Document And Entity Information
Document And Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Mar. 10, 2023 | Jun. 30, 2022 | |
Document Information [Line Items] | |||
Entity Central Index Key | 0001513818 | ||
Entity Registrant Name | Aravive, Inc. | ||
Amendment Flag | false | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2022 | ||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2022 | ||
Document Transition Report | false | ||
Entity File Number | 001-36361 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 26-4106690 | ||
Entity Address, Address Line One | 3730 Kirby Drive, Suite 1200 | ||
Entity Address, City or Town | Houston | ||
Entity Address, State or Province | TX | ||
Entity Address, Postal Zip Code | 77098 | ||
City Area Code | 936 | ||
Local Phone Number | 355-1910 | ||
Title of 12(b) Security | Common stock, par value $0.0001 per share | ||
Trading Symbol | ARAV | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
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 | ||
ICFR Auditor Attestation Flag | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 19,068,322 | ||
Entity Common Stock, Shares Outstanding | 59,844,850 | ||
Auditor Firm ID | 243 | ||
Auditor Name | BDO USA, LLP | ||
Auditor Location | Raleigh, North Carolina |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Current Assets | ||
Cash and cash equivalents | $ 53,689 | $ 59,424 |
Prepaid expenses and other current assets | 4,281 | 3,321 |
Total current assets | 57,970 | 62,745 |
Restricted cash | 2,445 | 2,431 |
Property and equipment, net | 270 | 400 |
Operating lease right-of-use assets | 1,462 | 2,207 |
Other assets | 6 | 4 |
Total assets | 62,153 | 67,787 |
Current liabilities | ||
Accounts payable | 8,765 | 2,657 |
Accrued liabilities | 6,738 | 8,416 |
Operating lease obligation, current portion | 2,195 | 2,297 |
Current portion of deferred revenue | 4,414 | 4,571 |
Total current liabilities | 22,112 | 17,941 |
Deferred revenue, net of current portion | 621 | 3,548 |
Operating lease obligation, net of current portion | 1,882 | 4,076 |
Warrant liability | 26,881 | 0 |
Total liabilities | 51,496 | 25,565 |
Commitments and contingencies (Note 7) | ||
Stockholders' equity | ||
Common stock, $0.0001 par value, 100,000,000 shares authorized at December 31, 2022 and December 31, 2021; 59,844,850 and 21,039,594 shares issued and outstanding at December 31, 2022 and December 31, 2021, respectively | 6 | 2 |
Additional paid-in capital | 626,778 | 582,025 |
Accumulated deficit | (616,127) | (539,805) |
Total stockholders' equity | 10,657 | 42,222 |
Total liabilities and stockholders’ equity | $ 62,153 | $ 67,787 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 100,000,000 | 100,000,000 |
Common stock, shares issued (in shares) | 59,844,850 | 21,039,594 |
Common stock, shares outstanding (in shares) | 59,844,850 | 21,039,594 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Revenue | ||
Total revenue | $ 9,137 | $ 7,442 |
Operating expenses | ||
Research and development | 66,938 | 37,541 |
General and administrative | 13,036 | 10,550 |
Total operating expenses | 79,974 | 48,091 |
Loss from operations | (70,837) | (40,649) |
Other income (expense), net: | ||
Interest income | 653 | 37 |
Change in fair value of warrant liability | (8,981) | 0 |
Other income, net | 2,843 | 1,461 |
Total other income (expense), net | (5,485) | 1,498 |
Net loss | $ (76,322) | $ (39,151) |
Net loss per share - basic and diluted (in dollars per share) | $ (2.10) | $ (1.95) |
Weighted-average common shares used to compute basic and diluted net loss per share (in shares) | 36,372 | 20,070 |
Collaborative Arrangement [Member] | ||
Revenue | ||
Total revenue | $ 9,137 | $ 7,442 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Direct Offering [Member] Common Stock [Member] | Direct Offering [Member] Additional Paid-in Capital [Member] | Direct Offering [Member] Retained Earnings [Member] | Direct Offering [Member] | At-the-market Offering [Member] Common Stock [Member] | At-the-market Offering [Member] Additional Paid-in Capital [Member] | At-the-market Offering [Member] Retained Earnings [Member] | At-the-market Offering [Member] | Registered Direct Offering [Member] Common Stock [Member] | Registered Direct Offering [Member] Additional Paid-in Capital [Member] | Registered Direct Offering [Member] Retained Earnings [Member] | Registered Direct Offering [Member] | Private Placement [Member] Common Stock [Member] | Private Placement [Member] Additional Paid-in Capital [Member] | Private Placement [Member] Retained Earnings [Member] | Private Placement [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Total |
Balance (in shares) at Dec. 31, 2020 | 16,481,099 | |||||||||||||||||||
Balance at Dec. 31, 2020 | $ 2 | $ 548,707 | $ (500,654) | $ 48,055 | ||||||||||||||||
Issuance of common stock upon exercise of options (in shares) | 219,109 | |||||||||||||||||||
Issuance of common stock upon exercise of options | $ 0 | 308 | 0 | 308 | ||||||||||||||||
Issuance of common stock under employee benefit plans (in shares) | 31,759 | |||||||||||||||||||
Issuance of common stock under employee benefit plans | $ 0 | 120 | 0 | 120 | ||||||||||||||||
Issuance of common stock, net (in shares) | 2,875,000 | 1,432,627 | ||||||||||||||||||
Issuance of common stock, net | $ 0 | $ 20,866 | $ 0 | $ 20,866 | $ 0 | $ 9,767 | $ 0 | $ 9,767 | ||||||||||||
Stock-based compensation | 0 | 2,257 | 0 | 2,257 | ||||||||||||||||
Net loss | $ 0 | 0 | (39,151) | (39,151) | ||||||||||||||||
Balance (in shares) at Dec. 31, 2021 | 21,039,594 | |||||||||||||||||||
Balance at Dec. 31, 2021 | $ 2 | 582,025 | (539,805) | $ 42,222 | ||||||||||||||||
Issuance of common stock upon exercise of options (in shares) | 0 | |||||||||||||||||||
Issuance of common stock under employee benefit plans (in shares) | 46,185 | |||||||||||||||||||
Issuance of common stock under employee benefit plans | $ 0 | 43 | 0 | $ 43 | ||||||||||||||||
Issuance of common stock, net (in shares) | 54,763 | 3,185,216 | 29,308,612 | |||||||||||||||||
Issuance of common stock, net | $ 0 | $ 123 | $ 0 | $ 123 | $ 0 | $ 9,291 | $ 0 | $ 9,291 | $ 3 | $ 24,144 | $ 0 | $ 24,147 | ||||||||
Stock-based compensation | 0 | 2,560 | 0 | 2,560 | ||||||||||||||||
Net loss | $ 0 | 0 | (76,322) | (76,322) | ||||||||||||||||
Issuance of common stock upon exercise of pre-funded warrants (in shares) | 6,210,480 | |||||||||||||||||||
Issuance of common stock upon exercise of pre-funded warrants | $ 1 | 8,592 | 0 | 8,593 | ||||||||||||||||
Balance (in shares) at Dec. 31, 2022 | 59,844,850 | |||||||||||||||||||
Balance at Dec. 31, 2022 | $ 6 | $ 626,778 | $ (616,127) | $ 10,657 |
Consolidated Statements of St_2
Consolidated Statements of Stockholders' Equity (Parentheticals) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Direct Offering [Member] | ||
Stock issuance costs | $ 98 | |
Stock issuance costs | 98 | |
At-the-market Offering [Member] | ||
Stock issuance costs | $ 3 | 250 |
Stock issuance costs | 3 | $ 250 |
Registered Direct Offering [Member] | ||
Stock issuance costs | 706 | |
Stock issuance costs | 706 | |
Private Placement [Member] | ||
Stock issuance costs | 921 | |
Stock issuance costs | $ 921 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Cash flows from operating activities | ||
Net loss | $ (76,322) | $ (39,151) |
Adjustments to reconcile net loss to net cash used in operating activities | ||
Depreciation and amortization | 886 | 974 |
Stock-based compensation expense | 2,560 | 2,257 |
Warrant issuance costs | 728 | |
Warrant liability fair value adjustment | 8,981 | 0 |
Changes in assets and liabilities | ||
Prepaid expenses and other assets | (962) | (2,167) |
Accounts payable | 6,108 | 157 |
Deferred revenue | (3,084) | 1,804 |
Accrued and other liabilities | (3,974) | 3,949 |
Net cash used in operating activities | (65,079) | (32,177) |
Cash flows from investing activities | ||
Purchase of property and equipment | (11) | 0 |
Net cash used in investing activities | (11) | 0 |
Cash flows from financing activities | ||
Proceeds from issuance of common stock in connection with employee benefit plans | 43 | 120 |
Proceeds from issuance of common stock in connection with exercise of options | 0 | 308 |
Net cash provided by financing activities | 59,369 | 31,061 |
Net change in cash, cash equivalents, and restricted cash | (5,721) | (1,116) |
Cash, cash equivalents, and restricted cash at beginning of period | 61,855 | 62,971 |
Cash, cash equivalents, and restricted cash at end of period | 56,134 | 61,855 |
Supplemental disclosure of noncash items | ||
Reclass to additional paid-in-capital upon exercise | 8,590 | 0 |
Direct Offering [Member] | ||
Cash flows from financing activities | ||
Proceeds from issuance of common stock and common stock warrants, net of issuance costs | 19,171 | 20,866 |
Private Placement [Member] | ||
Cash flows from financing activities | ||
Proceeds from issuance of common stock and common stock warrants, net of issuance costs | 40,032 | 0 |
At-the-market Offering [Member] | ||
Cash flows from financing activities | ||
Proceeds from issuance of common stock in at the market offering | $ 123 | $ 9,767 |
Note 1 - Formation and Business
Note 1 - Formation and Business of the Company | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Organization, Consolidation and Presentation of Financial Statements Disclosure [Text Block] | 1. Aravive, Inc. (“Aravive” or the “Company”) was incorporated on December 10, 2008 2007. Batiraxcept (formerly AVB- 500 GAS6 GAS6, In July 2016, June 1, 2016 November 30, 2019. three Aravive Biologics’ award from CPRIT requires it to pay CPRIT a portion of its revenues from sales of certain products, or received from its licensees or sublicensees, at tiered percentages of revenue in the low- to mid-single digits until the aggregate amount of such payments equals 400% of the grant award proceeds, and thereafter at a rate of less than one In April 2020, CCN2, AXL/GAS6 August 2022, In November 2020, 3D "3D 3D 3D second 2021, 3D first 3D first 3 In August 2021, 3D 3D 3 In October 2022, 3D 3 As consideration for the rights granted as part of a license agreement that Aravive Biologics entered into in 2012 third |
Note 2 - Summary of Significant
