Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2022 | Aug. 10, 2022 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Period End Date | Jun. 30, 2022 | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity File Number | 001-12584 | |
Entity Registrant Name | SYNTHETIC BIOLOGICS, INC. | |
Entity Incorporation, State or Country Code | NV | |
Entity Tax Identification Number | 13-3808303 | |
Entity Address, Address Line One | 9605 Medical Center Drive, Suite 270 | |
Entity Address, City or Town | Rockville | |
Entity Address, Country | MD | |
Entity Address, Postal Zip Code | 20850 | |
City Area Code | 301 | |
Local Phone Number | 417-4364 | |
Title of 12(b) Security | Common Stock | |
Trading Symbol | SYN | |
Security Exchange Name | NYSE | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 15,844,061 | |
Entity Central Index Key | 0000894158 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q2 | |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Jun. 30, 2022 | Dec. 31, 2021 |
Current Assets | ||
Cash and cash equivalents | $ 52,266,000 | $ 67,325,000 |
Prepaid expenses and other current assets | 2,622,000 | 1,533,000 |
Total Current Assets | 54,888,000 | 68,858,000 |
Non-Current Assets | ||
Property and equipment, net | 285,000 | 101,000 |
Restricted cash | 96,000 | |
Right of use asset | 1,292,000 | 1,383,000 |
In-process research and development | 20,562,000 | |
Goodwill | 5,185,000 | |
Deposits and other assets | 23,000 | 23,000 |
Total Assets | 82,331,000 | 70,365,000 |
Current Liabilities: | ||
Accounts payable | 1,003,000 | 524,000 |
Accrued expenses | 1,987,000 | 1,928,000 |
Accrued employee benefits | 788,000 | 978,000 |
Contingent consideration, current portion | 9,302,000 | |
Loans Payable-current | 56,000 | |
Operating lease liability | 128,000 | 124,000 |
Total Current Liabilities | 13,264,000 | 3,554,000 |
Non-current Liabilities | ||
Non-current contingent consideration | 2,374,000 | |
Loan Payable - Long term | 216,000 | |
Deferred tax liabilities, net | 3,505,000 | |
Lease liability - Long term | 1,298,000 | 1,403,000 |
Total Liabilities | 20,657,000 | 4,957,000 |
Commitments and Contingencies | ||
Stockholders' Equity (Deficit): | ||
Common stock, $0.001 par value; 20,000,000 shares authorized, 15,844,294 issued and 15,844,061 outstanding at June 30, 2022 and 13,204,487 issued and 13,204,254 outstanding at December 31, 2021 | 16,000 | 13,000 |
Additional paid-in capital | 343,500,000 | 336,679,000 |
Accumulated other comprehensive loss | (1,317,000) | |
Accumulated deficit | (280,525,000) | (271,284,000) |
Total Stockholders' Equity | 61,674,000 | 65,408,000 |
Total Liabilities and Stockholders' Equity | $ 82,331,000 | $ 70,365,000 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jul. 25, 2022 | Jul. 24, 2022 | Jul. 11, 2022 | Jun. 30, 2022 | Dec. 31, 2021 | Nov. 16, 2020 |
Condensed Consolidated Balance Sheets | ||||||
Preferred Stock, Par or Stated Value Per Share | $ 0.001 | |||||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 | |||
Common stock, Shares Authorized | 20,000,000 | 20,000,000 | 20,000,000 | |||
Common stock, Shares Issued | 15,844,294 | 13,204,487 | ||||
Common stock, Shares Outstanding | 15,844,061 | 158,437,840 | 15,844,061 | 13,204,254 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Operating Costs and Expenses: | ||||
General and administrative | $ 1,500,000 | $ 1,265,000 | $ 3,155,000 | $ 2,685,000 |
Research and development | 3,485,000 | 1,932,000 | 6,082,000 | 3,049,000 |
Total Operating Costs and Expenses | 4,985,000 | 3,197,000 | 9,237,000 | 5,734,000 |
Loss from Operations | (4,985,000) | (3,197,000) | (9,237,000) | (5,734,000) |
Other Expense: | ||||
Exchange loss | (9,000) | 0 | (31,000) | |
Interest income | 26,000 | 2,000 | 27,000 | 2,000 |
Total Other Income(Expense) | 17,000 | 2,000 | (4,000) | 2,000 |
Net Loss | (4,968,000) | (3,195,000) | (9,241,000) | (5,732,000) |
Net Loss Attributable to Non-controlling Interest | 0 | 0 | (1,000) | |
Net Loss Attributable to Synthetic Biologics, Inc. and Subsidiaries | (4,968,000) | (3,195,000) | (9,241,000) | (5,731,000) |
Effect of Series A Preferred Stock price adjustment | 0 | (7,402,000) | ||
Net Loss Attributable to Common Stockholders | $ (4,968,000) | $ (3,195,000) | $ (9,241,000) | $ (14,654,000) |
Net Loss Per Share - Basic | $ (0.31) | $ (0.24) | $ (0.62) | $ (1.31) |
Net Loss Per Share - Dilutive | $ (0.31) | $ (0.24) | $ (0.62) | $ (1.31) |
Weighted average number of shares outstanding during the period - basic | 15,844,061 | 13,204,254 | 14,837,832 | 11,153,902 |
Weighted average number of shares outstanding during the period - dilutive | 15,844,061 | 13,204,254 | 14,837,832 | 11,153,902 |
Series A Preferred Stock [Member] | ||||
Other Expense: | ||||
Preferred Stock Dividends, Income Statement Impact | $ 0 | $ 0 | $ (24,000) | |
Effect of Series A Preferred Stock price adjustment | 0 | 0 | (7,402,000) | |
Series B Preferred Stock [Member] | ||||
Other Expense: | ||||
Net Loss Attributable to Non-controlling Interest | 100,000 | |||
Preferred Stock Dividends, Income Statement Impact | 0 | 0 | $ (1,497,000) | |
Preferred Stock [Member] | Series B Preferred Stock [Member] | ||||
Other Expense: | ||||
Net Loss Attributable to Synthetic Biologics, Inc. and Subsidiaries | $ 0 | $ 0 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Operations and Comprehensive Loss (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Condensed Consolidated Statements of Operations and Comprehensive Loss | ||||
Net Loss | $ (4,968) | $ (3,195) | $ (9,241) | $ (5,732) |
Loss on foreign currency translation | (1,497) | 0 | (1,317) | |
Total comprehensive loss | (6,465) | (3,195) | (10,558) | (5,732) |
Comprehensive loss attributable to non-controlling interest | 0 | 0 | (1) | |
Comprehensive loss attributable to Synthetic Biologics, Inc. and Subsidiaries | $ (6,465) | $ (3,195) | $ (10,558) | $ (5,731) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders Equity (Deficit) - USD ($) | Common Stock | APIC | Accumulated Deficit | Accumulated other Comprehensive income | Non-Controlling InterestAccumulated Non-Controlling Stockholders' | Preferred Stock [Member] Series B Preferred | Series B Preferred | Total |
Balance at Dec. 31, 2020 | $ 3,000 | $ 240,847,000 | $ (248,094,000) | $ (2,773,000) | $ 2,477,000 | $ (7,540,000) | ||
Balance (in shares) at Dec. 31, 2020 | 2,924,993 | 3,973 | ||||||
Stock-based compensation | $ 0 | 101,000 | 0 | 0 | $ 0 | 101,000 | ||
Stock issued under "at-the-market" offering | $ 8,000 | 65,952,000 | 0 | 0 | $ 0 | 65,960,000 | ||
Stock issued under "at-the-market" offering (in shares) | 7,868,532 | 0 | ||||||
Warrants Exercised | $ 1,000 | 8,041,000 | 0 | 0 | $ 0 | 8,042,000 | ||
Warrants Exercised (In shares) | 1,165,575 | 0 | ||||||
Series A Preferred Stock Dividends | $ 0 | 0 | (24,000) | 0 | $ 0 | (24,000) | ||
Conversion of Series A Preferred Stock to Common | $ 1,000 | 12,821,000 | 0 | 0 | $ 0 | 12,822,000 | ||
Conversion of Series A Preferred Stock to Common (in shares) | 899,677 | 0 | ||||||
Conversion of Series B Preferred Stock to Common | $ 0 | 3,974,000 | (1,497,000) | 0 | $ (2,477,000) | 0 | ||
Conversion of Series B Preferred Stock to Common (in shares) | 345,478 | (3,973) | ||||||
Net loss | $ 0 | 0 | (2,536,000) | 0 | $ 0 | (2,536,000) | ||
Non-controlling interest | 0 | 0 | 0 | (1,000) | 0 | (1,000) | ||
Effect of Series A Preferred Stock price adjustment | $ 0 | 7,401,000 | (7,402,000) | 0 | $ 0 | $ 0 | ||
Issuance of Common Stock, preferred Stock and Warrants in Units Offering, net of issuance costs (in shares) | 7,900,000 | |||||||
Balance (in shares) at Mar. 31, 2021 | 13,204,255 | 0 | ||||||
Balance at Mar. 31, 2021 | $ 13,000 | 339,138,000 | (259,553,000) | (2,774,000) | $ 0 | $ 76,824,000 | ||
Balance at Dec. 31, 2020 | $ 3,000 | 240,847,000 | (248,094,000) | (2,773,000) | $ 2,477,000 | (7,540,000) | ||
Balance (in shares) at Dec. 31, 2020 | 2,924,993 | 3,973 | ||||||
Net loss | (5,731,000) | |||||||
Non-controlling interest | $ (100,000) | 1,000 | ||||||
Balance (in shares) at Jun. 30, 2021 | 13,204,255 | 0 | ||||||
Balance at Jun. 30, 2021 | $ 13,000 | 339,240,000 | (262,748,000) | (2,774,000) | $ 0 | 73,731,000 | ||
Balance at Mar. 31, 2021 | $ 13,000 | 339,138,000 | (259,553,000) | (2,774,000) | $ 0 | 76,824,000 | ||
Balance (in shares) at Mar. 31, 2021 | 13,204,255 | 0 | ||||||
Stock-based compensation | $ 0 | 102,000 | 0 | 0 | $ 0 | 102,000 | ||
Net loss | $ 0 | 0 | (3,195,000) | 0 | $ 0 | (3,195,000) | ||
Non-controlling interest | 0 | |||||||
Balance (in shares) at Jun. 30, 2021 | 13,204,255 | 0 | ||||||
Balance at Jun. 30, 2021 | $ 13,000 | 339,240,000 | (262,748,000) | $ (2,774,000) | $ 0 | 73,731,000 | ||
Balance at Dec. 31, 2021 | $ 13,000 | 336,679,000 | (271,284,000) | $ 0 | $ 0 | 65,408,000 | ||
Balance (in shares) at Dec. 31, 2021 | 13,204,531 | 0 | ||||||
Stock-based compensation | $ 0 | 112,000 | 0 | 0 | $ 0 | 112,000 | ||
Issuance of Common Stock for VCN Acquisition | $ 3,000 | 6,596,000 | 0 | 0 | $ 0 | 6,599,000 | ||
Issuance of Common Stock for VCN Acquisition (in shares) | 2,639,530 | 0 | ||||||
Translation gains (losses) | $ 0 | 0 | 0 | 181,000 | $ 0 | 181,000 | ||
Net loss | $ 0 | 0 | (4,273,000) | 0 | $ 0 | (4,273,000) | ||
Balance (in shares) at Mar. 31, 2022 | 15,844,061 | 0 | ||||||
Balance at Mar. 31, 2022 | $ 16,000 | 343,387,000 | (275,557,000) | 181,000 | $ 0 | 68,027,000 | ||
Balance at Dec. 31, 2021 | $ 13,000 | 336,679,000 | (271,284,000) | 0 | $ 0 | $ 65,408,000 | ||
Balance (in shares) at Dec. 31, 2021 | 13,204,531 | 0 | ||||||
Warrants Exercised (In shares) | 0 | |||||||
Net loss | $ (9,241,000) | |||||||
Issuance of Common Stock, preferred Stock and Warrants in Units Offering, net of issuance costs (in shares) | 0 | |||||||
Balance (in shares) at Jun. 30, 2022 | 15,844,061 | 0 | ||||||
Balance at Jun. 30, 2022 | $ 16,000 | 343,500,000 | (280,525,000) | (1,317,000) | $ 0 | $ 61,674,000 | ||
Balance at Mar. 31, 2022 | $ 16,000 | 343,387,000 | (275,557,000) | 181,000 | $ 0 | 68,027,000 | ||
Balance (in shares) at Mar. 31, 2022 | 15,844,061 | 0 | ||||||
Stock-based compensation | $ 0 | 113,000 | 0 | 0 | $ 0 | 113,000 | ||
Translation gains (losses) | 0 | 0 | 0 | (1,498,000) | 0 | $ (1,498,000) | ||
Warrants Exercised (In shares) | 0 | |||||||
Net loss | $ 0 | 0 | (4,968,000) | 0 | $ 0 | $ (4,968,000) | ||
Non-controlling interest | $ 0 | |||||||
Issuance of Common Stock, preferred Stock and Warrants in Units Offering, net of issuance costs (in shares) | 0 | |||||||
Balance (in shares) at Jun. 30, 2022 | 15,844,061 | 0 | ||||||
Balance at Jun. 30, 2022 | $ 16,000 | $ 343,500,000 | $ (280,525,000) | $ (1,317,000) | $ 0 | $ 61,674,000 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Cash Flows From Operating Activities: | ||
Net loss | $ (9,241,000) | $ (5,732,000) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 225,000 | 203,000 |
Change in fair value of contingent consideration | (483,000) | 0 |
Depreciation | 36,000 | 56,000 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 518,000 | 366,000 |
Right of use asset | 90,000 | 81,000 |
Accounts payable | (295,000) | (318,000) |
Accrued expenses | 265,000 | (131,000) |
Accrued employee benefits | (272,000) | (328,000) |
Lease liability | (101,000) | (121,000) |
Net Cash Used In Operating Activities | (9,258,000) | (5,924,000) |
Cash Flows from Investing Activities | ||
Purchase of property and equipment | (14,000) | (14,000) |
Cash paid for business combination, net of cash acquired | (3,863,000) | 0 |
Pre-acquisition loan to VCN | (417,000) | 0 |
Net Cash Used in Investing Activities | (4,294,000) | (14,000) |
Cash Flows from Financing Activities | ||
Payment of VCN's CDTI loan | (1,376,000) | |
Proceeds from "at the market" stock issuance | 0 | 65,960,000 |
Proceeds from issuance of common stock for warrant exercises | 0 | 8,042,000 |
Net Cash Provided (used in) by Financing Activities | (1,376,000) | 74,002,000 |
Effects of FX on cash | (35,000) | 0 |
Net increase (decrease) in cash and cash equivalents and restricted cash | (14,963,000) | 68,064,000 |
Cash and cash equivalents and restricted at the beginning of this period | 67,325,000 | 6,227,000 |
Cash and cash equivalents and restricted cash at the end of this period | 52,362,000 | 74,291,000 |
Reconciliation of cash, cash equivalents, and restricted cash reported in the statement of financial position | ||
Cash and cash equivalents | 52,266,000 | 74,291,000 |
Restricted cash included in other long-term assets | 96,000 | 0 |
Total cash, cash equivalents, and restricted cash shown in the statement of cash flows | 52,362,000 | 74,291,000 |
Supplemental non-cash investing and financing activities: | ||
Fair value of contingent consideration issued in a business combination | 12,158,000 | 0 |
Fair value of equity issued as consideration in a business combination | 6,599,000 | 0 |
Effective settlement of pre-closing VCN financing | 417,000 | 0 |
Goodwill measurement period adjustment | 277,000 | 0 |
Effect of Series A Preferred Stock price adjustment | 0 | 7,402,000 |
Right of use asset from operating lease | 0 | 1,270,000 |
Conversion of Series B Preferred Stock | 0 | 2,477,000 |
Deemed dividends for accretion of Series B Preferred Stock discount | 0 | 1,497,000 |
In-kind dividends paid in preferred stock | $ 0 | $ 23,000 |
Organization, Nature of Operati
Organization, Nature of Operations and Basis of Presentation | 6 Months Ended |
Jun. 30, 2022 | |
Organization, Nature of Operations and Basis of Presentation | |
