Cover
Cover - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2023 | Apr. 08, 2024 | Jun. 30, 2023 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Document Period End Date | Dec. 31, 2023 | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2023 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity File Number | 001-36138 | ||
Entity Registrant Name | AYALA PHARMACEUTICALS, INC. | ||
Entity Central Index Key | 0001100397 | ||
Entity Tax Identification Number | 02-0563870 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Address, Address Line One | 9 Deer Park Drive | ||
Entity Address, Address Line Two | Suite K-1 | ||
Entity Address, City or Town | Monmouth Junction | ||
Entity Address, State or Province | NJ | ||
Entity Address, Postal Zip Code | 08852 | ||
City Area Code | (609) | ||
Local Phone Number | 452-9813 | ||
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 | ||
Entity Shell Company | false | ||
Entity Public Float | $ 3.7 | ||
Entity Common Stock, Shares Outstanding | 42,633,400 | ||
Documents Incorporated by Reference [Text Block] | Portions of the definitive proxy statement for the registrant’s 2024 Annual Meeting of Stockholders (the “2024 Proxy Statement”) are incorporated by reference into Items 10, 11, 12, 13 and 14 in Part III of this Annual Report on Form 10-K. If the 2024 Proxy Statement is not filed by April 29, 2024 (the day that is 120 days after the last day of the registrant’s 2023 fiscal year), an amendment to this annual report on Form 10-K setting forth this information will be duly filed with the Securities and Exchange Commission | ||
ICFR Auditor Attestation Flag | false | ||
Document Financial Statement Error Correction [Flag] | false | ||
Auditor Firm ID | 1281 | ||
Auditor Name | KOST FORER GABBAY & KASIERER | ||
Auditor Location | Tel-Aviv, Israel |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 | |
Current Assets: | |||
Cash and Cash Equivalents | $ 4,882 | $ 2,408 | |
Trade Receivables | 234 | ||
Prepaid Expenses and Other Current Assets | 2,646 | 546 | |
Total Current Assets | 7,528 | 3,188 | |
Long-Term Assets: | |||
Deferred issuance costs | 1,953 | ||
Intangible assets, net | 3,898 | ||
Goodwill | 4,500 | ||
Operating lease right of use asset | 102 | 1,462 | |
Property and Equipment, Net | 540 | 960 | |
Other Assets | 11 | 206 | |
Total Long-Term Assets | 9,051 | 4,581 | |
Total Assets | 16,579 | 7,769 | |
Current Liabilities: | |||
Trade Payables | 6,076 | 4,080 | |
Operating lease liabilities | 166 | 419 | |
Accrued expenses and other payables | 5,554 | 708 | |
Side Agreement and reinvestment rights | [1] | 8,436 | |
Accrued payroll and employee benefits | 786 | 994 | |
Proceed from Asset Sale | 4,000 | ||
Total Current Liabilities | 25,018 | 6,201 | |
Long-Term Liabilities: | |||
Long-term warrant liability | [1] | 6,057 | |
Convertible Note | [1] | 8,141 | |
Uncertain tax position | 1,771 | 1,335 | |
Long-term operating lease liabilities | 9 | 1,332 | |
Total Long-Term Liabilities | 15,978 | 2,667 | |
Stockholders’ Equity: | |||
Common Stock of $0.001 par value per share; 170,000,000 and 37,480,000* shares authorized at December 31, 2023 and 2022, respectively; 11,896,845 and 2,695,067* shares issued at December 31, 2023 and 2022, respectively; 11,857,393 and 2,638,663* shares outstanding at December 31, 2023 and 2022, Respectively. | 12 | 3 | |
Additional Paid-in Capital | 172,797 | 148,052 | |
Accumulated Deficit | (197,226) | (149,154) | |
Total Stockholders’ Equity | (24,417) | (1,099) | |
Total Liabilities and Stockholders’ Equity | $ 16,579 | $ 7,769 | |
[1]Received from related party see note 14. |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2023 | Dec. 31, 2022 | |
Statement of Financial Position [Abstract] | |||
Common stock, par value | $ 0.001 | $ 0.001 | |
Common stock, shares authorized | 170,000,000 | 37,480,000 | [1] |
Common stock, shares issued | 11,896,845 | 2,695,067 | [1] |
Common stock, shares outstanding | 11,857,393 | 2,638,663 | [1] |
[1]All of the Common Stock, additional paid-in capital and per share data have been retroactively adjusted for the impact of the January 2023 merger between Old Ayala, Inc. (f/k/a Ayala Pharmaceuticals, Inc.) and Ayala Pharmaceutical, Inc.(f/k/a Advaxis, Inc.). See note 1. |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Statement [Abstract] | ||
Revenue | $ 13 | $ 692 |
Cost of Revenue | (13) | (602) |
Gross Profit | 90 | |
Research and Development | 24,081 | 27,851 |
General and Administrative | 12,185 | 9,742 |
Operating Loss | (36,266) | (37,503) |
Financial income (expenses), net | (15,718) | 74 |
Loss before taxes on income | (51,984) | (37,429) |
Taxes on Income | 3,912 | (584) |
Net Loss | $ (48,072) | $ (38,013) |
Net Loss per Share attributable to Common Stockholders, Basic | $ (7.99) | $ (13.13) |
Net Loss per Share attributable to Common Stockholders, Diluted | $ (7.99) | $ (13.13) |
Weighted Average Shares Used to Compute Net Loss per Share, Basic | 6,019,063 | 2,895,130 |
Weighted Average Shares Used to Compute Net Loss per Share, Diluted | 6,019,063 | 2,895,130 |
Statement of Changes in Stockho
Statement of Changes in Stockholders' Equity - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid-in Capital [Member] | [1] | Retained Earnings [Member] | Total | ||
Balance at Dec. 31, 2021 | $ 3 | [1] | $ 145,296 | $ (111,141) | $ 34,158 | ||
Balance, shares at Dec. 31, 2021 | [1] | 2,615,360 | |||||
Proceeds from Issuance of common stock, net of issuance cost of $14 | [1],[2] | 512 | 512 | ||||
Proceeds from Issuance of common stock, net of issuance cost, shares | [1] | 58,172 | |||||
Share based compensation | [1],[2] | 2,244 | 2,244 | ||||
Stock-based compensation, shares | [1] | 21,535 | |||||
Net Loss | [1] | (38,013) | (38,013) | ||||
Balance at Dec. 31, 2022 | $ 3 | [1] | 148,052 | (149,154) | $ (1,099) | ||
Balance, shares at Dec. 31, 2022 | [1] | 2,695,067 | |||||
Proceeds from Issuance of common stock, net of issuance cost, shares | 0.1874 | ||||||
Share based compensation | [1] | 1,223 | $ 1,223 | ||||
Stock-based compensation, shares | [1] | 41,650 | |||||
Net Loss | [1] | (48,072) | (48,072) | ||||
exercise of warrants | |||||||
exercise of warrants, shares | [1] | 246,192,000 | |||||
Issuance of shares upon January 2023 Merger, net of issuance costs of $3,153 | 2 | [1] | 16,947 | $ 16,949 | |||
Issuance of shares upon January 2023 Merger, net of issuance costs, shares | [1] | 1,815,951,000 | |||||
Issuance of shares upon Bio sight Merger | 6 | [1] | 5,508 | $ 5,514 | |||
Issuance of shares upon Bio sight Merger, shares | [1] | 5,913,480,000 | |||||
Conversion of SAFE | 1 | [1] | 1,067 | $ 1,068 | |||
Conversion of SAFE, shares | [1] | 1,145,053,000 | |||||
Balance at Dec. 31, 2023 | $ 12 | [1] | $ 172,797 | $ (197,226) | $ (24,417) | ||
Balance, shares at Dec. 31, 2023 | [1] | 11,857,393 | |||||
[1]All of the Common Stock and per share data have been retroactively adjusted and Additional paid in Capital to adjust for common stock amount, for the impact of the January 2023 merger between Old Ayala, Inc. (f/k/a Ayala Pharmaceuticals, Inc.) and Ayala Pharmaceutical, Inc.(f/k/a Advaxis, Inc.). See note 1[2]Represents an amount lower than $1. |
Statement of Changes in Stock_2
Statement of Changes in Stockholders' Equity (Parenthetical) $ in Thousands | 12 Months Ended |
Dec. 31, 2023 USD ($) | |
Statement of Stockholders' Equity [Abstract] | |
Common stock issuance cost | $ 3,153 |
Statements of Consolidated Cash
Statements of Consolidated Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Cash Flows from Operating Activities: | ||
Net Loss | $ (48,072) | $ (38,013) |
Adjustments to reconcile Net Loss to Net Cash used in Operating Activities: | ||
Shared Based Compensation | 1,223 | 2,244 |
Depreciation and Amortization | 369 | 162 |
Asset write-downs | 145 | |
Remeasurement of long-term warrant liability | 5,854 | |
Remeasurement of Side Letter Agreements | 7,751 | |
Remeasurement of convertible note | 2,141 | |
(Increase) Decrease in Prepaid Expenses and other Assets | (1,491) | 2,232 |
Decrease (Increase) in Trade Receivables | 234 | (234) |
Decrease in Trade Payables | (724) | (472) |
Decrease in operating lease right-of-use assets | 1,429 | 288 |
Decrease in operating lease liabilities | (1,641) | (536) |
Increase (decrease) in accrued expenses and other payables | 3,123 | 121 |
Increase (decrease) in accrued payroll and employee benefits | (248) | (767) |
Changes in uncertain tax position | 448 | 465 |
Other | (26) | |
Net Cash used in Operating Activities | (29,485) | (34,510) |
Cash Flows from Investing Activities: | ||
Proceed from Asset Sale | 4,000 | |
Cash acquired from the Biosight Merger | 1,909 | |
Other | 37 | (2) |
Net Cash used in Investing Activities | 5,946 | (2) |
Cash Flows from Financing Activities: | ||
Proceeds from issuance of convertible note from related party | 6,000 | |
Proceeds from issuance of shares, net of issuance cost of $14 | 512 | |
Issuance of shares upon January 2023 Merger, net of issuance costs | 20,001 | (615) |
Net Cash used in Financing Activities | 26,001 | (103) |
Effect of exchange rate changes on cash, cash equivalents and restricted cash | 26 | |
Increase (decrease)in Cash and Cash Equivalents and Restricted Cash | 2,488 | (34,615) |
Cash and Cash Equivalents and Restricted Cash at Beginning of the Year | 2,724 | 37,339 |
Cash and Cash Equivalents and Restricted Cash at End of the Year | 5,212 | 2,724 |
Supplemental Disclosure of investing and financing Activities | ||
Lease liabilities arising from new right-of-use assets | 537 | |
Deferred issuance costs accrued but not yet paid | 1,338 | |
Supplemental Disclosures of Cash Flow Information | ||
Cash Paid for Income Taxes | 371 | 244 |
Cash and Cash Equivalents | 4,882 | 2,408 |
Restricted Cash in Prepaid Expenses and Other Current Assets | 330 | 110 |
Restricted Cash in Other Assets | 206 | |
Cash and Cash Equivalents and Restricted Cash at End of the Year | $ 5,212 | $ 2,724 |
Statements of Consolidated Ca_2
Statements of Consolidated Cash Flows (Parenthetical) $ in Thousands | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Statement of Cash Flows [Abstract] | |
Common stock issuance cost | $ 14 |
General
General | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
General | 1. General In these financial statements, unless otherwise stated or the context otherwise indicates, references to “New Ayala” and the “Company,” refers to Ayala Pharmaceuticals, Inc., a Delaware corporation, which prior to the change of its name effected on January 19, 2023, was known as Advaxis, Inc. The name change was affected in connection with the January 2023 Merger, as described below. References to “former Advaxis” refer to the Company solely in the period prior to the January 2023 Merger. Prior to the January 2023 Merger, the Company was a clinical-stage biotechnology company focused on the development and commercialization of proprietary Listeria monocytogenes Lm Lm Lm Lm TM Following the January 2023 Merger, the Company became primarily a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations. The Company differentiated development approach is predicated on identifying and addressing tumorigenic drivers of cancer, through a combination of the Company’s bioinformatics platform and next-generation sequencing to deliver targeted therapies to underserved patient populations. The Company’s portfolio of product candidates following the January 2023 Merger, AL101 and AL102, targets the aberrant activation of the Notch pathway using gamma secretase inhibitors. All of the Company’s assets relating to AL 101 and AL 102 were sold on March 25, 2024 in the Asset Sale (as defined below). Following the January 2023 Merger, the Company also continued to conduct certain operations relating to former Advaxis’ operations as a clinical-stage biotechnology company focused on the development and commercialization of proprietary Listeria monocytogenes Lm Lm On July 26, 2023, the Company and its wholly owned subsidiary organized under the laws of the State of Israel, Advaxis Israel Ltd. (“Biosight Merger Sub”), entered into an Agreement and Plan of Merger and Reorganization (the “Merger Agreement”) with Biosight Ltd. (“Biosight”), a privately-held Israeli pharmaceutical company developing innovative therapeutics for hematological malignancies and disorders. Under the terms of the Merger Agreement, on October 18, 2023, Merger Sub merged with and into Biosight, which is now a wholly owned subsidiary of the Company (the “Biosight Merger”). See note 3. Based on the agreement, Ayala Pharmaceuticals, Inc. was the legal acquirer in the Biosight Merger. In addition, the Company considered ASC 805-10-55 to determine the accounting acquirer in the Biosight Merger. As the Company holds a majority of the members of the governing body of the combined Company and the