Note 2 - Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Significant Accounting Policies [Text Block] | 2. Basis of Presentation and Use of Estimates The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”). The preparation of the accompanying consolidated financial statements in accordance with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements, and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. The accompanying financial statements are consolidated for the years ended December 31, 2022 2021 Going Concern Uncertainty Since inception, the Company has incurred net losses and negative cash flows from operations. At December 31, 2022, not may December 31, 2022, 12 no may may Nasdaq Compliance On August 9, 2022, 30 June 27, 2022, August 8, 2022, not $1.00 5550 2 In order to regain compliance with Nasdaq’s minimum bid price requirement, the Company’s common stock must maintain a minimum closing bid price of $1.00 ten On November 10, 2022, 11 October 27, 2022 November 10, 2022, $1.00 Segments The Company operates in one one not Concentration of C redit R isk Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash and cash equivalents. All of the Company’s cash and cash equivalents are held at several financial institutions that management believes are of high credit quality. Such deposits may Risk and Uncertainties The Company’s future results of operations involve a number of risks and uncertainties. Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not Products developed by the Company require clearances from the U.S. Food and Drug Administration (“FDA”), the Pharmaceuticals Medicines and Devices Agency (“PMDA”), or other international regulatory agencies prior to commercial sales. There can be no The Company expects to incur substantial operating losses for the next several years and will need to obtain additional financing in order to launch and commercialize any product candidates for which it receives regulatory approval. The Company relies on third third third third not third third Cash and C ash E quivalents, Restricted Cash The Company considers all highly liquid investments purchased with an original maturity of three December 31, 2022 2021 Property and E quipment, Net Property and equipment are stated at cost and depreciated using the straight-line method over the estimated useful lives of the assets, generally between three five Leases The Company leases all of its office space in conducting its business. At inception, the Company determines whether an agreement represents a lease and at commencement the Company evaluates each lease agreement to determine whether the lease is an operating or financing lease. The Company records an operating lease right-of-use ("ROU") asset and an operating lease obligation on the consolidated balance sheet when entering into a lease. ROU assets represent the Company’s ROU of the underlying asset for the lease term and the lease obligation represents the Company’s commitment to make the lease payments arising from the lease. Lease obligations are recognized at the commencement date based on the present value of remaining lease payments over the lease term and ROU assets are calculated as the lease liability, adjusted by unamortized initial direct costs, unamortized lease incentives received, cumulative deferred or prepaid lease payments, and accumulated impairment losses. As the Company’s leases do not may not 12 not Warrant Liability Warrants for the purchase of shares of common stock issued in connection with the January 2022 “January 2022 March 31, 2022 not April 1, 2022, April 1, 2022, Warrants for the purchase of shares of common stock issued in connection with the October 2022 “October 2022 December 31, 2022, not The Company estimated the fair value of these liabilities using assumptions that are based on the individual characteristics of the warrants on the valuation date. The Company used the Black-Scholes option-pricing model and the fair value of the underlying stock to determine the fair value of these liabilities. The valuation model is based on inputs as of the valuation dates, including the estimated volatility of our stock, the remaining contractual term of the warrants and the risk-free interest rates. Refer to Note 4. Impairment of Long-Lived Assets The Company reviews property and equipment for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not no December 31, 2022. Fair Value of Financial Instruments The carrying value of the Company’s cash and cash equivalents, restricted cash, accounts payable and accrued liabilities approximate fair value due to the short-term nature of these items. Fair value is defined as the exchange price that would be received for an asset or an exit price paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The fair value hierarchy defines a three Level 1 Unadjusted quoted prices in active markets for identical assets or liabilities; Level 2 Inputs other than quoted prices included within Level 1 not Level 3 Unobservable inputs that are supported by little or no The categorization of a financial instrument within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement. The Company’s financial instruments consist of Level 1 December 31, 2022 2021 3 December 31, 2022. 1 3 Clinical Trial Accruals The Company’s clinical trial accruals are based on estimates of patient enrollment and related costs at clinical investigator sites as well as estimates for the services received and efforts expended pursuant to contracts with multiple research institutions and CROs that conduct and manage clinical trials on the Company’s behalf. The Company estimates preclinical and clinical trial expenses based on the services performed, pursuant to contracts with research institutions and CROs that conduct and manage preclinical studies and clinical trials on its behalf. In accruing service fees, the Company estimates the time period over which services will be performed and the level of patient enrollment and activity expended in each period. If the actual timing of the performance of services or the level of effort varies from the estimate, the Company will adjust the accrual accordingly. Payments made to third Research and D evelopment Research and development costs are charged to operations as incurred. Research and development costs include, but are not not no Income T axes The Company accounts for income taxes under the asset and liability approach. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial statement and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amounts expected to be realized. The Company assesses all material positions taken in any income tax return, including all significant uncertain positions, in all tax years that are still subject to assessment or challenge by relevant taxing authorities. Assessing an uncertain tax position begins with the initial determination of the position’s sustainability and is measured at the largest amount of benefit that is more than likely to be realized upon ultimate settlement. As of each balance sheet date, unresolved uncertain tax positions must be reassessed, and the Company will determine whether (i) the factors underlying the sustainability assertion have changed and (ii) the amount of the recognized tax benefit is still appropriate. The recognition and measurement of tax benefits requires significant judgment. Judgments concerning the recognition and measurement of a tax benefit might change as new information becomes available. Stock-Based C ompensation For stock options granted to employees, the Company recognizes compensation expense for all stock-based awards based on the grant-date estimated fair value. The value of the portion of the award that is ultimately expected to vest is recognized as expense ratably over the requisite service period. The fair value of stock options is determined using the Black-Scholes option pricing model. The determination of fair value for stock-based awards on the date of grant using an option pricing model requires management to make certain assumptions regarding a number of complex and subjective variables. Stock-based compensation expense related to stock options granted to nonemployees is recognized based on the fair value of the stock options, determined using the Black-Scholes option pricing model, as they are earned. The awards generally vest over the time period the Company expects to receive services from the nonemployee. Net Loss per Share of Common Stock Basic net loss per common share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period, without consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares and potentially dilutive securities outstanding for the period. For purposes of the diluted net loss per share calculation, stock options and restricted stock units are considered to be potentially dilutive securities. Because the Company has reported a net loss for the years ended December 31, 2022 2021 Collaborative Arrangements The Company records the elements of its collaboration agreements that represent joint operating activities in accordance with ASC Topic 808, Collaborative Arrangements 808 606 10 15, Revenue from Contracts with Customers Scope and Scope Exceptions third one 3D 5 Revenue Recognition The Company’s sole source of revenue for 2022 2021 may 3D The Company follows ASC 606, Revenue from Contracts with Customers 606 606, third The Company applies the following five i) Identify the contract with a customer. 606. ii) Identify the performance obligations in the contract. third iii) Determine the transaction price. not 606 None iv) Allocate the transaction price to performance obligations in the contract. v) Recognize revenue when or as we satisfy a performance obligation. Performance Obligations The following is a general description of principal goods and services from which the Company generates revenue. License to intellectual property The Company generates revenue from licensing its intellectual property including know-how and development and commercialization rights. The license provides a customer with the right to further research, develop and commercialize internally-discovered or collaborated drug candidates, or the right to use batiraxcept to further research, develop and commercialize customer drug candidates. The consideration the Company receives is in the form of nonrefundable upfront consideration related to the functional intellectual property licenses and is recognized when the Company transfers such license to the customer unless the license is combined with other goods or services into one Research and development services The Company generates revenue from research and development services it provides to its customers and primarily includes clinical trials, and assistance during regulatory approval application process. Revenue associated with these services is recognized based on the Company’s estimate of total consideration to be received for such services and the pattern in which the Company perform the services. The pattern of performance is generally determined to be the amount of incurred costs related to the service portion of the contract with the customer as a percentage of total expected costs associated with the service portion of the contract. Contracts with Multiple Performance Obligations The Company’s collaboration and license agreement with its customers contains multiple promised goods or services. Based on the characteristics of the promised goods and services the Company analyzes whether they are separate or combined performance obligations. The transaction price is allocated to the separate performance obligations on a relative standalone selling price basis. The estimated standalone selling price is based on the adjusted market assessment approach including estimated present value of future cash flows and cost-plus margin approach, taking into consideration the type of services, estimates of hourly market rates, and stage of the development. Variable Consideration The Company’s contracts with customers primarily include two one Due to uncertainty associated with achievement of the development and regulatory milestones, the related milestone payments are excluded from the contract consideration and the corresponding revenue is not not Product sales-based royalties under licensed intellectual property and one one The transaction price is reevaluated each reporting period and as uncertain events are resolved or other changes in circumstances occur. Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board, or FASB, or other standard setting bodies and adopted by us as of the specified effective date. Unless otherwise discussed, the impact of recently issued standards that are not not In June 2016, No. 2016 13, No. 2018 19, 326, No. 2019 04, No. 2019 05, 2019 10, 2019 11, 2020 02 2020 03 January 1, 2023. not |