Organization, Nature of Operations and Basis of Presentation | 1. Organization, Nature of Operations and Basis of Presentation Description of Business Synthetic Biologics, Inc. (the “Company” or “Synthetic Biologics”) is a diversified clinical-stage company developing therapeutics in areas of high unmet need. Prior to the acquisition of VCN (the “Acquisition”), the Company’s focus was on developing therapeutics designed to treat gastrointestinal (GI) diseases in areas which included our lead clinical development candidates: (1) SYN-004 (ribaxamase) which is designed to degrade certain commonly used intravenous (IV) beta-lactam antibiotics within the GI tract to prevent microbiome damage, Clostridioides difficile Basis of Presentation On July 11, 2022, the Board of Directors of the Company approved a reverse stock split of the Company's authorized, issued and outstanding shares of common stock, par value $0.001 per share, at a ratio of one As a result of the Reverse Stock Split, each ten (10) pre-split shares of common stock outstanding automatically combined into one All share amounts and exercise/conversion prices in the condensed consolidated financial statements and footnotes below have been adjusted retrospectively for the Reverse Stock Split. The accompanying condensed consolidated financial statements have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial information. Accordingly, they do not include all of the information and notes required by Accounting Principles Generally Accepted in the United States of America (“U.S. GAAP”) for complete financial statements. The accompanying condensed consolidated financial statements include all adjustments, comprised of normal recurring adjustments, considered necessary by management to fairly state the Company’s results of operations, financial position and cash flows. The operating results for the interim periods are not necessarily indicative of results that may be expected for any other interim period or for the full year. These condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto included in the Company’s 2021 Form 10-K. The interim results for the three and six months ended June 30, 2022 are not necessarily indicative of results for the full year. 1. Organization, Nature of Operations and Basis of Presentation – (continued) The condensed consolidated financial statements are prepared in conformity with U.S. GAAP, which requires the use of estimates, judgments and assumptions that affect the amounts of assets and liabilities at the reporting date and the amounts of revenue and expenses in the periods presented. The Company believes that the accounting estimates employed are appropriate and the resulting balances are reasonable; however, due to the inherent uncertainties in making estimates, actual results may differ from the original estimates, requiring adjustments to these balances in future periods. As of June 30, 2022 the Company has one operating segment (which includes the legacy Company business and the VCN business) and therefore one reporting segment. Business Combination The Company accounts for acquisitions using the acquisition method of accounting, which requires that all identifiable assets acquired, and liabilities assumed be recorded at their estimated fair values. The excess of the fair value of purchase consideration over the fair values of identifiable assets and liabilities is recorded as goodwill. When determining the fair values of assets acquired and liabilities assumed, management makes significant estimates and assumptions. Critical estimates in valuing certain intangible assets include but are not limited to future expected cash flows from acquired patented technology. Management’s estimates of fair value are based upon assumptions believed to be reasonable, but are inherently uncertain and unpredictable and, as a result, actual results may differ from estimates. As a result of the acquisition of VCN (see Note 2), the Company has two intangible assets, in-process research and development (“IPR&D”) and goodwill. The IPR&D and goodwill are deemed to have indefinite lives and therefore not amortized. IPR&D IPR&D assets represent the fair value assigned to technologies that the Company acquired, which at the time of acquisition have not reached technological feasibility and have no alternative future use. IPR&D assets are considered to have indefinite-lives until the completion or abandonment of the associated research and development projects. If and when development is complete, which generally occurs upon regulatory approval and the ability to commercialize products associated with the IPR&D assets, these assets are then deemed to have definite lives and are amortized based on their estimated useful lives at that point in time. If development is terminated or abandoned, the Company may have a full or partial impairment charge related to the IPR&D assets, calculated as the excess of carrying value of the IPR&D assets over fair value. During the period that the assets are considered indefinite-lived, they are tested for impairment on an annual basis on October 1, or more frequently if the Company becomes aware of any events occurring or changes in circumstances that could indicate an impairment. The impairment test consists of a comparison of the estimated fair value of the IPR&D with its carrying amount. If the carrying amount exceeds the fair value, an impairment charge is recognized in an amount equal to that excess. No impairment of the IPR&D asset was identified during the three and six months ended June 30, 2022. Goodwill The Company tests the carrying amounts of goodwill for recoverability on an annual basis on October 1 or more frequently if events or changes in circumstances indicate that the asset might be impaired. The Company performs a one-step test in its evaluation of the carrying value of goodwill if qualitative factors determine it is necessary to complete a goodwill impairment test. In the evaluation, the fair value of the relevant reporting unit is determined and compared to its carrying value. If the fair value is greater than the carrying value, then the carrying value is deemed to be recoverable, and no further action is required. If the fair value estimate is less than the carrying value, goodwill is considered impaired for the amount by which the carrying amount exceeds the reporting unit’s fair value, and a charge is reported in impairment of goodwill in the Company’s consolidated statements of operations. As of June 30, 2022, the Company has determined that it has one reporting unit. The Company has not identified any events or changes in circumstances that indicate the existence of potential impairment of goodwill during the three and six months ended June 30, 2022. 1. Organization, Nature of Operations and Basis of Presentation – (continued) Contingent Consideration Consideration paid in a business combination may include potential future payments that are contingent upon the acquired business achieving certain milestones in the future (“contingent consideration”). Contingent consideration liabilities are measured at their estimated fair value as of the date of acquisition, with subsequent changes in fair value recorded in the consolidated statements of operations. The Company estimates the fair value of the contingent consideration as of the acquisition date using the estimated future cash outflows based on the probability of meeting future milestones. The milestone payments will be made upon the achievement of clinical and commercialization milestones as well as single low digit royalty payments and payments upon receipt of sublicensing income. Subsequent to the date of acquisition, the Company reassesses the actual consideration earned and the probability-weighted future earn-out payments at each balance sheet date. Any adjustment to the contingent consideration liability will be recorded in the consolidated statements of operations. Contingent consideration liabilities expected to be settled within 12 months after the balance sheet date are presented in current liabilities, with the non-current portion recorded under long term liabilities in the consolidated balance sheets. Impairment of Long-Lived Assets Long-lived assets include property, equipment and right-of-use assets. Management reviews the Company’s long-lived assets for impairment annually or whenever events or changes in circumstances indicate that the carrying amount of an asset or asset group may not be fully recoverable. The Company determines the extent to which an asset may be impaired based upon its expectation of the asset’s future usability as well as whether there is reasonable assurance that the future cash flows associated with the asset will be in excess of its carrying amount. If the total of the expected undiscounted future cash flows is less than the carrying amount of the asset, a loss is recognized for the difference between the fair value and the carrying value of the asset. As a result, no impairment charges were recorded during the three and six months ended June 30, 2022 and 2021. Recent Accounting Pronouncements and Developments In August 2020, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2020-06 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 |
Business Combination
Business Combination | 6 Months Ended |
Jun. 30, 2022 | |
Business Combination | |
Business Combination | 2. Business Combination Summary On March 10, 2022, the Company completed the acquisition of all the outstanding shares of VCN (the “VCN Shares”) from the shareholders of VCN. VCN is a private, clinical-stage biopharmaceutical company developing new oncolytic adenoviruses for the treatment of cancer. VCN’s lead product candidate, VCN-01, is being studied in clinical trials for pancreatic cancer and retinoblastoma. VCN-01 is designed to be administered systemically, intratumorally or intravitreally, either as a monotherapy or in combination with standard of care, to treat a wide variety of cancer indications. VCN-01 is designed to replicate selectively and aggressively within tumor cells, and to degrade the tumor stroma barrier that serves as a significant physical and immunosuppressive barrier to cancer treatment. Degrading the tumor stroma has been shown to improve access to the tumor by the virus and additional therapies such as chemo- and immuno-therapies. Importantly, degrading the stroma exposes tumor antigens, turning “cold” tumors “hot” and enabling a sustained anti-tumor immune response. VCN has the rights to four exclusive patents for proprietary technologies, as well as technologies developed in collaboration with the Virotherapy Group of the Catalan Institute of Oncology (ICO-IDIBELL) and with Hospital Sant Joan de Deu (HSJD), with a number of additional patents pending. As consideration for the purchase of the VCN Shares, the Company paid $4,700,000 to Grifols Innovation and New Technologies Limited, the owner of approximately 86% of the equity of VCN, and issued to the remaining sellers and certain key VCN employees and consultants of VCN an aggregate of 2,639,530 shares of its common stock In addition to the consideration described above, under the terms of the Purchase Agreement, the Company assumed up to $2,390,000 of existing liabilities of VCN and has agreed to make cash payments of up to $70.2 million to Grifols upon the achievement of certain clinical and commercialization milestones. In anticipation of the Acquisition, prior to the Closing, the Company loaned VCN $417,000 to help finance the costs of certain of VCN’s research and development activities. At the Closing, VCN and Grifols entered into a sublease agreement for the sublease by VCN of laboratory and office space as well as a transitional services agreement. As a post-Closing covenant, the Company has agreed to commit to fund VCN’s research and development programs, including but not limited to VCN-01 in a pancreatic ductal adenocarcinoma PDAC phase 2 trial, VCN-01 in a retinoblastoma (RB) phase 2/3 trial and necessary G&A within a budgetary plan of approximately $27.8 million. Total purchase consideration including cash, restricted shares and contingent consideration was valued at approximately $23.9 million, as follows (in thousands): Cash paid at Closing $ 4,700 Receivable from VCN "effectively settled" 417 FV of common shares issued 6,599 FV of contingent consideration 12,159 $ 23,875 As of March 31, 2022, the fair value of the contingent consideration was approximately $12.2 million. During the three months ended June 30, 2022 the Company recognized a non-cash gain of $483,000 related to the decrease in the fair value of the contingent consideration. This gain was recorded as a reduction of general and administrative expense in the accompanying condensed consolidated statement of operations. The Company acquired VCN due to its track record of being a research and development growth engine capable of fueling sustainable growth, to expand the Company’s research and development pipeline, and to diversify the Company’s potential future revenue opportunities. 2. Business Combination - (continued) The preliminary allocation of the fair value of the VCN acquisition is shown in the table below. Estimated fair value ($in thousands) Cash and cash equivalents $ 837 Receivables 1,707 Property and equipment 216 In-process research and development intangible asset 21,703 Goodwill 5,765 Deferred tax assets (liabilities), net (3,699) Accounts payable (814) Accrued expenses (113) Accrued employee benefits (90) Loan Payable-current (67) Other long-term liabilities (1,570) Total purchase consideration $ 23,875 The above allocation of the purchase price is based upon certain preliminary valuations and other analyses that have not been finalized as of the date of this filing. Any changes in the estimated fair values of the purchase consideration and of the net assets recorded for this business combination upon the finalization of more detailed analyses of the facts and circumstances that existed at the date of the transaction may change the amount and allocation of the purchase price. As such, the purchase price amount and allocations for this transaction are preliminary estimates including in-process research and development, goodwill and contingent consideration, which may be subject to change within the measurement period. During the three months ended June 30, 2022 the Company recognized a measurement period adjustment related to the estimate of acquired liabilities resulting in a $277,000 reduction in accrued liabilities and Goodwill. The net assets were recorded at their estimated fair value. In valuing acquired assets and liabilities, fair value estimates were based primarily on future expected cash flows, market rate assumptions for contractual obligations, and appropriate discount rates. In connection with the acquisition, we recognized $21.7 million of indefinite-lived in-process research and development intangible assets. Goodwill is considered an indefinite-lived asset and relates primarily to intangible assets that do not qualify for separate recognition, such as the assembled workforce and synergies between the entities. Goodwill of $5.8 million was established as a result of the Acquisition and is not tax deductible. VCN operations recorded a net loss of $2.1 million from the date of acquisition through June 30, 2022. Pro Forma Consolidated Financial Information (unaudited) The following unaudited pro forma consolidated financial information summarizes the results of operations for the periods indicated as if the VCN acquisition had been completed as of January 1, 2021 (in thousands): Three Months Ended June 30, Six Months Ended June 30, (in thousands) 2022 2021 2022 2021 Net revenues $ — $ — — $ — Net loss $ (4,967) $ (3,897) (9,763) $ (6,997) 2. Business Combination - (continued) Transaction Costs In conjunction with the Acquisition, the Company incurred approximately $1.2 million and $0.2 million in 2021 and 2022, respectively, in transaction costs, which were expensed as general, and administrative expense in the consolidated statements of operations. |
