Document And Entity Information
Document And Entity Information - shares | 6 Months Ended | |
Jun. 30, 2022 | Aug. 12, 2022 | |
Document Information Line Items | ||
Entity Registrant Name | ACTINIUM PHARMACEUTICALS, INC. | |
Trading Symbol | ATNM | |
Document Type | 10-Q | |
Current Fiscal Year End Date | --12-31 | |
Entity Common Stock, Shares Outstanding | 25,184,654 | |
Amendment Flag | false | |
Entity Central Index Key | 0001388320 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Document Period End Date | Jun. 30, 2022 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q2 | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity File Number | 001-36374 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 74-2963609 | |
Entity Address, Address Line One | 275 Madison Ave, 7th Floor | |
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 $0.001 | |
Security Exchange Name | NYSE | |
Entity Interactive Data Current | Yes |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Current Assets: | ||
Cash and cash equivalents | $ 116,330 | $ 77,829 |
Restricted cash | 392 | 392 |
Security deposit | 50 | 50 |
Prepaid expenses and other current assets | 1,525 | 1,478 |
Total Current Assets | 118,297 | 79,749 |
Property and equipment, net of accumulated depreciation of $395 and $335 | 557 | 340 |
Security deposit – long term | 299 | |
Operating leases right-of-use assets | 2,629 | 241 |
Finance leases right-of-use assets | 18 | 58 |
Total Assets | 121,800 | 80,388 |
Current Liabilities: | ||
Accounts payable and accrued expenses | 5,767 | 5,535 |
Other revenue deferred– current liability | 204 | 998 |
Operating leases current liability | 292 | 245 |
Finance leases current liability | 19 | 62 |
Total Current Liabilities | 6,282 | 6,840 |
Long-term license revenue deferred | 35,000 | |
Long-term operating leases obligations | 2,335 | |
Long-term finance leases obligations | 2 | 3 |
Total Liabilities | 43,619 | 6,843 |
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 shares authorized; 24,870,623 and 22,143,974 shares issued and outstanding, respectively | 25 | 22 |
Additional paid-in capital | 346,800 | 329,271 |
Accumulated deficit | (268,644) | (255,748) |
Total Stockholders’ Equity | 78,181 | 73,545 |
Total Liabilities and Stockholders’ Equity | $ 121,800 | $ 80,388 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parentheticals) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Property and equipment, net of accumulated depreciation (in Dollars) | $ 395 | $ 335 |
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 | 1,000,000,000 |
Common stock, shares issued | 24,870,623 | 22,143,974 |
Common stock, shares outstanding | 24,870,623 | 22,143,974 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Revenue | ||||
Revenue | ||||
Other revenue | 45 | 266 | 985 | 888 |
Total revenue | 45 | 266 | 985 | 888 |
Operating expenses: | ||||
Research and development, net of reimbursements | 4,662 | 3,631 | 9,031 | 7,907 |
General and administrative | 3,233 | 1,710 | 4,968 | 3,428 |
Total operating expenses | 7,895 | 5,341 | 13,999 | 11,335 |
Loss from operations | (7,850) | (5,075) | (13,014) | (10,447) |
Other income: | ||||
Interest income - net | 83 | 54 | 118 | 106 |
Total other income | 83 | 54 | 118 | 106 |
Net loss | $ (7,767) | $ (5,021) | $ (12,896) | $ (10,341) |
Net loss per common share – basic and diluted (in Dollars per share) | $ (0.33) | $ (0.25) | $ (0.56) | $ (0.54) |
Weighted average common shares outstanding – basic and diluted (in Shares) | 23,731,886 | 20,231,278 | 22,942,317 | 19,308,487 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Operations (Unaudited) (Parentheticals) - $ / shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Income Statement [Abstract] | ||||
Net loss per common share – basic and diluted (in Dollars per share) | $ (0.33) | $ (0.25) | $ (0.56) | $ (0.54) |
Weighted average common shares outstanding – basic and diluted (in Shares) | 23,731,886 | 20,231,278 | 22,942,317 | 19,308,487 |
Condensed Consolidated Statem_3
