] | |
Milestone payment | $ 1 |
Description of royalty payment | Upon commercial sale of the drug, royalty payments of 2% of net sales will be due to FHCRC. |
Equity (Details)
Equity (Details) - USD ($) $ / shares in Units, $ in Thousands | Apr. 24, 2020 | Aug. 31, 2020 | Jun. 19, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Nov. 09, 2021 | Nov. 18, 2020 | Jun. 30, 2020 | Apr. 30, 2020 | Dec. 31, 2019 | Mar. 14, 2017 | Dec. 31, 2013 | Sep. 30, 2013 |
Equity (Details) [Line Items] | |||||||||||||
Sale of common stock, shares | 4,300,000 | 4,600,000 | 2,100,000 | ||||||||||
Warrants to purchase shares of common stock | 2,800,000 | ||||||||||||
Public offering each share of common stock (in Dollars per share) | $ 4.5 | ||||||||||||
Each pre-funded warrant (in Dollars per share) | 4.497 | ||||||||||||
Exercise price of warrant (in Dollars per share) | $ 0.003 | $ 0.003 | $ 0.003 | ||||||||||
Gross proceeds (in Dollars) | $ 31,600 | $ 36,500 | $ 22,600 | ||||||||||
Net proceeds of public offering (in Dollars) | $ 29,100 | ||||||||||||
Issuance of common stock | 700,000 | ||||||||||||
Pre-funded amount | 700,000 | ||||||||||||
Equity description | the Company entered into the Capital on Demand™ Sales Agreement with JonesTrading Institutional Services LLC (“JonesTrading”), pursuant to which the Company may sell, from time to time, through or to JonesTrading, up to an aggregate of $200 million of its common stock. Shares of common stock are offered pursuant to the Company’s shelf registration statement on Form S-3 filed with the SEC on August 7, 2020. | ||||||||||||
Net proceeds (in Dollars) | $ 35,300 | $ 21,700 | |||||||||||
Stock option | 881,000 | 458,000 | |||||||||||
Option exercise price minimum (in Dollars per share) | $ 6.02 | $ 6.63 | |||||||||||
Option exercise price maximum (in Dollars per share) | $ 9.25 | $ 12.41 | |||||||||||
Stock options, term | 10 years | 10 years | |||||||||||
Aggregated fair value (in Dollars) | $ 3,200 | ||||||||||||
Stock option cancelations | 333,000 | 23,000 | |||||||||||
Exercised for shares of common stock | 1,000 | ||||||||||||
Unrecognized compensation expense (in Dollars) | $ 4,900 | ||||||||||||
Vesting period | 3 years 3 months 18 days | ||||||||||||
Compensation expense related to stock options (in Dollars) | $ 1,500 | $ 1,200 | |||||||||||
Outstanding warrant to purchase shares of common stock, issued | 1,907 | ||||||||||||
Deemed dividend to common stockholders (in Dollars) | 1 | ||||||||||||
Stock based compensation expense warrants (in Dollars) | $ 16 | $ 13 | |||||||||||
2013 Amended and Restated Stock Plan [Member] | |||||||||||||
Equity (Details) [Line Items] | |||||||||||||
Number of shares authorized | 758,333 | 91,666 | |||||||||||
Equity Option [Member] | |||||||||||||
Equity (Details) [Line Items] | |||||||||||||
Aggregate fair value (in Dollars) | $ 3,900 | ||||||||||||
Minimum [Member] | Equity Option [Member] | |||||||||||||
Equity (Details) [Line Items] | |||||||||||||
Vesting period | 4 years | 4 years | |||||||||||
Maximum [Member] | Equity Option [Member] | |||||||||||||
Equity (Details) [Line Items] | |||||||||||||
Vesting period | 4 years 2 months 12 days | 4 years 2 months 12 days | |||||||||||
Warrant [Member] | |||||||||||||
Equity (Details) [Line Items] | |||||||||||||
Exercise price of warrant (in Dollars per share) | $ 15.62 | $ 26.4 | |||||||||||
2019 Amended and Restated Stock Plan [Member] | |||||||||||||
Equity (Details) [Line Items] | |||||||||||||
Number of shares authorized | 5,833,333 | 3,083,333 | 333,333 | ||||||||||
2013 Equity Incentive Plan [Member] | |||||||||||||
Equity (Details) [Line Items] | |||||||||||||
Number of shares authorized | 33,333 | 15,000 | |||||||||||
Pre-Funded Warrants [Member] | |||||||||||||
Equity (Details) [Line Items] | |||||||||||||
Exercise price of warrant (in Dollars per share) | $ 0.003 | ||||||||||||
Gross proceeds (in Dollars) | $ 25,000 | ||||||||||||
Net proceeds of public offering (in Dollars) | $ 23,000 | ||||||||||||
Issuance of common stock | 1,900,000 | 2,800,000 | |||||||||||
Warrant to purchase of common stock | 700,000 | ||||||||||||
Exercise price per share (in Dollars per share) | $ 0.003 | ||||||||||||
Common Stock [Member] | |||||||||||||
Equity (Details) [Line Items] | |||||||||||||
Share price (in Dollars per share) | $ 9.75 | ||||||||||||
Warrant [Member] | |||||||||||||
Equity (Details) [Line Items] | |||||||||||||
Share price (in Dollars per share) | $ 9.747 |
Equity (Details) - Schedule of
Equity (Details) - Schedule of stock option activity - Stock Option [Membe] - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Equity (Details) - Schedule of stock option activity [Line Items] | ||
Number of Options, Outstanding Beginning | 815 | 380 |
Weighted Average Exercise Price, Outstanding Beginning | $ 21.53 | $ 35.1 |