Goodwill and Intangibles
Goodwill and Intangibles | 6 Months Ended |
Jun. 30, 2022 | |
Goodwill and Intangibles | |
Goodwill and Intangibles | 3. Goodwill and Intangibles Goodwill of $5.8 million and in-process R&D of $21.7 million were recorded in connection with the Acquisition of VCN, as described in Note 2. The Company performs an impairment test for IPR&D and for goodwill on an annual basis on October 1 or more frequently if events or changes in circumstances indicate that the asset might be impaired. This analysis requires significant judgments, including primarily the estimation of future development costs, the probability of success in various phases of its development programs, potential post-launch cash flows and a risk-adjusted weighted average cost of capital. The Company did not identify any impairments to IPR&D and goodwill during the quarter ended June 30, 2022 The following table provides the Company’s goodwill as of June 30, 2022. During the three months ended June 30, 2022 the Company recognized a measurement period adjustment related to the estimate of acquired liabilities resulting in a $277,000 reduction in accrued liabilities and Goodwill. Goodwill (in thousands) Balance at December 31, 2021 $ — Goodwill from Acquisition of VCN 5,765 Goodwill impairment loss — Measurement Period Adjustment (277) Effects of exchange rates (303) Balance at June 30, 2022 $ 5,185 The following table provides the Company’s in-process R&D as of June 30, 2022. There was no change in in-process R&D during the quarter ended June 30, 2022. In-process R&D (in thousands) Balance at December 31, 2021 $ — Acquired IPR&D - 21,703 In-process R&D impairment loss — Effects of exchange rates (1,141) Balance at June 30, 2022 $ 20,562 |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 6 Months Ended |
Jun. 30, 2022 | |
Fair Value of Financial Instruments | |
Fair Value of Financial Instruments | 4. Fair Value of Financial Instruments Accounting Standards Codification (“ASC”) Topic 820, Fair Value Measurement ● Level 1 inputs: Quoted prices (unadjusted) for identical assets or liabilities in active markets; ● Level 2 inputs: Inputs, other than quoted prices, included in Level 1 that are observable either directly or indirectly; and ● Level 3 inputs: Unobservable inputs for which there is little or no market data, which require the reporting entity to develop its own assumptions. 4. Fair Value of Financial Instruments – (continued) In many cases, a valuation technique used to measure fair value includes inputs from multiple levels of the fair value hierarchy described above. The lowest level of significant input determines the placement of the entire fair value measurement in the hierarchy. The carrying amounts of the Company’s short-term financial instruments, including cash and cash equivalents, other current assets, accounts payable and accrued liabilities approximate fair value due to the relatively short period to maturity for these instruments. In connection with the Acquisition of VCN, the Company will be required pay up to $70.2 million in additional consideration upon the achievement of certain milestones, including regulatory filings completed noted in Note 3. The discounted cash flow method used to value this contingent consideration includes inputs of not readily observable market data, which are Level 3 inputs. As of the March 10, 2022 acquisition date, the contingent consideration had a fair value of $12.2 million. The fair value of the contingent consideration was $11.7 million as of June 30, 2022 and is reflected as current accrued contingent consideration of $9.3 million and non-current contingent consideration liability of $2.4 million in the consolidated balance sheet. During the three months ended June 30, 2022 the Company recognized in operating expense a $483,000 fair value adjustment decrease to contingent consideration. The fair value of financial instruments measured on a recurring basis is as follows (in thousands): As of March 10, 2022 Description Total Level 1 Level 2 Level 3 Liabilities: Contingent consideration $ 12,159 — — $ 12,159 As of June 30, 2022 Description Total Level 1 Level 2 Level 3 Liabilities: Contingent consideration $ 11,676 — — $ 11,676 The following table summarizes the change in fair value, as determined by Level 3 inputs, for all assets and liabilities using unobservable Level 3 inputs for the six months ended June 30, 2022 (in thousands): Contingent Consideration Balance at March 10, 2022 $ 12,159 Change in fair value (483) Balance at June 30, 2022 $ 11,676 4. Fair Value of Financial Instruments – (continued) The recurring Level 3 fair value measurements of contingent consideration for which a liability is recorded include the following significant unobservable inputs: As of March 10, 2022 Valuation Significant Weighted Average Methodology Unobservable Input (range, if applicable) Contingent Consideration Probability weighted Milestone dates 2022-2027 income approach Discount rate 7.3% to 8.6% Weighted Average Discount rate 7.77% Probability of Occurrence (periodic for each Milestone) 9.9% to 82.4% Probability of occurrence (cumulative through each Milestone) 5.1% to 62.8% As of June 30, 2022 Valuation Significant Weighted Average Methodology Unobservable Input (range, if applicable) Contingent Consideration Probability weighted Milestone dates 2022-2027 income approach Discount rate 11.6% to 13.1% Weighted Average Discount rate 7.75% Probability of Occurrence (periodic for each Milestone) 9.9% to 82.4% Probability of occurrence (cumulative through each Milestone) 5.1% to 62.8% |
Selected Balance Sheet Informat
Selected Balance Sheet Information | 6 Months Ended |
Jun. 30, 2022 | |
Selected Balance Sheet Information | |
Selected Balance Sheet Information | 5. Selected Balance Sheet Information Prepaid expenses and other current assets (in thousands) June 30, December 31, 2022 2021 Prepaid clinical research organizations $ 1,215 $ 458 Prepaid manufacturing expenses 519 — Prepaid insurances 353 803 VAT receivable 278 — Prepaid consulting, subscriptions and other expenses 257 272 Total $ 2,622 $ 1,533 Prepaid clinical research organizations (CROs) expense is classified as a current asset. The Company makes payments to the CROs based on agreed upon terms that include payments in advance of study services. 5. Selected Balance Sheet Information – (continued) Property and equipment, net (in thousands) June 30, December 31, 2022 2021 Computers and office equipment $ 790 $ 827 Other Property, Plant and Equipment 203 — Leasehold improvements 94 94 Software 11 11 1,098 932 Less: accumulated depreciation and amortization (813) (831) Total $ 285 $ 101 Accrued expenses (in thousands) June 30, December 31, 2022 2021 Accrued clinical consulting services $ 741 $ 696 Accrued manufacturing costs 617 204 Accrued vendor payments 506 1,028 VAT payable 123 — Total $ 1,987 $ 1,928 Accrued employee benefits (in thousands) June 30, December 31, 2022 2021 Accrued bonus expense $ 542 $ 886 Accrued vacation expense 128 92 Accrued compensation expense 118 — Total $ 788 $ 978 |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2022 | |
Stock-Based Compensation | |
Stock-Based Compensation | 6. Stock-Based Compensation Stock Incentive Plans On March 20, 2007, the Company’s Board of Directors approved the 2007 Stock Incentive Plan (the “2007 Stock Plan”) for the issuance of up to 7,143 shares of common stock to be granted through incentive stock options, nonqualified stock options, stock appreciation rights, dividend equivalent rights, restricted stock, restricted stock units and other stock-based awards to officers, other employees, directors and consultants of the Company and its subsidiaries. This plan was approved by the stockholders on November 2, 2007. The exercise price of stock options under the 2007 Stock Plan was determined by the compensation committee of the Board of Directors and could be equal to or greater than the fair market value of the Company’s common stock on the date the option is granted. As of June 30, 2022, there were 515 options issued and outstanding under the 2007 Stock Plan. 6. Stock-Based Compensation – (continued) On November 2, 2010, the Board of Directors and stockholders adopted the 2010 Stock Incentive Plan (“2010 Stock Plan”) for the issuance of up to 8,572 shares of common stock to be granted through incentive stock options, nonqualified stock options, stock appreciation rights, dividend equivalent rights, restricted stock, restricted stock units and other stock-based awards to officers, other employees, directors and consultants of the Company and its subsidiaries. On October 22, 2013, the stockholders approved and adopted an amendment to the Company’s 2010 Stock Plan to increase the number of shares of Company’s common stock reserved for issuance under the Plan from 8,572 to 17,143; on May 15, 2015, increased the number of shares from 17,143 to 22,858; on August 25, 2016, increased the number of shares from 22,858 to 40,000; on September 7, 2017, increased the number of shares from 40,000 to 50,000; on September 24, 2018 increased the number of shares from 50,000 to 100,000; and on September 5, 2019, increased the number of shares from 100,000 to 400,000 On September 17, 2020, the stockholders approved and adopted the 2020 Stock Incentive Plan (“2020 Stock Plan”) for the issuance of up to 400,000 shares of Common Stock to be granted through incentive stock options, nonqualified stock options, stock appreciation rights, dividend equivalent rights, restricted stock, restricted stock units and other stock-based awards to officers, other employees, directors and consultants of the Company and its subsidiaries. As of June 30, 2022, there were 368,000 options issued and outstanding under the 2010 Stock Plan. In the event of an employee’s termination, the Company will cease to recognize compensation expense for that employee. Stock forfeitures are recognized as incurred. There is no deferred compensation recorded upon initial grant date. Instead, the fair value of the stock-based payment is recognized over the stated vesting period. The Company has applied fair value accounting for all stock-based payment awards since inception. The fair value of each option or warrant granted is estimated on the date of grant using the Black-Scholes option pricing model. There were no options granted during the three and six months June 30, ended 2021. The assumptions used for the three and six months ended June 30, 2022 are as follows: 2022 Exercise price $ 2.60 Expected dividends 0 % Expected volatility 95 % Risk free interest rate 2.65 % Expected life of option (years) 4.3 Expected dividends — Expected volatility Risk-free interest rate Expected life of the option 6. Stock-Based Compensation – (continued) The Company records stock-based compensation based upon the stated vesting provisions in the related agreements. The vesting provisions for these agreements have various terms as follows: ● immediate vesting, ● in full on the one-year anniversary date of the grant date, ● half vesting immediately and the remaining over three years, ● quarterly over three years, ● annually over three years, ● one-third immediate vesting and the remaining annually over two years, ● one-half immediate vesting and the remaining over nine months, ● one-quarter immediate vesting and the remaining over three years, ● one-quarter immediate vesting and the remaining over 33 months, ● monthly over one year, and ● monthly over three years During the three and six months ended June 30, 2022, the Company granted 3,000 options to employees having an approximate fair value of $5,000 based upon the Black-Scholes option pricing model, respectively. There were no options granted during the three and six months ended June 30, 2021 6. Stock-Based Compensation – (continued) A summary of stock option activity for the six months ended June 30, 2022 and the year ended December 31, 2021 is as follows: Weighted Weighted Average Aggregate Average Exercise Remaining Intrinsic Options Price Contractual Life Value Balance - December 31, 2020 399,742 $ 23.50 6.09 years $ — Granted 226,000 3.30 Exercised — — Expired (215) 451.50 Forfeited — — Balance - December 31, 2021 625,527 16.10 5.58 years — Granted 3,000 2.60 Exercised — — Expired (6,651) 39.70 Forfeited (14,542) 3.60 Balance - June 30, 2022 - outstanding 607,334 $ 16.07 5.07 years $ — Balance - June 30, 2022 - exercisable 359,417 $ 24.67 4.42 years $ — Grant date fair value of options granted – three months ended June 30, 2022 $ 5,411 Weighted average grant date fair value – three months ended June 30, 2022 $ 1.80 Grant date fair value of options granted – year ended December 31, 2021 $ 50,100 Weighted average grant date fair value – year ended December 31, 2021 $ 2.20 Stock-based compensation expense included in general and administrative expenses relating to stock options issued to employees for the three and six months ended June 30, 2022 was $39,000 and $78,000, respectively, and $34,000 and $67,000 for the three and six months ended June 30, 2021, respectively. Stock-based compensation expense included in research and development expenses relating to stock options issued to employees for the three and six months ended June 30, 2022 was $21,000 and $41,000, respectively, and $16,000 and $31,000 for the three and six months ended June 30, 2021, respectively. Stock-based compensation expense included in general and administrative expenses relating to stock options issued to consultants for the three and six months ended June 30, 2022 was $46,000 and $93,000, respectively, and $49,000 and $98,000 for the three and six months ended June 30, 2021, respectively. Stock-based compensation expense included in research and development expenses relating to stock options issued to consultants for the three and six months ended June 30, 2022 was $7,000 and $14,000, respectively, and $3,000 and $7,000 for the three and six months ended June 30, 2020. As of June 30, 2022, total unrecognized stock-based compensation expense related to stock options was $516,000, which is expected to be expensed through April 2024. 6. Stock-Based Compensation – (continued) The FASB’s guidance for stock-based payments requires cash flows from excess tax benefits to be classified as a part of cash flows from operating activities. Excess tax benefits are realized tax benefits from tax deductions for exercised options in excess of the deferred tax asset attributable to stock compensation costs for such options. The Company did not record any excess tax benefits during the three and six months ended June 30, 2022 and 2021. |
Stock Warrants
Stock Warrants | 6 Months Ended |
Jun. 30, 2022 | |
