Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2023 | May 10, 2023 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Period End Date | Mar. 31, 2023 | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity File Number | 001-12584 | |
Entity Registrant Name | THERIVA 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 | TOVX | |
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 | 15,124,061 | |
Entity Central Index Key | 0000894158 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q1 | |
Amendment Flag | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Current Assets | ||
Cash and cash equivalents | $ 36,076 | $ 41,786 |
Prepaid expenses and other current assets | 4,223 | 3,734 |
Total Current Assets | 40,299 | 45,520 |
Non-Current Assets | ||
Property and equipment, net | 324 | 345 |
Restricted cash | 100 | 99 |
Right of use asset | 2,054 | 1,199 |
In-process research and development | 19,469 | 19,150 |
Goodwill | 5,617 | 5,525 |
Deposits and other assets | 23 | 23 |
Total Assets | 67,886 | 71,861 |
Current Liabilities: | ||
Accounts payable | 480 | 915 |
Accrued expenses | 2,076 | 1,496 |
Accrued employee benefits | 649 | 1,403 |
Contingent consideration, current portion | 4,911 | 2,973 |
Loans payable-current | 66 | 57 |
Operating lease liability | 437 | 216 |
Total Current Liabilities | 8,619 | 7,060 |
Non-current Liabilities | ||
Non-current contingent consideration | 5,408 | 7,211 |
Loan Payable - Long term | 160 | 221 |
Deferred tax liabilities, net | 1,311 | 1,618 |
Lease liability - Long term | 1,802 | 1,187 |
Total Liabilities | 17,300 | 17,297 |
Commitments and Contingencies | ||
Stockholders' Equity: | ||
Common stock, $0.001 par value; 350,000,000 shares authorized, 15,844,294 issued and 15,124,061 outstanding at March 31, 2023 and 15,844,294 issued and 15,124,061 outstanding at December 31, 2022 | 16 | 16 |
Additional paid-in capital | 343,876 | 343,750 |
Treasury stock at cost, 720,233 shares at March 31, 2023 and at December 31, 2022 | (288) | (288) |
Accumulated other comprehensive loss | (305) | (679) |
Accumulated deficit | (295,447) | (290,969) |
Total Stockholders' Equity | 47,852 | 51,830 |
Total Liabilities and Stockholders' Equity | 67,886 | 71,861 |
Series C convertible preferred stock | ||
Temporary Equity | ||
Convertible preferred stock | 2,006 | 2,006 |
Series D convertible preferred stock | ||
Temporary Equity | ||
Convertible preferred stock | $ 728 | $ 728 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2023 | Dec. 31, 2022 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 350,000,000 | 350,000,000 |
Common stock, shares issued | 15,844,294 | 15,844,294 |
Common stock, shares outstanding | 15,124,061 | 15,124,061 |
Treasury stock | 720,233 | 720,233 |
Series C convertible preferred stock | ||
Convertible preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Convertible preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Convertible preferred stock, shares issued | 275,000 | 275,000 |
Convertible preferred stock, shares outstanding | 275,000 | 275,000 |
Series D convertible preferred stock | ||
Convertible preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Convertible preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Convertible preferred stock, shares issued | 100,000 | 100,000 |
Convertible preferred stock, shares outstanding | 100,000 | 100,000 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Operating Costs and Expenses: | ||
General and administrative | $ 2,201 | $ 1,655 |
Research and development | 2,977 | 2,597 |
Total Operating Costs and Expenses | 5,178 | 4,252 |
Loss from Operations | (5,178) | (4,252) |
Other Income (Expense): | ||
Exchange income (loss) | 6 | (23) |
Interest income | 364 | 2 |
Total Other Income (Expense) | 370 | (21) |
Net Loss before income taxes | (4,808) | (4,273) |
Income tax benefit | 330 | 0 |
Net Loss Attributable to Common Stockholders | $ (4,478) | $ (4,273) |
Net Loss Per Share - Basic | $ (0.30) | $ (0.31) |
Net Loss Per Share - Dilutive | $ (0.30) | $ (0.31) |
Weighted average number of shares outstanding during the period - Basic | 15,124,061 | 13,820,144 |
Weighted average number of shares outstanding during the period - Dilutive | 15,124,061 | 13,820,144 |
Net Loss | $ (4,478) | $ (4,273) |
Gain on foreign currency translation | 374 | 181 |
Total comprehensive loss | $ (4,104) | $ (4,092) |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders Equity (Deficit) - USD ($) | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive income | Treasury Stock | Non-Controlling Interest | Total |
Balance at Dec. 31, 2021 | $ 13,000 | $ 336,679,000 | $ (271,284,000) | $ 0 | $ 65,408,000 | ||
Balance (in shares) at Dec. 31, 2021 | 13,204,531 | ||||||
Stock-based compensation | $ 0 | 112,000 | 0 | 0 | 112,000 | ||
Issuance of Common Stock for VCN Acquisition | $ 3,000 | 6,596,000 | 0 | 0 | 6,599,000 | ||
Issuance of Common Stock for VCN Acquisition (in shares) | 2,639,530 | ||||||
Translation gains | $ 0 | 0 | 0 | 181,000 | 181,000 | ||
Net loss | $ 0 | 0 | (4,273,000) | 0 | (4,273,000) | ||
Balance (in shares) at Mar. 31, 2022 | 15,844,061 | ||||||
Balance at Mar. 31, 2022 | $ 16,000 | 343,387,000 | (275,557,000) | $ 181,000 | 68,027,000 | ||
Balance at Dec. 31, 2022 | $ 16,000 | 343,750,000 | (290,969,000) | $ (679,000) | $ (288,000) | 51,830,000 | |
Balance (in shares) at Dec. 31, 2022 | 15,844,061 | ||||||
Stock-based compensation | $ 0 | 126,000 | 0 | 0 | 126,000 | ||
Translation gains | 0 | 0 | 0 | 374,000 | 374,000 | ||
Net loss | $ 0 | 0 | (4,478,000) | 0 | (4,478,000) | ||
Balance (in shares) at Mar. 31, 2023 | 15,844,061 | ||||||
Balance at Mar. 31, 2023 | $ 16,000 | $ 343,876,000 | $ (295,447,000) | $ (305,000) | $ (288,000) | $ 47,852,000 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Cash Flows From Operating Activities: | ||
Net loss | $ (4,478,000) | $ (4,273,000) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 126,000 | 112,000 |
Income tax benefit | (330,000) | 0 |
Change in fair value of contingent consideration | 135,000 | 0 |
Right of use asset | 82,000 | 45,000 |
Depreciation | 32,000 | 18,000 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | (447,000) | 390,000 |
Accounts payable | (440,000) | 13,000 |
Accrued expenses | 568,000 | (513,000) |
Accrued employee benefits | (758,000) | (645,000) |
Lease liability | (100,000) | (49,000) |
Net Cash Used In Operating Activities | (5,610,000) | (4,902,000) |
Cash Flows from Investing Activities | ||
Purchase of property and equipment | (8,000) | 0 |
Cash paid for business combination, net of cash acquired | 0 | (3,863,000) |
Pre-acquisition loan to VCN | 0 | (417,000) |
Net Cash Used in Investing Activities | (8,000) | (4,280,000) |
Cash Flows from Financing Activities | ||
Payment of debt | (55,000) | (1,376,000) |
Net Cash Provided by Financing Activities | (55,000) | (1,376,000) |
Effects of exchange rate changes on cash and cash equivalents | (35,000) | 28,000 |
Net decrease in cash and cash equivalents and restricted cash | (5,708,000) | (10,530,000) |
Cash and cash equivalents and restricted at the beginning of this period | 41,884,000 | 67,325,000 |
Cash and cash equivalents and restricted cash at the end of this period | 36,176,000 | 56,795,000 |
Reconciliation of cash, cash equivalents, and restricted cash reported in the statement of financial position | ||
Cash and cash equivalents | 36,076,000 | 56,692,000 |
Restricted cash included in other long-term assets | 100,000 | 103,000 |
Total cash, cash equivalents, and restricted cash shown in the statement of cash flows | 36,176,000 | 56,795,000 |
Supplemental non-cash investing and financing activities: | ||
Right of use assets obtained in exchange for lease liabilities | 937,000 | 0 |
Fair value of contingent consideration in a business combination | 0 | 12,158,000 |
Fair value of equity issued as consideration in a business combination | 0 | 6,599,000 |
Effective settlement of pre-closing VCN financing | $ 0 | $ 417,000 |
Organization and Nature of Oper
Organization and Nature of Operations and Basis of Presentation | 3 Months Ended |
Mar. 31, 2023 | |
Organization and Nature of Operations and Basis of Presentation | |