Note 3 - Balance Sheet Componen
Note 3 - Balance Sheet Components | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Supplemental Balance Sheet Disclosures [Text Block] | 3. Prepaid expenses and other current assets (in thousands) December 31, 2022 2021 Clinical $ 4,196 $ 3,288 Lease receivable 85 33 Total $ 4,281 $ 3,321 Property and equipment, net (in thousands) December 31, 2022 2021 Equipment and furniture $ 1,441 $ 1,430 Buildings, leasehold and building improvements 2,673 2,673 4,114 4,103 Less: Accumulated depreciation and amortization (2,840 ) (2,699 ) Accumulated impairment loss (1,004 ) (1,004 ) Property and equipment, net $ 270 $ 400 Depreciation expense was approximately $0.1 million for the years ended December 31, 2022 2021 Accrued liabilities (in thousands) December 31, 2022 2021 Payroll and related $ 1,930 $ 1,397 Clinical 4,730 6,727 Sublease prepayment — 227 Professional services 78 50 Other — 15 Total $ 6,738 $ 8,416 |
Note 4 - Fair Value Measurement
Note 4 - Fair Value Measurements | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Fair Value Disclosures [Text Block] | 4. The Company’s warrant liability for the January 2022 March 31, 2022, 3 April 1, 2022, April 1, 2022, 2. The fair value of the warrants was estimated using the Black-Scholes option-pricing model. For warrants that do not zero not The assumptions used in calculating the estimated fair value at the end of the reporting period and on the warrant exercise date represent the Company’s best estimate. However, inherent uncertainties are involved. If factors or assumptions change, the estimated fair value could be materially different. The Company’s financial instruments consist principally of cash and cash equivalents, prepaid expenses, accounts payable and accrued liabilities. The following financial instruments are reported on the Company’s consolidated balance sheets at amounts that approximate current fair value. The following table sets forth the Company’s financial instruments that were measured at fair value on a recurring basis by level within the fair value hierarchy (in thousands): Fair Value Measurements at December 31, 2022 Total Level 1 Level 2 Level 3 Assets Money market funds $ 52,905 $ 52,905 $ — $ — Liabilities Warrant liability $ 26,881 $ — $ — $ 26,881 Fair Value Measurements at December 31, 2021 Total Level 1 Level 2 Level 3 Assets Money market funds $ 49,217 $ 49,217 $ — $ — Warrant Liability The Company’s warrant liability for the October 2022 December 31, 2022 3 2. The fair value of the warrants was estimated using the Black-Scholes option-pricing model. The fair value of the common share has been adjusted for a discount for lack of marketability due to the uncertainty and timing of obtaining shareholder approval to increase our authorized number of common shares. For warrants that do not not The assumptions used in calculating the estimated fair value at the end of the reporting period represent the Company’s best estimate. However, inherent uncertainties are involved. If factors or assumptions change, the estimated fair value could be materially different. At December 31, 2022, October 2022 October 2022 Warrants December 31, 2022 Expected term (in years) 1.9 Expected volatility 49.9 % Risk-free interest rate 4.48 % Expected dividend yield 0.00 % Fair value of common share $ 1.25 Exercise price $ 0.7949 The following table provides a summary of changes in the estimated fair value of the Company’s warrant liability (in thousands): January 2022 Warrants October 2022 Warrants Balance at January 1, 2022 $ — $ — Issuance of warrants 10,000 — Change in fair value (1,228 ) — Balance at March 31, 2022 8,772 — Issuance of warrants — 16,490 Change in fair value (182 ) 10,391 Reclass to additional paid-in-capital upon exercise (8,590 ) — Balance at December 31, 2022 $ — $ 26,881 The Company recognizes transfers between levels of the fair value hierarchy as of the end of the reporting period. There were no transfers within the hierarchy during the years ended December 31, 2022 2021 |
Note 5 - Collaboration and Lice
Note 5 - Collaboration and License Agreement | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Collaborative Arrangement Disclosure [Text Block] | 5. On November 6, 2020, 3D 3D Under the terms of the Agreement, the Company was paid $27 million (inclusive of $15 million in milestone payments) and is eligible to receive from 3D no 3D January 25, 2012, The Company will also be entitled to receive tiered royalties ranging from low double digits to mid-teens on sales in the Territory, if any, of products containing batiraxcept. Royalties are payable with respect to each jurisdiction in the Territory until the latest to occur of: (i) the last-to-expire of specified patent rights in such jurisdiction in the Territory; or (ii) ten first Under the terms and conditions of the Agreement, 3D If either the Company or 3D not may may may 3D 3D may The Agreement contemplates that the Company will enter into ancillary arrangements with 3D The Company assessed this arrangement in accordance with ASC 606 1 2 3D The estimated total transaction price was allocated between performance obligations based on their relative standalone selling prices. The Company uses a discounted cash flow approach and an expected cost plus a margin approach to estimate the standalone selling price for the performance obligations. The Company allocated the $27.0 million transaction price as such: $14.5 million to the research and development services performance obligation and $12.5 million to the license to intellectual property. Accordingly, the Company will recognize revenue related to the allocable research and development services obligation on a proportional performance basis as the underlying services are performed pursuant to the current development plan which is commensurate with the period and consistent with the pattern over which the Company’s research and development services obligation is satisfied. The Company will recognize the revenue related to the license to intellectual property at a point in time. This is due to the fact the license was determined to be a functional license due to current stage in development of batiraxcept. Batiraxcept has been developed, dosing levels have already been determined and the drug is currently in a Phase III clinical trial related to its PROC study. As of December 31, 2022 no The Company recognized in revenue $6.3 and $3.2 million related to the research and development services for the years ended December 31, 2022 2021, December 31, 2022 2021, December 31, 2022, 3D December 31, 2022 December 31, 2021. December 31, 2022, |
Note 6 - Leases
Note 6 - Leases | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Lessee, Operating Leases [Text Block] | 6. In March 2017, 1020 August 2017 one five not not In August 2020, three fourth 2020. The Company’s rent expense including both short-term and variable lease components of $0.4 million associated with the facility leases was $1.8 million and $1.6 million for the years ended December 31, 2022 2021, December 31, 2022 2021, December 31, 2022, As of December 31, 2022 Year Ending December 31, 2023 3,039 2024 2,620 2025 116 2026 30 Total future minimum lease payments 5,805 Less: discount (1,728 ) Total lease liabilities $ 4,077 1020 On June 8, 2021, 1020 July 13, 2021. August 1, 2021 October 31, 2024, not December 31, 2022. December 31, 2022 2021, December 31, 2022 2021, Future base rent the Subtenant shall pay to the Company over the sublease term as of December 31, 2022, Year Ending December 31, 2023 2,372 2024 2,029 Total $ 4,401 |
Note 7 - Commitments and Contin
Note 7 - Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Commitments and Contingencies Disclosure [Text Block] | 7. Purchase Commitments The Company conducts research and development programs through a combination of internal and collaborative programs that include, among others, arrangements with contract manufacturing organizations and contract research organizations. The Company had contractual arrangements with these organizations including license agreements with milestone obligations and service agreements with obligations largely based on services performed. In the normal course of business, the Company enters into various firm purchase commitments related to certain preclinical and clinical studies. Contingencies In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and provide for general indemnifications. The Company’s exposure under these agreements is unknown because it involves claims that may not Indemnification In accordance with the Company’s amended and restated Certificate of Incorporation and amended and restated bylaws, the Company has indemnification obligations to its officers and directors for certain events or occurrences, subject to certain limits, while they are serving at the Company’s request in such capacity. There have been no may Litigation The Company may no December 31, 2022 |
Note 8 - Common Stock and Commo