Stock Warrants | |
Stock Warrants | 7. Stock Warrants On October 15, 2018, the Company closed its underwritten public offering pursuant to which it received gross proceeds of approximately $18.6 million before deducting underwriting discounts, commissions and other offering expenses payable by the Company and sold (i)Class A Units (the “Class A Units”), consisting of an aggregate of 252,000 shares of the Common Stock, and five-year warrant to purchase an aggregate of 252,000 shares of Common Stock at an exercise price of $13.80 per share, which subsequently was reduced to $6.90 per share (each a “Warrant” and collectively, the “Warrants”) and (ii) Class B Units (the “Class B Units”, and together with the Class A Units, the “Units”), consisting of an aggregate of 15,723 shares of the Company’s Series B Convertible Preferred Stock (the “Series B Preferred Stock”), with a stated value of $1,000 and convertible into shares of Common Stock at the stated value divided by a conversion price of $11.50 per share, with all shares of Series B Preferred Stock convertible into an aggregate of 1,367,218 shares of Common Stock, and issued with a warrant to purchase an aggregate of 1,367,218 shares of Common Stock. On November 16, 2020, the exercise price of the Warrants was reduced from $13.80 per Warrant per full share of the Company’s common stock, $0.001 par value per share (the “Common Stock”), to $6.90 per Warrant per full share of Common Stock in accordance with the anti-dilution terms of the Warrant. The reduction was the result of the issuance of shares of Common Stock by the Company through its “at the market offering” facility. The effect of the change in the exercise price of the warrants as a result of the triggering of the down round protection clause in the Warrants was recorded as a deemed dividend of $0.9 million during the year ended December 31, 2020, which reduces the income available to common stockholders. In addition, pursuant to the underwriting agreement that the Company had entered into with A.G.P./Alliance Global Partners (the “Underwriters”), as representative of the underwriters, the Company granted the Underwriters a 45 day option (the “Over-allotment Option”) to purchase up to an additional 242,883 shares of Common Stock and/or additional Warrants to purchase an additional 242,883 shares of Common Stock. The Underwriters partially exercised the Over-allotment Option by electing to purchase from the Company additional Warrants to purchase 180,783 shares of Common Stock. If, at the time of exercise, there is no effective registration statement registering, or no current prospectus available for, the issuance of the shares of Common Stock to the holder, then the Warrants may only be exercised through a cashless exercise. No fractional shares of Common Stock will be issued in connection with the exercise of a Warrant. In lieu of fractional shares, the holder will receive an amount in cash equal to the fractional amount multiplied by the fair market value of any such fractional shares. The Company has concluded that the Warrants are required to be equity classified. The Warrants were valued on the date of grant using Monte Carlo simulations. During the three months ended March 31, 2021, 1,165,575 warrants were exercised for cash proceeds of $8.0 million. There were no warrants exercised during the three and six months ended June 30, 2022. A summary of all warrant activity for the Company for the quarter ended June 30, 2022 and the year ended December 31, 2021 is as follows: Number of Weighted Average Warrants Exercise Price Balance at December 31, 2020 1,800,072 6.92 Granted — — Exercised (1,165,575) 6.92 Forfeited — — Balance at December 31, 2021 634,497 $ 6.92 Granted — — Exercised — — Forfeited — — Balance at June 30, 2022 634,497 $ 6.92 7. Stock Warrants – (continued) On December 26, 2017, the Company entered into a consulting agreement for advisory services for a period of six months. As compensation for such services, the consultant was paid an upfront payment, a monthly fee and on January 24, 2018 was issued a warrant exercisable for 71 shares of the Company’s common stock on the date of issue. The warrant is equity classified and the fair value of the warrant approximated $9,000 and was measured using the Black-Scholes option pricing model. A summary of all outstanding and exercisable common stock warrants as of June 30, 2022 is as follows: Weighted Average Warrants Warrants Remaining Exercise Price Outstanding Exercisable Contractual Life $ 6.90 634,426 634,426 1.28 years 182.00 71 71 0.49 years $ 6.90 634,497 634,497 1.28 years |
Net Loss per Share
Net Loss per Share | 6 Months Ended |
Jun. 30, 2022 | |
Net Loss per Share | |
Net Loss per Share | 8. Net Loss per Share Basic net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding. Diluted net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding including the effect of common share equivalents. Diluted net loss per share assumes the issuance of potential dilutive common shares outstanding for the period and adjusts for any changes in income and the repurchase of common shares that would have occurred from the assumed issuance, unless such effect is anti-dilutive. Net loss attributable to common stockholders for the three and six months ended June 30, 2022 was approximately $5.0 million and $9.2 million, respectively. Net loss attributable to common stockholders for the three and six months ended June 30, 2021 was approximately $3.2 million and $14.7 million, respectively and excludes net loss attributable to non-controlling interest of $0.1 million and includes the accretion of the Series B preferred discount of $1.5 million as a result of converted shares and Series A preferred stock accrued dividends of $0.1 million for the six months ended June 30, 2021 and the deemed dividend of $7.4 million resulting from the effect of the Series A preferred stock price adjustment during the first quarter of 2021. There were no shares of common stock underlying Series B Preferred shares convertible to common stock that were excluded from the computations of net loss per common share for the three and six months ended June 30, 2021 since all remaining Series B preferred stock were converted to common stock in 2021. The number of options and warrants for the purchase of common stock that were excluded from the computations of net loss per common share and for the three and six months ended June 30, 2022 were 607,334 and 634,497, respectively and for the three and six months ended June 30, 2021 were 399,742 and 634,497, respectively, because their effect is anti-dilutive. |
Non-controlling Interest and Re
Non-controlling Interest and Related Party | 6 Months Ended |
Jun. 30, 2022 | |
Non-controlling Interest and Related Party | |
Non-controlling Interest and Related Party | 9. Non-controlling Interest and Related Party On September 5, 2018, the Company entered into an agreement (the ‘Stock Purchase Agreement”) with Cedars-Sinai Medical Center (CSMC) for an investigator-sponsored Phase 2b clinical study of SYN-010 to be co-funded by the Company and CSMC (the “Study”). The Study will provide further evaluation of the efficacy and safety of SYN-010, the Company’s modified-release reformulation of lovastatin lactone, which is exclusively licensed to the Company by CSMC. SYN-010 is designed to reduce methane production by certain microorganisms (M. smithii) in the gut to treat an underlying cause of irritable bowel syndrome with constipation (IBS-C). In consideration of the support provided by CSMC for the Study, the Company paid $328,000 to support the Study and the Company entered into a Stock Purchase Agreement with CSMC pursuant to which the Company, upon the approval of the Study protocol by the Institutional Review Board (IRB): (i) issued to CSMC five thousand (5,000) shares of common stock of the Company; and (ii) transferred to CSMC an additional two million four hundred twenty thousand (2,420,000) shares of common stock of its subsidiary SYN Biomics, Inc. (“Synbiomics”) owned by the Company, such that after such issuance CSMC owns an aggregate of seven million four hundred eighty thousand (7,480,000) shares of common stock of SYN Biomics, representing seventeen percent (17%) of the issued and outstanding shares of SYN Biomics’ common stock. The services rendered are recorded to research and development expense in proportion with the progress of the study and based overall on the fair value of the shares ($285,000) as determined at the date of IRB approval. There was no expense recorded related to this transaction during the three and six months ended June 30, 2022 and 2021. 9. Non-controlling Interest and Related Party – (continued) The Agreement also provided CSMC with a right, commencing on the six month anniversary of issuance of the stock under certain circumstances in the event that the shares of stock of SYN Biomics are not then freely tradeable, and subject to NYSE American, LLC approval, to exchange its SYN Biomics shares for unregistered shares of the Company’s common stock, with the rate of exchange based upon the relative contribution of the valuation of SYN Biomics to the public market valuation of the Company at the time of each exchange. The Stock Purchase Agreement also provides for tag-along rights in the event of the sale by the Company of its shares of SYN Biomics. On September 30, 2020, CSMC MAST formally agreed to discontinue the ongoing Phase 2b investigator-sponsored clinical study of SYN-010 following the results of a planned interim futility analysis. Although it was concluded that SYN-010 was well tolerated, SYN-010 was unlikely to meet its primary endpoint by the time enrollment is completed. On November 9, 2020, the Company and its subsidiary, Synthetic Biomics, Inc. and CSMC mutually agreed to terminate the exclusive license agreement dated December 5, 2013 and all amendments thereto and the clinical trial agreement relating to SYN-010. The determination to terminate the SYN-010 license agreement was agreed following the completion of a planned interim futility analysis of the Phase 2b investigator-sponsored clinical trial of SYN-010. On September 30, 2020, CSMC (the Company’s SYN-010 clinical development partner) informed the Company that it discontinued the ongoing Phase 2b investigator-sponsored clinical study of SYN-010 IBS-C patients. During 2021, CSMC returned its shares of SYN Biomics to the Company. The Company’s interest in SYN Biomics is now 100%. This is reflected in the Consolidated Statements of Equity (Deficit). The Company’s non-controlling interest was accounted for under ASC 810, Consolidation and represents the minority stockholder’s ownership interest related to the Company’s subsidiary, SYN Biomics. In accordance with ASC 810, the Company reports its non-controlling interest in subsidiaries as a separate component of equity in the Consolidated Balance Sheets and reports both net loss attributable to the non-controlling interest and net loss attributable to the Company’s common stockholders in the face of the Consolidated Statements of Operations. |
Common and Preferred Stock
Common and Preferred Stock | 6 Months Ended |
Jun. 30, 2022 | |
Common and Preferred Stock | |
Common and Preferred Stock | 10. Common and Preferred Stock Series B Preferred Stock On October 15, 2018, the Company closed its underwritten public offering pursuant to which it received gross proceeds of approximately $18.6 million before deducting underwriting discounts, commissions and other offering expenses payable by the Company and sold (i) Class A Units (the “Class A Units”) consisting of an aggregate of 252,000 shares of the Common Stock, and five-year warrant to purchase an aggregate of 252,000 shares of Common Stock at an exercise price of $13.80 per share, which subsequently was reduced to $6.90 per share (each a “Warrant” and collectively, the “Warrants”), and (ii) Class B Units (the “Class B Units”, and together with the Class A Units, the “Units”), consisting of an aggregate of 15,723 share of the Company’s Series B Convertible Preferred Stock (the “Series B Preferred Stock”), with a stated value of $1,000 and convertible into shares of Common Stock at the stated value divided by a conversion price of $11.50 per share, with all shares of Series B Preferred Stock convertible into an aggregate of 1,367,218 shares of Common Stock, and issued with a warrant to purchase an aggregate of 1,367,218 shares of Common Stock.. Since the above units are equity instruments, the proceeds were allocated on a relative fair value basis which created the Series B Preferred Stock discount. In addition, pursuant to the Underwriting Agreement that the Company entered into with the Underwriters on October 10, 2018, the Company granted the Underwriters a 45 day option (the “Over-allotment Option”) to purchase up to an additional 242,883 shares of Common Stock and/or additional warrants to purchase an additional 242,883 shares of Common Stock. Each Warrant is exercisable for one share of common stock. The Underwriters partially exercised the Over-allotment Option by electing to purchase from the Company additional Warrants to purchase 180,783 shares of Common Stock. The conversion price of the Series B Preferred Stock and exercise price of the October 2018 Warrants is subject to appropriate adjustment in the event of recapitalization events, stock dividends, stock splits, stock combinations, reclassifications, reorganizations or similar events affecting the Common Stock. The exercise price of the Warrants is subject to adjustment in the event of certain dilutive issuances. 