Company’s former management dominates the majority of the senior management of the combined Company, and after considering all other factors according to ASC 805-10-55, the Company was identified as the accounting acquirer in the Biosight Merger. The Company has accounted for the Biosight Merger as a business combination according to ASC 805 “Business Combinations”. On February 5, 2024, the Company and Immunome, Inc. (“Immunome”), entered into an Asset Purchase Agreement (the “Asset Purchase Agreement”) pursuant to which Immunome agreed to acquire certain of the Company’s assets and liabilities related to its AL101 and AL102 programs (the “Asset Sale”), which constitute substantially all of the Company’s assets. On March 25, 2024, the Company and Immunome consummated the Asset Sale pursuant to the Asset Purchase Agreement. Immunome paid to the Company an aggregate purchase price of $ 20.0 4.0 2,175,489 0.0001 37.5 16.0 The Asset Purchase Agreement contains customary representations, warranties, conditions and covenants, including covenants (i) concerning the conduct of business by the Company prior to the closing of the Asset Sale, (ii) prohibiting the Company and its representatives from soliciting, initiating or knowingly inducing, encouraging or facilitating any competing acquisition proposal, (iii) prohibiting the Company and its controlled affiliates from competing with Immunome for five years following the closing of the Asset Sale in certain fields, and (iv) restricting the Company’s ability to make distributions to stockholders, dissolve or wind up its business or file for bankruptcy for six months following the closing of the Asset Sale. In the Asset Sale, the Company disposed of the assets relating to AL102, an oral gamma secretase inhibitor in Phase 3 clinical development, and AL 101, and as such, the Company’s clinical assets currently include aspacytarabine (BST-236), a novel proprietary anti-metabolite for first line treatment in unfit acute myeloid leukemia (AML). During the year ended December 31, 2023, the Company had a reduction in workforce in which the employment of approximately 50% of the Company’s employees was terminated. This reduction in workforce has not yet required the Company to cease any major development efforts. Following the reduction in workforce, the Company had 21 employees. See note 17 for information regarding the additional reduction of 18 employees and one officer during the first quarter of 2024, with the employment of a second officer to terminate on June 25, 2024. Going Concern The Company has incurred recurring losses since inception as a research and development organization. For the year ended December 31, 2023, the Company used approximately $ 29.5 48.1 4.9 25.0 197.2 Upon closing of the Asset Sale, on March 25, 2024, the Company received $ 13.0 3.0 2,175,489 2.0 financing, through the sale of a portion of the Immunome Shares or otherwise, in order to May 2024 Raising additional funds or the satisfactory sale of a portion of the Immunome Shares prior to the end of May 2024 is essential to provide sufficient cash flow to meet future liabilities and other obligations, such as tax payments arising from the Asset Sale. Furthermore, even if the Company is successful in selling a portion of the Immunome Shares or raising additional funds through other means, the Company cannot give any assurance that it will, in the future, be able to achieve a level of profitability from the sale of its products to sustain its operations. If the Company is unable to obtain funding, or able to receive sufficient funds from the sale of a portion of the Immunome Shares, the Company would be forced to delay, reduce, or eliminate its research and development programs, or the Company may be unable to continue operations. As such, those factors raise substantial doubt about the Company’s ability to continue as a going concern. As part of a cost reduction plan, during the year ended December 31, 2023, the Company had a reduction in workforce in which the employment of approximately 50% of the Company’s employees was terminated. During the first quarter of 2024, the Company gave notice of termination to 18 additional employees and two officers (including the Chief Financial Officer, whose employment will terminate on June 25, 2024). After the effectiveness of such terminations, the Chief Executive Officer will be the only employee of the Company. The Company expects to be able to meet its financial obligations to its employees. The Company can give no assurances that it will be successful in raising funds through the sale of a portion of the Immunome Shares or any other alternative. Any inability to so obtain additional financing or funding will likely cause the Company to cease business operations. The consolidated financial statements have been prepared assuming that the Company will continue as a going concern. Therefore, the consolidated financial statements for the year ended December 31, 2023, do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from uncertainty related to the Company’s ability to continue as a going concern. |
Significant Accounting Policies
Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies | 2. Significant Accounting Policies Basis of Presentation The consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”). The significant accounting policies followed in the preparation of the consolidated financial statements, are as follows: Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates, judgments and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. The Company’s management believes that the estimates, judgment and assumptions used are reasonable based upon information available at the time they are made. These estimates, judgments and assumptions can affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the dates of the consolidated financial statements. Actual results could differ from those estimates. Consolidated Financial Statements in U.S. Dollars A substantial portion of the Company’s financing activities, including equity transactions and cash investments, are incurred in U.S. dollars. The Company’s management believes that the U.S. dollar is the currency of the primary economic environment in which the Company operates. Thus, the functional and reporting currency of the Company is the U.S. dollar. A subsidiary’s functional currency is the currency of the primary economic environment in which the subsidiary operates; normally, that is the currency of the environment in which a subsidiary primarily generates and expends cash. In making the determination of the appropriate functional currency for a subsidiary, the Company considers cash flow indicators, local market indicators, financing indicators and the subsidiary’s relationship with both the parent company and other subsidiaries. For subsidiaries that are primarily a direct and integral component or extension of the parent entity’s operations, the U.S. dollar is the functional currency. The Company has determined the functional currency of its foreign subsidiary is the U.S. Dollar. The foreign operation is considered a direct and integral part or extension of the Company’s operations. The day-to-day operations of the foreign subsidiary are dependent on the economic environment of the U.S. Dollar. Accordingly, monetary accounts maintained in currencies other than the U.S. dollar are remeasured into U.S. dollars in accordance with Statement of the Accounting Standard Codification (“ASC”) No. 830 “Foreign Currency Matters” (“ASC No. 830”). All transaction gains and losses of the remeasured monetary balance sheet items are reflected in the statements of operations as financial income or expenses as appropriate. Principles of Consolidation The consolidated financial statements include the accounts of the Company and the Subsidiary. Intercompany balances and transactions have been eliminated upon consolidation. Cash and Cash Equivalents and Short-term restricted Cash and Cash Equivalents The Company considers all highly liquid certificates of deposits with original maturities of three months or less from the purchase date to be cash equivalents. Cash equivalents consist primarily of amounts invested in money market accounts in the United States and are stated at carrying value which approximate their fair values. Restricted Cash and Cash Equivalents consist of a bank deposit accounts that serves as collateral for a credit card agreement and lease agreements at one of the Company’s financial institutions. Property and Equipment, Net Property and equipment are stated at cost, less accumulated depreciation. Depreciation is calculated on a straight-line basis over the estimated useful lives of the related assets, at the following annual rates: Schedule of Property and Equipment Estimated Useful Lives Computers and Software 33 % Lab Equipment 15 % Office Furniture and Equipment 7 9 % Leasehold improvements are amortized on a straight-line basis over the shorter of the assets’ estimated useful life ( 10 10 50 Maintenance and repair costs are expensed as incurred. Impairment of Long-Lived Assets The Company’s long-lived assets are reviewed for impairment in accordance with ASC No. 360, “Property, Plant and Equipment,” whenever events or changes in circumstances indicate that the carrying amount of an asset (assets group) may not be recoverable. If indicators of impairment exist and the undiscounted future cash flows that the assets (assets group) are expected to generate are less than the carrying value of the assets (assets group), the Company reduces the carrying amount of the assets through an impairment charge, to their estimated fair values. During the years ended December 31, 2023, and 2022, no impairment loss have been recorded. Accrued Post-Employment Benefit Under Israeli employment laws, employees of the Company are included under Section 14 of the Severance Compensation Act, 1963 (“Section 14”) for a portion of their salaries. According to Section 14, these employees are entitled to monthly payments made by the Company on their behalf with insurance companies. Payments in accordance with Section 14 release the Company from any future severance payments with respect to those employees. The obligation to make the monthly deposits is expensed as incurred. In addition, the aforementioned deposits are not recorded as an asset in the consolidated balance sheet, and there is no liability recorded as the Company does not have a future obligation to make any additional payments. Severance costs amounted to approximately $ 0.2 0.3 The Company maintains a 401(k) retirement savings plan for its U.S. employees. Each eligible employee may elect to contribute a portion of the employee’s compensation to the plan. As of December 31, 2023, and 2022, the Company has matched 100 6 Leases The Company’s leases include offices for its facilities, as well as car leases, which are all classified as operating leases. Short-term leases with a term of 12 At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease. Operating lease liabilities and their corresponding right-of-use assets are recorded at commencement date. The Company records lease liabilities based on the present value of lease payments over the lease term. The ROU asset also includes any lease payments made and excludes lease incentives. The Company generally uses an incremental borrowing rate to discount its lease liabilities, as the rate implicit in the lease is typically not readily determinable. Certain lease agreements include renewal options that are under the Company’s control. The Company includes optional renewal periods in the lease term only when it is reasonably certain that The Company will exercise its option. Certain lease agreements contain variable payments, which are expensed as incurred and not included in the operating lease right-of-use (“ROU”) assets and liabilities. Fair Value of Financial Instruments The Company measures and discloses the fair value of financial assets and liabilities in accordance with ASC Topic 820, “Fair Value Measurement.” Fair value is based on the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at 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 accounting standard establishes a fair value hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three broad levels, which are described below: Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. Level 2: Observable inputs that are based on inputs not quoted on active markets but corroborated by market data. Level 3: Unobservable inputs are used when little or no market data are available. Restricted Cash and Cash Equivalent, trade receivables, trade payables are stated at their carrying value, which approximates fair value due to the short time to the expected receipt or payment date. Research and Development Research and development costs are expensed as incurred. Research and development costs include payroll and personnel expenses, consulting costs, external contract research and development expenses, raw materials, drug product manufacturing costs, and allocated overhead including depreciation, rent, and utilities. Research and development costs that are paid in advance of performance are classified as a prepaid expense and amortized over the service period as the services are provided. Clinical Trial Costs Clinical trial costs are a component of research and development expenses. The Company bases its expenses related to Clinical Research Organization (“CRO”) on the services received, and efforts expanded pursuant to agreements with them. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. For reoccurring services fees, the Company records the services over the time period which services will are based on inputs received from CRO. If the actual timing of the performance of services varies from the calculation, the Company adjusts the accrual or amount of prepaid expenses accordingly to adjust for such changes in time. Patent Costs Legal and related patent costs are expensed as incurred as their realization is uncertain. Costs related to patent registration are classified as general and administrative expenses, and costs related to acquired patents are classified as research and development expenses in the accompanying consolidated statements of operations. Contingent Liabilities The Company accounts for its contingent liabilities in accordance with ASC No. 450, “Contingencies”. A provision is recorded when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. With respect to legal matters, provisions are reviewed and adjusted to reflect the impact of negotiations, estimated settlements, legal rulings, advice of legal counsel and other information and events pertaining to a particular matter. See Note 7. Income Taxes The Company accounts for income taxes in accordance with ASC 740, “Income Taxes”. This standard prescribes the use of the liability method whereby deferred tax asset and liability account balances are determined based on differences between financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company provides a valuation allowance, if necessary, to reduce deferred tax assets to their estimated realizable value, if it is more likely than not that some portion of the entire deferred tax asset will not be realized. The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740-10, “Income Taxes”. Accounting guidance addresses the determination of whether tax benefits claimed or expected to be claimed on a tax return should be recorded in the consolidated financial statements, under which a Company may recognize the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by the taxing authorities, based on the technical merits of the position. The tax benefits recognized in the consolidated financial statements from such a position should be measured based on the largest benefit that has a greater than fifty percent likelihood of being realized upon ultimate settlement. Although the Company believes that it has adequately reserved for its uncertain tax positions (including net interest and penalties), it can provide no assurance that the final tax outcome of these matters will not be materially different. The Company makes adjustments to these reserves when facts and circumstances change, such as the closing of a tax audit or the refinement of an estimate. To the extent that the final tax outcome of these matters is different from the amounts recorded, such differences will affect the income tax expense in the period in which such determination is made. Concentrations of Credit Risk Financial instruments that potentially subject the Company to a concentration of credit risk consist primarily of cash and cash equivalents. Bank deposits are held by accredited financial institutions and these deposits may at times be in excess of insured limits. Money Market funds are of Prime A and only invested in government issued securities. The Company limits its credit risk associated with cash and cash equivalents by placing them with financial institutions that it believes are of high-quality credit rating. The Company has not experienced any losses on its deposits of cash or cash equivalents. The Company did not have any customers as of December 31, 2023. The Company’s trade receivables as of December 31, 2022 were from one customer. In addition, the potential risk of loss with any one counterparty resulting from this type of credit risk is monitored on an ongoing basis. Stock-Based Compensation The Company measures its stock-based payment awards made to employees, directors, and non-employee service providers based on estimated fair values. The fair value of each option award is estimated on the grant date using the Black-Scholes option pricing model. The Company recognizes compensation expenses based on the accelerated method over the requisite service period. The Company recognizes forfeitures of awards as they occur. The Black-Scholes option pricing model requires a number of assumptions, of which the most significant are share price, expected volatility, expected option term (the time from the grant date until the options are exercised or expire), risk-free rate, and expected divided rate. After the IPO, the fair value of each ordinary share was based on the closing price of the Company’s publicly traded ordinary shares as reported on the date of the grant. Expected volatility As the Company has a short trading history for its ordinary shares, the expected volatility is derived from the average historical share volatilities of several unrelated public companies within the Company’s industry that the Company considers to be comparable to its own business over a period equivalent to the option’s expected term. Expected Dividend Yield The Company has historically not paid dividends and has no foreseeable plans to pay dividends, and therefore the Company uses an expected dividend yield of 0 Risk-Free Interest Rate The risk-free interest rate is based on the yield from U.S. Treasury zero-coupon bonds with an equivalent expected term. Expected Term Restricted shares are valued at the fair value of shares on the date of grant. Basic and Diluted Net Loss per Share Basic loss per share is computed by dividing the net loss by the weighted average number of shares of Common Stock outstanding during the period. Diluted loss per share is computed by dividing the net loss by the weighted average number of shares of Common Stock outstanding together with the number of additional shares of Common Stock that would have been outstanding if all potentially dilutive shares of Common Stock had been issued. Diluted net loss per share is the same as basic net loss per share in periods when the effects of potentially dilutive shares of Common Stock are anti-dilutive. Business combinations The Company accounts for business combinations by applying the provisions of ASC 805, Business Combination (“ASC 805”) and allocates the fair value of the purchase consideration to the tangible and intangible assets acquired and liabilities assumed based on their estimated fair values. The excess of the fair value of purchase consideration over the fair value of these identifiable assets and liabilities is recorded as goodwill. When determining the fair value of assets acquired and liabilities assumed, management makes significant estimates and assumptions, especially with respect to intangible assets. Acquisition-related expenses are expensed as incurred. Goodwill and acquired intangible assets Goodwill and acquired intangible assets recorded in the Company’s financial statements result from both business combinations. Goodwill represents the excess of the purchase price in a business combination over the fair value of identifiable tangible and intangible assets acquired and liabilities assumed. Goodwill is not amortized as it is estimated to have an indefinite life. As such, goodwill is subject to an annual impairment test. The Company allocates goodwill to reporting units based on the expected benefit from the business combination. Reporting units are evaluated when changes in the Company’s operating structure occur, and if necessary, goodwill is reassigned using a relative fair value allocation approach. The Company operates in one operating segment, and this segment is the only reporting unit. ASC 350, Intangibles—Goodwill and Other During the last quarter of 2023, the Company experienced a significant decline in the stock price, which might suggest the fair value of the reporting unit is less than its carrying amount. However, when the Company performed its annual goodwill impairment test on December 31, 2023, it was noted that the reporting unit have a negative carrying amount. The Company concluded that no goodwill impairment should be recorded since after performing a quantitative test, the reporting unit’s fair value is not less than its carrying amount. Separately acquired intangible assets are measured on initial recognition at cost including directly attributable costs. Intangible assets acquired in a business combination are measured at fair value at the acquisition date. Acquired identifiable finite-lived intangible assets are amortized on a straight-line basis over the estimated useful life of the respective asset. Each period the Company evaluates the estimated remaining useful lives of its intangible assets and whether events or changes in circumstances warrant a revision to the remaining period of amortization. Acquired indefinite-lived intangible assets are not amortized but are tested for impairment at least annually or more frequently if events or changes in circumstances indicate that the intangible asset may be impaired. Segment Information Financial information is available for evaluation by the chief operating decision maker, the Company’s Chief Executive Officer, in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business in one operating segment. Operating segments are defined as components of an enterprise in which separate financial information is evaluated regularly by the chief operating decision maker in deciding how to allocate resources and assessing performance. The geographical regions of the Company’s intangible assets are as follows: Schedule of Geographical Region of Long-Lived Assets 2023 2022 Year ended December 31, December 31, 2023 2022 Israel 3,800 - United States 98 - Total 3,898 - Total intangible assets 3,898 - The geographical regions of the Company’s long lived asset including rights of use are as follows: Year ended Year ended December 31, December 31, 2023 2022 Israel 600 2,392 United States 42 30 Total 642 2,422 Total rights of use of assets and property and equipment 642 2,422 A ll Schedule of Geographical Region of Revenues Revenue Recognition The Company recognizes revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers, which applies to all contracts with customers. Under Topic 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of Topic 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. At contract inception, once the contract is determined to be within the scope of Topic 606, the Company assesses the goods or services promised within the contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. Customer option to acquire additional goods or services gives rise to a performance obligation in the contract only if the option provides a material right to the customer that it would not receive without entering into that contract. In a contract with multiple performance obligations, the Company develop estimates and assumptions that require judgment to determine the underlying stand-alone selling price for each performance obligation, which determines how the transaction price is allocated among the performance obligations. The Company evaluates each performance obligation to determine if it can be satisfied at a point in time or over time. Revenue is recognized when control of the promised goods or services is transferred to the customers, in an amount that reflects the consideration the Company expect to be entitled to receive in exchange for those goods or services. Recently Adopted Accounting Pronouncements In June 2016, the FASB issued ASU No. 2016-13 (Topic 326), Financial Instruments—Credit Losses: Measurement of Credit Losses on Financial Instruments, which replaces the existing incurred loss impairment model with an expected credit loss model and requires a financial asset measured at amortized cost to be presented at the net amount expected to be collected. The new guidance was effective for the Company on January 1, 2023 and the adoption did not have a material impact on the Company’s consolidated financial statements. Recently Issued Accounting Pronouncements Not Yet Adopted In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which requires public entities to disclose information about their reportable segments’ significant expenses and other segment items on an interim and annual basis. Public entities with a single reportable segment are required to apply the disclosure requirements in ASU 2023-07, as well as all existing segment disclosures and reconciliation requirements in ASC 280 on an interim and annual basis. ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, and for interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact of adopting ASU 2023-07. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which requires public entities, on an annual basis, to provide disclosure of specific categories in the rate reconciliation, as well as disclosure of income taxes paid disaggregated by jurisdiction. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact of adopting ASU 2023-09. |