Condensed Consolidated Statement of Changes in Stockholders’ Equity (Unaudited) - USD ($) $ in Thousands | Common Stock | Additional Paid-In Capital | Accumulated Deficit | Total |
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 | 376 | 376 | ||
Sale of common stock, net of costs | $ 1 | 14,360 | 14,361 | |
Sale of common stock, net of costs (in Shares) | 1,712,745 | |||
Net loss | (5,320) | (5,320) | ||
Balance at Mar. 31, 2021 | $ 19 | 307,011 | (236,294) | 70,736 |
Balance (in Shares) at Mar. 31, 2021 | 19,245,638 | |||
Balance at Dec. 31, 2020 | $ 18 | 292,275 | (230,974) | 61,319 |
Balance (in Shares) at Dec. 31, 2020 | 17,532,893 | |||
Net loss | (10,341) | |||
Balance at Jun. 30, 2021 | $ 21 | 321,793 | (241,315) | 80,499 |
Balance (in Shares) at Jun. 30, 2021 | 21,090,931 | |||
Balance at Mar. 31, 2021 | $ 19 | 307,011 | (236,294) | 70,736 |
Balance (in Shares) at Mar. 31, 2021 | 19,245,638 | |||
Stock-based compensation | 459 | 459 | ||
Stock-based compensation (in Shares) | 8,705 | |||
Sale of common stock, net of issuance costs | $ 2 | 14,317 | 14,319 | |
Sale of common stock, net of issuance costs (in Shares) | 1,835,688 | |||
Exercise of stock options | 6 | 6 | ||
Exercise of stock options (in Shares) | 900 | |||
Net loss | (5,021) | (5,021) | ||
Balance at Jun. 30, 2021 | $ 21 | 321,793 | (241,315) | 80,499 |
Balance (in Shares) at Jun. 30, 2021 | 21,090,931 | |||
Balance at Dec. 31, 2021 | $ 22 | 329,271 | (255,748) | 73,545 |
Balance (in Shares) at Dec. 31, 2021 | 22,143,974 | |||
Stock-based compensation | 421 | 421 | ||
Net loss | (5,129) | (5,129) | ||
Balance at Mar. 31, 2022 | $ 22 | 329,692 | (260,877) | 68,837 |
Balance (in Shares) at Mar. 31, 2022 | 22,143,974 | |||
Balance at Dec. 31, 2021 | $ 22 | 329,271 | (255,748) | 73,545 |
Balance (in Shares) at Dec. 31, 2021 | 22,143,974 | |||
Net loss | (12,896) | |||
Balance at Jun. 30, 2022 | $ 25 | 346,800 | (268,644) | 78,181 |
Balance (in Shares) at Jun. 30, 2022 | 24,870,623 | |||
Balance at Mar. 31, 2022 | $ 22 | 329,692 | (260,877) | 68,837 |
Balance (in Shares) at Mar. 31, 2022 | 22,143,974 | |||
Stock-based compensation | 425 | 425 | ||
Sale of common stock, net of issuance costs | $ 3 | 16,683 | 16,686 | |
Sale of common stock, net of issuance costs (in Shares) | 2,726,649 | |||
Net loss | (7,767) | (7,767) | ||
Balance at Jun. 30, 2022 | $ 25 | $ 346,800 | $ (268,644) | $ 78,181 |
Balance (in Shares) at Jun. 30, 2022 | 24,870,623 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Cash Flows From Operating Activities: | ||
Net loss | $ (12,896) | $ (10,341) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 846 | 835 |
Depreciation | 317 | 254 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | (47) | 106 |
Payment of security deposit | (299) | |
Accounts payable and accrued expenses | 232 | (913) |
Other revenue deferred– current liability | (794) | |
Long-term license revenue deferred | 35,000 | |
Operating lease liabilities | (222) | (167) |
Net Cash Provided By/Used In Operating Activities | 22,137 | (10,226) |
Purchase of property and equipment | (277) | (65) |
Net Cash Used In Investing Activities | (277) | (65) |
Payments on finance leases | (45) | (42) |
Sales of shares of common stock, net of costs | 16,686 | 28,680 |
Proceeds from exercise of stock options | 6 | |
Net Cash Provided By Financing Activities | 16,641 | 28,644 |
Net change in cash, cash equivalents, and restricted cash | 38,501 | 18,353 |
Cash, cash equivalents, and restricted cash at beginning of period | 78,221 | 63,999 |
Cash, cash equivalents, and restricted cash at end of period | 116,722 | 82,352 |
Supplemental disclosure of cash flow information: | ||
Cash paid for interest | ||
Cash paid for income taxes |
Description of Business and Sum
Description of Business and Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2022 | |