10. Common and Preferred Stock – (continued) On November 16, 2020, the exercise price of the Warrants was reduced from $13.80 per Warrant per full share of common stock to $6.90 per Warrant per full share of common stock. The reduction was the result of the issuance of shares of Common Stock by the Company through its “at the market offering” facility. The effect of the change in the exercise price of the warrants as a result of the triggering of the down round protection clause in the Warrants was recorded as a deemed dividend in accumulated deficit of $880,000, which reduces the income available to common stockholders for the year ended December 31, 2020. The October 2018 Warrants are immediately exercisable at a price of $6.90 (effective November 16, 2020) per share of common stock and will expire on October 15, 2023. If, at the time of exercise, there is no effective registration statement registering, or no current prospectus available for, the issuance of the shares of common stock to the holder, then the October 2018 warrants may only be exercised through a cashless exercise. No fractional shares of common stock will be issued in connection with the exercise of any October 2018 warrants. In lieu of fractional shares, the holder will receive an amount in cash equal to the fractional amount multiplied by the fair market value of any such fractional shares. Since the effective conversion price of the Series B Preferred Stock is less than the fair value of the underlying common stock at the date of issuance, there is a beneficial conversion feature (“BCF”) at the issuance date. Because the Series B Preferred Stock has no stated maturity or redemption date and is immediately convertible at the option of the holder, the discount created by the BCF is immediately charged to accumulated deficit as a “deemed dividend” and impacts earnings per share. During the three months ended March 31, 2021, 398 shares were converted resulting in the recognition of a deemed dividends of $1.5 million for the amortization of the Series B Preferred Stock discount upon conversion. During the three and six months ended June 30, 2022 there were no shares converted as all shares were converted in 2021 and 2020. Series A Preferred Stock On September 11, 2017, the Company entered into a share purchase agreement (the “Purchase Agreement”) with an investor (the “Investor”), pursuant to which the Company offered and sold in a private placement 12,000 shares of its Series A Convertible Preferred Stock, par value $0.001 per share (the “Series A Preferred Stock”) for an aggregate purchase price of $12 million, or $10 per share. The Series A Preferred Stock ranks senior to the shares of the Company's common stock, and any other class or series of stock issued by the Company with respect to dividend rights, redemption rights and rights to the distribution of assets on any voluntary or involuntary liquidation, dissolution or winding up of the affairs of the Company. Holders of Series A Preferred Stock are entitled to a cumulative dividend at the rate of 2.0% per annum, payable quarterly in arrears, as set forth in the Certificate of Designation of Series A Preferred Stock classifying the Series A Preferred Stock. The Series A Preferred Stock is convertible at the option of the holders at any time into shares of common stock at an initial conversion price of $5.40 per share which was increased to $189.0 after taking into account the 2018 reverse stock split, subject to certain customary anti-dilution adjustments and was decreased to $15.0 on January 27, 2021, see below. Any conversion of Series A Preferred Stock may be settled by the Company in shares of common stock only. The holder’s ability to convert the Series A Preferred Stock into common stock is subject to (i) a 19.99% blocker provision to comply with NYSE American Listing Rules, (ii) if so elected by the Investor, a 4.99% blocker provision that will prohibit beneficial ownership of more than 4.99% of the outstanding shares of the Company’s common stock or voting power at any time, and (iii) applicable regulatory restrictions. In the event of any liquidation, dissolution or winding-up of the Company, holders of the Series A Preferred Stock are entitled to a preference on liquidation equal to the greater of (i) an amount per share equal to the stated value plus any accrued and unpaid dividends on such share of Series A Preferred Stock (the “Accreted Value”), and (ii) the amount such holders would receive in such liquidation if they converted their shares of Series A Preferred Stock (based on the Accreted Value and without regard to any conversion limitation) into shares of the common stock immediately prior to any such liquidation, dissolution or winding-up (the greater of (i) and (ii), is referred to as the “Liquidation Value”). 10. Common and Preferred Stock – (continued) Except as otherwise required by law, the holders of Series A Preferred Stock have no voting rights, other than customary protections against adverse amendments and issuance of pari passu On or at any time after (i) the VWAP (as defined in the Certificate of Designation) for at least 20 trading days in any 30 trading day period is greater than $70.00, subject to adjustment in the case of stock split, stock dividends or the like the Company has the right, after providing notice not less than 6 months prior to the redemption date, to redeem, in whole or in part, on a pro rata basis from all holders thereof based on the number of shares of Series A Preferred Stock then held, the outstanding Series A Preferred Stock, for cash, at a redemption price per share of Series A Preferred Stock of $7,875.00, subject to appropriate adjustment in the event of any stock dividend, stock split, combination or other similar recapitalization with respect to the Series A Convertible Preferred Stock or (ii) the five year anniversary of the issue date, the Company shall have the right to redeem, in whole or in part, on a pro rata basis from all holders thereof based on the number of shares of Series A Convertible Preferred Stock then held, the outstanding Series A Preferred Stock, for cash, at a redemption price per share equal to the Liquidation Value. The Series A Preferred Stock was classified as temporary equity due to the shares being redeemable based on contingent events outside of the Company’s control. Since the effective conversion price of the Series A Preferred Stock is less than the fair value of the underlying common stock at the date of issuance, there is a beneficial conversion feature (“BCF”) at the issuance date. Because the Series A Preferred Stock has no stated maturity or redemption date and is immediately convertible at the option of the holder, the discount created by the BCF is immediately charged to accumulated deficit as a “deemed dividend” and impacts earnings per share. During the year ended December 31, 2017, the Company recorded a discount of $6.9 million. Because the Series A Preferred Stock is not currently redeemable, the discount arising from issuance costs was allocated to temporary equity and will not be accreted until such time that redemption becomes probable. The stated dividend rate of 2% per annum is cumulative and the Company accrues the dividend on a quarterly basis (in effect accreting the dividend regardless of declaration because the dividend is cumulative). During the three months ended March 31,2021 and 2020, the Company accrued dividends of $24,000 and $62,000, respectively. Once the dividend is declared, the Company will reclassify the declared amount from temporary equity to a dividends payable liability. When the redemption of the Series A Preferred Stock becomes probable, the temporary equity will be accreted to redemption value as a deemed dividend. On January 27, 2021, the Company filed an amendment to the Certificate of Designation for the Series A Preferred Stock to (i) lower the stated Conversion Price through September 30, 2021 and (ii) remove their change in control put, as an inducement for the holder to fully convert its Series A Preferred Stock. The Amendment to the Certificate of Designation for its Series A Convertible Preferred Stock (the “Certificate of Amendment”) with the Secretary of State of the State of Nevada adjusted the conversion price from $189 per share to $15 per share and removed the redemption upon change of control. The Company received notice from the holder of the Series A Preferred Stock that it was increasing the Maximum Percentage as defined in the “Certificate of Designation” from 4.99% to 9.99%, such increase to be effective 61 days from the date hereof. During the three months ended March 31, 2021, all outstanding shares of Series A Convertible Preferred Stock were converted to approximately 0.9 million shares of the Company’s common stock. There are no remaining shares of the Series A Convertible Preferred stock outstanding after these conversions. During January and February 2021, the Company issued 899,677 shares of its common stock upon the conversion effected on such date by the holder of 12,000 shares of its Series A Convertible Preferred Stock. The fair value of the consideration issued to the holder to induce conversion is accounted for as a deemed dividend and increased net loss available to common shareholders for purposes of calculating loss per share. The Company estimated fair value of the inducement consideration of $7.4 million and as a result has recorded a corresponding deemed dividend of $7.4 million during the three months ended March 31, 2021. 10. Common and Preferred Stock – (continued) B. Riley Securities Sales Agreement On August 5, 2016, the Company entered into the B. Riley FBR Sales Agreement with FBR Capital Markets & Co. (now known as B. Riley Securities), which enables the Company to offer and sell shares of common stock from time to time through B. Riley Securities, Inc. as the Company’s sales agent. Sales of common stock under the B. Riley Securities Sales Agreement are made in sales deemed to be “at-the-market” equity offerings as defined in Rule 415 promulgated under the Securities Act. B. Riley Securities, Inc. is entitled to receive a commission rate of up to 3.0% of gross sales in connection with the sale of the Common Stock sold on the Company’s behalf. On February 9, 2021, the Company entered into an amended and restated sales agreement with B. Riley Securities, Inc. (“B. Riley”) and A.G.P./Alliance Global Partners (“AGP”) in order to include AGP as an additional sales agent for the Company’s “at the market offering” program (the “Amended and Restated Sales Agreement”). The Sales Agreement amended and restated the At Market Issuance Sales Agreement, dated August 5, 2016, with B. Riley Securities, Inc. (formerly known as B. Riley FBR, Inc.), as amended by amendment no. 1, dated May 7, 2018, to the At Market Issuance Sales Agreement. During the three months ended March 31, 2021, the Company sold through the At Market Issuance Sales Agreement and the Amended and Restated Sales Agreement approximately 7.9 million shares of the Company’s common stock and received net proceeds of approximately $66.0 million. During the three and six months ended June 30, 2022, there were no sales of the Company’s common stock through the At Market Issuance Sales Agreement and the Amended and Restated Sales Agreement. |
Indebtedness
Indebtedness | 6 Months Ended |
Jun. 30, 2022 | |
Indebtedness | |
Indebtedness | 11. Indebtedness As a result of the acquisition of VCN the company acquired interest-free or below-market interest rates loans (0%-1%) extended by Spanish governmental institutions of Ministerio de Ciencia , Innovacion y Universidades and ACC10 Generalitat de Catalunya The maturities of these loans are between 2027 and 2028. As a result of the VCN acquisition, the company maintains a restricted cash collateral account of $96,000 relating to the RETOS 2015 loan, which is reflected as a non-current asset on the balance sheet. June 30, 2022 June, 2022 Current Non-current NEBT Loan $ 6 $ 37 RETOS 2015 50 179 $ 56 $ 216 The difference between the fair value of these liabilities (when relevant conditions associated with the grants are met) and the amount received is recognized as a government grant and classified as other operating income in the statement of profit and loss. A maturity analysis of the debt as of June 30, 2022 is as follows (amounts in thousands of dollars) 2023 $ 56 2024 61 2025 60 2026 49 2027 30 2028 16 Total $ 272 |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2022 | |
Commitments and Contingencies | |
Commitments and Contingencies | 12. Commitments and Contingencies The Company’s existing lease as of June 30, 2022 for its U.S. location is classified as an operating lease. As of June 30, 2022, the Company has two operating leases for facilities. During the quarter ended June 30, 2021, the Company renewed its Rockville MD facility lease by entering into a Second Lease Amendment which extends the lease term for 63 months beginning on September 1, 2022 and ending on December 31, 2027 at stated rental rates and including a 3-month rent abatement. The Second Amendment also has options for a Tenant Improvement Allowance and a Second Extension Term. The Second Amendment also gives the Company the right to expand their space by giving notice to the landlord before December 31, 2021. The Company did not give notice to expand the space during 2021. The Second Extension Term is offered at market rates and there is no economic incentive for the lessee, therefore the Company has determined that it is not part of the original lease term. There is an option in this Second Amendment to Lease for the Company to borrow funds for tenant improvements subject to an 8.5% interest rate. The Company also leases research and office facilities in Barcelona Spain. The current lease is short term agreement with a 90-day Operating lease costs are presented as part of general and administrative expenses in the condensed consolidated statements of operations, and for the three and six months ended June 30, 2022 approximated $138,000 and $245,000, respectively and for the three and six months ended June 30, 2021 approximated $68,000 and $118,000, respectively. For the three and six months ended June 30, 2022, operating cash flows used for operating leases approximated $144,000 and $257,000, respectively, For the three and six months ended June 30, 2021, operating cash flows used for operating leases approximated $80,000 and $160,000, respectively, and the right of use assets exchanged for operating the lease obligation was $1.3 million. The day one non-cash addition of right of use assets due to adoption of ASC 842 was $538,000. A maturity analysis of our operating leases as of June 30, 2022 is as follows (amounts in thousands of dollars) Future undiscounted cash flow for the years ending March 31, 2022 $ 82 2023 327 2024 337 2025 347 2026 357 2027 368 Total 1,818 Discount factor (392) Lease liability 1,426 Lease liability – current (128) Lease liability – long term $ 1,298 Risks and Uncertainties On January 30, 2020, the World Health Organization (“WHO”) announced a global health emergency because of COVID-19 and the risks to the international community as the virus spreads globally beyond its point of origin. In March 2020, the WHO classified the COVID-19 outbreak as a pandemic, based on the rapid increase in exposure globally. 12. Commitments and Contingencies (continued) As COVID-19 continued to spread around the globe, the Company experienced disruptions that impacted its business and clinical trials, including the postponement of clinical site initiation of the Phase 1b/2a clinical trial of SYN-004. The extent to which the COVID-19 pandemic impacts the Company’s business, the clinical development of VCN-01, SYN-004 (ribaxamase) and SYN-020, the business of the Company’s suppliers and other commercial partners, the Company’s corporate development objectives and the value of and market for the Company’s common stock, will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time, especially in light of the new variants, such as the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the United States, Europe and other countries, and the effectiveness of actions taken globally to contain and treat the disease. The global economic slowdown, the overall disruption of global healthcare systems and the other risks and uncertainties associated with the pandemic could have a material adverse effect on the Company's business, financial condition, results of operations and growth prospects. In addition, to the extent the ongoing COVID-19 pandemic adversely affects the Company’s business and results of operations, it may also have the effect of heightening many of the other risks and uncertainties which the Company faces. Through the VCN Acquisition, the Company has operations in Spain and may conduct research and development, manufacturing, and clinical trials in Western European countries. The invasion of Ukraine by Russia and the retaliatory measures that have been taken, or could be taken in the future, by the United States, NATO, and other countries have created global security concerns that could result in a regional conflict and otherwise have a lasting impact on regional and global economies, any or all of which could disrupt our supply chain, and despite the fact that we currently do not plan any clinical trials in Eastern Europe, may adversely impact the cost and conduct of R&D, manufacturing, and international clinical trials of our product candidates. |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2022 | |