Note 8 - Common Stock and Common Stock Warrants | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Stockholders' Equity Note Disclosure [Text Block] | 8. The Amended and Restated Certificate of Incorporation, as amended, authorizes the Company to issue 100,000,000 shares of common stock as of December 31, 2022 no one The Company had reserved shares of common stock for future issuances as follows: December 31, 2022 2021 Issuance of equity-based awards under stock plan 1,001,087 2,131,671 Issuance upon exercise of options under stock plan 4,570,432 2,439,253 Warrants (Pre-funded and March 31, 2022 Warrants) 20,720,440 — Total 26,291,959 4,570,924 At the Market Offering Program In September 2020, 3 November 20, 2020 ( 3” September 4, 2020, December 31, 2022 2021, 3 Registered Direct Offerings Related Party Transactions On February 12, 2021, February 18, 2021 In January 2022, December 31, 2021, January 2022 March 31, 2022, January 2022 April 1, 2022; January 2022 January 2022 On April 1, 2022, 5635 January 2022 April 1, 2022, January 2022 On March 31, 2022, five January 2022 five 480, Distinguishing Liabilities from Equity 815, Derivatives and Hedging The 1,665,025 pre-funded warrants issued to the institutional investor were exercised on June 6, 2022. As of December 31, 2022, Number of Shares Exercise Price Expiration Date 3,990,025 $ 1.88 March 30, 2027 860,216 $ 2.20 March 30, 2027 Private placement equity financing On October 27, 2022, 15 one 3 50% 30 480, Distinguishing Liabilities from Equity 815, Derivatives and Hedging December 31, 2022. As of December 31, 2022, Security Number of Shares Exercise Price Expiration Date Pre-Funded 15,870,199 $ 0.0001 No expiration Series A 22,589,410 $ 0.7949 April 16, 2024 (1) Series B 22,589,401 $ 0.7949 July 16, 2025 ( 1 These warrants expire on the date that is the later of: (i) 15 January 17, 2023), one 3 |
Note 9 - Stock Based Awards
Note 9 - Stock Based Awards | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Shareholders' Equity and Share-Based Payments [Text Block] | 9. Equity Incentive Plans The Company’s Board of Directors (the "Board") and stockholders approved the 2019 "2019 September 12, 2019. 2019 2014 2017 2010 December 31, 2022 2019 not not 2019 January 1, 2020 January 1, 2029, January 1 December 31 2019 Activity under the Company’s stock option plans is set forth below: Weighted Average Weighted Remaining Aggregate Average Contractual Intrinsic Number of Exercise Life Value Shares Price (in years) (in thousands) Balances, January 1, 2022 2,439,253 $ 3.96 Options granted 2,888,641 1.61 Options cancelled (757,462 ) 3.81 Options exercised — — Balances, December 31, 2022 4,570,432 $ 2.50 7.2 $ 1,239 Outstanding and expected to vest as of December 31, 2022 4,100,681 $ 2.54 7.1 $ 1,184 Exercisable as of December 31, 2022 2,348,015 $ 2.89 5.3 $ 877 The intrinsic values of outstanding, vested and exercisable options were determined by multiplying the number of shares by the difference in exercise price of the options and the fair value of the common stock. The intrinsic value of stock options exercised during the year ended December 31, 2021 December 31, 2022. Stock Options Granted to Employees During the years ended December 31, 2022 2021 4 No As of December 31, 2022 The fair value of employee stock options was estimated using the Black-Scholes model with the following weighted-average assumptions: December 31, December 31, 2022 2021 Expected volatility 113.0 % 114.2 % Risk-free interest rate 2.2 % 0.8 % Dividend yield 0.0 % 0.0 % Expected life (in years) 6.0 6.0 Determining Fair Value of Stock Options The fair value of each grant of stock options was determined by the Company using the methods and assumptions discussed below. Each of these inputs is subjective and generally requires significant judgment to determine. Expected Volatility Risk-Free Interest Rate Expected Dividend Expected Term Forfeiture Rate Fair Value of Common Stock Stock-based compensation expense, net of estimated forfeitures, is reflected in the statements of operations as follows (in thousands): Year Ended December 31, 2022 2021 Operating Expenses Research and development $ 889 $ 932 General and administrative 1,671 1,325 Total $ 2,560 $ 2,257 2014 The board of directors adopted, and the Company’s stockholders approved, the 2014 March 2014. March 20, 2014. The maximum aggregate number of shares of common stock that may October 2018). January 1, 2015 January 1, 2024, December 31 October 2018). may first no January 1 not An employee may not 5% $25,000 The administrator may not 27 may one one The ESPP permits participants to purchase shares of our common stock through payroll deductions with up to 15% not 85% first December 31, 2022 2021 |
Note 10 - Income Taxes
Note 10 - Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Income Tax Disclosure [Text Block] | 10. The provision (benefit) for federal income taxes in 2022 2021 December 31, 2022 2021 Current Federal $ — $ — State — — — — Deferred Federal $ — $ — State — — Total deferred tax expense — — Total income tax expense $ — $ — Income tax expense (benefit) in 2022 2021 December 31, 2022 2021 Federal tax benefit at statutory rate 21 % 21 % Change in valuation allowance 6.5 % (21 )% Section 382 limitation (24.1 )% — Other non-deductible expenses — (1 )% Stock based compensation — — Other (3.4 )% 1 % Total — — Deferred income taxes reflect the net tax effects of net operating loss and tax credit carryforwards and temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company’s net deferred tax assets at December 31, 2022 2021 December 31, 2022 2021 Net operating loss carry forwards $ 504 $ 18,205 Research and development tax credits 232 404 Capitalized research and development 13,026 — Stock based compensation and other 3,878 3,694 Operating lease obligation 856 1,339 Total deferred tax assets 18,496 23,642 Less: Valuation allowance (18,189 ) (23,179 ) Deferred tax liabilities — — Operating lease right-of-use assets (307 ) (463 ) Net deferred tax assets $ — $ — The Company’s accounting for deferred taxes involves the evaluation of a number of factors concerning the realizability of its net deferred tax assets. The Company primarily considered such factors as its history of operating losses, the nature of the Company’s deferred tax assets, and the timing, likelihood and amount, if any, of future taxable income during the periods in which those temporary differences and carryforwards become deductible. At present, the Company does not not no The valuation allowance decreased by approximately $5.0 million in 2022 2021 At December 31, 2022 2036. Due to the Company’s lack of earnings history and uncertainties surrounding its ability to generate future taxable income, the net deferred tax assets have been fully offset by a valuation allowance. The deferred tax assets were primarily comprised of federal tax net operating losses and tax credit carryforwards. Utilization of net operating losses and tax credit carryforwards may 382 382 may December 31, 2022. April 1, 2022, The Company follows the provisions of FASB Accounting Standards Codification 740 10 740 10 Accounting for Uncertainty in Income Taxes 740 10 No December 31, 2022 2021 December 31, 2022 no not 12 Because the statute of limitations does not April 1, 2022 A reconciliation of the beginning and ending amount of unrecognized tax benefits is as follows (in thousands): Amount Balance at January 1, 2021 $ 164 Gross increase/ (decrease) related to prior year tax positions — Gross increase related to current year positions — Reductions to unrecognized tax benefits related to lapsing statute of limitations — Balance at December 31, 2021 $ 164 Gross increase/ (decrease) related to prior year tax positions — Gross increase related to current year positions 1 Reductions to unrecognized tax benefits related to lapsing statute of limitations — Balance at December 31, 2022 $ 165 All tax years remain open for examination by federal and state tax authorities. |
Note 11 - Employee Benefit Plan
Note 11 - Employee Benefit Plans | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Defined Benefit Plan [Text Block] | 11. Defined Contribution Plan The Company sponsors a 401 401 may December 31, 2022 2021, |
Note 12 - Net Loss Per Share of
Note 12 - Net Loss Per Share of Common Stock | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Earnings Per Share [Text Block] | 12. The following table summarizes the computation of basic and diluted net loss per share attributable to common stockholders of the Company (in thousands, except per share data): Year Ended December 31, 2022 2021 Net loss $ (76,322 ) $ (39,151 ) Basic and diluted net loss per share $ (2.10 ) $ (1.95 ) Weighted-average shares used to compute basic and diluted net loss per share 36,372 20,070 Basic net loss attributable to common stockholders per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding for the period. Weighted-average number of common shares outstanding for the period includes the weighted average effect of the Company’s outstanding pre-funded warrants , not no December 31, 2022 2021 not The following potentially dilutive securities outstanding at the end of the years presented have been excluded from the computation of diluted shares outstanding: Year Ended December 31, 2022 2021 Options to purchase common stock 4,570,432 2,439,253 Common stock warrants 50,029,052 — |
Note 13 - Subsequent Events
Note 13 - Subsequent Events | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Subsequent Events [Text Block] | 13. On January 17, 2023, 2023 January 13, 2023. |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Basis of Accounting, Policy [Policy Text Block] | Basis of Presentation and Use of Estimates The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”). The preparation of the accompanying consolidated financial statements in accordance with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements, and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. The accompanying financial statements are consolidated for the years ended December 31, 2022 2021 |
Going Concern Uncertainty Policy [Policy Text Block] | Going Concern Uncertainty Since inception, the Company has incurred net losses and negative cash flows from operations. At December 31, 2022, not may December 31, 2022, 12 no may may |
NASDAQ Compliance [Policy Text Block] | Nasdaq Compliance On August 9, 2022, 30 June 27, 2022, August 8, 2022, not $1.00 5550 2 In order to regain compliance with Nasdaq’s minimum bid price requirement, the Company’s common stock must maintain a minimum closing bid price of $1.00 ten On November 10, 2022, 11 October 27, 2022 November 10, 2022, $1.00 |
Segment Reporting, Policy [Policy Text Block] | Segments The Company operates in one one not |
Concentration Risk, Credit Risk, Policy [Policy Text Block] | Concentration of C redit R isk Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash and cash equivalents. All of the Company’s cash and cash equivalents are held at several financial institutions that management believes are of high credit quality. Such deposits may |
Risks and Uncertainties [Policy Text Block] | Risk and Uncertainties The Company’s future results of operations involve a number of risks and uncertainties. Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not Products developed by the Company require clearances from the U.S. Food and Drug Administration (“FDA”), the Pharmaceuticals Medicines and Devices Agency (“PMDA”), or other international regulatory agencies prior to commercial sales. There can be no The Company expects to incur substantial operating losses for the next several years and will need to obtain additional financing in order to launch and commercialize any product candidates for which it receives regulatory approval. The Company relies on third third third third not third third |