Mergers
Mergers | 12 Months Ended |
Dec. 31, 2023 | |
Business Combination and Asset Acquisition [Abstract] | |
Mergers | 3. Mergers Merger with Ayala Pharmaceuticals, Inc. On October 18, 2022, the Company, which at the time was named Advaxis, Inc., entered into a Merger Agreement (the “Merger Agreement”), with an entity then known as Ayala Pharmaceuticals, Inc. (which shortly prior to the closing of the merger in January 2023 changed its name to Old Ayala, Inc., (“Old Ayala”) and Doe Merger Sub, Inc. (“Merger Sub”), a direct, wholly-owned subsidiary of the Company. Under the terms of the Merger Agreement, Merger Sub merged with and into Old Ayala, with Old Ayala continuing as the surviving company and a wholly-owned subsidiary of the Company (the “January 2023 Merger”). Immediately after the January 2023 Merger, former Advaxis stockholders as of immediately prior to the Merger own approximately 37.5 62.5 At the effective time of the January 2023 Merger (the “Effective Time”), each share of share capital of Old Ayala issued and outstanding immediately prior to the Effective Time was converted into the right to receive a number of shares of the Company’s common stock, par value $ 0.001 0.1874 The January 2023 Merger has been accounted for as a reverse merger with Old Ayala as the accounting acquirer and former Advaxis as the accounting acquiree. In identifying Old Ayala as the accounting acquirer, the companies considered ASC 805-10-55 including the structure of the January 2023 Merger, relative outstanding share ownership at closing and the composition of the combined Company’s board of directors and senior management. The financial reporting reflects the accounting from the perspective of Old Ayala (“accounting acquirer”), except for the legal capital, which has been retroactively adjusted to reflect the capital of former Advaxis (“accounting acquiree”) in accordance with ASC 805-40-45. As such, the historical financial information presented is that of Old Ayala as the accounting acquirer in the January 2023 Merger. Because most of the value of the assets of former Advaxis was in cash and cash equivalents, the January 2023 Merger is treated primarily as a financing transaction for accounting purposes with a small component as a business acquisition. Therefore, no gain or loss is recorded as a result of the January 2023 Merger. Old Ayala’s transaction costs were capitalized and offset against the shareholder’s equity upon the January 2023 Merger, and former Advaxis’ transaction costs were expensed as merger costs. The consolidated financial statements from the closing date of the January 2023 Merger include the assets, liabilities, and results of operations of the combined company. Fair Value Allocation The following sets forth the fair value of acquired identifiable assets and assumed liabilities of former Advaxis which includes adjustments to reflect the fair value of intangible assets acquired (in thousands) as of January 19, 2023: Schedule of fair value of Intangible Assets Acquired Amounts Cash and cash equivalents $ 22,539 Prepaid expenses and other current assets 300 Property and equipment, net 34 Intangible assets 130 Operating right-of-use asset 5 Other assets 11 Goodwill Total assets 23,019 SAFE liability Common stock warrant liability (203 ) Other current liabilities and trade payables (2,714 ) Total liabilities (2,917 ) Net assets acquired $ 20,102 The fair value estimate for all identifiable assets and liabilities assumed is preliminary and is based on assumptions that market participants would use in pricing an asset, based on the most advantageous market for the asset (i.e., its highest and best use). This fair value estimate could include assets that are not intended to be used, may be sold, or are intended to be used in a manner other than their best use. The Company recognized intangible assets related to the January 2023 Merger, which consist of the Patents and License agreements valued at $ 130 The results of operations of Advaxis have been included in the consolidated financial statements since the acquisition date of January 19, 2023.There is no practical way to determine net income attributable to the former Advaxis due to integration. Merger with Biosight Ltd. On July 26, 2023, the Company and its wholly owned subsidiary organized under the laws of the State of Israel, Advaxis Israel Ltd. (“Biosight Merger Sub”), entered into an Agreement and Plan of Merger and Reorganization (the “Merger Agreement”) with Biosight Ltd. (“Biosight”), a privately-held Israeli pharmaceutical company developing innovative therapeutics for hematological malignancies and disorders. Under the terms of the Merger Agreement, on October 18, 2023, Merger Sub merged with and into Biosight, which is now a wholly owned subsidiary of the Company (the “Biosight Merger”). At completion of the Biosight Merger, Ayala’s then-current equity holders own approximately 45 55 Based on the agreement, the Company was the legal acquirer in the Biosight Merger. In addition, the Company considered ASC 805-10-55 to determine the accounting acquirer in the Biosight Merger. As the Company holds a majority of the members of the governing body of the combined Company and the Company’s former management dominates the majority of the senior management of the combined Company, and after considering all other factors according to ASC 805-10-55, the Company was identified as the accounting acquirer in the Biosight Merger. The Company has accounted for the Biosight Merger as a business combination according to ASC 805 “Business Combinations”. Fair Value Allocation The following sets forth the fair value of acquired identifiable assets and assumed liabilities of Biosight which includes to reflect the fair value of intangible assets acquired (in thousands) as of October 18, 2023: Schedule of fair value of Intangible Assets Acquired Amounts Cash and cash equivalents $ 1,909 Fixed Assets, net 64 Prepaid expenses and other current assets 89 Intangible assets 3,800 Goodwill 4,500 Total assets 10,363 Side Letter Agreement Liability (685 ) SAFE liability (1,068 ) Other current liabilities and trade payables (3,096 ) Total liabilities (4,849 ) Net assets acquired $ 5,514 The fair value estimate for all identifiable assets and liabilities assumed and is based on assumptions that market participants would use in pricing an asset, based on the most advantageous market for the asset (i.e., its highest and best use). This preliminary fair value estimate could include assets that are not intended to be used, may be sold, or are intended to be used in a manner other than their best use. Such estimates are subject to change during the measurement period, which is not expected to exceed one year. Any adjustments identified during the measurement period will be recognized in the period in which the adjustments are determined. The Company recognized intangible assets related to the Biosight Merger, consisting of certain patents and license agreements (“In Process Technology”) valued at $ 3.8 4.5 Acquisition-related transaction costs are not included as components of consideration transferred but are accounted for as expenses in the period in which the costs are incurred. The Company incurred transaction costs of $ 1.0 The results of operations of Biosight have been included in the consolidated financial statements since the acquisition date of October 18, 2023. There is no practical way to determine net income attributable to Biosight due to integration. The following unaudited table provides certain pro forma financial information for the Company as if the January 2023 Merger and the Biosight Merger occurred on January 1, 2022 (in thousands except per share amounts): Schedule of Pro Forma Financial Information Year Year ended ended December 31, December 31, 2023 2022* Unaudited Unaudited Revenue $ 13 $ 942 Net loss $ (57,344 ) $ (63,011 ) * The pro forma amounts above are derived from historical numbers of the Company, Old Ayala and Biosight. The results of operations for the year ended December 31, 2022 include the operations of the Company for the period from November 1, 2022 to October 31, 2023 which was the fiscal year 2022 prior to the change in the Company’s fiscal year end from October 31 to December 31, which change was effected in January 2023. There are no such adjustments for Biosight as the fiscal year ended on December 31, 2023. The unaudited pro forma results have been prepared based on estimates and assumptions, which we believe are reasonable; however, they are not necessarily indicative of the consolidated results of operations had the acquisition occurred on January 1, 2022, or of future results of operations. |
Property and Equipment, net
Property and Equipment, net | 12 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, net | 4. Property and Equipment, net Property and Equipment, net consists of the following: Schedule of Property and Equipment, Net December 31, December 31, 2023 2022 (in thousands) Cost: Computers and Software $ 60 $ 73 Lab Equipment 95 296 Office Furniture and Equipment 92 146 Leasehold Improvements 1,105 1,105 Property and Equipment, Gross 1,352 1,620 Less: Accumulated Depreciation 812 660 Property and Equipment, Net $ 540 $ 960 Depreciation expenses for the years ended December 31, 2023, and 2022 was approximately $ 334 162 During the year ended December 31, 2023 the Company recorded a write down to assets due to inactivity of lab equipment and intention to dispose or sell all of them of $ 145 |
Leases
Leases | 12 Months Ended |
Dec. 31, 2023 | |
Leases | |
Leases | 5. Leases The Company adopted ASC 842, relating to lease accounting, in the first quarter of 2022 using the modified retrospective method. Results for reporting periods beginning after December 31, 2021, have been presented in accordance with the standard. The cumulative effect of initially applying the new leases standard was recognized as an adjustment to the opening consolidated balance sheet as of January 1, 2022. The Company elected a package of practical expedients for leases that commenced prior to January 1, 2022, and did not reassess historical conclusions on: (i) whether any expired or existing contracts are or contain leases; (ii) lease classification for any expired or existing leases; and (iii) initial direct costs capitalization for any existing leases. This standard had a significant impact on the Company’s consolidated balance sheet but did not have a significant impact on the Company’s consolidated statements of operations. The most significant effects relate to the recognition on the consolidated balance sheet of ROU assets and lease liabilities for offices and for car operating leases. Upon adoption, the Company recognized lease liabilities and corresponding ROU assets, adjusted for the accrued rent and remaining lease incentives received on the adoption date, as follows: Schedule of Lease Liabilities and ROU Assets ROU assets Lease liabilities January 1, 2022 ROU Lease liabilities Offices $ 1,448 $ 2,020 Cars 302 267 Total operating leases $ 1,750 $ 2,287 In January 2019, the Company signed a new lease agreement. The term of the lease is for 63 60 0.5 A subsidiary of the Company obtained a bank guarantee in the amount of approximately $ 0.2 million On March 25, 2021, the Company entered into a one-year lease agreement for its corporate office/lab with base rent of approximately $ 29 March 31, 2023 March 31, 2025 36 65 The Company did not extend the lease for an additional five years, and as such the Company recognized a gain of $ 238 The Company has the following operating ROU assets and lease liabilities: Schedule of Operating Right of Use Assets and Lease Liabilities December 31, 2023 ROU assets Lease liabilities Offices $ 42 $ 134 Cars 60 41 Total operating leases $ 102 $ 175 December 31, 2022 ROU Lease liabilities Offices $ 1,273 $ 1,612 Cars 189 139 Total operating leases $ 1,462 $ 1,751 December 31, 2023 December 31, 2022 Lease liabilities Lease Current lease liabilities $ 166 $ 419 Non-current lease liabilities 9 1,332 Total lease liabilities $ 175 $ 1,751 The following table summarizes the lease costs recognized in the consolidated statement of operations: Schedule of Lease Costs December 31, 2023 December 31, 2022 Operating lease cost $ 457 $ 442 Variable lease cost 19 10 Total lease cost $ 476 $ 452 As of December 31, 2023, the weighted-average remaining lease term and weighted-average discount rate for operating leases are 0.7 14.16 The following table summarizes the future payments of the Company for its operating lease liabilities: Schedule of Future Payments Operating Lease Liabilities December 31, 2023 2024 171 2025 9 Total undiscounted lease payments $ 180 Less: Interest (5 ) Total lease liabilities - operating $ 175 |