Subsequent Events | |
Subsequent Events | 13. Subsequent Events On July 29, 2022, the Company closed a private placement offering pursuant to the terms of a Securities Purchase Agreement dated as of July 28, 2022 entered into with MSD Credit Opportunity Master Fund, L.P. (the “SPA”), pursuant to which the Company agreed to issue and sell 275,000 shares of the Company’s Series C Convertible Preferred Stock, par value $0.001 per share, and 100,000 shares of the Company’s Series D Convertible Preferred Stock, par value $0.001 per share, at an offering price of $8.00 per share, for gross proceeds of approximately $3.0 million in the aggregate, before the deduction of discounts, fees and offering expenses. The shares of Preferred Stock will be convertible, at a conversion price of $1.22 per share (subject in certain circumstances to adjustments), into an aggregate of 2,459,016 shares of the Company’s common stock, par value $0.001 per share, at the option of the holders of the Preferred Stock and, in certain circumstances, by the Company. The Purchase Agreement contains customary representations, warranties and agreements by the Company and customary conditions to closing. In order to comply with Section 122 of the NYSE American Company Guide, on August 9, 2022 the Company and the holder of the Company’s Series C preferred stock and Series D preferred stock amended the SPA to provide that the holder may only submit 1,549,295 of the votes relating to the Series C Preferred Stock that it would otherwise be entitled to vote. On August 3, 2022 the Company announced the exercise price of warrants issued by the Company in October 2018 was reduced from $6.90 per Warrant per full share of the Company’s common stock, $0.001 par value per share to $1.22 per Warrant per full share of Common Stock. The reduction was the result of the issuance of shares of Preferred Stock by the Company in a private placement. |
Business Combination (Tables)
Business Combination (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Business Combination | |
Tabular disclosure of Purchase consideration | Total purchase consideration including cash, restricted shares and contingent consideration was valued at approximately $23.9 million, as follows (in thousands): Cash paid at Closing $ 4,700 Receivable from VCN "effectively settled" 417 FV of common shares issued 6,599 FV of contingent consideration 12,159 $ 23,875 |
Schedule of allocation of fair value of assets and liabilities acquired | Estimated fair value ($in thousands) Cash and cash equivalents $ 837 Receivables 1,707 Property and equipment 216 In-process research and development intangible asset 21,703 Goodwill 5,765 Deferred tax assets (liabilities), net (3,699) Accounts payable (814) Accrued expenses (113) Accrued employee benefits (90) Loan Payable-current (67) Other long-term liabilities (1,570) Total purchase consideration $ 23,875 |
Schedule of Pro Forma Consolidated Financial Information | The following unaudited pro forma consolidated financial information summarizes the results of operations for the periods indicated as if the VCN acquisition had been completed as of January 1, 2021 (in thousands): Three Months Ended June 30, Six Months Ended June 30, (in thousands) 2022 2021 2022 2021 Net revenues $ — $ — — $ — Net loss $ (4,967) $ (3,897) (9,763) $ (6,997) |
Goodwill and Intangibles (Table
Goodwill and Intangibles (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Goodwill and Intangibles | |
Schedule of Goodwill | Goodwill (in thousands) Balance at December 31, 2021 $ — Goodwill from Acquisition of VCN 5,765 Goodwill impairment loss — Measurement Period Adjustment (277) Effects of exchange rates (303) Balance at June 30, 2022 $ 5,185 |
Schedule of Company's in-process R&D | In-process R&D (in thousands) Balance at December 31, 2021 $ — Acquired IPR&D - 21,703 In-process R&D impairment loss — Effects of exchange rates (1,141) Balance at June 30, 2022 $ 20,562 |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Fair Value of Financial Instruments | |
Summarizes the change in fair value, as determined by Level 3 inputs, for all assets and liabilities using unobservable Level 3 inputs | The following table summarizes the change in fair value, as determined by Level 3 inputs, for all assets and liabilities using unobservable Level 3 inputs for the six months ended June 30, 2022 (in thousands): Contingent Consideration Balance at March 10, 2022 $ 12,159 Change in fair value (483) Balance at June 30, 2022 $ 11,676 |
Schedule of recurring Level 3 fair value measurements of contingent consideration significant unobservable inputs | As of March 10, 2022 Description Total Level 1 Level 2 Level 3 Liabilities: Contingent consideration $ 12,159 — — $ 12,159 As of June 30, 2022 Description Total Level 1 Level 2 Level 3 Liabilities: Contingent consideration $ 11,676 — — $ 11,676 As of March 10, 2022 Valuation Significant Weighted Average Methodology Unobservable Input (range, if applicable) Contingent Consideration Probability weighted Milestone dates 2022-2027 income approach Discount rate 7.3% to 8.6% Weighted Average Discount rate 7.77% Probability of Occurrence (periodic for each Milestone) 9.9% to 82.4% Probability of occurrence (cumulative through each Milestone) 5.1% to 62.8% As of June 30, 2022 Valuation Significant Weighted Average Methodology Unobservable Input (range, if applicable) Contingent Consideration Probability weighted Milestone dates 2022-2027 income approach Discount rate 11.6% to 13.1% Weighted Average Discount rate 7.75% Probability of Occurrence (periodic for each Milestone) 9.9% to 82.4% Probability of occurrence (cumulative through each Milestone) 5.1% to 62.8% |
Selected Balance Sheet Inform_2
Selected Balance Sheet Information (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Selected Balance Sheet Information | |
Schedule of prepaid expenses and other current assets | Prepaid expenses and other current assets (in thousands) June 30, December 31, 2022 2021 Prepaid clinical research organizations $ 1,215 $ 458 Prepaid manufacturing expenses 519 — Prepaid insurances 353 803 VAT receivable 278 — Prepaid consulting, subscriptions and other expenses 257 272 Total $ 2,622 $ 1,533 |
Schedule of property, plant and equipment, net | Property and equipment, net (in thousands) June 30, December 31, 2022 2021 Computers and office equipment $ 790 $ 827 Other Property, Plant and Equipment 203 — Leasehold improvements 94 94 Software 11 11 1,098 932 Less: accumulated depreciation and amortization (813) (831) Total $ 285 $ 101 |
Schedule of accrued expenses | Accrued expenses (in thousands) June 30, December 31, 2022 2021 Accrued clinical consulting services $ 741 $ 696 Accrued manufacturing costs 617 204 Accrued vendor payments 506 1,028 VAT payable 123 — Total $ 1,987 $ 1,928 |
Schedule of accrued employee benefits | Accrued employee benefits (in thousands) June 30, December 31, 2022 2021 Accrued bonus expense $ 542 $ 886 Accrued vacation expense 128 92 Accrued compensation expense 118 — Total $ 788 $ 978 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Stock-Based Compensation | |
Schedule of assumptions used for awards | 2022 Exercise price $ 2.60 Expected dividends 0 % Expected volatility 95 % Risk free interest rate 2.65 % Expected life of option (years) 4.3 |
Summary of stock option activity | A summary of stock option activity for the six months ended June 30, 2022 and the year ended December 31, 2021 is as follows: Weighted Weighted Average Aggregate Average Exercise Remaining Intrinsic Options Price Contractual Life Value Balance - December 31, 2020 399,742 $ 23.50 6.09 years $ — Granted 226,000 3.30 Exercised — — Expired (215) 451.50 Forfeited — — Balance - December 31, 2021 625,527 16.10 5.58 years — Granted 3,000 2.60 Exercised — — Expired (6,651) 39.70 Forfeited (14,542) 3.60 Balance - June 30, 2022 - outstanding 607,334 $ 16.07 5.07 years $ — Balance - June 30, 2022 - exercisable 359,417 $ 24.67 4.42 years $ — Grant date fair value of options granted – three months ended June 30, 2022 $ 5,411 Weighted average grant date fair value – three months ended June 30, 2022 $ 1.80 Grant date fair value of options granted – year ended December 31, 2021 $ 50,100 Weighted average grant date fair value – year ended December 31, 2021 $ 2.20 |
Stock Warrants (Tables)
Stock Warrants (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Stock Warrants | |
Summary of all warrant activity | A summary of all warrant activity for the Company for the quarter ended June 30, 2022 and the year ended December 31, 2021 is as follows: Number of Weighted Average Warrants Exercise Price Balance at December 31, 2020 1,800,072 6.92 Granted — — Exercised (1,165,575) 6.92 Forfeited — — Balance at December 31, 2021 634,497 $ 6.92 Granted — — Exercised — — Forfeited — — Balance at June 30, 2022 634,497 $ 6.92 |
Summary of all outstanding and exercisable warrants | A summary of all outstanding and exercisable common stock warrants as of June 30, 2022 is as follows: Weighted Average Warrants Warrants Remaining Exercise Price Outstanding Exercisable Contractual Life $ 6.90 634,426 634,426 1.28 years 182.00 71 71 0.49 years $ 6.90 634,497 634,497 1.28 years |
Indebtedness (Tables)
Indebtedness (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Indebtedness | |
Schedule of debt | June 30, 2022 June, 2022 Current Non-current NEBT Loan $ 6 $ 37 RETOS 2015 50 179 $ 56 $ 216 |
Schedule of Maturity analysis of debt | 2023 $ 56 2024 61 2025 60 2026 49 2027 30 2028 16 Total $ 272 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Commitments and Contingencies | |
Schedule of maturity analysis of operating leases | Future undiscounted cash flow for the years ending March 31, 2022 $ 82 2023 327 2024 337 2025 347 2026 357 2027 368 Total 1,818 Discount factor (392) Lease liability 1,426 Lease liability – current (128) Lease liability – long term $ 1,298 |
Organization, Nature of Opera_2
Organization, Nature of Operations and Basis of Presentation - (Details) | 3 Months Ended | 6 Months Ended | ||||
Jul. 25, 2022 shares | Jun. 30, 2022 USD ($) $ / shares shares | Jun. 30, 2022 USD ($) segment item Asset $ / shares shares | Jul. 24, 2022 shares | Jul. 11, 2022 $ / shares | Dec. 31, 2021 $ / shares shares | |
Organization, Nature of Operations and Basis of Presentation | ||||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 | ||
Reverse stock split | 0.1 | |||||
Common stock, Shares Outstanding | shares | 15,844,061 | 15,844,061 | 15,844,061 | 158,437,840 | 13,204,254 | |
Common Stock, Discount on Shares | $ | $ 200,000,000 | $ 200,000,000 | ||||
Common Stock, Shares Authorized | shares | 20,000,000 | 20,000,000 | 20,000,000 | 20,000,000 | ||
Number of operating segments | segment | 1 | |||||
Number of reportable segments | segment | 1 | |||||
Impairment charges | $ | $ 0 | $ 0 | ||||
Intangible assets acquired | Asset | 2 | |||||
Number of reporting units | item | 1 |
Business Combination (Details)
Business Combination (Details) - USD ($) | Mar. 10, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Dec. 31, 2021 |
Business Acquisition [Line Items] | ||||
Common Stock, Shares, Issued | 15,844,294 | 13,204,487 | ||
Budgetary plan | $ 12,159,000 | |||
Grifols Innovation | ||||
Business Acquisition [Line Items] | ||||
Consideration purchase paid | $ 4,700,000 | |||
V C N | ||||
Business Acquisition [Line Items] | ||||
Common Stock, Shares, Issued | 2,639,530 | |||
Existing liabilities | $ 2,390,000 | |||
Cash payments | 70,200,000 | |||
Finance costs | 417,000 | |||
Budgetary plan | $ 27,800,000 | $ 11,700,000 | $ 12,200,000 | |
V C N | New technologies | ||||
Business Acquisition [Line Items] | ||||
Business Acquisition, Percentage of Voting Interests Acquired | 86% |
Business Combination - Tabular
Business Combination - Tabular disclosure of Purchase consideration (Details) - USD ($) | 3 Months Ended | ||
Mar. 10, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | |
Business Acquisition [Line Items] | |||
Cash paid at Closing | $ 4,700,000 | ||
Receivable from V C N "effectively settled" | 417,000 | ||
FV of common shares issued | 6,599,000 | ||
FV of contingent consideration | 12,159,000 | ||
V C N | |||
Business Acquisition [Line Items] | |||
FV of contingent consideration | 27,800,000 | $ 11,700,000 | $ 12,200,000 |
Purchase consideration | $ 23,875,000 | ||
Non cash gain recognized related to the decrease in the fair value of the contingent consideration | $ 483,000 |
Business Combination - Schedule
Business Combination - Schedule of allocation of fair value of assets and liabilities acquired (Details) $ in Thousands | Jun. 30, 2022 USD ($) |
Business Acquisition [Line Items] | |
Goodwill | $ 5,185 |
V C N | |
Business Acquisition [Line Items] | |
Cash and cash equivalents | 837 |
Receivables | 1,707 |
Property and equipment | 216 |
In-process research and development intangible asset | 21,703 |
Goodwill | 5,765 |
Deferred tax assets (liabilities), net | (3,699) |
Accounts payable | (814) |
Accrued expenses | (113) |
Accrued employee benefits | (90) |
Loan Payable-current | (67) |