Cash and Cash Equivalents, Restricted Cash and Cash Equivalents, Policy [Policy Text Block] | Cash and C ash E quivalents, Restricted Cash The Company considers all highly liquid investments purchased with an original maturity of three December 31, 2022 2021 |
Property, Plant and Equipment, Policy [Policy Text Block] | Property and E quipment, Net Property and equipment are stated at cost and depreciated using the straight-line method over the estimated useful lives of the assets, generally between three five |
Lessee, Leases [Policy Text Block] | Leases The Company leases all of its office space in conducting its business. At inception, the Company determines whether an agreement represents a lease and at commencement the Company evaluates each lease agreement to determine whether the lease is an operating or financing lease. The Company records an operating lease right-of-use ("ROU") asset and an operating lease obligation on the consolidated balance sheet when entering into a lease. ROU assets represent the Company’s ROU of the underlying asset for the lease term and the lease obligation represents the Company’s commitment to make the lease payments arising from the lease. Lease obligations are recognized at the commencement date based on the present value of remaining lease payments over the lease term and ROU assets are calculated as the lease liability, adjusted by unamortized initial direct costs, unamortized lease incentives received, cumulative deferred or prepaid lease payments, and accumulated impairment losses. As the Company’s leases do not may not 12 not |
Warrant Liability Policy [Policy Text Block] | Warrant Liability Warrants for the purchase of shares of common stock issued in connection with the January 2022 “January 2022 March 31, 2022 not April 1, 2022, April 1, 2022, Warrants for the purchase of shares of common stock issued in connection with the October 2022 “October 2022 December 31, 2022, not The Company estimated the fair value of these liabilities using assumptions that are based on the individual characteristics of the warrants on the valuation date. The Company used the Black-Scholes option-pricing model and the fair value of the underlying stock to determine the fair value of these liabilities. The valuation model is based on inputs as of the valuation dates, including the estimated volatility of our stock, the remaining contractual term of the warrants and the risk-free interest rates. Refer to Note 4. |
Impairment or Disposal of Long-Lived Assets, Policy [Policy Text Block] | Impairment of Long-Lived Assets The Company reviews property and equipment for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not no December 31, 2022. |
Fair Value of Financial Instruments, Policy [Policy Text Block] | Fair Value of Financial Instruments The carrying value of the Company’s cash and cash equivalents, restricted cash, accounts payable and accrued liabilities approximate fair value due to the short-term nature of these items. Fair value is defined as the exchange price that would be received for an asset or an exit price paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The fair value hierarchy defines a three Level 1 Unadjusted quoted prices in active markets for identical assets or liabilities; Level 2 Inputs other than quoted prices included within Level 1 not Level 3 Unobservable inputs that are supported by little or no The categorization of a financial instrument within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement. The Company’s financial instruments consist of Level 1 December 31, 2022 2021 3 December 31, 2022. 1 3 |
Clinical Trial Accruals [Policy Text Block] | Clinical Trial Accruals The Company’s clinical trial accruals are based on estimates of patient enrollment and related costs at clinical investigator sites as well as estimates for the services received and efforts expended pursuant to contracts with multiple research institutions and CROs that conduct and manage clinical trials on the Company’s behalf. The Company estimates preclinical and clinical trial expenses based on the services performed, pursuant to contracts with research institutions and CROs that conduct and manage preclinical studies and clinical trials on its behalf. In accruing service fees, the Company estimates the time period over which services will be performed and the level of patient enrollment and activity expended in each period. If the actual timing of the performance of services or the level of effort varies from the estimate, the Company will adjust the accrual accordingly. Payments made to third |
Research and Development Expense, Policy [Policy Text Block] | Research and D evelopment Research and development costs are charged to operations as incurred. Research and development costs include, but are not not no |
Income Tax, Policy [Policy Text Block] | Income T axes The Company accounts for income taxes under the asset and liability approach. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial statement and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amounts expected to be realized. The Company assesses all material positions taken in any income tax return, including all significant uncertain positions, in all tax years that are still subject to assessment or challenge by relevant taxing authorities. Assessing an uncertain tax position begins with the initial determination of the position’s sustainability and is measured at the largest amount of benefit that is more than likely to be realized upon ultimate settlement. As of each balance sheet date, unresolved uncertain tax positions must be reassessed, and the Company will determine whether (i) the factors underlying the sustainability assertion have changed and (ii) the amount of the recognized tax benefit is still appropriate. The recognition and measurement of tax benefits requires significant judgment. Judgments concerning the recognition and measurement of a tax benefit might change as new information becomes available. |
Compensation Related Costs, Policy [Policy Text Block] | Stock-Based C ompensation For stock options granted to employees, the Company recognizes compensation expense for all stock-based awards based on the grant-date estimated fair value. The value of the portion of the award that is ultimately expected to vest is recognized as expense ratably over the requisite service period. The fair value of stock options is determined using the Black-Scholes option pricing model. The determination of fair value for stock-based awards on the date of grant using an option pricing model requires management to make certain assumptions regarding a number of complex and subjective variables. Stock-based compensation expense related to stock options granted to nonemployees is recognized based on the fair value of the stock options, determined using the Black-Scholes option pricing model, as they are earned. The awards generally vest over the time period the Company expects to receive services from the nonemployee. |
Earnings Per Share, Policy [Policy Text Block] | Net Loss per Share of Common Stock Basic net loss per common share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period, without consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares and potentially dilutive securities outstanding for the period. For purposes of the diluted net loss per share calculation, stock options and restricted stock units are considered to be potentially dilutive securities. Because the Company has reported a net loss for the years ended December 31, 2022 2021 |
Collaborative Arrangement, Accounting Policy [Policy Text Block] | Collaborative Arrangements The Company records the elements of its collaboration agreements that represent joint operating activities in accordance with ASC Topic 808, Collaborative Arrangements 808 606 10 15, Revenue from Contracts with Customers Scope and Scope Exceptions third one 3D 5 |
Revenue [Policy Text Block] | Revenue Recognition The Company’s sole source of revenue for 2022 2021 may 3D The Company follows ASC 606, Revenue from Contracts with Customers 606 606, third The Company applies the following five i) Identify the contract with a customer. 606. ii) Identify the performance obligations in the contract. third iii) Determine the transaction price. not 606 None iv) Allocate the transaction price to performance obligations in the contract. v) Recognize revenue when or as we satisfy a performance obligation. Performance Obligations The following is a general description of principal goods and services from which the Company generates revenue. License to intellectual property The Company generates revenue from licensing its intellectual property including know-how and development and commercialization rights. The license provides a customer with the right to further research, develop and commercialize internally-discovered or collaborated drug candidates, or the right to use batiraxcept to further research, develop and commercialize customer drug candidates. The consideration the Company receives is in the form of nonrefundable upfront consideration related to the functional intellectual property licenses and is recognized when the Company transfers such license to the customer unless the license is combined with other goods or services into one Research and development services The Company generates revenue from research and development services it provides to its customers and primarily includes clinical trials, and assistance during regulatory approval application process. Revenue associated with these services is recognized based on the Company’s estimate of total consideration to be received for such services and the pattern in which the Company perform the services. The pattern of performance is generally determined to be the amount of incurred costs related to the service portion of the contract with the customer as a percentage of total expected costs associated with the service portion of the contract. Contracts with Multiple Performance Obligations The Company’s collaboration and license agreement with its customers contains multiple promised goods or services. Based on the characteristics of the promised goods and services the Company analyzes whether they are separate or combined performance obligations. The transaction price is allocated to the separate performance obligations on a relative standalone selling price basis. The estimated standalone selling price is based on the adjusted market assessment approach including estimated present value of future cash flows and cost-plus margin approach, taking into consideration the type of services, estimates of hourly market rates, and stage of the development. Variable Consideration The Company’s contracts with customers primarily include two one Due to uncertainty associated with achievement of the development and regulatory milestones, the related milestone payments are excluded from the contract consideration and the corresponding revenue is not not Product sales-based royalties under licensed intellectual property and one one The transaction price is reevaluated each reporting period and as uncertain events are resolved or other changes in circumstances occur. |