Goodwill and intangible assets,
Goodwill and intangible assets, net | 12 Months Ended |
Dec. 31, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Goodwill and intangible assets, net | 6. Goodwill and intangible assets, net Goodwill The following table represents the changes in the carrying amounts of the Company’s total goodwill: Schedule of Goodwill Carrying Amount Balance as of December 31, 2022 - Addition from acquisitions 4,500 Balance as of December 31, 2023 4,500 Intangible assets, net Schedule of Intangible Assets December 31, 2023 December 31, 2023 Unamortized Amortized Cost: In Process Technology $ 3,800 $ 130 Less - accumulated amortization - 32 Intangible assets, net $ 3,800 $ 98 As of December 31, 2023, the Company did not have any acquired intangible assets. Estimated amortization expense for the years ended: Schedule of Amortization Expenses 2024 $ 33 2025 33 2026 32 2027 - Thereafter 3,800 Total $ 3,898 Amortization expense of $ 32 For the year ended December 31, 2022, the Company did not have acquired intangible assets. |
Commitments and Contingent Liab
Commitments and Contingent Liabilities | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingent Liabilities | 7. Commitments and Contingent Liabilities Asset Transfer and License Agreement with Bristol-Myers Squibb Company. In November 2017, the Company entered into a license agreement, or the BMS License Agreement, with Bristol-Myers Squibb Company, or BMS, under which BMS granted the Company a worldwide, non-transferable, exclusive, sublicensable license under certain patent rights and know-how controlled by BMS to research, discover, develop, make, have made, use, sell, offer to sell, export, import and commercialize AL101 and AL102, or the BMS Licensed Compounds, and products containing AL101 or AL102, or the BMS Licensed Products, for all uses including the prevention, treatment or control of any human or animal disease, disorder or condition. On March 25, 2024, we sold our assets and liabilities related to AL101 and AL102 programs to Immunome, and the Company transferred the BMS License Agreement to Immunome as part of such transaction. Under the BMS License Agreement, we were obligated to use commercially reasonable efforts to develop at least one BMS Licensed Product, and had sole responsibility for, and bear the cost of, conducting research and development and preparing all regulatory filings and related submissions with respect to the BMS Licensed Compounds and/or BMS Licensed Products. BMS has assigned and transferred all INDs for the BMS Licensed Compounds to the Company. The Company is also required to use commercially reasonable efforts to obtain regulatory approvals in certain major market countries for at least one BMS Licensed Product, as well as to effect the first commercial sale of and commercialize each BMS Licensed Product after obtaining such regulatory approval. Under the BMS License Agreement, we had sole responsibility for, and bear the cost of, commercializing BMS Licensed Products. For a limited period of time, the Company may not, engage directly or indirectly in the clinical development or commercialization of a Notch inhibitor molecule that is not a BMS Licensed Compound. The Company was required to pay BMS payments upon the achievement of certain development or regulatory milestone events of up to $ 95 47 50 The Company accounted for the acquisition of the rights granted by BMS as an asset acquisition because it did not meet the definition of a business. The Company recorded the total consideration transferred and value of shares issued to BMS as research and development expense in the consolidated statement of operations as incurred since the acquired the rights granted by BMS represented in-process research and development and had no alternative future use. The Company accounts for contingent consideration payable upon achievement of sales milestones in such asset acquisitions when the underlying contingency is resolved. Both we and BMS had the right to terminate the BMS License Agreement in its entirety upon written notice to the licensee under certain circumstances described therein. On March 25, 2024, the Company sold the assets and liabilities related to the AL101 and AL102 programs to Immunome, and the Company transferred the BMS License Agreement to Immunome as part of such transaction. Exclusive worldwide license agreement with Penn. The Company entered into an exclusive worldwide license agreement with Penn, on July 1, 2002 with respect to the innovative work of Yvonne Paterson, Ph.D., Associate Dean for Research at the School of Nursing at Penn, and former Professor of Microbiology at Penn, in the area of innate immunity, or the immune response attributed to immune cells, including dendritic cells, macrophages and natural killer cells, that respond to pathogens non-specifically (subject to certain U.S. government rights). This agreement was amended and restated as of February 13, 2007, and, thereafter, has been amended from time to time. This license, unless sooner terminated in accordance with its terms, terminates upon the latter of (a) the expiration of the last to expire of the Penn patent rights; or (b) twenty years after the effective date of the license. Penn may terminate the license agreement early upon the occurrence of certain defaults by the Company, including, but not limited to, a material breach by the Company of the Penn license agreement that is not cured within 60 days after notice of the breach is provided to the company. The license provides the Company with the exclusive commercial rights to the patent portfolio developed by Penn as of the effective date of the license, in connection with Dr. Paterson and requires the Company to pay various milestone, legal, filing and licensing payments to commercialize the technology. In exchange for the license, Penn received shares of our Common Stock. In addition, Penn is entitled to receive a non-refundable initial license fee, royalty payments and milestone payments based on net sales and percentages of sublicense fees and certain commercial milestones. Under the amended licensing agreement, Penn is entitled to receive 2.5 250 2.75 250 250 2 40 775 100 Upon first regulatory approval in humans (US or EU), Penn will be entitled to a milestone payment of $ 600,000 2.5 1.0 OS Therapies LLC On September 4, 2018, the Company entered into a development, license and supply agreement with OS Therapies (“OST”) for the use of ADXS31-164, also known as ADXS-HER2, for evaluation in the treatment of osteosarcoma in humans. Under the terms of the license agreement, as amended, OST is responsible for the conduct and funding of a clinical study evaluating ADXS-HER2 in recurrent, completely resected osteosarcoma. Under the most recent amendment to the licensing agreement, the Company will initiate the transfer of the intellectual property and licensing rights of ADXS31-164, which were licensed pursuant to the Penn Agreement, back to the University of Pennsylvania. Contemporaneously, OST will enter negotiations with the University of Pennsylvania to establish a licensing agreement for ADXS31-164 to OST for clinical and commercial development of the ADXS31-164 technology. Purported Stockholder Claims Purported Stockholder Claims Related to January 2023 Merger with Old Ayala On December 15, 2022, a purported stockholder of Old Ayala filed a complaint in the U.S. District Court for the Southern District of New York against Old Ayala and the members of its Board, captioned Stephen Bushansky v. Ayala Pharmaceuticals, Inc., Case No.1:22-cv-10621 (S.D.N.Y.) (the “Complaint”). The Complaint asserts claims against all defendants under Section 14(a) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) and Rule 14a-9 promulgated thereunder for omitting or misrepresenting material information from Old Ayala’s Proxy Statement and against the individual defendants under Section 20(a) of the Exchange Act for alleged “control person” liability with respect to such alleged omissions and misrepresentations. The allegations in the Complaint include that the Proxy Statement omitted material information regarding Old Ayala’s financial projections and the financial analyses of Old Ayala’s financial advisor for the January 2023 Merger. The Complaint seeks, among other relief, (1) to enjoin defendants from consummating the January 2023 Merger; (2) to enjoin a vote on the January 2023 Merger; (3) to rescind the January 2023 Merger Agreement or recover damages, if the Merger is completed; (4) a declaration that defendants violated Sections 14(a) or 20(a) and Rule 14a-9 of the Exchange Act; and (5) attorneys’ fees and costs. The complaint was never served on all defendants. In addition, approximately nine purported stockholders of Old Ayala sent letters to those noted in the above-referenced Complaint alleging similar deficiencies in Old Ayala’s Proxy Statement (collectively, the “Demand Letters”). A final settlement agreement relating to these claims was entered into on March 21, 2024, and in connection therewith, the Company has accrued $ 200 Stockholder letter with regards to breaches of fiduciary duty On March 6, 2024, a stockholder of Ayala Pharmaceuticals, Inc. (the “Company”), submitted a letter (the “Letter”) threatening legal action against the Company and alleging breaches of fiduciary duty in connection with the Company’s January 9, 2023 merger with Advaxis, Inc., the Company’s October 19, 2023 merger with Biosight, Ltd., the Company’s November 17, 2023 issuance of Senior Convertible Promissory Notes and warrants for the purchase of 15,000,000 At this time, the Company is unable to predict the likelihood of an unfavorable outcome with respect to the Demand Letter. |
Common Stock Purchase Warrants
Common Stock Purchase Warrants and Warrant Liability | 12 Months Ended |
Dec. 31, 2023 | |
Common Stock Purchase Warrants And Warrant Liability | |
Common Stock Purchase Warrants and Warrant Liability | 8. Common Stock Purchase Warrants and Warrant Liability Common Stock Rights The Common Stock Rights confer upon the holders the right to vote in annual and special meetings of the Company, and to participate in the distribution of the surplus assets of the Company upon liquidation of the Company. Warrants As of December 31, 2023 there were 22,965,771 warrants outstanding of which 22,790,706 were exercisable warrants to purchase shares of our common stock, with exercise prices ranging from $ 0.34 to $ 224.00 per share. As of December 31, 2022, there were outstanding and exercisable warrants to purchase 337,320 0.05 96.58 Schedule Of Warrants Outstanding Number of Shares Underlying Exercise Price Warrants Expiration Date Type of Financing $ 2.79 879 September 2024 September 2018 Public Offering $ 224.00 4,092 July 2024 July 2019 Public Offering $ 28.00 57,230 November 2025 November 2020 Public Offering $ 56.00 140,552 April 2026 April 2021 Registered Direct Offering (Accompanying Warrants) $ 56.00 175,065 5 years April 2021 Private Placement (Private Placement Warrants) $ 96.58 87,453 * February 2024 February 2021 Private Placement (issued by Old Ayala) $ 0.34 22,500,500 ** November 2028 November 17, 2023 Financing Grand Total 22,965,771 On November 17, 2023, the Company issued securities convertible into or exercisable for 22,500,500 As of December 31, 2023, the Company had 289,327 22,965,771 A summary of warrant activity for the year ended December 31, 2023 was as follows (in thousands, except share and per share data): Shares Weighted Avg. Exercise Price Weighted Avg. Remaining Contractual Life in Years Aggregate Intrinsic Value Outstanding and Exercisable Warrants at December. 