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 - Basis of Presentation - Principles of Consolidation - Use of Estimates 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 hybrid working for its office-based staff, while its research staff has been actively working in its laboratory throughout the pandemic and thus far, has not experienced a significant disruption or delay in its operations as it relates to the clinical development, preclinical research or drug production of its 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, Cash Equivalents and Restricted Cash - The following is a summary of cash, cash equivalents and restricted cash at June 30, 2022 and December 31, 2021: (in thousands) June 30, December 31, Cash and cash equivalents $ 116,330 $ 77,829 Restricted cash 392 392 Cash, cash equivalents and restricted cash $ 116,772 $ 78,221 Restricted cash 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. Leases 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 - . Grant Revenue – License Revenue – Upfront license fees Development, regulatory or commercial milestone payments Sales-based milestone payments and royalties Upfront payments and fees may require deferral of revenue recognition to a future period until the Company performs its obligations under these arrangements or when it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur or when the uncertainty associated with any variable consideration is subsequently resolved. Amounts payable to the Company are recorded as accounts receivable when the Company’s right to consideration is unconditional. Research and Development Costs - Share-Based Payments - Net Loss Per Common Share (in thousands) June 30, June 30, Options 1,431 859 Warrants 2,053 2,114 Total 3,484 2,973 Recently Adopted Accounting Pronouncements – 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 November 2021, the FASB issued ASU 2021-10, Government Assistance (Topic 832), Disclosures by Business Entities about Government Assistance Recently Issued Accounting Pronouncements – Business Combinations (Topic 805), Account for Contract Assets and Contract Liabilities from Contracts with Customers |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 2 - 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 U.S. Food and Drug Administration (“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. |
Leases
Leases | 6 Months Ended |
Jun. 30, 2022 | |
Leases [Abstract] | |
Leases | Note 3 - Leases The Company entered into a lease for corporate office space, effective June 1, 2022. As of June 30, 2022, the Company has two operating leases for corporate office space and two finance leases for office equipment and furniture located in one of the corporate office spaces. 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. The components of lease expense are as follows: Three months ended Six months ended (in thousands) June 30, June 30, June 30, June 30, Operating lease expense $ 141 $ 93 $ 234 $ 186 Finance lease cost Amortization of right-to-use assets $ 20 $ 21 $ 41 $ 41 Interest on lease liabilities $ 1 $ 2 $ 2 $ 5 Total finance lease cost $ 21 $ 23 $ 43 $ 46 Supplemental cash flow information related to leases are as follows: Cash flow information: Six months ended (in thousands) June 30, June 30, Cash paid for amounts included in the measurement of lease liabilities: Operating cash flow use from operating leases $ 239 $ 188 Operating cash flow use from finance leases $ 2 $ 5 Financing cash flow use from finance leases $ 45 $ 42 Non-cash activity: Right-of-use assets obtained in exchange for lease obligations: Operating leases $ 2,605 $ - Finance Leases $ - $ - Weighted average remaining lease terms are as follows at June 30, 2022: Weighted average remaining lease term: Operating leases 5.0 years Finance Leases 0.5 year 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 4.8% Finance Leases 8.0% Maturities of lease liabilities are as follows: (in thousands) Operating Finance 2022 (excluding six months ended June 30, 2022) $ 113 $ 17 2023 606 5 2024 618 - 2025 630 - 2026 643 - 2027 380 - Total lease payments $ 2,990 $ 22 Less imputed interest (363 ) (1 ) Present value of lease liabilities $ 2,627 $ 21 |
Other Revenue
Other Revenue | 6 Months Ended |
Jun. 30, 2022 | |
Other revenue [Abstract] | |