Other long-term liabilities | (1,570) |
Total purchase consideration | $ 23,875 |
Business Combination - Schedu_2
Business Combination - Schedule of Pro Forma Consolidated Financial Information (Details) - V C N - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Business Acquisition [Line Items] | ||||
Net revenues | $ 0 | $ 0 | $ 0 | $ 0 |
Net loss | $ (4,967) | $ (3,897) | $ (9,763) | $ (6,997) |
Business Combination - Narrativ
Business Combination - Narrative (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2022 | Jun. 30, 2021 | |
Business Acquisition [Line Items] | |||
In-process research and development intangible asset | $ 21,700,000 | $ 21,700,000 | |
Net loss of V C N Operations | 2,100,000 | ||
V C N | |||
Business Acquisition [Line Items] | |||
Measurement period adjustment related to the estimate of acquired liabilities | 277,000 | ||
In-process research and development intangible asset | 21,700,000 | 21,700,000 | |
V C N | General and Administrative Expense [Member] | |||
Business Acquisition [Line Items] | |||
Transaction costs on acquisition | $ 200,000 | $ 200,000 | $ 1,200,000 |
Goodwill and Intangibles - Good
Goodwill and Intangibles - Goodwill (Details) - USD ($) | 3 Months Ended | 6 Months Ended |
Jun. 30, 2022 | Jun. 30, 2022 | |
Goodwill [Roll Forward] | ||
Goodwill from Acquisition of VCN | $ 5,765,000 | |
Goodwill impairment loss | $ 277,000 | |
Measurement Period Adjustment | (277,000) | |
Effects of exchange rates | (303,000) | |
Balance at the end | $ 5,185,000 | $ 5,185,000 |
Goodwill and Intangibles - Inta
Goodwill and Intangibles - Intangible assets (Details) - In-process R&D $ in Thousands | 6 Months Ended |
Jun. 30, 2022 USD ($) | |
Finite-Lived Intangible Assets [Roll Forward] | |
Balance at the beginning | $ 0 |
Acquired IPR&D - | 21,703 |
In-process R&D impairment loss | 0 |
Effects of exchange rates | (1,141) |
Balance at the end | $ 20,562 |
Goodwill and Intangibles (Detai
Goodwill and Intangibles (Details) | 3 Months Ended | 6 Months Ended |
Jun. 30, 2022 USD ($) | Jun. 30, 2022 USD ($) | |
Goodwill and Intangibles | ||
Goodwill from Acquisition of VCN | $ 5,765,000 | |
In-process research and development intangible asset | $ 21,700,000 | $ 21,700,000 |
Goodwill impairment | $ 277,000 |
Fair Value of Financial Instr_3
Fair Value of Financial Instruments - Fair value of financial instruments measured on a recurring basis (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Mar. 10, 2022 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
FV of contingent consideration | $ 12,159 | |
Contingent consideration | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
FV of contingent consideration | $ 11,676 | 12,159 |
Level 3 | Contingent consideration | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
FV of contingent consideration | $ 11,676 | $ 12,159 |
Fair Value of Financial Instr_4
Fair Value of Financial Instruments - Change in fair value of Contingent Consideration (Details) - Contingent consideration $ in Thousands | 4 Months Ended |
Jun. 30, 2022 USD ($) | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Balance at March 10, 2022 | $ 12,159 |
Change in fair value | (483) |
Balance at June 30, 2022 | $ 11,676 |
Fair Value of Financial Instr_5
Fair Value of Financial Instruments - Contingent Consideration (Details) - Level 3 - Contingent consideration | Jun. 30, 2022 | Mar. 10, 2022 |
Discount rate | Minimum | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||
Contingent Consideration, Measurement Input | 11.6 | 7.3 |
Discount rate | Maximum | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||
Contingent Consideration, Measurement Input | 13.1 | 8.6 |
Weighted Average Discount rate | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||
Contingent Consideration, Measurement Input | 7.75 | 7.77 |
Probability of occurrence | Minimum | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||
Contingent Consideration, Measurement Input | 9.9 | 9.9 |
Probability of occurrence | Maximum | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||
Contingent Consideration, Measurement Input | 82.4 | 82.4 |
Probability Of Occurrence | Minimum | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||
Contingent Consideration, Measurement Input | 5.1 | 5.1 |
Probability Of Occurrence | Maximum | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||
Contingent Consideration, Measurement Input | 62.8 | 62.8 |
Fair Value of Financial Instr_6
Fair Value of Financial Instruments (Details) - USD ($) | 6 Months Ended | |||
Jun. 30, 2022 | Jun. 30, 2021 | Mar. 31, 2022 | Mar. 10, 2022 | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||
FV of contingent consideration | $ 12,159,000 | |||
Non-current contingent consideration | $ 2,374,000 | |||
Decrease in fair value of contingent consideration | 483,000 | $ 0 | ||
V C N | ||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||
Additional consideration related to the achievement of certain milestones | 70,200,000 | |||
FV of contingent consideration | 11,700,000 | $ 12,200,000 | $ 27,800,000 | |
Non-current contingent consideration | 2,400,000 | |||
Accrued contingent consideration | $ 9,300,000 |
Selected Balance Sheet Inform_3
Selected Balance Sheet Information - Schedule of Prepaid expenses and other current assets (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Selected Balance Sheet Information | ||
Prepaid clinical research organizations | $ 1,215 | $ 458 |
Prepaid manufacturing expenses | 519 | 0 |
Prepaid insurance | 353 | 803 |
VAT receivable | 278 | 0 |
Prepaid consulting, subscriptions and other expenses | 257 | 272 |
Total | $ 2,622 | $ 1,533 |
Selected Balance Sheet Inform_4
Selected Balance Sheet Information - Schedule of Property and equipment, net (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Property and equipment, net | ||
Property, Plant and Equipment, Gross, Total | $ 1,098 | $ 932 |
Less: accumulated depreciation and amortization | (813) | (831) |
Total | 285 | 101 |
Computers and office equipment | ||
Property and equipment, net | ||
Property, Plant and Equipment, Gross, Total | 790 | 827 |
Other Property, Plant and Equipment | ||
Property and equipment, net | ||
Property, Plant and Equipment, Gross, Total | 203 | |
Leasehold improvements | ||
Property and equipment, net | ||
Property, Plant and Equipment, Gross, Total | 94 | 94 |
Software | ||
Property and equipment, net | ||
Property, Plant and Equipment, Gross, Total | $ 11 | $ 11 |
Selected Balance Sheet Inform_5
Selected Balance Sheet Information - Schedule of Accrued expenses (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Selected Balance Sheet Information | ||
Accrued clinical consulting services | $ 741 | $ 696 |
Accrued manufacturing costs | 617 | 204 |
Accrued vendor payments | 506 | 1,028 |
Vat payable | 123 | |
Total | $ 1,987 | $ 1,928 |
Selected Balance Sheet Inform_6
Selected Balance Sheet Information - Schedule of Accrued employee benefits (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Selected Balance Sheet Information | ||
Accrued bonus expense | $ 542 | $ 886 |
Accrued vacation expense | 128 | 92 |
Accrued compensation expense | 118 | |
Total | $ 788 | $ 978 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock incentive plan and other information (Details) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||||||||||||||||||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Sep. 17, 2020 | Sep. 05, 2019 | Sep. 04, 2019 | Sep. 24, 2018 | Sep. 23, 2018 | Sep. 07, 2017 | Sep. 06, 2017 | Aug. 25, 2016 | Aug. 24, 2016 | May 15, 2015 | May 14, 2015 | Oct. 22, 2013 | Oct. 21, 2013 | Nov. 02, 2010 | Mar. 20, 2007 | |
Share-based Compensation Arrangement by Share-based Payment Award | |||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 625,527 | ||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 3,000 | ||||||||||||||||||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Stock Options | $ 516,000 | $ 516,000 | |||||||||||||||||||||
Stock Option [Member] | |||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award | |||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 607,334 | 607,334 | 399,742 | ||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 0 | 0 | 226,000 | ||||||||||||||||||||
General and Administrative Expense [Member] | Employees [Member] | |||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award | |||||||||||||||||||||||
Allocated Share-based Compensation Expense | $ 39,000 | $ 34,000 | $ 78,000 | $ 67,000 | |||||||||||||||||||
Research and Development Expenses | Employees [Member] | |||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award | |||||||||||||||||||||||
Allocated Share-based Compensation Expense | 21,000 | 16,000 | 41,000 | 31,000 | |||||||||||||||||||
Consultant [Member] | General and Administrative Expense [Member] | |||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award | |||||||||||||||||||||||
Allocated Share-based Compensation Expense | 46,000 | $ 49,000 | 93,000 | $ 98,000 | |||||||||||||||||||
Consultant [Member] | Research and Development Expenses | |||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award | |||||||||||||||||||||||
Allocated Share-based Compensation Expense | $ 7,000 | $ 3,000 | $ 14,000 | $ 7,000 | |||||||||||||||||||
Employees | |||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award | |||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 3,000 | 3,000 | |||||||||||||||||||||
Employees | General and Administrative Expense [Member] | |||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award | |||||||||||||||||||||||
Allocated Share-based Compensation Expense | $ 5,000,000 | $ 5,000,000 | |||||||||||||||||||||
2007 Stock Plan [Member] | |||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award | |||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 515 | 515 | 7,143 | ||||||||||||||||||||
Amended Stock Plan 2010 | |||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award | |||||||||||||||||||||||
Common Stock, Capital Shares Reserved for Future Issuance | 400,000 | 100,000 | 100,000 | 50,000 | 50,000 | 40,000 | 40,000 | 22,858 | 22,858 | 17,143 | 17,143 | 8,572 | |||||||||||
2010 Stock Plan [Member] | |||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award | |||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 368,000 | 368,000 | 8,572 | ||||||||||||||||||||
2010 Stock Plan [Member] | Board of Directors [Member] | |||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award | |||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 238,820 | 238,820 | |||||||||||||||||||||
2020 Stock Plan [Member] | |||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award | |||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 400,000 |
Stock-Based Compensation - Fair
Stock-Based Compensation - Fair value of assumptions used for awards (Details) - $ / shares | 3 Months Ended | 6 Months Ended |
Jun. 30, 2022 | Jun. 30, 2022 | |
Stock-Based Compensation | ||
Exercise price | $ 2.60 | $ 2.60 |
Expected dividends | 0% | 0% |
Expected volatility | 95% | 95% |
Risk -free interest rate | 2.65% | 2.65% |
Expected life of option (years) | 4 years 3 months 18 days | 4 years 3 months 18 days |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of stock option activity (Details) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||
Nov. 16, 2020 | Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Options, Beginning Balance | 625,527 | ||||||
Options, Granted | 3,000 | ||||||
Options, Exercised | 0 | ||||||
Options, Expired | (6,651) | ||||||
Options, Forfeited | 14,542 | ||||||
Options, Ending Balance | 625,527 | ||||||
Weighted Average Exercise Price, Beginning Balance | $ 16.10 | ||||||
Weighted Average Exercise Price, Granted | 2.60 | ||||||
Weighted Average Exercise Price, Exercised | 0 | ||||||
Weighted Average Exercise Price, Expired | 39.70 | ||||||
Weighted Average Exercise Price, Forfeited | $ 3.60 | ||||||
Weighted Average Exercise Price, Ending Balance | $ 16.10 | ||||||
Aggregate Intrinsic Value, Ending Balance | $ 0 | ||||||
Stock Option [Member] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Options, Beginning Balance | 399,742 | 399,742 | |||||
Options, Granted | 0 | 0 | 226,000 | ||||
Options, Exercised | 0 | ||||||
Options, Expired | (215) | ||||||
Options, Forfeited | 0 | ||||||
Options, Ending Balance | 607,334 | 607,334 | 399,742 | ||||
Options, Exercisable | 359,417 | 359,417 | |||||
Weighted Average Exercise Price, Beginning Balance | $ 23.50 | $ 23.50 | |||||
Weighted Average Exercise Price, Granted | 3.30 | ||||||
Weighted Average Exercise Price, Exercised | 0 | ||||||
Weighted Average Exercise Price, Expired | $ 451.50 | ||||||
Weighted Average Exercise Price, Forfeited | $ 0 | ||||||
Weighted Average Exercise Price, Ending Balance | $ 16.07 | 16.07 | $ 23.50 | ||||
Weighted Average Exercise Price, Exercisable | $ 24.67 | $ 24.67 | |||||
Weighted Average Remaining Contractual Life, Balance Outstanding | 5 years 25 days | 5 years 6 months 29 days | 6 years 1 month 2 days | ||||
Weighted Average Remaining Contractual Life, Exercisable | 4 years 5 months 1 day | ||||||
Aggregate Intrinsic Value, Ending Balance | $ 0 | $ 0 | $ 0 | ||||
Aggregate Intrinsic Value, Exercisable | 0 | $ 0 | |||||
Grant date fair value of options granted | $ 5,411 | $ 50,100 | |||||
Exercise price of options granted | $ 1.80 | $ 2.20 |
Stock Warrants (Details)
Stock Warrants (Details) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||||||||||
Nov. 16, 2020 | Oct. 15, 2018 | Oct. 10, 2018 | Jun. 30, 2022 | Mar. 31, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Aug. 03, 2022 | Jul. 29, 2022 | Nov. 15, 2020 | Oct. 31, 2018 | Dec. 26, 2017 | |
Equity, Class of Treasury Stock | ||||||||||||||
Proceeds from "at the market" stock issuance | $ 18,600,000 | |||||||||||||
Stock Issued During Period, Shares, New Issues | 0 | 7,900,000 | 0 | |||||||||||
Exercise price per warrant | $ 6.90 | $ 13.80 | $ 13.80 | $ 6.90 | ||||||||||
Preferred Stock, Par or Stated Value Per Share | $ 0.001 | |||||||||||||
Effect of Warrant exercise price adjustment | $ 900,000 | $ 880,000 | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period | 0 | |||||||||||||
Cash proceeds from exercise of warrants | $ 8,000,000 | $ 0 | $ 8,042,000 | |||||||||||
Warrants Exercised | 0 | 0 | ||||||||||||
Warrants Not Settleable in Cash, Fair Value Disclosure | $ 9,000 | |||||||||||||
Subsequent Event | ||||||||||||||
Equity, Class of Treasury Stock | ||||||||||||||
Exercise price per warrant | $ 6.90 | |||||||||||||
Sale of Stock, Price Per Share | $ 8 | |||||||||||||
Series B Preferred Stock [Member] | ||||||||||||||
Equity, Class of Treasury Stock | ||||||||||||||
Stock Issued During Period, Shares, New Issues | 15,723 | |||||||||||||
Stock Issued During Period, Value, Issued for Services | $ 1,000 | |||||||||||||