Organization and Nature of Operations and Basis of Presentation | 1. Organization, Nature of Operations and Basis of Presentation Description of Business Theriva Biologics, Inc. (the “Company” or “Theriva Biologics”) is a diversified clinical-stage company developing therapeutics in areas of high unmet need. As a result of the acquisition of Theriva Biologics S.L. (“VCN”, formerly known as VCN Biosciences, S.L.) (the “Acquisition”), described in more detail below, the Company transitioned its strategic focus to oncology through the development of VCN’s new oncolytic adenovirus platform designed for intravenous and intravitreal delivery to trigger tumor cell death, improve access of co-administered cancer therapies to the tumor, and promote a robust and sustained anti-tumor response by the patient’s immune system. Prior to the Acquisition, the Company’s focus was on developing therapeutics designed to treat gastrointestinal (GI) diseases in areas which included our 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 thereby preventing overgrowth and infection by pathogenic organisms such as Clostridioides difficile Basis of Presentation 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 2022 Form 10-K. The interim results for the three months ended March 31, 2023 are not necessarily indicative of results for the full year. 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 March 31, 2023 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 3), the Company recorded 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. 1. Organization, Nature of Operations and Basis of Presentation – (continued) 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. 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. 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. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2023 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies 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. No impairment charges were recorded during the three months ended March 31, 2023 and 2022. 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 | 3 Months Ended |
Mar. 31, 2023 | |
BUSINESS COMBINATION | |
BUSINESS COMBINATION | 3. BUSINESS COMBINATION Summary On March 10, 2022, the Company completed the acquisition of all the outstanding shares of Theriva Biologics, S.L , which at the time was known as VCN Biosciences, S.L.(the “VCN Shares”) from the shareholders of VCN. VCN is a clinical-stage biopharmaceutical company developing new oncolytic adenoviruses for the treatment of cancer. Theriva’s lead product candidate, VCN-01, is being studied in a Company sponsored Phase 2 clinical trial for pancreatic cancer with additional investigator sponsored trials in indications including head and neck squamous cell carcinoma (HNSCC) , retinoblastoma, brain tumors and pancreatic and ovarian cancers. VCN-01 is designed to be administered systemically, intratumorally or intravitreally, either as a monotherapy or in combination with standard of care chemotherapies or immunotherapies, 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. Theriva has the exclusive rights to four patent families 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 and pursuant to the terms of a purchase agreement that the parties entered into (the “Purchase Agreement”), the Company paid $4,700,000 to Grifols Innovation and New Technologies Limited (“Grifols”), 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, $0.001 par value per share (the “Common Stock”). In addition to the consideration described above, under the terms of the purchase agreement that the parties entered into, 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 September 2022, the Company received approval from the FDA to proceed with the Phase 2 clinical trial of VCN-01 in PDAC. Due to this approval, the Company paid Grifols $3.0 million in the fourth quarter of 2022. 3. BUSINESS COMBINATION - (continued) 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, common shares and contingent consideration was valued at approximately $22.8 million, as follows (in thousands): Cash paid at Closing $ 4,700 Receivable from VCN “effectively settled” 417 Fair value of common shares issued 6,599 Fair value of contingent consideration 11,093 $ 22,809 As of March 31, 2023 and December 31, 2022, the fair value of the contingent consideration was approximately $10.3 million and 10.1 million, respectively. During the three months ended March 31, 2023, the Company recognized in operating expense a $135,000 fair value adjustment increase to contingent consideration. There was no fair value adjustment to contingent consideration for the three months ended March 31, 2022. The allocation of the fair value of the VCN acquisition updated for measurement period and other adjustments is shown in the table below. Estimated fair value ($in thousands) Cash and cash equivalents $ 837 Receivables 1,889 Property and equipment 216 In-process research and development intangible asset 19,742 Goodwill 5,696 Deferred tax assets (liabilities), net (3,209) Accounts payable (522) Accrued expenses (113) Accrued employee benefits (90) Loan Payable-current (67) Other long-term liabilities (1,570) Total purchase consideration $ 22,809 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 $19.7 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 $5.7 million was established as a result of the Acquisition and is not tax deductible. Theriva Biologics, S.L. operations recorded a net loss of $7.8 million from the date of Acquisition through March 31, 2023. 3. BUSINESS COMBINATION - (continued) During the year ended December 31, 2022, the Company recognized the following measurement period adjustments: ● estimate of acquired liabilities resulting in a $277,000 reduction in accrued expenses and goodwill, ● estimate in the receivable from the prior owner resulting in a $176,000 increase in other receivables and reduction in goodwill. ● estimated fair value of its in-process R&D resulting in a $810,000 increase in in-process R&D, an increase of $202,000 in deferred tax liabilities and a decrease of $607,000 in goodwill. The cumulative impact of the re-measurements as of the year ended December 31, 2022, was a reduction in accrued liabilities of $277,000, and increase in other receivables or $176,000, an increase in in-process R&D of $810,000; an increase in deferred tax liabilities of $202,000 and a decrease in goodwill of $1,061,000. 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, 2022 (in thousands): Three months Ended March 31 (in thousands) 2023 2022 Net revenues — $ — Net loss $ (4,478) $ (4,796) Transaction Costs In conjunction with the Acquisition, the Company incurred approximately $0.2 million in transaction costs during the three months ended March 31, 2022, which were expensed as general, and administrative expense in the consolidated statements of operations. There were no acquisition costs incurred during the three months ended March 31, 2023. |
Goodwill and Intangibles
Goodwill and Intangibles | 3 Months Ended |
Mar. 31, 2023 | |
Goodwill and Intangibles | |
Goodwill and Intangibles | 4. Goodwill and Intangibles The following table provides the Company’s Goodwill as of March 31, 2023. Goodwill (in thousands) Balance at December 31, 2021 $ — Goodwill from Acquisition of VCN 6,757 Goodwill impairment loss — Measurement Period Adjustments (1,061) Effects of exchange rates (171) Balance at December 31, 2022 5,525 Effects of exchange rates 92 Balance at March 31, 2023 $ 5,617 4. Goodwill and Intangibles – (continued) The following table provides the Company’s in-process R&D as of March 31, 2023. In-process R&D (in thousands) Balance at December 31, 2021 $ — Acquired IPR&D 18,932 Measurement Period Adjustments 810 Effects of exchange rates (592) Balance at December 31, 2022 19,150 Effects of exchange rates 319 Balance at March 31, 2023 $ 19,469 During the quarter ending September 30, 2022, and the quarter ended December 31, 2022, the Company experienced a sustained decline in the quoted market price of the Company’s common stock and the Company deemed this to be a trigger event for impairment. The Company performed an impairment analysis and concluded that the Goodwill and IPR&D was not impaired as of September 30, 2022, and December 31, 2022. There was no trigger event during the three months ended March 31, 2023. |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 3 Months Ended |