31 2022 337,320 $ 25.08 1.14 $ 144,083 Merged Warrants 377,818 $ 53.45 Issued as part of November 17 financing 22,500,500 $ 0.34 Exercised (249,867 ) $ 0.05 Outstanding Warrants at December 31, 2023 22,965,771 $ 1.58 4.84 $ 7,537,668 Exercisable Warrants at December 31, 2023 22,790,706 $ 1.15 4.84 $ 7,537,668 * Exercise price and warrant numbers have been retroactively adjusted for the impact of the January 2023 Merger, see note 1. ** See details under Warrant Liability Senior Convertible Notes for information on the exercise price Shares Issued for Warrants Exercises During the year ended December 31, 2023, 249,867 246,192 Convertible Note Following the consummation of the January 2023 Merger, management of the Company, in consultation with the Board, determined that the Company would require additional financing to further the development of Old Ayala’s late-stage program. As a result, the Company continued to pursue potential financing alternatives. However, despite significant efforts in this regard over a number of months, the Company was not able to find such feasible financing alternatives. On August 7, 2023, having concluded that there were at that time no other readily available alternatives, and in order to obtain temporary financing as it pursued its ongoing efforts to achieve longer-term financing, the Company entered into an agreement for the issuance of Senior Secured Convertible Promissory Notes (the “Secured Notes”) to Israel Biotech Fund I, L.P. The Secured Notes provided for the borrowing by the Company of up to $ 2.0 million dollars, which borrowings which the Company received on September 1, 2023. On November 17, 2023, having once again concluded that there were at that time no other readily available alternatives, and in order to obtain temporary financing as it pursued its ongoing efforts to achieve longer-term financing, and having concluded that the Company would not able to survive financially without additional funds the Company issued Senior Convertible Promissory Notes (collectively, the “Senior Convertible Notes”), in an aggregate amount of $ 4.0 0.001 (i) 50% of the Common Stock’s price per share as of market close on November 16, 2023 and (ii) 50% of the Common Stock’s price per share as of the close of market on the Trading Day immediately prior to the date of the Notice of Conversion, subject to certain adjustments. In connection with the issuance of the Senior Convertible Notes, the Company issued to the noteholders warrants to purchase an aggregate of 15,000,000 shares of the Common Stock with an exercise price equal to the lower of (A) 50% of the Common Stock’s price per share as of market close on November 16, 2023 and (ii) 50% of the Common Stock’s price per share as of the close of market on the Trading Day immediately prior to the date of the Notice of Exercise of the warrant, subject to adjustment, which exercise may be on a cashless basis The noteholders also obtained the right, pursuant to a Side Letter Agreement between the noteholders and the Company, to lend an additional $ 4.0 The Company has elected the fair value option to measure the Secured Notes and the Senior Convertible Notes upon issuance and conversion, in accordance with ASC 825-10. Under the fair value option, the Secured Notes and the Senior Convertible Notes are measured at fair value each period with changes in fair value reported in the consolidated statements of operations. According to ASC 825-10, changes in fair value that are caused by changes in the instrument-specific credit risk will be presented separately in other comprehensive income (loss). Prior to the modification of the terms of the Secured Notes, the Company has elected the fair value option to measure the Secured Notes. The change in fair value as a result of the modification was recorded in the consolidated statement of operation. The Convertible Notes were valued at the end of the year using a probability-weighted expected return model, which incorporated significant unobservable inputs such as the likelihood of a voluntary note conversion (60% likelihood), the notes being held to maturity (20% likelihood) and the mandatory conversion of the notes in a PIPE (20% likelihood). This resulted in an implied borrowing rate of 50% was used as an input to the fair value measurement. None of the change in fair value was deemed to be attributable to instrument-specific credit risk and thus the full amount of such change was recognized in the statements of operations. As discussed above, the Company had no financial alternatives at that time of the issuance of the Senior Convertible Notes and the Company issued the notes to its principal stockholders, which are also related parties of the Company. The Company received $ 4.0 6.6 0.6 , which at time of grant had fair value of $ 7.1 The Company used the following significant inputs in measuring the Secured Notes and Senior Convertible Notes : Schedule Of Assumptions Used In Warrant Liability December 31, November 17, August 7, Stock price $ 0.67 $ 0.77 $ 1.15 Interest rate 12.4 7.2 % 7.3 % Implied discount 47.7 % 75.2 % (32.4 )% Risk Free Rate 5.60 % 4.50 % 4.20 % Warrant Liability Senior Convertible Notes On November 17, 2023, in connection with the issuance of the Senior Convertible Notes, the Company amended the Secured Notes to match the same terms described above, and issued to the holders of the Secured Notes and Senior Convertible Notes, collectively, warrants to purchase an aggregate of 22,500,500 shares of the Common Stock with an exercise price equal to the lower of (A) 50% of the Common Stock’s price per share as of market close on November 16, 2023 and (ii) 50% of the Common Stock’s price per share as of the close of market on the Trading Day immediately prior to the date of the Notice of Exercise of the warrant, subject to adjustment, which exercise may be on a cashless basis. The warrants require liability classification as the warrants contains an unpermitted adjustment to the exercise price, which precludes an equity classification. The Company used the Black Scholes model to calculate the fair value of these warrants at the issuance and at each reporting date In measuring the warrant liability for the warrants issued on November 17, 2023 at December 31, 2023, the Company used the following inputs in its Black Scholes model: December 31, 2023 November 17, 2023 Assumed Exercise Price $ 0.04 $ 0.05 Diluted Stock Price $ 0.26 $ 0.31 Expected Term 4.9 5.0 Volatility % 95.7 % 96.3 % Risk Free Rate 3.85 % 4.45 % For the year ended December 31, 2023, the Company reported a loss of approximately $ 6.0 Side Agreement and reinvestment rights On September 11, 2023, the Company entered into the Side Letter Agreement for Conversion (“September Side Agreement”) in reference to the Simple Agreement for Future Equity (“SAFE”) by and between Biosight Ltd. and various investors. The September Side Agreement provided that amounts invested in Biosight Ltd under the SAFE shall convert to shares of the Common Stock upon the closing of the Biosight Merger. In addition the uninvested amount of $ 1.8 35 35 The September Side Agreement is a freestanding equity contract which is considered issued for accounting purposes. As the September Side Agreement does not meet all the conditions to be classified as equity pursuant to ASC 815-40-25-10, the Company classified the September Side Agreement as a liability with changes in fair value recorded in the consolidated statements of operations. On November 17, 2023, as part of the Senior Convertible Notes (with the same terms as the Senior Convertible Notes described above) an additional side letter agreement was signed (“November Side Agreement”), allowing a portion ($ 1,458 349 In addition to conversion of the first September Side Agreement, and as part of the Senior Convertible Notes, the November Side Agreement also allowed investors of the Senior Convertible Notes to re-invest up to their original investment (up to $ 4.0 2.2 For the year ended December 31, 2023, the Company reported a loss of approximately $ 7.2 Warrant Liability April 2021 Private Placement and The September 2018 Public Placement The warrants issued in the April 2021 Private Placement will become exercisable only on such day, if ever, that is 14 days after the Company files an amendment to the Company’s Amended and Restated Certificate of Incorporation to increase the number of authorized shares of common stock, $ 0.001 170,000,000 300,000,000 The September 2018 Public Offering warrants contain a down round feature, except for exempt issuances as defined in the warrant agreement, in which the exercise price would immediately be reduced to match a dilutive issuance of common stock, options, convertible securities and changes in option price or rate of conversion. As of December 31, 2023, the down round feature was triggered five times and the exercise price of the warrants were reduced from $ 1,800.00 2.79 In measuring the warrant liability for the warrants issued in the April 2021 Private Placement and September 2018 Public Offering at December 31, 2023, the Company used the following inputs in its Black Scholes model: December 31, 2023 January 19, 2023 Exercise Price $ 55.73 $ 55.73 Stock Price $ 0.67 $ 2.95 Expected Term 4.98 4.98 Volatility % 127 % 117 % Risk Free Rate 3.85 % 3.60 % For the year ended December 31, 2023, the Company reported a gain of approximately $ 161 |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 9. Fair Value Measurements As of December 31, 2022 the Company did not have any assets or liabilities carried at fair value on a recurring basis. The following table provide the liabilities carried at fair value measured on a recurring basis as of December 31, 2023: Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis Fair Value Measured at December 31, 2023 Level 1 Level 2 Level 3 Total Financial liabilities at fair value: Convertible note $ - - $ 8,141 $ 8,141 Side Letter Agreements - - 8,436 8,436 Long term warrant liability - - 6,057 6,057 Total financial liabilities at fair value $ - $ - $ 22,634 $ 22,634 The changes in the fair value of the Company’s Level 3 financial liabilities, which are measured on a recurring basis are as follows (in thousands): Schedule of Fair Value Liabilities Measured on Recurring Basis For the year ended December 31, 2023 December 31, 2022 - Long term warrant assumed from January 2023 Merger 203 Proceed from issuance of Convertible Notes $ 2,000 Side Letter Agreement in connection with Biosight Merger 685 SAFE assumed from Biosight Merger 1,068 Conversion of of shares to SAFE (1,068 ) Proceed from issuance of Senior Convertible Notes 4,000 Remeasurement recorded in financial loss, net 15,746 December 31, 2023 22,634 |
Common Stock
Common Stock | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
Common Stock | 10. Common Stock The Common Stock confer upon the holders the right vote in annual and special meetings of the Company, and to participate in the distribution of the surplus assets of the Company upon liquidation of the Company, after the distribution of the preferred stock liquidation preference. No dividends have been declared as of December 31, 2023 and 2022. * Does not include 39,452 80,839 ** All of the Common Stock and per share data have been retroactively adjusted for the impact of the January 2023 merger between Old Ayala, Inc. (f/k/a Ayala Pharmaceuticals, Inc.) and Ayala Pharmaceutical, Inc.(f/k/a Advaxis, Inc.). See note 1 |
Stock-Based Plans
Stock-Based Plans | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Plans | 11. Stock-Based Plans The. 2015 Incentive Plan (the “2015 Plan”) was originally ratified and approved by the Company’s stockholders on May 27, 2015. Subject to proportionate adjustment in the event of stock splits and similar events, the aggregate number of shares of common stock that may be issued under the 2015 Plan is 81,248 As of December 31, 2023, there were 69,513 Pursuant to the January 2023 merger, the Company assumed 117,360 107,623 The following table set forth the parameters used in the computation of the fair value of options granted to employees: Schedule of Fair Value of Stock Options Granted Year ended December 31, 2023 2022 Expected volatility - % 80 % Expected dividends - % 0 % Expected term (in years) - 6.34 Risk free rate - % 0.98 3.53 % * no shares have been granted The Company recorded stock-based compensation for the period indicated as follows (in thousands): Schedule of Share Based Compensation Expense Year ended Year ended December 31, December 31, 2023 2022 Research and Development $ 119 $ 717 General and Administrative 1,104 1,527 Total Stock-Based Compensation $ 1,223 $ 2,244 A summary of the Company’s stock option activity granted to employees under the Plan is as follows: Schedule of Changes in Stock Option Plan Year ended December 31, 2023 Weighted average Weighted remaining average contractual Aggregate Number of exercise term intrinsic options price (in years) value Outstanding at Beginning of Year 197,897 $ 38.34 6.10 $ - Assumed in advaxis merger 9,815 1,243.88 6.30 Granted - - - - Forfeited (6,539 ) 38.34 7.30 Expired (98,281 ) 38.91 5.92 Outstanding, December 31, 2023 102,892 $ 151.86 6.20 $ - Exercisable Options, December 31, 2023 90,596 $ 131.77 6.02 $ - The Company did not grant any options during 2023. The weighted-average grant date per-share fair value of stock options granted during 2022 was $ 5.74 0.1 1.14 Company’s restricted shares: In May 2022, the Company granted 80,050 three years In August 2022, the Company granted 4,947 four years The following table summarizes information relating to restricted shares, as well as changes to such awards during the fiscal years ended December 31, 2023 and 2022: Schedule of Summarizes Information Relating to Restricted Shares Year ended December 31, Weighted average Fair value on grant date Year ended December 31, Weighted average Fair value on grant date 2022 2023 Opening balance 23,303 $ 58.09 80,840 18.78 Forfeited (5,926 ) 16.67 (5,176 ) 10.67 Granted 84,997 10.42 - - Vested (21,534 ) 28.92 (58,607 ) 21.37 80,840 $ 18.78 17,057 - The weighted average fair value at grant date of restricted shares granted for the year ended December 31, 2022 was $ 2.00 no Restricted shares are subject to a repurchase right by the Company on certain occasions. Under the repurchase right, the Company may reacquire restricted shares, for no consideration, if certain conditions occur including the employees’ end of service with the Company. |