Weighted Average Remaining Contractual Term (in years), Outstanding Beginning | 7 years 10 months 17 days | |
Aggregate Intrinsic Value, Outstanding Beginning | $ 155 | |
Number of Options, Outstanding Ending | 1,362 | 815 |
Weighted Average Exercise Price, Outstanding Ending | $ 12.45 | $ 21.53 |
Weighted Average Remaining Contractual Term (in years), Outstanding Ending | 8 years 8 months 8 days | 8 years 6 months 3 days |
Aggregate Intrinsic Value, Outstanding Ending | $ 120 | |
Number of Options, Exercisable Ending | 354 | |
Weighted Average Exercise Price, Exercisable Ending | $ 27.04 | |
Weighted Average Remaining Contractual Term (in years), Exercisable Ending | 6 years 11 months 1 day | |
Number of Options, Granted | 881 | 458 |
Weighted Average Exercise Price, Granted | $ 6.43 | $ 9.99 |
Number of Options, Exercised | (1) | |
Weighted Average Exercise Price, Exercised | $ 6.69 | |
Number of Options, Cancelled | (333) | (23) |
Weighted Average Exercise Price, Cancelled | $ 18.78 | $ 16.84 |
Equity (Details) - Schedule _2
Equity (Details) - Schedule of warrant activities - Warrant [Member] - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Class of Warrant [Line Items] | ||
Number of Warrants, Outstanding, Beginning | 2,113 | 2,871 |
Weighted Average Exercise Price, Beginning | $ 20.55 | $ 20.71 |
Weighted average remaining contractual term (in years), beginning | 2 years 11 months 12 days | |
Aggregate Intrinsic Value, Beginning | $ 362 | $ 301 |
Number of Warrants, Outstanding, Ending | 2,112 | 2,113 |
Weighted Average Exercise Price, Ending | $ 20.52 | $ 20.55 |
Weighted Average Remaining Contractual Term (in years), Ending | 1 year 9 months 3 days | 2 years 9 months 3 days |
Aggregate Intrinsic Value, Ending | $ 276 | $ 362 |
Number of Warrants, Exercisable | 2,108 | |
Weighted Average Exercise Price, Exercisable | $ 20.12 | |
Weighted Average Remaining Contractual Term (in years), Exercisable | 1 year 9 months 3 days | |
Aggregate Intrinsic Value, Exercisable | $ 276 | |
Number of Warrants, Granted | 1 | |
Weighted Average Exercise Price, Granted | $ 8.3 | |
Number of Warrants, Exercised | (2) | |
Weighted Average Exercise Price, Exercised | $ 15 | |
Number of Warrants, Cancelled/Expired | (2) | (756) |
Weighted Average Exercise Price, Cancelled/Expired | $ 50.17 | $ 20.99 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Taxes (Details) [Line Items] | ||
Deferred tax assets, valuation allowance | $ 62.6 | $ 56.2 |
Federal income tax purposes, net operating losses | $ 163 | |
Net operating losses, description | NOLs of $120.8 million generated prior to 2018 will begin to expire if unused in 2022. NOLs generated in 2018 and later years of $42.2 million have an indefinite life, but will be limited to 80% of their value if used in a tax year ending after January 1, 2022. | |
State income tax purposes, net operating losses | $ 87.9 | |
Federal Research and Development Tax Credits [Member] | ||
Income Taxes (Details) [Line Items] | ||
Net operating loss expiration date | The Company has federal research and development tax credits of $2.9 million at December 31, 2021 which will begin to expire in 2034 if unused and orphan drug credits of $11.6 million which will begin to expire in 2028 if unused. | |
Net operating losses | $ 2.9 | |
Orphan Drug Credits [Member] | ||
Income Taxes (Details) [Line Items] | ||
Net operating losses | $ 11.6 |
Income Taxes (Details) - Schedu
Income Taxes (Details) - Schedule of deferred tax assets and liabilities - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Deferred tax assets: | ||
Net operating losses carry forward | $ 36,405 | $ 33,955 |
Share-based compensation | 1,213 | 1,689 |
Research and development/orphan drug credits | 14,536 | 12,638 |
Intangibles | 10,426 | 7,873 |
Others | 19 | 19 |
Less: valuation allowance | (62,599) | (56,174) |
Deferred tax assets, net |
Income Taxes (Details) - Sche_2
Income Taxes (Details) - Schedule of difference between income tax provision and U.S federal statutory rates - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Schedule of difference between income tax provision and U.S federal statutory rates [Abstract] | ||
Federal statutory income taxes | $ (5,202) | $ (4,665) |
Federal statutory income taxes, percentage | (21.00%) | (21.00%) |
State income taxes | $ (373) | $ 56 |
State income taxes, percentage | (1.50%) | 0.30% |
Deferred true-up | $ 562 | $ (64) |
Deferred true-up, percentage | 2.30% | (0.30%) |
Research and development/orphan drug tax credit | $ (1,898) | $ (1,766) |
Research and development/orphan drug tax credit, percentage | (7.70%) | (8.00%) |
Other | $ 486 | $ 202 |
Other, percentage | 2.00% | 0.90% |
Change in valuation allowance | $ 6,425 | $ 6,237 |
Change in valuation allowance, percentage | 25.90% | 28.10% |
Provision for income tax | ||
Provision for income tax, percentage |