Mar. 31, 2023 | |
Fair Value of Financial Instruments | |
Fair Value of Financial Instruments | 5. Fair Value of Financial Instruments Accounting Standards Codification (“ASC”) 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, 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. 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, 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. In September 2022 the Company received approval from the FDA to proceed with the Phase 2 clinical trial of VCN-01 in PDAC. Due to this approval the Company paid Grifols Innovation and New Technologies Limited (“Grifols”) $3.0 million in Q4 2022. The discounted cash flow method used to value this contingent consideration includes inputs of not readily observable market data, which are Level 3 inputs. The fair value of the contingent consideration was $10.3 million as of March 31, 2023 and is reflected as current accrued contingent consideration of $4.9 million and non-current contingent consideration liability of $5.4 million in the consolidated balance sheet. During the three months ended March 31, 2023 the Company recognized in operating expense a $135,000 fair value adjustment increase to contingent consideration. There was no fair value adjustment during the three months ended March 31, 2022. 5. Fair Value of Financial Instruments – (continued) The fair value of financial instruments measured on a recurring basis is as follows: As of March 31, 2023 Description Total Level 1 Level 2 Level 3 Liabilities: Contingent consideration $ 10,319 — — $ 10,319 As of December 31, 2022 Description Total Level 1 Level 2 Level 3 Liabilities: Contingent consideration $ 10,184 — — $ 10,184 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 31, 2023 Valuation Significant Weighted Average Methodology Unobservable Input (range, if applicable) Contingent Consideration Discounted Cash Flows Milestone dates 2023-2028 Discount rate 13.9% to 15.1% Weighted Average Discount rate 14.04% Probability of Occurrence (periodic for each Milestone) 11.7% to 95.0% Probability of occurrence (cumulative through each Milestone) 6.9% to 95.0% As of December 31, 2022 Valuation Significant Weighted Average Methodology Unobservable Input (range, if applicable) Contingent Consideration Discounted Cash Flows Milestone dates 2023-2028 Discount rate 13.4% to 14.1% Weighted Average Discount rate 13.6% Probability of Occurrence (periodic for each Milestone) 11.7% to 95.0% Probability of occurrence (cumulative through each Milestone) 6.9% to 95.0% |
Selected Balance Sheet Informat
Selected Balance Sheet Information | 3 Months Ended |
Mar. 31, 2023 | |
Selected Balance Sheet Information | |
Selected Balance Sheet Information | 6. Selected Balance Sheet Information Prepaid expenses and other current assets (in thousands) March 31, December 31, 2023 2022 Prepaid clinical research organizations $ 2,474 $ 2,293 Prepaid manufacturing expenses 879 418 Prepaid insurance 440 637 Receivable from prior owner 229 144 Prepaid consulting, subscriptions and other expenses 197 155 VAT receivable 4 87 Total $ 4,223 $ 3,734 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. Receivable from prior VCN owner includes amounts due related to research and development tax rebates, VAT and corporate taxes. Property and equipment, net (in thousands) March 31, December 31, 2023 2022 Computers and office equipment $ 905 $ 897 Other Property, Plant and Equipment 210 208 Leasehold improvements 94 94 Software 12 11 1,221 1,210 Less: accumulated depreciation and amortization (897) (865) Total $ 324 $ 345 Accrued expenses (in thousands) March 31, December 31, 2023 2022 Accrued manufacturing costs $ 863 $ 197 Accrued clinical consulting services 838 807 Accrued vendor payments 375 492 Total $ 2,076 $ 1,496 Accrued employee benefits (in thousands) March 31, December 31, 2023 2022 Accrued bonus expense $ 325 $ 1,216 Accrued vacation expense 142 100 Accrued compensation expense 182 87 Total $ 649 $ 1,403 |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2023 | |
Stock-Based Compensation and Warrants | |
Stock-Based Compensation and Warrants | 7. 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 March 31, 2023, there were 372 options issued 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. From time to time the number of shares authorized for options was increased such that 400,000 were authorized as of September 5, 2019. The exercise price of stock options under the 2010 Stock Plan is determined by the compensation committee of the Board of Directors and may be equal to or greater than the fair market value of the Company’s common stock on the date the option is granted. Options become exercisable over various periods from the date of grant and expire between five issued 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. The number of shares authorized for options was increased such that 7,000,000 were authorized as of March 31, 2023. As of March 31, 2023, there were 2,093,002 options issued and outstanding under the 2020 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. 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 granted is estimated on the date of grant using the Black-Scholes option pricing model. There were no options granted during the three months ended March 31, 2023 and 2022. Expected dividends — Expected volatility Risk-free interest rate Expected life of the option 7. 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. 7. Stock-Based Compensation – (continued) A summary of stock option activity for the three months ended March 31, 2023 and the year ended December 31, 2022 is as follows: Weighted Weighted Average Aggregate Average Exercise Remaining Intrinsic Options Price Contractual Life Value Balance - December 31, 2021 625,565 $ 16.12 5.58 years $ — Granted 1,728,000 0.58 Exercised — — Expired (43,126) 67.81 Forfeited (14,541) 3.61 Balance - December 31, 2022 2,295,898 3.53 6.44 years — Granted — — Exercised — — Expired (429) 404.83 Forfeited — — Balance - March 31, 2023 - outstanding 2,295,469 $ 3.46 6.19 years $ 172,500 Balance - March 31, 2023 - exercisable 636,009 $ 10.43 5.06 years $ 18,542 Grant date fair value of options granted – three months ended March 31, 2023 $ — Weighted average grant date fair value – three months ended March 31, 2023 $ — Grant date fair value of options granted – year ended December 31, 2022 $ 706,264 Weighted average grant date fair value – year ended December 31, 2022 $ 0.41 Stock-based compensation expense included in general and administrative expenses and research and development expenses relating to stock options issued to employees for the three months ended March 31, 2023 and 2022 was $83,000 and $59,000, respectively. Stock-based compensation expense included in general and administrative expenses and research and development expenses relating to stock options issued to consultants for the three months ended March 31, 2023 and 2022 were $43,000 and $53,000, respectively. As of March 31, 2023, total unrecognized stock-based compensation expense related to stock options was $841,000, which is expected to be expensed through May 2025. 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 months ended March 31, 2023 and 2022. |
Stock Warrants
Stock Warrants | 3 Months Ended |
Mar. 31, 2023 | |
Stock Warrants | |