Taxes on Income
Taxes on Income | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Taxes on Income | 12. Taxes on Income The Company records income tax expense related to profits realized in the United States and realized by its subsidiary in Israel. United States: On December 22, 2017, the United States enacted the Tax Cuts and Jobs Act (the “U.S. Tax Reform”); a comprehensive tax legislation that includes significant changes to the taxation of business entities. These changes, most of which are effective for tax years beginning after December 31, 2017, include several key tax provisions that might impact the Company, among others: (i) a permanent reduction to the statutory federal corporate income tax rate from 35% (top rate) to 21% (flat rate) effective for tax years beginning after December 31, 2017 (ii) a new tax deduction in the amount of 37.5% of “foreign derived intangible income” that effectively reduces the federal corporate tax on certain qualified foreign derived sales/licenses/leases and service income in excess of a base amount to 13.125% (as compared to the regular corporate income tax rate of 21%); (iii) stricter limitation on the tax deductibility of business interest expense; (iv) a shift of the U.S. taxation of multinational corporations from a tax on worldwide income to a territorial system (along with certain rules designed to prevent erosion of the U.S. income tax base) (v) a one-time deemed repatriation tax on accumulated offshore earnings held in cash and illiquid assets, with the latter taxed at a lower rate and (vi) an expansion of the U.S. controlled foreign corporation (“CFC”) anti deferral starting with the CFC’s first tax year beginning in 2018 intended to tax in the U.S. “global intangible low-taxed income” (“GILTI”) The Company recorded loss from continuing operations, before taxes on income for the period indicated as follows (in thousands): Schedule of Income Before Income Tax Year ended Year ended December 31, December 31, 2023 2022 United States $ (49,912 ) $ (36,674 ) Israel (2,072 ) (755 ) Net loss before tax $ (51,984 ) $ (37,429 ) Income tax expense is summarized as follows (in thousands): Schedule of Income Tax Expense Year ended Year ended December 31, December 31, 2023 2022 Current: Domestic $ (4,335 ) $ 57 Foreign 423 527 Current Income tax expense $ (3,912 ) $ 584 Income tax expense $ (3,912 ) $ 584 The effective income tax rate differed from the amount computed by applying the federal statutory rate to our loss before income taxes as follows: Schedule of Tax Federal Statutory Rate Year ended Year ended December, 31 December, 31 2023 2022 U.S. federal tax provision at statutory rate 21.00 % 21.00 % State and local tax, net of federal benefit 37.96 0.72 Foreign rate differences 0.03 (0.06 ) Non-deductible stock compensation (0.49 ) (1.26 ) Section 951A GILTI 0.00 0.00 Effect of other permanent differences (0.05 ) (0.01 ) Uncertain tax positions (0.81 ) (1.15 ) Change in valuation allowance (48.44 ) (25.51 ) Federal Tax Reform Rate Change 0.00 0.00 Tax Credits - 4.14 Provision to Return ( 1.68 ) 1.67 Other adjustments (0.01 ) (1.10 ) Effective tax rate 7.51 % (1.56 )% Deferred Income Taxes Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company’s deferred tax assets are as follows (in thousands): Schedule of Deferred Tax Assets 2023 2022 ($ in thousands) As of December 31, 2023 2022 Deferred tax assets: Federal net operating loss carry forwards $ 69,040 $ 27,592 Tax credit carry forwards 16,668 4,862 Intangible and other related assets 3,095 2,990 Research and Development Costs 36,632 3,074 Accrued expenses 169 72 Warrant and other fair value Liabilities 5,142 - Stock Based Compensation 4,782 - Lease Liability 460 410 Total deferred tax assets before valuation allowance 135,988 39,000 Valuation allowance (135,570 ) (38,652 ) Total deferred tax assets 418 348 Deferred tax liabilities: Right of Use Asset 418 348 Total deferred tax liabilities 418 348 Net deferred tax assets $ - $ - As of December 31, 2023, the Company has provided a valuation allowance of approximately $ 135.6 Available Carryforward Tax Losses At December 31, 2023, the Company had federal net operation loss (NOL) carryforwards of approximately $ 214.9 11.4 190.5 Uncertain Tax Positions The Company has reviewed the tax positions taken, or to be taken, in our tax returns for all tax years currently open to examination by a taxing authority. As of December 31, 2023, and 2022, the Company has recorded an uncertain tax position liability exclusive of interest and penalties of approximately $ 1.8 1.3 Schedule of Reconciliation of Company’s Unrecognized Tax Benefits 2023 2022 (in thousands) (in thousands) Uncertain tax position at the beginning of year $ 1,335 $ 858 Additions for uncertain tax position of prior years (foreign exchange and interest) 13 36 Additions for tax positions of current year 423 441 Uncertain tax position at the end of the year $ 1,771 $ 1,335 The Company remains subject to examination until the statute of limitations expires for each respective tax jurisdiction. The statute of limitations is currently open for 2018, 2019, 2020, 2021 and 2022 for all tax jurisdictions. Israel: The Israeli corporate income tax rate was 23 |
Net Loss Per Share Attributable
Net Loss Per Share Attributable to Common Stockholders | 12 Months Ended |
Dec. 31, 2023 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share Attributable to Common Stockholders | 13. Net Loss Per Share Attributable to Common Stockholders The following table sets forth the computation of the loss per share for the period presented (in thousands, except for share data): The table below sets forth the number of potential shares of common stock that have been excluded from diluted net loss per share Schedule of Diluted Net Loss Per Share 2023 2022 For the year Ended December 31, 2023 2022 Net loss attributable to common stockholders, basic and diluted (48,072 ) (38,013 ) Weighted average common shares outstanding, basic and diluted* 6,019,063 2,895,130 Warrants 22,965,771 87,453 Stock options 102,892 197,897 Anti dilutive shares outstanding which were not included in the diluted calculation 23,068,663 285,350 Net loss per share attributable to common stockholders, basic and diluted $ (7.99 ) $ (13.13 ) |
Related parties
Related parties | 12 Months Ended |
Dec. 31, 2023 | |
Related Party Transactions [Abstract] | |
Related parties | 14. Related parties a. Israel Biotech Fund I, L.P., Israel Biotech Fund II, L.P., Arkin Bio Ventures L.P. hold each 20 75 Schedule of Related Party Transactions b. The following related party balances are included in the consolidated balance sheets: 2023 2022 December 31, 2023 2022 Convertible Loan (1) $ 8,007 $ - Long-term warrant liability (1) $ 5,915 - Side Letter Agreement liabilities $ 8,175 $ - Accrued expenses (2) $ 118 $ 69 c. The following related party transactions are included in the consolidated statements of income (loss): 2023 2022 Year ended December 31, 2023 2022 Financial expenses (income), net (1) $ 8,351 $ - General and Administrative (2) $ 128 $ 65 (1) In August and November 2023, the Company entered into Convertible Note agreement. See note 8. (2) For director fees to members of Israel Biotech Fund I, L.P., Israel Biotech Fund II, L.P., Arkin Bio Ventures L.P. (3) In November 2023, the Company entered into the Side Letter Agreement. See note 8. |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 12 Months Ended |
Dec. 31, 2023 | |
Prepaid Expenses And Other Current Assets | |
Prepaid Expenses and Other Current Assets | 15. Prepaid Expenses and Other Current Assets Schedule of Prepaid Expenses and Other Current Assets 2023 2022 December 31, 2023 2022 Prepaid Insurances $ 2,144 $ 431 Short-term restricted bank deposits 330 110 Other Assets 172 5 Total $ 2,646 $ 546 |
Finance expenses net
Finance expenses net | 12 Months Ended |
Dec. 31, 2023 | |
Finance Expenses Net | |
Finance expenses net | 16. Finance expenses net Schedule of Finance Expenses Net 2023 2022 December 31, 2023 2022 Remeasurement of long-term warrant liability $ 5,854 $ - Remeasurement of Side Letter Agreements 7,751 - Remeasurement of convertible note 2,141 - Others (28 ) (74 ) Total $ 15,718 $ (74 ) |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | 17. Subsequent Events On February 5, 2024, the Company and Immunome, Inc. (“Immunome”), entered into an Asset Purchase Agreement (the “Asset Purchase Agreement”) pursuant to which Immunome agreed to acquire certain of the Company’s assets and liabilities related to its AL101 and AL102 programs (the “Asset Sale”), which constitute substantially all of the Company’s assets. See Note 1 for additional information. On February 7, 2024, the Secured Notes issued in August 2023 and the Senior Convertible Notes issued in November 2023 were converted into 15,456,432 22,500,500 15,280,123 On March 1, 2024, the Company issued an additional $ 2.0 On March 6, 2024, the Company received a letter from a stockholder threatening legal action against the Company and alleging breaches of fiduciary duty in connection with the Company’s January 9, 2023 merger with Advaxis, Inc., the Company’s October 19, 2023 merger with Biosight, Ltd., the Company’s November 17, 2023 issuance of Senior Convertible Promissory Notes and warrants for the purchase of 15,000,000 On March 21, 2024 the Company settled the Purported Stockholder Claims related to the January 2023 Merger with Old Ayala (see Note 7) for a cash settlement payment of $ 200 As part of a cost reduction plan, during the year ended December 31, 2023, the Company had a reduction in workforce in which the employment of approximately 50% of the Company’s employees was terminated. During the first quarter of 2024, the Company gave notice of termination to 18 additional employees and two officers (including the Chief Financial Officer, whose employment will terminate on June 25, 2024). After the effectiveness of such terminations, the Chief Executive Officer will be the only employee of the Company. The Company expects to be able to meet its financial obligations to its employees. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”). The significant accounting policies followed in the preparation of the consolidated financial statements, are as follows: |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates, judgments and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. The Company’s management believes that the estimates, judgment and assumptions used are reasonable based upon information available at the time they are made. These estimates, judgments and assumptions can affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the dates of the consolidated financial statements. Actual results could differ from those estimates. |