New Accounting Pronouncements, Policy [Policy Text Block] | Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board, or FASB, or other standard setting bodies and adopted by us as of the specified effective date. Unless otherwise discussed, the impact of recently issued standards that are not not In June 2016, No. 2016 13, No. 2018 19, 326, No. 2019 04, No. 2019 05, 2019 10, 2019 11, 2020 02 2020 03 January 1, 2023. not |
Note 3 - Balance Sheet Compon_2
Note 3 - Balance Sheet Components (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Table Text Block] | December 31, 2022 2021 Clinical $ 4,196 $ 3,288 Lease receivable 85 33 Total $ 4,281 $ 3,321 |
Property, Plant and Equipment [Table Text Block] | December 31, 2022 2021 Equipment and furniture $ 1,441 $ 1,430 Buildings, leasehold and building improvements 2,673 2,673 4,114 4,103 Less: Accumulated depreciation and amortization (2,840 ) (2,699 ) Accumulated impairment loss (1,004 ) (1,004 ) Property and equipment, net $ 270 $ 400 |
Schedule of Accrued Liabilities [Table Text Block] | December 31, 2022 2021 Payroll and related $ 1,930 $ 1,397 Clinical 4,730 6,727 Sublease prepayment — 227 Professional services 78 50 Other — 15 Total $ 6,738 $ 8,416 |
Note 4 - Fair Value Measureme_2
Note 4 - Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis [Table Text Block] | Fair Value Measurements at December 31, 2022 Total Level 1 Level 2 Level 3 Assets Money market funds $ 52,905 $ 52,905 $ — $ — Liabilities Warrant liability $ 26,881 $ — $ — $ 26,881 Fair Value Measurements at December 31, 2021 Total Level 1 Level 2 Level 3 Assets Money market funds $ 49,217 $ 49,217 $ — $ — |
Fair Value Measurement Inputs and Valuation Techniques [Table Text Block] | October 2022 Warrants December 31, 2022 Expected term (in years) 1.9 Expected volatility 49.9 % Risk-free interest rate 4.48 % Expected dividend yield 0.00 % Fair value of common share $ 1.25 Exercise price $ 0.7949 |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Table Text Block] | January 2022 Warrants October 2022 Warrants Balance at January 1, 2022 $ — $ — Issuance of warrants 10,000 — Change in fair value (1,228 ) — Balance at March 31, 2022 8,772 — Issuance of warrants — 16,490 Change in fair value (182 ) 10,391 Reclass to additional paid-in-capital upon exercise (8,590 ) — Balance at December 31, 2022 $ — $ 26,881 |
Note 6 - Leases (Tables)
Note 6 - Leases (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Lessee, Operating Lease, Liability, Maturity [Table Text Block] | Year Ending December 31, 2023 3,039 2024 2,620 2025 116 2026 30 Total future minimum lease payments 5,805 Less: discount (1,728 ) Total lease liabilities $ 4,077 |
Lessor, Operating Lease, Payment to be Received, Fiscal Year Maturity [Table Text Block] | Year Ending December 31, 2023 2,372 2024 2,029 Total $ 4,401 |
Note 8 - Common Stock and Com_2
Note 8 - Common Stock and Common Stock Warrants (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Reserved Shares of Common Stock for Future Issuances [Table Text Block] | December 31, 2022 2021 Issuance of equity-based awards under stock plan 1,001,087 2,131,671 Issuance upon exercise of options under stock plan 4,570,432 2,439,253 Warrants (Pre-funded and March 31, 2022 Warrants) 20,720,440 — Total 26,291,959 4,570,924 |
Schedule of Stockholders' Equity Note, Warrants or Rights [Table Text Block] | Number of Shares Exercise Price Expiration Date 3,990,025 $ 1.88 March 30, 2027 860,216 $ 2.20 March 30, 2027 Security Number of Shares Exercise Price Expiration Date Pre-Funded 15,870,199 $ 0.0001 No expiration Series A 22,589,410 $ 0.7949 April 16, 2024 (1) Series B 22,589,401 $ 0.7949 July 16, 2025 |
Note 9 - Stock Based Awards (Ta
Note 9 - Stock Based Awards (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Share-Based Payment Arrangement, Option, Activity [Table Text Block] | Weighted Average Weighted Remaining Aggregate Average Contractual Intrinsic Number of Exercise Life Value Shares Price (in years) (in thousands) Balances, January 1, 2022 2,439,253 $ 3.96 Options granted 2,888,641 1.61 Options cancelled (757,462 ) 3.81 Options exercised — — Balances, December 31, 2022 4,570,432 $ 2.50 7.2 $ 1,239 Outstanding and expected to vest as of December 31, 2022 4,100,681 $ 2.54 7.1 $ 1,184 Exercisable as of December 31, 2022 2,348,015 $ 2.89 5.3 $ 877 |
Schedule of Share-Based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | December 31, December 31, 2022 2021 Expected volatility 113.0 % 114.2 % Risk-free interest rate 2.2 % 0.8 % Dividend yield 0.0 % 0.0 % Expected life (in years) 6.0 6.0 |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Table Text Block] | Year Ended December 31, 2022 2021 Operating Expenses Research and development $ 889 $ 932 General and administrative 1,671 1,325 Total $ 2,560 $ 2,257 |
Note 10 - Income Taxes (Tables)
Note 10 - Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Schedule of Components of Income Tax Expense (Benefit) [Table Text Block] | December 31, 2022 2021 Current Federal $ — $ — State — — — — Deferred Federal $ — $ — State — — Total deferred tax expense — — Total income tax expense $ — $ — |
Schedule of Effective Income Tax Rate Reconciliation [Table Text Block] | December 31, 2022 2021 Federal tax benefit at statutory rate 21 % 21 % Change in valuation allowance 6.5 % (21 )% Section 382 limitation (24.1 )% — Other non-deductible expenses — (1 )% Stock based compensation — — Other (3.4 )% 1 % Total — — |
Schedule of Deferred Tax Assets and Liabilities [Table Text Block] | December 31, 2022 2021 Net operating loss carry forwards $ 504 $ 18,205 Research and development tax credits 232 404 Capitalized research and development 13,026 — Stock based compensation and other 3,878 3,694 Operating lease obligation 856 1,339 Total deferred tax assets 18,496 23,642 Less: Valuation allowance (18,189 ) (23,179 ) Deferred tax liabilities — — Operating lease right-of-use assets (307 ) (463 ) Net deferred tax assets $ — $ — |
Summary of Income Tax Contingencies [Table Text Block] | Amount Balance at January 1, 2021 $ 164 Gross increase/ (decrease) related to prior year tax positions — Gross increase related to current year positions — Reductions to unrecognized tax benefits related to lapsing statute of limitations — Balance at December 31, 2021 $ 164 Gross increase/ (decrease) related to prior year tax positions — Gross increase related to current year positions 1 Reductions to unrecognized tax benefits related to lapsing statute of limitations — Balance at December 31, 2022 $ 165 |
Note 12 - Net Loss Per Share _2
Note 12 - Net Loss Per Share of Common Stock (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Schedule of Earnings Per Share, Basic and Diluted [Table Text Block] | Year Ended December 31, 2022 2021 Net loss $ (76,322 ) $ (39,151 ) Basic and diluted net loss per share $ (2.10 ) $ (1.95 ) Weighted-average shares used to compute basic and diluted net loss per share 36,372 20,070 |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block] | Year Ended December 31, 2022 2021 Options to purchase common stock 4,570,432 2,439,253 Common stock warrants 50,029,052 — |
Note 1 - Formation and Busine_2
Note 1 - Formation and Business of the Company (Details Textual) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | 26 Months Ended | 41 Months Ended | 42 Months Ended | ||||
Nov. 06, 2020 | Jun. 01, 2016 | Oct. 31, 2022 | Jun. 30, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2022 | Nov. 30, 2019 | Nov. 30, 2019 | Aug. 31, 2021 | |
Revenue from Contract with Customer, Excluding Assessed Tax, Total | $ 9,137,000 | $ 7,442,000 | ||||||||
Cancer Prevention and Research Institute of Texas [Member] | ||||||||||
Revenue from Contract with Customer, Excluding Assessed Tax, Total | $ 20,000,000 | |||||||||
Percentage of Cash Required to Raise in Matching Funds | 50% | |||||||||
Cash Required to Raise in Matching Funds | $ 10,000,000 | |||||||||
Matching Funds Required to Raise, Project Term (Year) | 3 years | |||||||||
Cash Required in Matching Funds, Amount Raised | $ 10,000,000 | |||||||||
Percentage of Grant Award Proceeds Required to Pay | 400% | |||||||||
3D Medicines, Inc [Member] | ||||||||||
Proceeds from Collaborators | 15,000,000 | $ 27,000,000 | ||||||||
Proceeds from Milestone Achievement | $ 6,000,000 | $ 6,000,000 | ||||||||
Collaborative Agreement, Expected Milestone Payments to be Received | $ 3,000,000 | |||||||||
3D Medicines, Inc [Member] | Mainland China,Taiwan, Hong Kong and Macau [Member] | ||||||||||
Proceeds from Collaborators | $ 12,000,000 | |||||||||
Leland Stanford Junior University [Member] | ||||||||||
Maximum Milestone Payments Upon Achievement of Clinical and Regulatory Milestones | $ 1,000,000 | $ 1,000,000 |
Note 2 - Summary of Significa_2
Note 2 - Summary of Significant Accounting Policies (Details Textual) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | |
Retained Earnings (Accumulated Deficit), Total | $ (616,127) | $ (539,805) |
Working Capital (Deficit) | 35,900 | |
Cash and Cash Equivalents, at Carrying Value, Total | $ 53,689 | $ 59,424 |
Number of Operating Segments | 1 | |
Minimum [Member] | ||
Property, Plant and Equipment, Useful Life (Year) | 3 years | |
Maximum [Member] | ||
Property, Plant and Equipment, Useful Life (Year) | 5 years |
Note 3 - Balance Sheet Compon_3
Note 3 - Balance Sheet Components (Details Textual) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Leasehold Improvements [Member] | ||
Depreciation, Total | $ 0.1 | $ 0.1 |
Note 3 - Balance Sheet Compon_4
Note 3 - Balance Sheet Components - Schedule of Balance Sheet Components (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Clinical | $ 4,196 | $ 3,288 |
Lease receivable | 85 | 33 |
Total | $ 4,281 | $ 3,321 |
Note 3 - Balance Sheet Compon_5
Note 3 - Balance Sheet Components - Schedule of Property and Equipment, Net (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Property, Plant and Equipment, Gross | $ 4,114 | $ 4,103 |
Less: Accumulated depreciation and amortization | (2,840) | (2,699) |
Accumulated impairment loss | (1,004) | (1,004) |
Property and equipment, net | 270 | 400 |
Equipment and Furniture [Member] | ||
Property, Plant and Equipment, Gross | 1,441 | 1,430 |
Buildings, Leasehold, and Building Improvements [Member] | ||