Stock Warrants | 8. 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 and then again to $1.22 (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, to $6.90 per Warrant per full share of Common Stock in accordance with the antidilution 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 year ended December 31, 2022, or the three months ended March 31, 2023. 8. Stock Warrants – (continued) 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. 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 $340,000 during the year ended December 31, 2022, which reduces the income available to common stockholders. A summary of all warrant activity for the Company for the quarter ended March 31, 2023 and the year ended December 31, 2022 is as follows: Weighted Average Number of Weighted Average Remaining Warrants Exercise Price Contractual Life Balance at December 31, 2021 634,497 1.24 1.78 years Granted — — Exercised — — Forfeited (71) 182 Balance at December 31, 2022 634,426 $ 1.22 0.78 years Granted — — Exercised — — Forfeited — — Balance at March 31, 2023 634,426 $ 1.22 0.53 years 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 714 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. The warrant expired in December 2022. |
Net Loss per Share
Net Loss per Share | 3 Months Ended |
Mar. 31, 2023 | |
Net Loss per Share | |
Net Loss per Share | 9. 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 months ended March 31, 2023 was $4.5 million. Net loss attributable to common stockholders for the three months ended March 31, 2022 was $4.3 million. 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 months ended March 31, 2023 were 2,295,469 and 634,426, respectively and for the three months ended March 31, 2022 were 610,772 and 634,426, respectively, because their effect is anti-dilutive. |
Related Party
Related Party | 3 Months Ended |
Mar. 31, 2023 | |
Related Party | |
Related Party | 10. Related Party On December 15, 2022, the Company approved the retention of MaryAnn Shallcross, the wife of Steven Shallcross, as director of Clinical Operations, for compensation of $145,000 and the grant of an option to purchase 50,000 shares of common stock having a value of $20,000. Ms. Shallcross had been performing services for us during 2022 for total compensation of less than $120,000. |
Common and Preferred Stock
Common and Preferred Stock | 3 Months Ended |
Mar. 31, 2023 | |
Common and Preferred Stock | |
Common and Preferred Stock | 11. Common and Preferred Stock Series C and D Preferred Stock 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 “Securities Purchase Agreement”), pursuant to which the Company issued and sold 275,000 shares of the Company’s Series C Convertible Preferred Stock, par value $0.001 per share (the “Series C Preferred Stock”), and 100,000 shares of the Company’s Series D Convertible Preferred Stock, par value $0.001 per share (the “Series D Preferred Stock,” and together with the Series C Preferred Stock, the “Preferred Stock”), 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 are convertible, at a conversion price (the “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, at the option of the holders of the Preferred Stock and, in certain circumstances, by the Company. The Securities Purchase Agreement contains customary representations, warranties and agreements by the Company and customary conditions to closing. The Company included certain proposals at its 2022 annual meeting of stockholders, including to consider (i) an amendment to the Company’s Articles of Incorporation, as amended (the “Charter”), to change the name of the Company to “Theriva Biologics, Inc.” (the “Name Change”), (ii) an amendment to the Articles of Incorporation, as amended to increase the number of authorized shares of Common Stock from 20,000,000 to 350,000,000 (the “Authorized Common Stock Increase”) and (iii) any proposal to adjourn any meeting of stockholders called for the purpose of voting on the Authorized Common Stock Increase (collectively, the “Stockholder Items”). The purchaser of the Preferred Stock agreed in the Purchase Agreement to (i) not transfer, offer, sell, contract to sell, hypothecate, pledge or otherwise dispose of the shares of the Preferred Stock until the earlier of the date that the Authorized Common Stock Increase is effected or October 26, 2022 (which may be extended to December 31, 2022 if certain conditions are met), and (ii) vote the shares of the Series C Preferred Stock purchased in the Offering in favor of the Stockholder Items. Pursuant to the Securities Purchase Agreement, the Company filed certificates of designation (the “Certificates of Designation”) with the Secretary of the State of Nevada designating the rights, preferences and limitations of the shares of Series C Preferred Stock and Series D Preferred Stock. The Certificate of Designation for the Series C Preferred Stock provides, in particular, that the Series C Preferred Stock will have no voting rights other than the right to vote as a class on the Stockholder Items and the right to cast votes on an as converted to Common Stock basis on the Stockholder Items. The Certificate of Designation for the Series D Preferred Stock provides, in particular, that the Series D Preferred Stock will have no voting rights other than the right to vote as a class on the Stockholder Items and the right to cast 20,000 votes per share of Series D Preferred Stock on the Stockholder Items and to vote the shares of the Series D Preferred Stock purchased in the Offering in the same proportion as shares of Common Stock and any other shares of capital stock of the Company that are entitled to vote thereon (excluding any shares of Common Stock that are not voted) on the Stockholder Items. The holders of Preferred Stock will be entitled to dividends, on an as-if converted basis, equal to dividends actually paid, if any, on shares of Common Stock. The Conversion Price may be adjusted pursuant to the Certificates of Designation for stock dividends and stock splits, subsequent rights offering, pro rata distributions of dividends or the occurrence of a fundamental transaction (as defined in the applicable Certificate of Designation). The Series C Preferred Stock and Series D Preferred Stock is classified as temporary equity as a result of the deemed liquidation provision. Transaction expenses paid to third parties will be charged to temporary equity and will not be accreted as deemed dividends until redemption becomes probable. 11. Common and Preferred Stock – (continued) 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 Securities Purchase Agreement entered into between them on July 28, 2022 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. B. Riley Securities Sales Agreement On August 5, 2016, the Company entered into the Sales Agreement (the “Original Sales Agreement”) with FBR Capital Markets & Co. (now known as B. Riley Securities) to act as a sales agent, which agreement was amended and restated on February 9, 2021 to add Alliance Global Partners as a sale agent. The amended and restated Sales Agreement (the “Amended and Restated Sales Agreement”) enables the Company to offer and sell shares of common stock from time to time through B. Riley Securities, Inc. and A.G.P./Alliance Global Partners as the Company’s sales agent. Sales of common stock under the Sales Agreement are made in sales deemed to be “at-the-market” equity offerings as defined in Rule 415 promulgated under the Securities Act. The sales agents are 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. The Company did not sell any shares of common stock during the three months ended March 31, 2023 through the Amended and Restated Sales Agreement. |
Indebtedness
Indebtedness | 3 Months Ended |
Mar. 31, 2023 | |
Indebtedness | |
Indebtedness | 12. 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 (CDIT loans) 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 $100,000 relating to the RETOS loan, which is reflected a non-current assets on the balance sheet. March 31, 2023 March 31, 2023 December 31, 2022 December 31, 2022 Current Non-current Current Non-current NEBT Loan 8 $ 32 13 31 RETOS 2015 58 128 44 190 $ 66 $ 160 $ 57 $ 221 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 March 31, 2023 is as follows (amounts in thousands of dollars) 2023 8 2024 61 2025 64 2026 52 2027 32 2028 9 Total 226 |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2023 | |
Commitments and Contingencies | |