Other revenue | Note 4 – Other revenue 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. Other revenue recognized during the three months and six months ended June 30, 2022 was $0.0 million and $0.9 million, respectively, and for the three months and six months ended June 30, 2021 was $0.3 million and $0.9 million, respectively. 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. Other revenue recognized during the three months and six months ended June 30, 2022 was $0.0 million and $0.1 million, respectively. There was no other revenue recognized from a grant from a government-sponsored entity during the six months ended June 30, 2021. On April 7, 2022, the Company entered into a license and supply agreement (the “License Agreement”) with Immedica Pharma AB (“Immedica”), pursuant to which Immedica licensed the exclusive product rights for commercialization of Iomab-B (I-131 apamistamab) in the European Economic Area, Middle East and North Africa (EUMENA) including Algeria, Andorra, Bahrain, Cyprus, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Monaco, Morocco, Oman, Palestine, Qatar, San Marino, Saudi Arabia, Switzerland, Syria, Tunisia, Turkey, the United Arab Emirates, the United Kingdom, the Vatican City and Yemen. Upon signing, the Company was entitled to an upfront payment of $35 million from Immedica, which was received in May 2022. Under the terms of the License Agreement, the Company is eligible to receive regulatory and commercial milestone payments and is entitled to receive royalties in the mid-20 percent range on net sales of the product in certain countries that may result from the License Agreement. The Company will continue to be responsible for certain clinical development activities and the manufacturing of Iomab-B and will retain commercialization rights in the U.S. and rest of the world. The Company’s contract liabilities are recorded within Other revenue deferred – current liability or Long-term license revenue deferred in its condensed consolidated balance sheets depending on the short-term or long-term nature of the payments to be recognized. The Company’s contract liabilities primarily consist of advanced payments from licensees. Other revenue deferred – current liability was $0.2 million at June 30, 2022 and $0.9 million at December 31, 2021. Long-term license revenue deferred was $35.0 million at June 30, 2022; there was no long-term license revenue deferred at December 31, 2021. This deferred revenue will be recognized upon EU regulatory approval of Iomab B. |
Equity
Equity | 6 Months Ended |
Jun. 30, 2022 | |
Stockholders' Equity Note [Abstract] | |
Equity | Note 5 - Equity In August 2020 the Company entered into the Capital on Demand™ Sales Agreement with JonesTrading Institutional Services LLC, or 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 a shelf registration statement on Form S-3 filed with the SEC on August 7, 2020. As of December 31, 2021, the Company had sold 6.7 million shares of common stock, resulting in gross proceeds of $59.1 million and net proceeds of $57.0 million. For the six months ended June 30, 2022, the Company sold 2.7 million shares of common stock, resulting in gross proceeds of $17.2 million and net proceeds of $16.7 million. For the six months ended June 30, 2021, the Company sold 3.5 million shares of common stock, resulting in gross proceeds of $29.6 million and net proceeds of $28.7 million. On June 28, 2022, the Company entered into an Amendment and Restated Capital on Demand™ Sales Agreement (the “A&R Sales Agreement”) with JonesTrading and B. Riley Securities, Inc. (“B. Riley Securities”). The A&R Sales Agreement modifies the original Capital on Demand™ Sales Agreement to include B. Riley Securities as an additional sales agent thereunder. Stock Options The following is a summary of stock option activity for the six months ended June 30, 2022: (in thousands, except for per-share amounts) Number of Weighted Weighted Aggregate Outstanding, January 1, 2022 1,362 $ 12.45 8.69 $ - Granted 120 5.23 Cancelled (51 ) 8.89 Outstanding, June 30, 2022 1,431 11.97 8.36 - Exercisable, June 30, 