Property, Plant and Equipment, Gross | $ 2,673 | $ 2,673 |
Note 3 - Balance Sheet Compon_6
Note 3 - Balance Sheet Components - Schedule of Accrued Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Payroll and related | $ 1,930 | $ 1,397 |
Clinical | 4,730 | 6,727 |
Sublease prepayment | 0 | 227 |
Professional services | 78 | 50 |
Other | 0 | 15 |
Total | $ 6,738 | $ 8,416 |
Note 4 - Fair Value Measureme_3
Note 4 - Fair Value Measurements (Details Textual) Pure in Thousands, $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Fair Value Assumptions, Expected Dividend Payments | $ 0 | |
Fair Value, Assets and Liabilities, Transfers, Amount | $ 0 | $ 0 |
Measurement Input, Expected Dividend Payment [Member] | Valuation Technique, Option Pricing Model [Member] | ||
Warrants and Rights Outstanding, Measurement Input | 0 |
Note 4 - Fair Value Measureme_4
Note 4 - Fair Value Measurements - Financial Instruments Measured at Fair Value on a Recurring Basis (Details) - Fair Value, Recurring [Member] - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Warrant [Member] | ||
Warrant liability | $ 26,881 | |
Fair Value, Inputs, Level 1 [Member] | Warrant [Member] | ||
Warrant liability | ||
Fair Value, Inputs, Level 2 [Member] | Warrant [Member] | ||
Warrant liability | ||
Fair Value, Inputs, Level 3 [Member] | Warrant [Member] | ||
Warrant liability | 26,881 | |
Money Market Funds [Member] | ||
Money market funds | 52,905 | $ 49,217 |
Money Market Funds [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Money market funds | 52,905 | 49,217 |
Money Market Funds [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Money market funds | 0 | |
Money Market Funds [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Money market funds | $ 0 |
Note 4 - Fair Value Measureme_5
Note 4 - Fair Value Measurements - Estimated Fair Value Assumptions (Details) - January 2022 Warrants [Member] | Dec. 31, 2022 |
Measurement Input, Expected Term [Member] | |
Measurement Input | 1.9 |
Measurement Input, Price Volatility [Member] | |
Measurement Input | 0.499 |
Measurement Input, Risk Free Interest Rate [Member] | |
Measurement Input | 0.0448 |
Measurement Input, Expected Dividend Rate [Member] | |
Measurement Input | 0 |
Measurement Input, Share Price [Member] | |
Measurement Input | 1.25 |
Measurement Input, Exercise Price [Member] | |
Measurement Input | 0.7949 |
Note 4 - Fair Value Measureme_6
Note 4 - Fair Value Measurements - Summary of Change in Estimated Fair VAlue of Level 3 Financial Liabilities (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |
Mar. 31, 2022 | Dec. 31, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Reclass to additional paid-in-capital upon exercise | $ 8,590 | $ 0 | ||
Warrant [Member] | January 2022 Warrants [Member] | ||||
Balance at January 1, 2022 | $ 0 | $ 8,772 | 0 | |
Issuance of warrants | 10,000 | 0 | ||
Change in fair value | (1,228) | (182) | ||
Reclass to additional paid-in-capital upon exercise | (8,590) | |||
Balance at March 31, 2022 | 8,772 | 0 | 0 | 0 |
Warrant [Member] | October 2022 Warrants [Member] | ||||
Balance at January 1, 2022 | 0 | 0 | 0 | |
Issuance of warrants | 0 | 16,490 | ||
Change in fair value | 0 | 10,391 | ||
Reclass to additional paid-in-capital upon exercise | 0 | |||
Balance at March 31, 2022 | $ 0 | $ 26,881 | $ 26,881 | $ 0 |
Note 5 - Collaboration and Li_2
Note 5 - Collaboration and License Agreement (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | 26 Months Ended | ||
Nov. 06, 2020 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2022 | |
Revenue from Contract with Customer, Excluding Assessed Tax, Total | $ 9,137 | $ 7,442 | ||
Contract with Customer, Liability, Current | 4,414 | 4,571 | $ 4,414 | |
Contract with Customer, Liability, Noncurrent | 621 | 3,548 | 621 | |
3D Medicines, Inc [Member] | ||||
Proceeds from Collaborators | 15,000 | 27,000 | ||
Collaborative Agreement, Maximum Clinical Development, Regulatory and Commercial Milestone Payments | $ 207,000 | |||
Collaborative Agreement, Royalty, Period After First Commercial Sale of Product (Year) | 10 years | |||
Revenue, Remaining Performance Obligation, Amount | 27,000 | 27,000 | ||
Contract with Customer, Liability, Total | 5,000 | 8,100 | 5,000 | |
Contract with Customer, Liability, Current | 4,400 | 4,400 | ||
Contract with Customer, Liability, Noncurrent | 600 | 600 | ||
Contract with Customer, Liability, Revenue Recognized | $ 5,300 | |||
Service Period (Year) | 2 years | |||
3D Medicines, Inc [Member] | Research and Development Services [Member] | ||||
Revenue, Remaining Performance Obligation, Amount | $ 14,500 | 14,500 | ||
Revenue from Contract with Customer, Excluding Assessed Tax, Total | 6,300 | 3,200 | ||
3D Medicines, Inc [Member] | License [Member] | ||||
Revenue, Remaining Performance Obligation, Amount | 12,500 | $ 12,500 | ||
Revenue from Contract with Customer, Excluding Assessed Tax, Total | $ 2,800 | $ 4,200 |
Note 6 - Leases (Details Textua
Note 6 - Leases (Details Textual) $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Aug. 31, 2020 USD ($) ft² | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Mar. 31, 2017 ft² | |
Short-term and Variable Lease, Cost | $ 400 | |||
Lease, Cost, Total | 1,800 | $ 1,600 | ||
Operating Lease, Payments | $ 3,000 | 2,500 | ||
Operating Lease, Weighted Average Remaining Lease Term (Year) | 1 year 10 months 24 days | |||
Operating Lease, Weighted Average Discount Rate, Percent | 7.62% | |||
Sublease Income | $ 2,900 | 1,000 | ||
Proceeds from Lease Payment, Operating Activity | $ 2,800 | $ 900 | ||
The 1020 Marsh Road Facility [Member] | ||||
Area of Real Estate Property (Square Foot) | ft² | 34,500 | |||
Lessee, Operating Lease, Term of Contract (Month) | 87 months | |||
Lessee, Operating Lease, Number of Renewal Options | 1 | |||
Lessee, Operating Lease, Renewal Term (Year) | 5 years | |||
Office Space in North Carolina [Member] | ||||
Area of Real Estate Property (Square Foot) | ft² | 4,128 | |||
Lessee, Operating Lease, Term of Contract (Month) | 63 months | |||
Lessee, Operating Lease, Monthly Payments | $ 9 | |||
Lessee, Operating Lease, Abatement Term (Month) | 3 months |
Note 6 - Leases - Minimum Lease
Note 6 - Leases - Minimum Lease Payments Under Non-cancellable Operating Leases (Details) $ in Thousands | Dec. 31, 2022 USD ($) |
2023 | $ 3,039 |
2024 | 2,620 |
2025 | 116 |
2026 | 30 |
Total future minimum lease payments | 5,805 |
Less: discount | (1,728) |
Total lease liabilities | $ 4,077 |
Note 6 - Leases - Future Based
Note 6 - Leases - Future Based Rent (Details) - The 1020 Marsh Road Facility [Member] - Grail, Inc [Member] $ in Thousands | Dec. 31, 2022 USD ($) |
2023 | $ 2,372 |
2024 | 2,029 |
Total | $ 4,401 |
Note 7 - Commitments and Cont_2
Note 7 - Commitments and Contingencies (Details Textual) $ in Thousands | Dec. 31, 2022 USD ($) |
Estimated Litigation Liability | $ 0 |
Note 8 - Common Stock and Com_3
Note 8 - Common Stock and Common Stock Warrants (Details Textual) - USD ($) | 12 Months Ended | ||||||||
Oct. 27, 2022 | Jun. 06, 2022 | Apr. 01, 2022 | Mar. 31, 2022 | Jan. 05, 2022 | Feb. 18, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | Sep. 04, 2020 | |
Common Stock, Shares Authorized (in shares) | 100,000,000 | 100,000,000 | |||||||
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 0.0001 | $ 0.0001 | |||||||
Common Stock, Shares, Issued (in shares) | 59,844,850 | 21,039,594 | |||||||
Proceeds from Issuance of Common Stock and Warrants, Net | $ 9,300,000 | ||||||||
January 2022 Warrants [Member] | |||||||||
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ 0.0001 | ||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 4,545,455 | 4,545,455 | 4,545,455 | ||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 2.20 | ||||||||
Common Stock, Shares, Issued (in shares) | 10,000,000 | ||||||||
Stock and Warrants Issued During Period, Value, Preferred Stock and Warrants | $ 10,000,000 | ||||||||
Stock Issued During Period, Shares, Exercise of Warrants (in shares) | 4,545,455 | ||||||||
Pre-funded Warrants [Member] | |||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 0.001 | ||||||||
Class of Warrant or Right, Issued During Period (in shares) | 1,665,025 | ||||||||
Class of Warrant or Right, Exercised During Period (in shares) | 1,665,025 | ||||||||
Common Stock Warrants [Member] | |||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 45,178,811 | 4,850,241 | |||||||
Prefunded Warrant and Common Stock Warrants [Member] | |||||||||
Class of Warrant or Right, Purchase Price of Warrants or Rights (in dollars per share) | $ 0.9198 | ||||||||
Common Stock Warrants 1 [Member] | |||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | 0.7949 | ||||||||
Common Stock Warrants 2 [Member] | |||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 0.7949 | ||||||||
Eshelman Ventures [Member] | Pre-funded Warrants [Member] | |||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 860,216 | ||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 2.20 | ||||||||
Warrants and Rights Outstanding, Term (Year) | 5 years | ||||||||
Institutional Investor [Member] | Pre-funded Warrants [Member] | |||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 3,990,025 | ||||||||
Institutional Investor [Member] | Common Stock Warrants [Member] | |||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 3,990,025 | ||||||||
At-the-market Offering [Member] | |||||||||
Stock Issued During Period, Value, New Issues | $ 123,000 | $ 9,767,000 | |||||||
Proceeds from Issuance of Common Stock | $ 123,000 | $ 9,767,000 | |||||||
At-the-market Offering [Member] | Piper Sandler & Co. and Cantor Fitzgerald & Co. [Member] | |||||||||
Equity Distribution Agreement, Maximum Aggregate Offering Price | $ 60,000,000 | ||||||||
Stock Issued During Period, Shares, New Issues (in shares) | 54,763 | 1,432,627 | |||||||
Stock Issued During Period, Value, New Issues | $ 100,000 | $ 9,800,000 | |||||||
Securities Purchase Agreement [Member] | Eshelman Ventures [Member] | |||||||||
Stock Issued During Period, Shares, New Issues (in shares) | 2,875,000 | ||||||||
Shares Issued, Price Per Share (in dollars per share) | $ 7.29 | ||||||||
Proceeds from Issuance of Common Stock | $ 20,900,000 | ||||||||
Direct Offering [Member] | |||||||||
Stock Issued During Period, Value, New Issues | 20,866,000 | ||||||||
Proceeds from Issuance of Common Stock and Warrants, Net of Issuance Costs | 19,171,000 | 20,866,000 | |||||||
Direct Offering [Member] | January 2022 Warrants [Member] | |||||||||
Proceeds from Issuance of Common Stock and Warrants, Net of Issuance Costs | $ 9,900,000 | ||||||||
Registered Direct Offering [Member] | |||||||||
Stock Issued During Period, Shares, New Issues (in shares) | 3,185,216 | ||||||||
Stock Issued During Period, Value, New Issues | 9,291,000 | ||||||||
Registered Direct Offering [Member] | Eshelman Ventures [Member] | |||||||||
Stock Issued During Period, Shares, New Issues (in shares) | 860,216 | ||||||||