Commitments and Contingencies | 13. Commitments and Contingencies The Company’s existing lease as of March 31, 2023 for its U.S. location is classified as an operating lease. As of March 31, 2023, 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 The Company also leases research and office facilities in Barcelona Spain for its 100 percent owned VCN subsidiary. 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 quarter ended March 31, 2023 and 2022 approximated $144,000 and $107,000, respectively. For the Barcelona lease, the day one non-cash addition of right of use assets due to adoption of ASC 842 was $937,000. A maturity analysis of our operating leases as of March 31, 2023 is as follows (amounts in thousands of dollars) Future undiscounted cash flow for the years ending March 31, 2023 490 2024 663 2025 673 2026 589 2027 368 Total 2,783 Discount factor (544) Lease liability 2,239 Lease liability – current (437) Lease liability – long term $ 1,802 13. Commitments and Contingencies (continued) Risks and Uncertainties The uncertain financial markets, disruptions in supply chains, mobility restraints, and changing priorities as well as volatile asset values could impact our business in the future. The outbreak and government measures taken in response to the pandemic have also had a significant impact, both direct and indirect, on businesses and commerce, as worker shortages have occurred; supply chains have been disrupted; facilities and production have been suspended; and demand for certain goods and services, such as medical services and supplies, have spiked, while demand for other goods and services, such as travel, have fallen. The future progression of the pandemic and its effects on the Company’s business and operations are uncertain. The Company may face difficulties recruiting or retaining patients in its ongoing and planned clinical trials if patients are affected by the virus or are fearful of traveling to our clinical trial sites because of the outbreak. We and our third-party contract manufacturers, contract research organizations, and clinical sites may also face disruptions in procuring items that are essential to our research and development activities, including, for example, medical and laboratory supplies used in its clinical trials or preclinical studies, in each case, that are sourced from abroad or for which there are shortages because of ongoing efforts to address the outbreak. Further, although the Company have not experienced any material adverse effects on its business due to increasing inflation, it has raised operating costs for many businesses and, in the future, could impact demand or pricing manufacturing of its drug candidates or services providers, foreign exchange rates or employee wages. The Company is actively monitoring the effects these disruptions and increasing inflation could have on its operations. 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 | 3 Months Ended |
Mar. 31, 2023 | |
Subsequent Events | |
Subsequent Events | 14. Subsequent Events Effective May 10, 2023, The Company entered into a Separation Agreement and Release with Frank Tufaro (the “Separation Agreement”) and a consulting agreement with Mr. Tufaro. Mr. Tufaro had entered into an employment agreement with the Company on March 22, 2022 (the “Employment Agreement”) to serve as our Chief Operating Officer. In accordance with the terms of the Employment Agreement, the Separation Agreement provides for (i) the payment to Mr. Tufaro of a total of $196,875, paid in bi-monthly installments, less applicable withholding, for a period of six months, (ii) reimbursement of COBRA coverage for himself, his spouse and other eligible dependents for the lesser of: six months or until he commences new employment or substantial self-employment, and (iii) acceleration of the vesting of his outstanding stock options (the “Option Awards”)and (iv) the extension of the period of time for which Mr. Tufaro has the right to exercise any vested shares subject to options until the earlier of (i) the expiration date of the Option Awards, or (ii) six (6) months from the separation date. The Separation Agreement contains mutual general releases of claims and non-disparagement provisions. The Consulting Agreement has a term of six months unless sooner terminated. Either party may terminate the Consulting Agreement without cause at any time upon thirty (days’ prior written notice or with cause immediately. Mr. Tufaro will be compensated a set daily rate for each full day that he provides consulting services, pro-rated for any days services are provided less than eight hours. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2023 | |
Summary of Significant Accounting Policies | |
Long-Lived Assets | 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. No impairment charges were recorded during the three months ended March 31, 2023 and 2022. |
Recent Accounting Pronouncements and Developments | 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 (Tables)
BUSINESS COMBINATION (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
BUSINESS COMBINATION | |
Schedule of purchase consideration | Total purchase consideration including cash, common shares and contingent consideration was valued at approximately $22.8 million, as follows (in thousands): Cash paid at Closing $ 4,700 Receivable from VCN “effectively settled” 417 Fair value of common shares issued 6,599 Fair value of contingent consideration 11,093 $ 22,809 |
Schedule of allocation of fair value of assets and liabilities acquired | Estimated fair value ($in thousands) Cash and cash equivalents $ 837 Receivables 1,889 Property and equipment 216 In-process research and development intangible asset 19,742 Goodwill 5,696 Deferred tax assets (liabilities), net (3,209) Accounts payable (522) Accrued expenses (113) Accrued employee benefits (90) Loan Payable-current (67) Other long-term liabilities (1,570) Total purchase consideration $ 22,809 |
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, 2022 (in thousands): Three months Ended March 31 (in thousands) 2023 2022 Net revenues — $ — Net loss $ (4,478) $ (4,796) |
Goodwill and Intangibles (Table
Goodwill and Intangibles (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Goodwill and Intangibles | |
Schedule of Company's goodwill | Goodwill (in thousands) Balance at December 31, 2021 $ — Goodwill from Acquisition of VCN 6,757 Goodwill impairment loss — Measurement Period Adjustments (1,061) Effects of exchange rates (171) Balance at December 31, 2022 5,525 Effects of exchange rates 92 Balance at March 31, 2023 $ 5,617 |
Schedule of Company's in-process R&D | In-process R&D (in thousands) Balance at December 31, 2021 $ — Acquired IPR&D 18,932 Measurement Period Adjustments 810 Effects of exchange rates (592) Balance at December 31, 2022 19,150 Effects of exchange rates 319 Balance at March 31, 2023 $ 19,469 |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Fair Value of Financial Instruments | |
Schedule of recurring Level 3 fair value measurements of contingent consideration significant unobservable inputs | As of March 31, 2023 Description Total Level 1 Level 2 Level 3 Liabilities: Contingent consideration $ 10,319 — — $ 10,319 As of December 31, 2022 Description Total Level 1 Level 2 Level 3 Liabilities: Contingent consideration $ 10,184 — — $ 10,184 As of March 31, 2023 Valuation Significant Weighted Average Methodology Unobservable Input (range, if applicable) Contingent Consideration Discounted Cash Flows Milestone dates 2023-2028 Discount rate 13.9% to 15.1% Weighted Average Discount rate 14.04% Probability of Occurrence (periodic for each Milestone) 11.7% to 95.0% Probability of occurrence (cumulative through each Milestone) 6.9% to 95.0% As of December 31, 2022 Valuation Significant Weighted Average Methodology Unobservable Input (range, if applicable) Contingent Consideration Discounted Cash Flows Milestone dates 2023-2028 Discount rate 13.4% to 14.1% Weighted Average Discount rate 13.6% Probability of Occurrence (periodic for each Milestone) 11.7% to 95.0% Probability of occurrence (cumulative through each Milestone) 6.9% to 95.0% |
Selected Balance Sheet Inform_2
Selected Balance Sheet Information (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Selected Balance Sheet Information | |