2022 473 22.19 7.07 - During the six months ended June 30, 2022, the Company granted new employees options to purchase 120 thousand shares of common stock with an exercise price ranging from $5.20 to $5.93 per share, a term of 10 years, and a vesting period of 4 years. The options have an aggregated fair value of $442 thousand 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 1.52% to 3.03% (2) expected life of 6 years, (3) expected volatility range from 78.8% to 79.9%, and (4) zero expected dividends. The fair values of all options issued and outstanding are being amortized over their respective vesting periods. The unrecognized compensation expense at June 30, 2022 was $4.4 million related to unvested options, which is expected to be expensed over a weighted average of 3.0 years. During the six months ended June 30, 2022 and 2021, the Company recorded compensation expense related to stock options of $0.8 million and $0.7 million, respectively. Warrants Following is a summary of warrant activity for the six months ended June 30, 2022: (in thousands, except for per-share amounts) Number of Shares Weighted Weighted Aggregate Outstanding, January 1, 2022 2,112 $ 20.52 1.76 $ 276 Granted - - Exercised - - Cancelled/Expired (59 ) 3.62 Outstanding, June 30, 2022 2,053 $ 21.01 1.32 $ - Exercisable, June 30, 2022 2,049 $ 20.57 1.31 $ - |
Subsequent Event
Subsequent Event | 6 Months Ended |
Jun. 30, 2022 | |
Subsequent Event [Abstract] | |
Subsequent Event | Note 6 – Subsequent Event Since June 30, 2022, the Company has sold 0.3 million shares of common stock under its A&R Sales Agreement, resulting in net proceeds of $1.4 million. On August 2, 2022, warrants to purchase an aggregate of 0.6 million shares of common stock expired. These warrants were issued on August 2, 2017, when the Company completed an underwritten offering of 0.7 million shares of its common stock and warrants to purchase an aggregate of 0.6 million shares of its common stock at a price of $22.50 per share and related warrant. The warrants were exercisable for a period of 5 years at an exercise price of $31.50 per share. As of August 12, 2022, the Company has 1.4 million warrants outstanding. |
Accounting Policies, by Policy
Accounting Policies, by Policy (Policies) | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
Nature of Business | Nature of Business - |
Basis of Presentation | Basis of Presentation - |
Principles of Consolidation | Principles of Consolidation - |
Use of Estimates | Use of Estimates |
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 hybrid working for its office-based staff, while its research staff has been actively working in its laboratory throughout the pandemic and thus far, has not experienced a significant disruption or delay in its operations as it relates to the clinical development, preclinical research or drug production of its 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, Cash Equivalents and Restricted Cash | Cash, Cash Equivalents and Restricted Cash - The following is a summary of cash, cash equivalents and restricted cash at June 30, 2022 and December 31, 2021: (in thousands) June 30, December 31, Cash and cash equivalents $ 116,330 $ 77,829 Restricted cash 392 392 Cash, cash equivalents and restricted cash $ 116,772 $ 78,221 Restricted cash 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. |
Leases | Leases |
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 - . |
Grant Revenue | Grant Revenue – |
License Revenue | License Revenue – Upfront license fees Development, regulatory or commercial milestone payments Sales-based milestone payments and royalties Upfront payments and fees may require deferral of revenue recognition to a future period until the Company performs its obligations under these arrangements or when it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur or when the uncertainty associated with any variable consideration is subsequently resolved. Amounts payable to the Company are recorded as accounts receivable when the Company’s right to consideration is unconditional. |