Registered Direct Offering [Member] | Institutional Investor [Member] | |||||||||
Stock Issued During Period, Shares, New Issues (in shares) | 2,325,000 | ||||||||
Common Stock Warrants [Member] | Eshelman Ventures [Member] | |||||||||
Class of Warrant or Right, Purchase Price of Warrants or Rights (in dollars per share) | $ 2.325 | ||||||||
Common Stock Warrants [Member] | Institutional Investor [Member] | |||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | 1.88 | ||||||||
Class of Warrant or Right, Purchase Price of Warrants or Rights (in dollars per share) | $ 2.005 | ||||||||
Warrants and Rights Outstanding, Term (Year) | 5 years | ||||||||
Pre-funded Warrants [Member] | Institutional Investor [Member] | |||||||||
Class of Warrant or Right, Purchase Price of Warrants or Rights (in dollars per share) | $ 2.004 | ||||||||
Private Placement [Member] | |||||||||
Stock Issued During Period, Shares, New Issues (in shares) | 45,178,811 | ||||||||
Stock Issued During Period, Value, New Issues | 24,147,000 | ||||||||
Proceeds from Issuance of Common Stock and Warrants, Net of Issuance Costs | $ 40,032,000 | $ 0 | |||||||
Shares and Warrants Issued, Price Per Share (in dollars per share) | $ 0.9199 | ||||||||
Proceeds from Issuance or Sale of Equity, Total | $ 40,000,000 |
Note 8 - Common Stock and Com_4
Note 8 - Common Stock and Common Stock Warrants - Reserved Shares of Common Stock for Future Issuances (Details) - shares | Dec. 31, 2022 | Dec. 31, 2021 |
Reserved shares of common stock for future issuances (in shares) | 26,291,959 | 4,570,924 |
Equity-based Awards [Member] | ||
Reserved shares of common stock for future issuances (in shares) | 1,001,087 | 2,131,671 |
Share-Based Payment Arrangement, Option [Member] | ||
Reserved shares of common stock for future issuances (in shares) | 4,570,432 | 2,439,253 |
Pre-funded and March 31, 2022 Warrants [Member] | ||
Reserved shares of common stock for future issuances (in shares) | 20,720,440 | 0 |
Note 8 - Common Stock and Com_5
Note 8 - Common Stock and Common Stock Warrants - Common Stock Warrants Outstanding (Details) - $ / shares | Dec. 31, 2022 | Apr. 01, 2022 | Mar. 31, 2022 | |
Exercise price (in dollars per share) | $ 0.0001 | $ 0.0001 | ||
Common Stock Warrants Related to Registered Direct Offering 1 [Member] | ||||
Exercise price (in dollars per share) | $ 1.88 | |||
Number of warrants (in shares) | 3,990,025 | |||
Pre-funded Warrants Related to Private Placement [Member] | ||||
Exercise price (in dollars per share) | $ 0.0001 | |||
Number of warrants (in shares) | 15,870,199 | |||
Common Stock Warrants Related to Registered Direct Offering 2 [Member] | ||||
Exercise price (in dollars per share) | $ 2.20 | |||
Number of warrants (in shares) | 860,216 | |||
Common Stock Warrants Related to Private Placement Series A [Member] | ||||
Exercise price (in dollars per share) | [1] | $ 0.7949 | ||
Number of warrants (in shares) | 22,589,410 | |||
Common Stock Warrants Related to Private Placement Series B [Member] | ||||
Exercise price (in dollars per share) | $ 0.7949 | |||
Number of warrants (in shares) | 22,589,401 | |||
[1]These warrants expire on the date that is the later of: (i) 15 months from the date an increase in the number of authorized shares of common stock is effected (which occurred on January 17, 2023), or (ii) one month after the public announcement of the topline Phase 3 platinum-resistant ovarian cancer PROC data. |
Note 9 - Stock Based Awards (De
Note 9 - Stock Based Awards (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |||
Jan. 01, 2021 | Mar. 20, 2014 | Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period, Intrinsic Value | $ 1,000 | |||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Exercises in Period (in shares) | 0 | |||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value (in dollars per share) | $ 1.53 | $ 4.43 | ||
Share-Based Payment Arrangement, Option [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period (Year) | 4 years | |||
Share-based Payment Arrangement, Expense, Tax Benefit | $ 0 | |||
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount, Total | $ 2,900 | |||
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition (Year) | 2 years 6 months | |||
The 2019 Plan [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant (in shares) | 673,591 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Percentage of Outstanding Stock Maximum | 4.50% | |||
Employee Stock Purchase Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized (in shares) | 2,500 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized, Percentage | 1% | |||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized (in shares) | 50,000 |
Note 9 - Stock Based Awards - A
Note 9 - Stock Based Awards - Activity Under Stock Option Plan (Details) $ / shares in Units, $ in Thousands | 12 Months Ended |
Dec. 31, 2022 USD ($) $ / shares shares | |
Balances, number of shares (in shares) | shares | 2,439,253 |
Balances, weighted average exercise price (in dollars per share) | $ / shares | $ 3.96 |
Options granted, number of shares (in shares) | shares | 2,888,641 |
Options granted, weighted average exercise price (in dollars per share) | $ / shares | $ 1.61 |
Options cancelled, number of shares (in shares) | shares | (757,462) |
Options cancelled, weighted average exercise price (in dollars per share) | $ / shares | $ 3.81 |
Options exercised, number of shares (in shares) | shares | 0 |
Options exercised, weighted average exercise price (in dollars per share) | $ / shares | $ 0 |
Balances, number of shares (in shares) | shares | 4,570,432 |
Balances, weighted average exercise price (in dollars per share) | $ / shares | $ 2.50 |
Balances, weighted average remaining contractual life (Year) | 7 years 2 months 12 days |
Balances, aggregate intrinsic value | $ | $ 1,239 |
Outstanding and expected to vest, number of shares (in shares) | shares | 4,100,681 |
Outstanding and expected to vest, weighted average exercise price (in dollars per share) | $ / shares | $ 2.54 |
Outstanding and expected to vest, weighted average remaining contractual life (Year) | 7 years 1 month 6 days |
Outstanding and expected to vest, aggregate intrinsic value | $ | $ 1,184 |
Exercisable, number of shares (in shares) | shares | 2,348,015 |
Exercisable, weighted average exercise price (in dollars per share) | $ / shares | $ 2.89 |
Exercisable, weighted average remaining contractual life (Year) | 5 years 3 months 18 days |
Exercisable, aggregate intrinsic value | $ | $ 877 |
Note 9 - Stock Based Awards - W
Note 9 - Stock Based Awards - Weighted-average Assumptions (Details) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Expected volatility | 113% | 114.20% |
Risk-free interest rate | 2.20% | 0.80% |
Dividend yield | 0% | 0% |
Expected life (in years) (Year) | 6 years | 6 years |
Note 9 - Stock Based Awards - S
Note 9 - Stock Based Awards - Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Stock-based compensation expense | $ 2,560 | $ 2,257 |
Research and Development Expense [Member] | ||
Stock-based compensation expense | 889 | 932 |
General and Administrative Expense [Member] | ||
Stock-based compensation expense | $ 1,671 | $ 1,325 |
Note 10 - Income Taxes (Details
Note 10 - Income Taxes (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Valuation Allowance, Deferred Tax Asset, Increase (Decrease), Amount | $ 5,000 | $ 8,100 | |
Operating Loss Carryforwards | 2,400 | ||
Unrecognized Tax Benefits, Ending Balance | 165 | $ 164 | $ 164 |
Research Tax Credit Carryforward [Member] | |||
Tax Credit Carryforward, Amount | $ 300 |
Note 10 - Income Taxes - Provis
Note 10 - Income Taxes - Provision (Benefit) for Federal Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Federal | $ 0 | $ 0 |
State | 0 | 0 |
Federal | 0 | 0 |
State | 0 | 0 |
Total deferred tax expense | 0 | 0 |
Total income tax expense | $ 0 | $ 0 |
Note 10 - Income Taxes - Effect
Note 10 - Income Taxes - Effect Income Tax Rate Reconciliation (Details) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Federal tax benefit at statutory rate | 21% | 21% |
Change in valuation allowance | 6.50% | (21.00%) |
Section 382 limitation | (24.10%) | 0% |
Other non-deductible expenses | 0% | (1.00%) |
Stock based compensation | 0% | 0% |
Other | (3.40%) | 1% |
Total | 0% | 0% |
Note 10 - Income Taxes - Net De
Note 10 - Income Taxes - Net Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Net operating loss carry forwards | $ 504 | $ 18,205 |
Research and development tax credits | 232 | 404 |
Capitalized research and development | 13,026 | 0 |
Stock based compensation and other | 3,878 | 3,694 |
Operating lease obligation | 856 | 1,339 |
Total deferred tax assets | 18,496 | 23,642 |
Less: Valuation allowance | (18,189) | (23,179) |
Operating lease right-of-use assets | (307) | (463) |
Net deferred tax assets | $ 0 | $ 0 |
Note 10 - Income Taxes - Unreco
Note 10 - Income Taxes - Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Balance at January 1, 2021 | $ 164 | $ 164 |
Gross increase/ (decrease) related to prior year tax positions | 0 | 0 |
Gross increase related to current year positions | 1 | 0 |
Reductions to unrecognized tax benefits related to lapsing statute of limitations | 0 | 0 |
Balance at December 31, 2021 | $ 165 | $ 164 |
Note 11 - Employee Benefit Pl_2
Note 11 - Employee Benefit Plans (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Defined Contribution Plan, Cost | $ 103 | $ 88 |
Note 12 - Net Loss Per Share _3
Note 12 - Net Loss Per Share of Common Stock (Details Textual) - shares shares in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Weighted Average Number of Shares Outstanding, Diluted, Adjustment, Total (in shares) | 0 | 0 |
Note 12 - Net Loss Per Share _4
Note 12 - Net Loss Per Share of Common Stock - Summary of Computation of Basic and Diluted Net Loss Per Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Net loss | $ (76,322) | $ (39,151) |
Net loss per share - basic and diluted (in dollars per share) | $ (2.10) | $ (1.95) |
Weighted-average shares used to compute basic and diluted net loss per share (in shares) | 36,372 | 20,070 |
Note 12 - Net Loss Per Share _5
Note 12 - Net Loss Per Share of Common Stock - Antidilutive Securities (Details) - shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-Based Payment Arrangement, Option [Member] | ||
Anti-dilutive securities (in shares) | 4,570,432 | 2,439,253 |
Common Stock Warrants [Member] | ||
Anti-dilutive securities (in shares) | 50,029,052 | 0 |
Note 13 - Subsequent Events (De
Note 13 - Subsequent Events (Details Textual) - $ / shares | Jan. 17, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Sep. 04, 2020 |
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | |
Common Stock, Shares Authorized (in shares) | 100,000,000 | 100,000,000 | ||
Subsequent Event [Member] | ||||
Common Stock, Shares Authorized (in shares) | 250,000,000 |