Schedule of prepaid expenses and other current assets | Prepaid expenses and other current assets (in thousands) March 31, December 31, 2023 2022 Prepaid clinical research organizations $ 2,474 $ 2,293 Prepaid manufacturing expenses 879 418 Prepaid insurance 440 637 Receivable from prior owner 229 144 Prepaid consulting, subscriptions and other expenses 197 155 VAT receivable 4 87 Total $ 4,223 $ 3,734 |
Schedule of property, plant and equipment, net | Property and equipment, net (in thousands) March 31, December 31, 2023 2022 Computers and office equipment $ 905 $ 897 Other Property, Plant and Equipment 210 208 Leasehold improvements 94 94 Software 12 11 1,221 1,210 Less: accumulated depreciation and amortization (897) (865) Total $ 324 $ 345 |
Schedule of accrued expenses | Accrued expenses (in thousands) March 31, December 31, 2023 2022 Accrued manufacturing costs $ 863 $ 197 Accrued clinical consulting services 838 807 Accrued vendor payments 375 492 Total $ 2,076 $ 1,496 |
Schedule of accrued employee benefits | Accrued employee benefits (in thousands) March 31, December 31, 2023 2022 Accrued bonus expense $ 325 $ 1,216 Accrued vacation expense 142 100 Accrued compensation expense 182 87 Total $ 649 $ 1,403 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Stock-Based Compensation and Warrants | |
Summary of stock option activity | A summary of stock option activity for the three months ended March 31, 2023 and the year ended December 31, 2022 is as follows: Weighted Weighted Average Aggregate Average Exercise Remaining Intrinsic Options Price Contractual Life Value Balance - December 31, 2021 625,565 $ 16.12 5.58 years $ — Granted 1,728,000 0.58 Exercised — — Expired (43,126) 67.81 Forfeited (14,541) 3.61 Balance - December 31, 2022 2,295,898 3.53 6.44 years — Granted — — Exercised — — Expired (429) 404.83 Forfeited — — Balance - March 31, 2023 - outstanding 2,295,469 $ 3.46 6.19 years $ 172,500 Balance - March 31, 2023 - exercisable 636,009 $ 10.43 5.06 years $ 18,542 Grant date fair value of options granted – three months ended March 31, 2023 $ — Weighted average grant date fair value – three months ended March 31, 2023 $ — Grant date fair value of options granted – year ended December 31, 2022 $ 706,264 Weighted average grant date fair value – year ended December 31, 2022 $ 0.41 |
Stock Warrants (Tables)
Stock Warrants (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Stock Warrants | |
Summary of all warrant activity | A summary of all warrant activity for the Company for the quarter ended March 31, 2023 and the year ended December 31, 2022 is as follows: Weighted Average Number of Weighted Average Remaining Warrants Exercise Price Contractual Life Balance at December 31, 2021 634,497 1.24 1.78 years Granted — — Exercised — — Forfeited (71) 182 Balance at December 31, 2022 634,426 $ 1.22 0.78 years Granted — — Exercised — — Forfeited — — Balance at March 31, 2023 634,426 $ 1.22 0.53 years |
Indebtedness (Tables)
Indebtedness (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Indebtedness | |
Schedule of debt | March 31, 2023 March 31, 2023 December 31, 2022 December 31, 2022 Current Non-current Current Non-current NEBT Loan 8 $ 32 13 31 RETOS 2015 58 128 44 190 $ 66 $ 160 $ 57 $ 221 |
Schedule of maturity analysis of debt | A maturity analysis of the debt as of March 31, 2023 is as follows (amounts in thousands of dollars) 2023 8 2024 61 2025 64 2026 52 2027 32 2028 9 Total 226 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Commitments and Contingencies | |
Schedule of maturity analysis of operating leases | A maturity analysis of our operating leases as of March 31, 2023 is as follows (amounts in thousands of dollars) Future undiscounted cash flow for the years ending March 31, 2023 490 2024 663 2025 673 2026 589 2027 368 Total 2,783 Discount factor (544) Lease liability 2,239 Lease liability – current (437) Lease liability – long term $ 1,802 |
Organization and Nature of Op_2
Organization and Nature of Operations and Basis of Presentation - (Details) | 3 Months Ended |
Mar. 31, 2023 segment Asset | |
Organization and Nature of Operations and Basis of Presentation | |
Number of operating segments | 1 |
Number of reportable segments | 1 |
Intangible assets acquired | Asset | 2 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Summary of Significant Accounting Policies | ||
Impairment charges | $ 0 | $ 0 |
BUSINESS COMBINATION (Details)
BUSINESS COMBINATION (Details) - USD ($) | 3 Months Ended | |||||
Mar. 10, 2022 | Mar. 31, 2023 | Dec. 31, 2022 | Mar. 31, 2022 | Aug. 03, 2022 | Jul. 29, 2022 | |
BUSINESS COMBINATION | ||||||
Common stock, shares issued | 15,844,294 | 15,844,294 | 2,459,016 | |||
Common stock, price per share | $ 0.001 | $ 0.001 | $ 0.001 | |||
V C N | ||||||
BUSINESS COMBINATION | ||||||
Common stock, shares issued | 2,639,530 | |||||
Existing liabilities | $ 2,390,000 | |||||
Cash payments | 70,200,000 | |||||
Amount to be paid due to approval | $ 3,000,000 | |||||
Finance costs | 417,000 | |||||
Contingent consideration | $ 11,093,000 | $ 10,300,000 | $ 10,100,000 | |||
Operating expense of fair value increase to contingent consideration | $ 135,000 | $ 0 | ||||
Common stock, price per share | $ 0.001 | |||||
V C N | General and administrative expenses | ||||||
BUSINESS COMBINATION | ||||||
Contingent consideration | $ 27,800,000 | |||||
V C N | Grifols Innovation | ||||||
BUSINESS COMBINATION | ||||||
Consideration purchase paid | $ 4,700,000 | |||||
V C N | New technologies | ||||||
BUSINESS COMBINATION | ||||||
Business acquisition, percentage of voting interests acquired | 86% |
BUSINESS COMBINATION - Tabular
BUSINESS COMBINATION - Tabular disclosure of Purchase consideration (Details) - V C N - USD ($) $ in Thousands | Mar. 10, 2022 | Mar. 31, 2023 | Dec. 31, 2022 |
BUSINESS COMBINATION | |||
Cash paid at closing | $ 4,700 | ||
Receivable from VCN "effectively settled" | 417 | ||
Fair value of common shares issued | 6,599 | ||
Fair value of contingent consideration | 11,093 | $ 10,300 | $ 10,100 |
Purchase consideration | $ 22,809 |
BUSINESS COMBINATION - Schedule
BUSINESS COMBINATION - Schedule of allocation of fair value of assets and liabilities acquired (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |||
Mar. 31, 2023 | Dec. 31, 2022 | Mar. 10, 2023 | Mar. 10, 2022 | Dec. 31, 2021 | |
BUSINESS COMBINATION | |||||
Goodwill | $ 5,617,000 | $ 5,525,000 | $ 0 | ||
V C N | |||||
BUSINESS COMBINATION | |||||
Cash and cash equivalents | $ 837,000 | ||||
Receivables | 1,889,000 | ||||
Property and equipment | 216,000 | ||||
In-process research and development intangible asset | 19,742,000 | ||||
Goodwill | 5,696,000 | ||||
Deferred tax assets (liabilities), net | (3,209,000) | ||||
Accounts payable | (522,000) | ||||
Accrued expenses | (113,000) | ||||
Accrued employee benefits | (90,000) | ||||
Loan Payable-current | (67,000) | ||||
Other long-term liabilities | (1,570,000) | ||||
Total purchase consideration | $ 22,809,000 | ||||
Indefinite-lived in-process research and development intangible asset | $ 19,700,000 | ||||
Net loss of V C N Operations | $ 7,800,000 | ||||
Measurement period adjustment related to the estimate of acquired liabilities | 277,000 | ||||
increase in other receivables | 176,000 | ||||
In-process R&D measurement period adjustment | 810,000 | ||||
In-process R&D deferred tax liabilities | 202,000 | ||||
In-process R&D decrease in goodwill | 607,000 | ||||
Cumulative impact of decrease in goodwill | $ 1,061,000 |
BUSINESS COMBINATION - Schedu_2
BUSINESS COMBINATION - Schedule of Pro Forma Consolidated Financial Information (Details) - V C N - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
BUSINESS COMBINATION | ||
Net revenues | $ 0 | $ 0 |
Net loss | $ (4,478) | $ (4,796) |
BUSINESS COMBINATION - Transact
BUSINESS COMBINATION - Transaction Costs (Details) - V C N - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
BUSINESS COMBINATION | ||
Acquisition Cost | $ 0 | |
General and administrative expenses | ||
BUSINESS COMBINATION | ||
Transaction costs on acquisition | $ 200 |
Goodwill and Intangibles - Good
Goodwill and Intangibles - Goodwill (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2023 | Dec. 31, 2022 | |
Goodwill | ||
Balance at the beginning | $ 5,525 | $ 0 |
Goodwill from Acquisition of VCN | 6,757 | |
Measurement Period Adjustment | (1,061) | |