Research and Development Costs | Research and Development Costs - |
Share-Based Payments | Share-Based Payments - |
Net Loss Per Common Share | Net Loss Per Common Share |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements – 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 November 2021, the FASB issued ASU 2021-10, Government Assistance (Topic 832), Disclosures by Business Entities about Government Assistance |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements – Business Combinations (Topic 805), Account for Contract Assets and Contract Liabilities from Contracts with Customers |
Description of Business and S_2
Description of Business and Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
Schedule of cash, cash equivalents and restricted cash | (in thousands) June 30, December 31, Cash and cash equivalents $ 116,330 $ 77,829 Restricted cash 392 392 Cash, cash equivalents and restricted cash $ 116,772 $ 78,221 |
Schedule of diluted net loss per share anti-dilutive | (in thousands) June 30, June 30, Options 1,431 859 Warrants 2,053 2,114 Total 3,484 2,973 |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Leases [Abstract] | |
Schedule of components of lease expense | Three months ended Six months ended (in thousands) June 30, June 30, June 30, June 30, Operating lease expense $ 141 $ 93 $ 234 $ 186 Finance lease cost Amortization of right-to-use assets $ 20 $ 21 $ 41 $ 41 Interest on lease liabilities $ 1 $ 2 $ 2 $ 5 Total finance lease cost $ 21 $ 23 $ 43 $ 46 |
Schedule of supplemental cash flow information related to leases | Six months ended (in thousands) June 30, June 30, Cash paid for amounts included in the measurement of lease liabilities: Operating cash flow use from operating leases $ 239 $ 188 Operating cash flow use from finance leases $ 2 $ 5 Financing cash flow use from finance leases $ 45 $ 42 Non-cash activity: Right-of-use assets obtained in exchange for lease obligations: Operating leases $ 2,605 $ - Finance Leases $ - $ - |
Schedule of weighted average remaining lease terms | Weighted average remaining lease term: Operating leases 5.0 years Finance Leases 0.5 year |
Schedule of weighted average discount rates | Weighted average discount rates: Operating leases 4.8% Finance Leases 8.0% |
Schedule of maturities of lease liabilities | (in thousands) Operating Finance 2022 (excluding six months ended June 30, 2022) $ 113 $ 17 2023 606 5 2024 618 - 2025 630 - 2026 643 - 2027 380 - Total lease payments $ 2,990 $ 22 Less imputed interest (363 ) (1 ) Present value of lease liabilities $ 2,627 $ 21 |
Equity (Tables)
Equity (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Option [Member] | |
Equity (Tables) [Line Items] | |
Schedule of stock option activity | (in thousands, except for per-share amounts) Number of Weighted Weighted Aggregate Outstanding, January 1, 2022 1,362 $ 12.45 8.69 $ - Granted 120 5.23 Cancelled (51 ) 8.89 Outstanding, June 30, 2022 1,431 11.97 8.36 - Exercisable, June 30, 2022 473 22.19 7.07 - |
Warrant [Member] | |
Equity (Tables) [Line Items] | |
Schedule of warrant activities | (in thousands, except for per-share amounts) Number of Shares Weighted Weighted Aggregate Outstanding, January 1, 2022 2,112 $ 20.52 1.76 $ 276 Granted - - Exercised - - Cancelled/Expired (59 ) 3.62 Outstanding, June 30, 2022 2,053 $ 21.01 1.32 $ - Exercisable, June 30, 2022 2,049 $ 20.57 1.31 $ - |
Description of Business and S_3
Description of Business and Summary of Significant Accounting Policies (Details) - Schedule of cash, cash equivalents and restricted cash - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Schedule of cash, cash equivalents and restricted cash [Abstract] | ||
Cash and cash equivalents | $ 116,330 | $ 77,829 |
Restricted cash | 392 | 392 |
Cash, cash equivalents and restricted cash | $ 116,772 | $ 78,221 |
Description of Business and S_4
Description of Business and Summary of Significant Accounting Policies (Details) - Schedule of diluted net loss per share anti-dilutive - shares | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 3,484 | 2,973 |