Preferred Stock Conversion Price Per Share | $ 11.50 | |||||||||||||
Conversion of Stock, Shares Converted | 1,367,218 | 0 | 398 | 0 | ||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 1,367,218 | |||||||||||||
Common Class A [Member] | ||||||||||||||
Equity, Class of Treasury Stock | ||||||||||||||
Stock Issued During Period, Shares, New Issues | 252,000 | |||||||||||||
Warrant Term | 5 years | |||||||||||||
Over-Allotment Option [Member] | ||||||||||||||
Equity, Class of Treasury Stock | ||||||||||||||
Stock Issued During Period, Shares, New Issues | 242,883 | 242,883 | ||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 242,883 | 242,883 | ||||||||||||
Issue of warrants to purchase common stock | 180,783 | 180,783 | ||||||||||||
Warrant | ||||||||||||||
Equity, Class of Treasury Stock | ||||||||||||||
Exercise price per warrant | $ 6.90 | $ 6.90 | ||||||||||||
Conversion of Stock, Shares Converted | 1,367,218 | |||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 1,165,575 | |||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award Non Option Equity Instruments Warrants Exercisable Number | 71 |
Stock Warrants - Summary of all
Stock Warrants - Summary of all warrant activity (Details) - $ / shares | 6 Months Ended | 12 Months Ended |
Jun. 30, 2022 | Dec. 31, 2021 | |
Stock Warrants | ||
Number of Warrants, Beginning Balance | 634,497 | 1,800,072 |
Number of Warrants, Granted | 0 | |
Number of Warrants, Exercised | (1,165,575) | |
Number of Warrants, Ending Balance | 634,497 | 634,497 |
Weighted Average Exercise Price, Beginning Balance | $ 6.92 | $ 6.92 |
Weighted Average Exercise Price, Granted | 0 | |
Weighted Average Exercise Price, Exercised | 6.92 | |
Weighted Average Exercise Price, Ending Balance | $ 6.92 | $ 6.92 |
Stock Warrants - Summary of a_2
Stock Warrants - Summary of all outstanding and exercisable warrants (Details) | 6 Months Ended |
Jun. 30, 2022 $ / shares shares | |
Exercise Price 6.90 [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Exercise Price | $ / shares | $ 6.90 |
Warrants Outstanding | 634,426 |
Warrants Exercisable | 634,426 |
Weighted Average Remaining Contractual Life (in years) | 1 year 3 months 10 days |
Exercise Price 18.20 [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Exercise Price | $ / shares | $ 182 |
Warrants Outstanding | 71 |
Warrants Exercisable | 71 |
Weighted Average Remaining Contractual Life (in years) | 5 months 26 days |
Exercise Price 6.90 Two [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Exercise Price | $ / shares | $ 6.90 |
Warrants Outstanding | 634,497 |
Warrants Exercisable | 634,497 |
Weighted Average Remaining Contractual Life (in years) | 1 year 3 months 10 days |
Net Loss per Share - Additional
Net Loss per Share - Additional Information (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||||||
Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2021 | Mar. 31, 2021 | Mar. 31, 2020 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2017 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||||||
Net Income (Loss) Attributable to Parent | $ (4,968,000) | $ (4,273,000) | $ (3,195,000) | $ (2,536,000) | $ (9,241,000) | $ (5,731,000) | ||
Net loss attributable to common stockholders | (4,968,000) | (3,195,000) | $ (9,241,000) | (14,654,000) | ||||
Net Loss Attributable to Non-controlling Interest | 0 | 0 | 1,000 | (1,000) | ||||
Series A Preferred Stock [Member] | ||||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||||||
Accretion of Preferred Stock Deemed Dividend | 7,400,000 | |||||||
Preferred Stock Redemption Discount | $ 6,900,000 | |||||||
Accretion of preferred discount | 100,000 | |||||||
Preferred stock accrued dividends | 0 | 0 | 24,000 | $ 62,000 | 24,000 | |||
Series B Preferred Stock [Member] | ||||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||||||
Net Loss Attributable to Non-controlling Interest | 100,000 | |||||||
Accretion of Preferred Stock Deemed Dividend | $ 1,500,000 | |||||||
Accretion of preferred discount | 1,500,000 | |||||||
Preferred stock accrued dividends | $ 0 | $ 0 | $ 1,497,000 | |||||
Equity Option [Member] | ||||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 607,334 | 399,742 | 634,497 | 634,497 |
Non-controlling Interest and _2
Non-controlling Interest and Related Party (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Sep. 05, 2018 | Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Noncontrolling Interest | |||||
Related Party Transaction, Expenses from Transactions with Related Party | $ 328,000 | ||||
SYN Biomics [Member] | |||||
Noncontrolling Interest | |||||
Equity Method Investment, Ownership Percentage | 100% | 100% | |||
Related Party Transaction, Expenses from Transactions with Related Party | $ 0 | $ 0 | $ 0 | $ 0 | |
Cedarssinai Medical Center [Member] | |||||
Noncontrolling Interest | |||||
Number Of Common Stock To Be Issued | 5,000 | ||||
Fair Value Of Shares Issued | $ 285,000 | ||||
Cedarssinai Medical Center [Member] | SYN Biomics [Member] | |||||
Noncontrolling Interest | |||||
Additional Number Of Common Stock To Be Issued | 2,420,000 | ||||
Number Of Common Stock To Be Held By Related Party | 7,480,000 | ||||
Noncontrolling Interest, Ownership Percentage by Noncontrolling Owners | 17% |
Common and Preferred Stock (Det
Common and Preferred Stock (Details) | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||||||||||||||||
Jan. 27, 2021 $ / shares | Nov. 16, 2020 $ / shares shares | Oct. 15, 2018 USD ($) $ / shares shares | Oct. 10, 2018 shares | Sep. 11, 2017 USD ($) D $ / shares shares | Jun. 30, 2022 USD ($) shares | Jun. 30, 2021 USD ($) | Mar. 31, 2021 USD ($) shares | Mar. 31, 2020 USD ($) | Jun. 30, 2022 USD ($) shares | Jun. 30, 2021 USD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | Aug. 03, 2022 $ / shares | Feb. 28, 2021 shares | Jan. 31, 2021 shares | Jan. 26, 2021 | Nov. 15, 2020 $ / shares | Oct. 31, 2018 $ / shares | Dec. 31, 2017 USD ($) | Aug. 05, 2016 | |
Proceeds from Issuance or Sale of Equity | $ | $ 18,600,000 | ||||||||||||||||||||
Stock Issued During Period, Shares, New Issues | 0 | 7,900,000 | 0 | ||||||||||||||||||
Preferred Stock, Par or Stated Value Per Share | $ / shares | $ 0.001 | ||||||||||||||||||||
Exercise price per warrant | $ / shares | $ 6.90 | $ 13.80 | $ 13.80 | $ 6.90 | |||||||||||||||||
Effect of Warrant exercise price adjustment | $ | $ 900,000 | $ 880,000 | |||||||||||||||||||
Common stock issued upon conversion | 899,677 | 899,677 | |||||||||||||||||||
Proceeds from Issuance of Common Stock | $ | $ 66,000,000 | $ 0 | $ 65,960,000 | ||||||||||||||||||
Common Stock, Discount on Shares | $ | $ 200,000,000 | $ 200,000,000 | |||||||||||||||||||
Subsequent Event | |||||||||||||||||||||
Exercise price per warrant | $ / shares | $ 6.90 | ||||||||||||||||||||
Over-Allotment Option [Member] | |||||||||||||||||||||
Stock Issued During Period, Shares, New Issues | 242,883 | 242,883 | |||||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 242,883 | 242,883 | |||||||||||||||||||
Issue of warrants to purchase common stock | 180,783 | 180,783 | |||||||||||||||||||
Fbr Capital Markets Co [Member] | |||||||||||||||||||||
Brokerage Commission percentage | 3% | ||||||||||||||||||||
Warrant | |||||||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 1,165,575 | ||||||||||||||||||||
Conversion of Stock, Shares Converted | 1,367,218 | ||||||||||||||||||||
Exercise price per warrant | $ / shares | $ 6.90 | $ 6.90 | |||||||||||||||||||
Series A Preferred Stock [Member] | |||||||||||||||||||||
Preferred Stock Conversion Price Per Share | $ / shares | $ 189 | $ 5.40 | |||||||||||||||||||
Accretion of Preferred Stock Deemed Dividend | $ | $ 7,400,000 | ||||||||||||||||||||
Preferred Stock, Dividend Rate, Percentage | 2% | ||||||||||||||||||||
Preferred Stock, Convertible, Conversion Price, Increase | $ / shares | 189 | ||||||||||||||||||||
Preferred Stock, Convertible, Conversion Price, Decrease | $ / shares | $ 15 | ||||||||||||||||||||
Convertible Preferred Stock, Terms of Conversion | (i) a 19.99% blocker provision to comply with NYSE American Listing Rules, (ii) if so elected by the Investor, a 4.99% blocker provision that will prohibit beneficial ownership of more than 4.99% of the outstanding shares of the Company’s common stock or voting power at any time, and (iii) applicable regulatory restrictions. | ||||||||||||||||||||
Debt Instrument, Convertible, Threshold Trading Days | D | 20 | ||||||||||||||||||||
Debt Instrument, Convertible, Threshold Consecutive Trading Days | D | 30 | ||||||||||||||||||||
Dividends Payable, Amount Per Share | $ / shares | $ 70 | ||||||||||||||||||||
Adjustments to Additional Paid in Capital, Stock Split | $ | $ 7,875 | ||||||||||||||||||||
Preferred Stock Redemption Discount | $ | $ 6,900,000 | ||||||||||||||||||||
Percentage of stated dividend rate | 2% | ||||||||||||||||||||
Preferred stock accrued dividends | $ | $ 0 | $ 0 | $ 24,000 | $ 62,000 | 24,000 | ||||||||||||||||
Maximum percentage | 9.99% | 4.99% | |||||||||||||||||||
Number of common shares issued for convertible preferred stock | 900,000 | ||||||||||||||||||||
Preferred Stock Shares Converted | 0 | ||||||||||||||||||||
Preferred Stock, Shares Outstanding | 12,000 | 12,000 | |||||||||||||||||||
Estimated fair value of inducement consideration | $ | $ 7,400,000 | ||||||||||||||||||||
Series A Preferred Stock [Member] | Private Placement [Member] | |||||||||||||||||||||
Stock Issued During Period, Shares, New Issues | 12,000 | ||||||||||||||||||||
Preferred Stock, Par or Stated Value Per Share | $ / shares | $ 0.001 | ||||||||||||||||||||
Proceeds from Issuance of Convertible Preferred Stock | $ | $ 12,000,000 | ||||||||||||||||||||
Sale of Stock, Consideration Received Per Transaction | $ | $ 10 | ||||||||||||||||||||
Series B Preferred Stock [Member] | |||||||||||||||||||||
Stock Issued During Period, Shares, New Issues | 15,723 | ||||||||||||||||||||
Stock Issued During Period, Value, Issued for Services | $ | $ 1,000 | ||||||||||||||||||||
Preferred Stock Conversion Price Per Share | $ / shares | $ 11.50 | ||||||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 1,367,218 | ||||||||||||||||||||
Conversion of Stock, Shares Converted | 1,367,218 | 0 | 398 | 0 | |||||||||||||||||
Accretion of Preferred Stock Deemed Dividend | $ | $ 1,500,000 | ||||||||||||||||||||
Preferred stock accrued dividends | $ | $ 0 | $ 0 | $ 1,497,000 | ||||||||||||||||||
Common Class A [Member] | |||||||||||||||||||||
Stock Issued During Period, Shares, New Issues | 252,000 | ||||||||||||||||||||
Warrant Term | 5 years |
Indebtedness - Schedule of debt
Indebtedness - Schedule of debt (Details) $ in Thousands | Jun. 30, 2022 USD ($) |
Schedule of Capitalization, Long-term Debt [Line Items] | |
Debt, Current | $ 56 |
Debt, Non current | 216 |
NEBT Loans | |
Schedule of Capitalization, Long-term Debt [Line Items] | |
Debt, Current | 6 |
Debt, Non current | 37 |
RETOS 2015 | |
Schedule of Capitalization, Long-term Debt [Line Items] | |
Debt, Current | 50 |
Debt, Non current | $ 179 |
Indebtedness - Schedule of Matu
Indebtedness - Schedule of Maturity analysis of debt (Details) $ in Thousands | Jun. 30, 2022 USD ($) |
Indebtedness | |
2023 | $ 56 |
2024 | 61 |
2025 | 60 |
2026 | 49 |
2027 | 30 |
2028 | 16 |
Total | $ 272 |
Indebtedness - Additional Infor
Indebtedness - Additional Information (Details) - USD ($) | Jun. 30, 2022 | Dec. 31, 2021 | Jun. 30, 2021 |
Restricted cash included in other long-term assets | $ 96,000 | $ 0 | |
Minimum | |||
Loans acquired, Interest rate | 0% | ||
Maximum | |||
Loans acquired, Interest rate | 1% |
Commitments and Contingencies -
Commitments and Contingencies - Maturity analysis of operating leases (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Commitments and Contingencies | ||
2022 | $ 82 | |
2023 | 327 | |
2024 | 337 | |
2025 | 347 | |
2026 | 357 | |
2027 | 368 | |
Total | 1,818 | |
Discount factor | (392) | |
Lease liability | 1,426 | |
Lease liability - current | (128) | $ (124) |
Lease liability - Long term | $ 1,298 | $ 1,403 |
Commitments and Contingencies_2
Commitments and Contingencies - Additional Information (Details) | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Jun. 30, 2022 USD ($) | Jun. 30, 2021 USD ($) | Jun. 30, 2022 USD ($) item | Jun. 30, 2021 USD ($) | Dec. 31, 2019 USD ($) | Dec. 31, 2021 | |
Number of operating lease for facilities | item | 2 | |||||
Renewed lease term | 63 months | 63 months | ||||
Lease rent abatement period | 3 months | 3 months | ||||
Rate of interest of funds borrowed by company | 8.5 | 8.5 | ||||
Termination notice period (in days) | 90 days | 90 days | ||||
Additional renew lease term | 5 years | 5 years | ||||
Operating Lease, Cost | $ 138,000 | $ 68,000 | $ 245,000 | $ 118,000 | ||
Operating Lease, Payments | $ 144,000 | $ 80,000 | 257,000 | 160,000 | ||
Right-of-Use Asset Obtained in Exchange for Operating Lease Liability | 0 | $ 1,270,000 | ||||
ASU 2016-02 | ||||||
Right-of-Use Asset Obtained in Exchange for Operating Lease Liability | $ 1,300,000 | $ 538,000 | ||||
Minimum | ||||||
Loans acquired, Interest rate | 0% | |||||
Maximum | ||||||
Loans acquired, Interest rate | 1% |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) $ / shares in Units, $ in Millions | Aug. 09, 2022 | Jul. 29, 2022 | Aug. 03, 2022 | Jul. 11, 2022 | Jun. 30, 2022 | Dec. 31, 2021 | Nov. 16, 2020 | Nov. 15, 2020 | Oct. 31, 2018 | Oct. 15, 2018 |
Subsequent Event [Line Items] | ||||||||||
Preferred Stock, Par or Stated Value Per Share | $ 0.001 | |||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 6.90 | $ 13.80 | $ 6.90 | $ 13.80 | ||||||
Common stock, Shares Issued | 15,844,294 | 13,204,487 | ||||||||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 | |||||||
Subsequent Event | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Offering price | $ 8 | |||||||||
Gross proceeds | $ 3 | |||||||||
conversion price | $ 1.22 | |||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 6.90 | |||||||||
Common stock, Shares Issued | 2,459,016 | |||||||||
Common stock, par value (in dollars per share) | $ 0.001 | |||||||||
Preferred Stock Dividends, Shares | 1,549,295 | |||||||||
Common Stock | Subsequent Event | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | 1.22 | |||||||||
Common stock, par value (in dollars per share) | $ 0.001 | |||||||||
Series C Convertible Preferred Stock | Subsequent Event | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Preferred Stock, Shares Issued | 275,000 | |||||||||
Preferred Stock, Par or Stated Value Per Share | $ 0.001 | |||||||||
Series D Convertible Preferred Stock | Subsequent Event | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Preferred Stock, Shares Issued | 100,000 | |||||||||
Preferred Stock, Par or Stated Value Per Share | $ 0.001 |