Effects of exchange rates | 92 | (171) |
Balance at the end | $ 5,617 | $ 5,525 |
Goodwill and Intangibles - In-p
Goodwill and Intangibles - In-process R&D (Details) - In-process R&D - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2023 | Dec. 31, 2022 | |
Finite-Lived Intangible Assets | ||
Balance at the beginning | $ 19,150 | $ 0 |
Acquired IPR&D - | 18,932 | |
Measurement Period Adjustments | 810 | |
Effects of exchange rates | 319 | (592) |
Balance at the end | $ 19,469 | $ 19,150 |
Fair Value of Financial Instr_3
Fair Value of Financial Instruments - Fair value of financial instruments measured on a recurring basis (Details) - Contingent consideration - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Fair Value of Financial Instruments | ||
Fair value of contingent consideration | $ 10,319 | $ 10,184 |
Level 3 | ||
Fair Value of Financial Instruments | ||
Fair value of contingent consideration | $ 10,319 | $ 10,184 |
Fair Value of Financial Instr_4
Fair Value of Financial Instruments - Contingent Consideration (Details) - Level 3 - Contingent consideration | Mar. 31, 2023 | Dec. 31, 2022 |
Discount rate | Minimum | ||
Fair Value of Financial Instruments | ||
Contingent consideration, measurement Input | 13.9 | 13.4 |
Discount rate | Maximum | ||
Fair Value of Financial Instruments | ||
Contingent consideration, measurement Input | 15.1 | 14.1 |
Weighted Average Discount rate | ||
Fair Value of Financial Instruments | ||
Contingent consideration, measurement Input | 14.04 | 13.6 |
Probability of occurrence | Minimum | ||
Fair Value of Financial Instruments | ||
Contingent consideration, measurement Input | 11.7 | 11.7 |
Probability of occurrence | Maximum | ||
Fair Value of Financial Instruments | ||
Contingent consideration, measurement Input | 95 | 95 |
Probability of occurrence (cumulative through each Milestone) | Minimum | ||
Fair Value of Financial Instruments | ||
Contingent consideration, measurement Input | 6.9 | 6.9 |
Probability of occurrence (cumulative through each Milestone) | Maximum | ||
Fair Value of Financial Instruments | ||
Contingent consideration, measurement Input | 95 | 95 |
Fair Value of Financial Instr_5
Fair Value of Financial Instruments (Details) - USD ($) | 3 Months Ended | ||
Mar. 31, 2023 | Dec. 31, 2022 | Mar. 31, 2022 | |
Fair Value Measurement Inputs and Valuation Techniques | |||
Non-current contingent consideration | $ 5,408,000 | $ 7,211,000 | |
Operating expense relating to fair value adjustment | 135,000 | $ 0 | |
V C N | |||
Fair Value Measurement Inputs and Valuation Techniques | |||
Additional consideration related to the achievement of certain milestones | 70,200,000 | ||
Amount to be paid due to approval | $ 3,000,000 | ||
Fair value of contingent consideration | 10,300,000 | ||
Accrued contingent consideration | 4,900,000 | ||
Non-current contingent consideration | $ 5,400,000 |
Selected Balance Sheet Inform_3
Selected Balance Sheet Information - Schedule of Prepaid expenses and other current assets (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Selected Balance Sheet Information | ||
Prepaid clinical research organizations | $ 2,474 | $ 2,293 |
Prepaid manufacturing expenses | 879 | 418 |
Prepaid insurance | 440 | 637 |
Receivable from prior owner | 229 | 144 |
Prepaid consulting, subscriptions and other expenses | 197 | 155 |
VAT receivable | 4 | 87 |
Total | $ 4,223 | $ 3,734 |
Selected Balance Sheet Inform_4
Selected Balance Sheet Information - Schedule of Property and equipment, net (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Selected Balance Sheet Information | ||
Property, Plant and Equipment, Gross Total | $ 1,221 | $ 1,210 |
Less: accumulated depreciation and amortization | (897) | (865) |
Total | 324 | 345 |
Computers and office equipment | ||
Selected Balance Sheet Information | ||
Property, Plant and Equipment, Gross Total | 905 | 897 |
Other Property, Plant and Equipment | ||
Selected Balance Sheet Information | ||
Property, Plant and Equipment, Gross Total | 210 | 208 |
Leasehold improvements | ||
Selected Balance Sheet Information | ||
Property, Plant and Equipment, Gross Total | 94 | 94 |
Software | ||
Selected Balance Sheet Information | ||
Property, Plant and Equipment, Gross Total | $ 12 | $ 11 |
Selected Balance Sheet Inform_5
Selected Balance Sheet Information - Schedule of Accrued expenses (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Selected Balance Sheet Information | ||
Accrued manufacturing costs | $ 863 | $ 197 |
Accrued clinical consulting services | 838 | 807 |
Accrued vendor payments | 375 | 492 |
Total | $ 2,076 | $ 1,496 |
Selected Balance Sheet Inform_6
Selected Balance Sheet Information - Schedule of Accrued employee benefits (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Selected Balance Sheet Information | ||
Accrued bonus expense | $ 325 | $ 1,216 |
Accrued vacation expense | 142 | 100 |
Accrued compensation expense | 182 | 87 |
Total | $ 649 | $ 1,403 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock incentive plan and other information (Details) - USD ($) | 3 Months Ended | |||||
Sep. 05, 2019 | Nov. 02, 2010 | Mar. 31, 2023 | Mar. 31, 2022 | Sep. 17, 2020 | Mar. 20, 2007 | |
Stock-Based Compensation and Warrants | ||||||
Share-based payment award, options, grants in period, gross | 0 | 0 | ||||
Unrecognized stock-based compensation expense | $ 841,000 | |||||
Stock issued for exercise of stock options (in shares) | 0 | |||||
General and administrative expenses | Employees | ||||||
Stock-Based Compensation and Warrants | ||||||
Allocated share-based compensation expense | 83,000 | $ 59,000 | ||||
Research and Development Expenses | Employees | ||||||
Stock-Based Compensation and Warrants | ||||||
Allocated share-based compensation expense | $ 43,000 | $ 53,000 | ||||
2007 Stock Plan | ||||||
Stock-Based Compensation and Warrants | ||||||
Share-based payment award, options, outstanding, number | 372 | 7,143 | ||||
Share-based payment award, options, issued, number | $ 372 | |||||
2010 Stock Plan | ||||||
Stock-Based Compensation and Warrants | ||||||
Share-based payment award, options, outstanding, number | 8,572 | |||||
Share-based compensation arrangement by share-based payment award, number of shares authorized | 400,000 | |||||
Share-based compensation arrangement by share-based payment award, shares issued | 0 | 0 | ||||
2010 Stock Plan | Board of Directors | ||||||
Stock-Based Compensation and Warrants | ||||||
Share-based payment award, options, outstanding, number | 202,095 | |||||
Share-based payment award, options, issued, number | $ 202,095 | |||||
2010 Stock Plan | Minimum | ||||||
Stock-Based Compensation and Warrants | ||||||
Share-based payment award, options, grants, expired period | 5 years | |||||
2010 Stock Plan | Maximum | ||||||
Stock-Based Compensation and Warrants | ||||||
Share-based payment award, options, grants, expired period | 10 years | |||||
2020 Stock Plan | ||||||
Stock-Based Compensation and Warrants | ||||||
Share-based payment award, options, outstanding, number | 2,093,002 | 400,000 | ||||
Share-based compensation arrangement by share-based payment award, number of shares authorized | 7,000,000 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of stock option activity (Details) - USD ($) | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Stock-Based Compensation and Warrants | ||||
Options granted (in shares) | 0 | 0 | ||
Options, Exercised | 0 | |||
Weighted Average Remaining Contractual Life, Outstanding | 6 months 10 days | 9 months 10 days | 1 year 9 months 10 days | |
Stock Option | ||||
Stock-Based Compensation and Warrants | ||||
Options, Beginning balance | 2,295,898 | 625,565 | 625,565 | |
Options granted (in shares) | 1,728,000 | |||
Options, Expired | (429) | (43,126) | ||
Options, Forfeited | (14,541) | |||
Options, Ending balance | 2,295,469 | 2,295,898 | 625,565 | |
Options, Exercisable | 636,009 | |||
Weighted Average Exercise Price, Beginning balance | $ 3.53 | $ 16.12 | $ 16.12 | |
Weighted Average Exercise Price, Granted | 0.58 | |||
Weighted Average Exercise Price, Expired | 404.83 | 67.81 | ||
Weighted Average Exercise Price, Forfeited | 3.61 | |||