Options [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 1,431 | 859 |
Warrants [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 2,053 | 2,114 |
Commitments and Contingencies (
Commitments and Contingencies (Details) $ in Millions | 1 Months Ended |
Jun. 15, 2012 USD ($) | |
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. |
Leases (Details)
Leases (Details) | 6 Months Ended |
Jun. 30, 2022 | |
Leases [Abstract] | |
Number of operating lease | 2 |
Number of finance lease | 2 |
Operating lease of auxiliary corporate office space | 1 |
Leases (Details) - Schedule of
Leases (Details) - Schedule of components of lease expense - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Schedule of components of lease expense [Abstract] | ||||
Operating lease expense | $ 141 | $ 93 | $ 234 | $ 186 |
Amortization of right-to-use assets | 20 | 21 | 41 | 41 |
Interest on lease liabilities | 1 | 2 | 2 | 5 |
Total finance lease cost | $ 21 | $ 23 | $ 43 | $ 46 |
Leases (Details) - Schedule o_2
Leases (Details) - Schedule of supplemental cash flow information related to leases - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Schedule of supplemental cash flow information related to leases [Abstract] | ||
Operating cash flow use from operating leases | $ 239 | $ 188 |
Operating cash flow use from finance leases | 2 | 5 |
Financing cash flow use from finance leases | 45 | 42 |
Non-cash activity: | ||
Operating leases | 2,605 | |
Finance Leases |
Leases (Details) - Schedule o_3
Leases (Details) - Schedule of weighted average remaining lease terms | Jun. 30, 2022 |
Weighted average remaining lease term: | |
Operating leases | 5 years |
Finance Leases | 6 months |
Leases (Details) - Schedule o_4
Leases (Details) - Schedule of weighted average discount rates | Jun. 30, 2022 |
Weighted average discount rates: | |
Operating leases | 4.80% |
Finance Leases | 8% |
Leases (Details) - Schedule o_5
Leases (Details) - Schedule of maturities of lease liabilities $ in Thousands | Jun. 30, 2022 USD ($) |
Operating Leases [Member] | |
Leases (Details) - Schedule of maturities of lease liabilities [Line Items] | |
2022 | $ 113 |
2023 | 606 |
2024 | 618 |
2025 | 630 |
2026 | 643 |
2027 | 380 |
Total lease payments | 2,990 |
Less imputed interest | (363) |
Present value of lease liabilities | 2,627 |
Finance Leases [Member] | |
Leases (Details) - Schedule of maturities of lease liabilities [Line Items] | |
2022 | 17 |
2023 | 5 |
2024 | |
2025 | |
2026 | |
2027 | |
Total lease payments | 22 |
Less imputed interest | (1) |
Present value of lease liabilities | $ 21 |
Other Revenue (Details)
Other Revenue (Details) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||||
Apr. 07, 2022 | Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | |
Other revenue [Abstract] | ||||||
Recognition of deferred revenue | $ 0 | $ 0.3 | $ 0.9 | $ 0.9 | ||
Revenue recognized | 0 | 0.1 | ||||
Upfront payment | $ 35 | |||||
Other revenue - current liability | 0.2 | 0.2 | $ 0.9 | |||
Long-term license revenue deferred | $ 35 | $ 35 |
Equity (Details)
Equity (Details) - USD ($) $ / shares in Units, shares in Millions, $ in Millions | 1 Months Ended | 6 Months Ended | 12 Months Ended | |
Aug. 31, 2020 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | |
Equity (Details) [Line Items] | ||||
Purchase of common stock, description | During the six months ended June 30, 2022, the Company granted new employees options to purchase 120 thousand shares of common stock with an exercise price ranging from $5.20 to $5.93 per share, a term of 10 years, and a vesting period of 4 years. | |||
Equity Option [Member] | ||||
Equity (Details) [Line Items] | ||||
Stock option term | 10 years | |||
Vesting period of stock option | 4 years | |||
Aggregate fair value | $ 442 | |||
Stock option, description | Variables used in the Black-Scholes option-pricing model include: (1) discount rate range from 1.52% to 3.03% (2) expected life of 6 years, (3) expected volatility range from 78.8% to 79.9%, and (4) zero expected dividends. | |||
Unrecognized compensation expense | $ 4.4 | |||
Weighted average term | 3 years | |||
Compensation expense related to stock options | $ 0.8 | $ 0.7 | ||
Equity Option [Member] | Minimum [Member] | ||||
Equity (Details) [Line Items] | ||||
Exercise price (in Dollars per share) | $ 5.2 | |||
Equity Option [Member] | Maximum [Member] | ||||
Equity (Details) [Line Items] | ||||
Exercise price (in Dollars per share) | $ 5.93 | |||
Capital on Demand Sales Agreement [Member] | ||||
Equity (Details) [Line Items] | ||||
Aggregate value of common stock | $ 200 | |||
Sale of common stock, shares (in Shares) | 2.7 | 3.5 | 6.7 | |
Gross proceeds | $ 17.2 | $ 29.6 | $ 59.1 | |
Net proceeds | $ 16.7 | $ 28.7 | $ 57 |
Equity (Details) - Schedule of
Equity (Details) - Schedule of stock option activity | 6 Months Ended |
Jun. 30, 2022 USD ($) $ / shares shares | |
Schedule of stock option activity [Abstract] | |
Number of Shares, Outstanding Beginning | shares | 1,362 |
Weighted Average Exercise Price, Outstanding Beginning | $ / shares | $ 12.45 |
Weighted Average Remaining Contractual Term (in years),Outstanding Beginning | 8 years 8 months 8 days |
Aggregate Intrinsic Value, Outstanding Beginning | $ | |
Number of Shares, Granted | shares | shares | 120 |
Weighted Average Exercise Price, Granted | $ / shares | $ 5.23 |
Number of Shares, Cancelled | shares | (51) |
Weighted Average Exercise Price, Cancelled | $ / shares | $ 8.89 |
Number of Shares, Outstanding Ending | shares | 1,431 |
Weighted Average Exercise Price, Outstanding Ending | $ / shares | $ 11.97 |
Weighted Average Remaining Contractual Term, Outstanding Ending | 8 years 4 months 9 days |
Aggregate Intrinsic Value, Outstanding Ending | $ | |
Number of Shares Exercisable Ending | shares | 473 |
Weighted Average Exercise Price, Exercisable Ending | $ / shares | $ / shares | $ 22.19 |
Weighted Average Remaining Contractual Term (in years), Exercisable Ending | 7 years 25 days |
Aggregate Intrinsic Value, Exercisable Ending | $ |
Equity (Details) - Schedule _2
Equity (Details) - Schedule of warrant activities - Warrant [Member] $ / shares in Units, $ in Thousands | 6 Months Ended |
Jun. 30, 2022 USD ($) $ / shares shares | |
Class of Warrant [Line Items] | |
Number of Shares, Outstanding Beginning | shares | 2,112 |
Weighted Average Exercise Price, Outstanding Beginning | $ / shares | $ 20.52 |
Weighted average remaining contractual term (in years),Outstanding beginning | 1 year 9 months 3 days |
Aggregate Intrinsic Value, Outstanding Beginning | $ | $ 276 |
Number of Shares, Outstanding Ending | shares | 2,053 |
Weighted Average Exercise Price,Outstanding Ending | $ / shares | $ 21.01 |
Weighted Average Remaining Contractual Term (in years),Outstanding Ending | 1 year 3 months 25 days |
Aggregate Intrinsic Value,Outstanding Ending | $ | |
Number of Shares, Exercisable Ending | shares | 2,049 |
Weighted Average Exercise Price, Exercisable Ending | $ / shares | $ 20.57 |
Weighted Average Remaining Contractual Term (in years), Exercisable Ending | 1 year 3 months 21 days |
Aggregate Intrinsic Value, Exercisable Ending | $ | |
Number of Shares, Granted | shares | |
Weighted Average Exercise Price, Granted | $ / shares | |
Number of Shares, Exercised | shares | |
Weighted Average Exercise Price, Exercised | $ / shares | |
Number of Shares, Cancelled/Expired | shares | (59) |
Weighted Average Exercise Price, Cancelled/Expired | $ / shares | $ 3.62 |
Subsequent Event (Details)
Subsequent Event (Details) - USD ($) $ / shares in Units, shares in Millions, $ in Millions | Aug. 12, 2022 | Aug. 02, 2017 | Jun. 30, 2022 |
Subsequent Event (Details) [Line Items] | |||
Shares of common stock value | $ 0.3 | ||
Net proceeds | $ 1.4 | ||
Aggregate purchase of common stock | $ 0.6 | ||
Underwritten offering | $ 0.7 | ||
Price pe share (in Dollars per share) | $ 22.5 | ||
Warrants exercisable term | 5 years | ||
Exercise price per share (in Dollars per share) | $ 31.5 | ||
Warrants outstanding (in Shares) | 1.4 | ||
Warrant [Member] | |||
Subsequent Event (Details) [Line Items] | |||
Aggregate purchase of common stock | $ 0.6 |