Weighted Average Exercise Price, Ending balance | 3.46 | $ 3.53 | $ 16.12 | |
Weighted Average Exercise Price, Exercisable | $ 10.43 | |||
Weighted Average Remaining Contractual Life, Outstanding | 6 years 2 months 8 days | 6 years 5 months 8 days | 5 years 6 months 29 days | |
Weighted Average Remaining Contractual Life, Exercisable | 5 years 21 days | |||
Aggregate Intrinsic Value, Ending Balance | $ 172,500 | |||
Aggregate Intrinsic Value, Exercisable | $ 18,542 | |||
Grant date fair value of options granted | $ 706,264 | |||
Weighted average grant date fair value | $ 0.41 |
Stock Warrants (Details)
Stock Warrants (Details) - USD ($) | 3 Months Ended | 12 Months Ended | ||||||
Aug. 03, 2022 | Nov. 16, 2020 | Oct. 15, 2018 | Mar. 31, 2023 | Mar. 31, 2021 | Dec. 31, 2022 | Dec. 31, 2020 | Jan. 24, 2018 | |
Stock Warrants | ||||||||
Gross proceeds | $ 18,600,000 | |||||||
Exercise price per warrant | $ 13.80 | |||||||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 | |||||
Deemed dividend | $ 340,000 | $ 900,000 | ||||||
Over allotment option period | 45 days | |||||||
Warrants exercised | 0 | 1,165,575 | 0 | |||||
Cash proceeds from exercise of warrants | $ 8,000,000 | |||||||
Warrants exercisable for shares | 714 | |||||||
Fair value of the warrant | $ 9,000 | |||||||
Preferred stock of convertible conversion price decrease | 1.22 | |||||||
Class A common stock | ||||||||
Stock Warrants | ||||||||
Number of shares issued | 252,000 | |||||||
Warrant term | 5 years | |||||||
Number of warrants to purchase shares | 252,000 | |||||||
Exercise price per warrant | $ 13.80 | |||||||
Series B Preferred Stock | ||||||||
Stock Warrants | ||||||||
Number of shares issued | 15,723 | |||||||
Number of warrants to purchase shares | 1,367,218 | |||||||
Preferred stock, par or stated value per share | $ 1,000 | |||||||
Preferred stock conversion price per share | $ 11.50 | |||||||
Conversion of stock, shares converted | 1,367,218 | |||||||
October 2018 Warrants | ||||||||
Stock Warrants | ||||||||
Exercise price per warrant | $ 6.90 | |||||||
Over-allotment option | ||||||||
Stock Warrants | ||||||||
Number of shares issued | 242,883 | |||||||
Number of warrants to purchase shares | 242,883 | |||||||
Issue of warrants to purchase common stock | 180,783 | |||||||
Warrant | ||||||||
Stock Warrants | ||||||||
Exercise price per warrant | $ 6.90 | $ 6.90 | ||||||
Warrant | Class A common stock | ||||||||
Stock Warrants | ||||||||
Exercise price per warrant | $ 1.22 |
Stock Warrants - summary of all
Stock Warrants - summary of all warrant activity (Details) - $ / shares | 3 Months Ended | 12 Months Ended |
Mar. 31, 2023 | Dec. 31, 2022 | |
Stock Warrants | ||
Number of Warrants, Beginning balance | 634,426 | 634,497 |
Number of Warrants, Granted | 0 | 0 |
Number of Warrants, Exercised | 0 | 0 |
Number of Warrants, Forfeited | 0 | (71) |
Number of Warrants, Ending balance | 634,426 | 634,426 |
Weighted Average Exercise Price, Beginning balance | $ 1.22 | $ 1.24 |
Weighted Average Exercise Price, Granted | 0 | 0 |
Weighted Average Exercise Price, Exercised | 0 | 0 |
Weighted Average Exercise Price, Forfeited | 0 | 182 |
Weighted Average Exercise Price, Ending balance | $ 1.22 | $ 1.22 |
Net Loss per Share (Details)
Net Loss per Share (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Net Loss per Share | ||
Net loss attributable to common stockholders | $ (4,478) | $ (4,273) |
Equity Option | ||
Net Loss per Share | ||
Number of options and warrants for the purchase of common stock that were excluded from the computations of net loss per common share | 2,295,469 | 610,772 |
Warrant | ||
Net Loss per Share | ||
Number of options and warrants for the purchase of common stock that were excluded from the computations of net loss per common share | 634,426 | 634,426 |
Related Party (Details)
Related Party (Details) - USD ($) | 3 Months Ended | 12 Months Ended | ||
Dec. 15, 2022 | Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Related Party | ||||
Options granted (in shares) | 0 | 0 | ||
Ms. Shallcross | ||||
Related Party | ||||
Compensation | $ 145,000 | |||
Options granted (in shares) | 50,000 | |||
Value of options granted | $ 20,000 | |||
Ms. Shallcross | Maximum | ||||
Related Party | ||||
Compensation | $ 120,000 |
Common and Preferred Stock (Det
Common and Preferred Stock (Details) $ / shares in Units, $ in Millions | Jul. 29, 2022 USD ($) $ / shares shares | Jul. 28, 2022 Vote | Mar. 31, 2023 $ / shares shares | Dec. 31, 2022 $ / shares shares | Aug. 03, 2022 $ / shares | Aug. 05, 2016 |
Common and Preferred Stock | ||||||
Offering price | $ / shares | $ 8 | |||||
Gross proceeds | $ | $ 3 | |||||
Conversion price | $ / shares | $ 1.22 | |||||
Common stock, shares issued | 2,459,016 | 15,844,294 | 15,844,294 | |||
Common stock, par value (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 | $ 0.001 | |||
Common stock, shares authorized | 350,000,000 | 350,000,000 | ||||
Votes per share | 20,000 | |||||
Votes relating to preferred stock | Vote | 1,549,295 | |||||
FBR Capital Markets Co | ||||||
Common and Preferred Stock | ||||||
Brokerage commission percentage | 3% | |||||
Amendment 2022 | ||||||
Common and Preferred Stock | ||||||
Common stock, shares authorized | 350,000,000 | 20,000,000 | ||||
Series C convertible preferred stock | ||||||
Common and Preferred Stock | ||||||
Convertible preferred stock, shares issued | 275,000 | 275,000 | 275,000 | |||
Convertible preferred stock, par value (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 | $ 0.001 | |||
Series D convertible preferred stock | ||||||
Common and Preferred Stock | ||||||
Convertible preferred stock, shares issued | 100,000 | 100,000 | 100,000 | |||
Convertible preferred stock, par value (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 | $ 0.001 |
Indebtedness (Details)
Indebtedness (Details) - USD ($) | Mar. 31, 2023 | Mar. 31, 2022 |
Indebtedness | ||
Restricted cash included in other long-term assets | $ 100,000 | $ 103,000 |
Minimum | ||
Indebtedness | ||
Loans acquired, Interest rate | 0% | |
Maximum | ||
Indebtedness | ||
Loans acquired, Interest rate | 1% |
Indebtedness - Debt (Details)
Indebtedness - Debt (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Indebtedness | ||
Debt, Current | $ 66 | $ 57 |
Debt, Non current | 160 | 221 |
NEBT Loan | ||
Indebtedness | ||
Debt, Current | 8 | 13 |
Debt, Non current | 32 | 31 |
RETOS 2015 Loan | ||
Indebtedness | ||
Debt, Current | 58 | 44 |
Debt, Non current | $ 128 | $ 190 |
Indebtedness - Maturity analysi
Indebtedness - Maturity analysis of debt (Details) $ in Thousands | Mar. 31, 2023 USD ($) |
Indebtedness | |
2023 | $ 8 |
2024 | 61 |
2025 | 64 |
2026 | 52 |
2027 | 32 |
2028 | 9 |
Total | $ 226 |
Commitments and Contingencies -
Commitments and Contingencies - Maturity analysis of operating leases (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Commitments and Contingencies | ||
2023 | $ 490 | |
2024 | 663 | |
2025 | 673 | |
2026 | 589 | |
2027 | 368 | |
Total | 2,783 | |
Discount factor | (544) | |
Lease liability | 2,239 | |
Lease liability - current | (437) | $ (216) |
Lease liability - Long term | $ 1,802 | $ 1,187 |
Commitments and Contingencies_2
Commitments and Contingencies - Additional Information (Details) | 3 Months Ended | ||
Jan. 01, 2019 USD ($) | Mar. 31, 2023 USD ($) item | Mar. 31, 2022 USD ($) | |
Commitments And Contingencies Disclosure [Line Items] | |||
Number of operating leases for facilities | item | 2 | ||
Renewed lease term | 63 months | ||
Lease rent abatement period | 3 months | ||
Rate of interest of funds borrowed by company | 8.5 | ||
Percentage of office leases owned by subsidiary | 100% | ||
Termination notice period (in days) | 90 days | ||
Additional lease renewal term | 5 years | ||
Operating lease cost | $ 144,000 | $ 107,000 | |
Right of use assets exchanged for operating lease obligation | $ 937,000 | $ 0 | |
ASU 2016-02 | |||
Commitments And Contingencies Disclosure [Line Items] | |||
Right of use assets exchanged for operating lease obligation | $ 937,000 |
Subsequent Events (Details)
Subsequent Events (Details) | May 10, 2023 USD ($) |
Mr. Tufaro | |
Subsequent Events | |
Consideration purchase paid | $ 196,875 |