Consolidated Financial Statements in U.S. Dollars | Consolidated Financial Statements in U.S. Dollars A substantial portion of the Company’s financing activities, including equity transactions and cash investments, are incurred in U.S. dollars. The Company’s management believes that the U.S. dollar is the currency of the primary economic environment in which the Company operates. Thus, the functional and reporting currency of the Company is the U.S. dollar. A subsidiary’s functional currency is the currency of the primary economic environment in which the subsidiary operates; normally, that is the currency of the environment in which a subsidiary primarily generates and expends cash. In making the determination of the appropriate functional currency for a subsidiary, the Company considers cash flow indicators, local market indicators, financing indicators and the subsidiary’s relationship with both the parent company and other subsidiaries. For subsidiaries that are primarily a direct and integral component or extension of the parent entity’s operations, the U.S. dollar is the functional currency. The Company has determined the functional currency of its foreign subsidiary is the U.S. Dollar. The foreign operation is considered a direct and integral part or extension of the Company’s operations. The day-to-day operations of the foreign subsidiary are dependent on the economic environment of the U.S. Dollar. Accordingly, monetary accounts maintained in currencies other than the U.S. dollar are remeasured into U.S. dollars in accordance with Statement of the Accounting Standard Codification (“ASC”) No. 830 “Foreign Currency Matters” (“ASC No. 830”). All transaction gains and losses of the remeasured monetary balance sheet items are reflected in the statements of operations as financial income or expenses as appropriate. |
Principles of Consolidation | Principles of Consolidation The consolidated financial statements include the accounts of the Company and the Subsidiary. Intercompany balances and transactions have been eliminated upon consolidation. |
Cash and Cash Equivalents and Short-term restricted Cash and Cash Equivalents | Cash and Cash Equivalents and Short-term restricted Cash and Cash Equivalents The Company considers all highly liquid certificates of deposits with original maturities of three months or less from the purchase date to be cash equivalents. Cash equivalents consist primarily of amounts invested in money market accounts in the United States and are stated at carrying value which approximate their fair values. Restricted Cash and Cash Equivalents consist of a bank deposit accounts that serves as collateral for a credit card agreement and lease agreements at one of the Company’s financial institutions. |
Property and Equipment, Net | Property and Equipment, Net Property and equipment are stated at cost, less accumulated depreciation. Depreciation is calculated on a straight-line basis over the estimated useful lives of the related assets, at the following annual rates: Schedule of Property and Equipment Estimated Useful Lives Computers and Software 33 % Lab Equipment 15 % Office Furniture and Equipment 7 9 % Leasehold improvements are amortized on a straight-line basis over the shorter of the assets’ estimated useful life ( 10 10 50 Maintenance and repair costs are expensed as incurred. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company’s long-lived assets are reviewed for impairment in accordance with ASC No. 360, “Property, Plant and Equipment,” whenever events or changes in circumstances indicate that the carrying amount of an asset (assets group) may not be recoverable. If indicators of impairment exist and the undiscounted future cash flows that the assets (assets group) are expected to generate are less than the carrying value of the assets (assets group), the Company reduces the carrying amount of the assets through an impairment charge, to their estimated fair values. During the years ended December 31, 2023, and 2022, no impairment loss have been recorded. |
Accrued Post-Employment Benefit | Accrued Post-Employment Benefit Under Israeli employment laws, employees of the Company are included under Section 14 of the Severance Compensation Act, 1963 (“Section 14”) for a portion of their salaries. According to Section 14, these employees are entitled to monthly payments made by the Company on their behalf with insurance companies. Payments in accordance with Section 14 release the Company from any future severance payments with respect to those employees. The obligation to make the monthly deposits is expensed as incurred. In addition, the aforementioned deposits are not recorded as an asset in the consolidated balance sheet, and there is no liability recorded as the Company does not have a future obligation to make any additional payments. Severance costs amounted to approximately $ 0.2 0.3 The Company maintains a 401(k) retirement savings plan for its U.S. employees. Each eligible employee may elect to contribute a portion of the employee’s compensation to the plan. As of December 31, 2023, and 2022, the Company has matched 100 6 |
Leases | Leases The Company’s leases include offices for its facilities, as well as car leases, which are all classified as operating leases. Short-term leases with a term of 12 At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease. Operating lease liabilities and their corresponding right-of-use assets are recorded at commencement date. The Company records lease liabilities based on the present value of lease payments over the lease term. The ROU asset also includes any lease payments made and excludes lease incentives. The Company generally uses an incremental borrowing rate to discount its lease liabilities, as the rate implicit in the lease is typically not readily determinable. Certain lease agreements include renewal options that are under the Company’s control. The Company includes optional renewal periods in the lease term only when it is reasonably certain that The Company will exercise its option. Certain lease agreements contain variable payments, which are expensed as incurred and not included in the operating lease right-of-use (“ROU”) assets and liabilities. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The Company measures and discloses the fair value of financial assets and liabilities in accordance with ASC Topic 820, “Fair Value Measurement.” Fair value is based on the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at 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 accounting standard establishes a fair value hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three broad levels, which are described below: Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. Level 2: Observable inputs that are based on inputs not quoted on active markets but corroborated by market data. Level 3: Unobservable inputs are used when little or no market data are available. Restricted Cash and Cash Equivalent, trade receivables, trade payables are stated at their carrying value, which approximates fair value due to the short time to the expected receipt or payment date. |
Research and Development | Research and Development Research and development costs are expensed as incurred. Research and development costs include payroll and personnel expenses, consulting costs, external contract research and development expenses, raw materials, drug product manufacturing costs, and allocated overhead including depreciation, rent, and utilities. Research and development costs that are paid in advance of performance are classified as a prepaid expense and amortized over the service period as the services are provided. |
Clinical Trial Costs | Clinical Trial Costs Clinical trial costs are a component of research and development expenses. The Company bases its expenses related to Clinical Research Organization (“CRO”) on the services received, and efforts expanded pursuant to agreements with them. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. For reoccurring services fees, the Company records the services over the time period which services will are based on inputs received from CRO. If the actual timing of the performance of services varies from the calculation, the Company adjusts the accrual or amount of prepaid expenses accordingly to adjust for such changes in time. |
Patent Costs | Patent Costs Legal and related patent costs are expensed as incurred as their realization is uncertain. Costs related to patent registration are classified as general and administrative expenses, and costs related to acquired patents are classified as research and development expenses in the accompanying consolidated statements of operations. |
Contingent Liabilities | Contingent Liabilities The Company accounts for its contingent liabilities in accordance with ASC No. 450, “Contingencies”. A provision is recorded when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. With respect to legal matters, provisions are reviewed and adjusted to reflect the impact of negotiations, estimated settlements, legal rulings, advice of legal counsel and other information and events pertaining to a particular matter. See Note 7. |
Income Taxes | Income Taxes The Company accounts for income taxes in accordance with ASC 740, “Income Taxes”. This standard prescribes the use of the liability method whereby deferred tax asset and liability account balances are determined based on differences between financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company provides a valuation allowance, if necessary, to reduce deferred tax assets to their estimated realizable value, if it is more likely than not that some portion of the entire deferred tax asset will not be realized. The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740-10, “Income Taxes”. Accounting guidance addresses the determination of whether tax benefits claimed or expected to be claimed on a tax return should be recorded in the consolidated financial statements, under which a Company may recognize the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by the taxing authorities, based on the technical merits of the position. The tax benefits recognized in the consolidated financial statements from such a position should be measured based on the largest benefit that has a greater than fifty percent likelihood of being realized upon ultimate settlement. Although the Company believes that it has adequately reserved for its uncertain tax positions (including net interest and penalties), it can provide no assurance that the final tax outcome of these matters will not be materially different. The Company makes adjustments to these reserves when facts and circumstances change, such as the closing of a tax audit or the refinement of an estimate. To the extent that the final tax outcome of these matters is different from the amounts recorded, such differences will affect the income tax expense in the period in which such determination is made. |
Concentrations of Credit Risk | Concentrations of Credit Risk Financial instruments that potentially subject the Company to a concentration of credit risk consist primarily of cash and cash equivalents. Bank deposits are held by accredited financial institutions and these deposits may at times be in excess of insured limits. Money Market funds are of Prime A and only invested in government issued securities. The Company limits its credit risk associated with cash and cash equivalents by placing them with financial institutions that it believes are of high-quality credit rating. The Company has not experienced any losses on its deposits of cash or cash equivalents. The Company did not have any customers as of December 31, 2023. The Company’s trade receivables as of December 31, 2022 were from one customer. In addition, the potential risk of loss with any one counterparty resulting from this type of credit risk is monitored on an ongoing basis. |
Stock-Based Compensation | Stock-Based Compensation The Company measures its stock-based payment awards made to employees, directors, and non-employee service providers based on estimated fair values. The fair value of each option award is estimated on the grant date using the Black-Scholes option pricing model. The Company recognizes compensation expenses based on the accelerated method over the requisite service period. The Company recognizes forfeitures of awards as they occur. The Black-Scholes option pricing model requires a number of assumptions, of which the most significant are share price, expected volatility, expected option term (the time from the grant date until the options are exercised or expire), risk-free rate, and expected divided rate. After the IPO, the fair value of each ordinary share was based on the closing price of the Company’s publicly traded ordinary shares as reported on the date of the grant. |
Expected volatility | Expected volatility As the Company has a short trading history for its ordinary shares, the expected volatility is derived from the average historical share volatilities of several unrelated public companies within the Company’s industry that the Company considers to be comparable to its own business over a period equivalent to the option’s expected term. |
Expected Dividend Yield | Expected Dividend Yield The Company has historically not paid dividends and has no foreseeable plans to pay dividends, and therefore the Company uses an expected dividend yield of 0 |
Risk-Free Interest Rate | Risk-Free Interest Rate The risk-free interest rate is based on the yield from U.S. Treasury zero-coupon bonds with an equivalent expected term. |
Expected Term | Expected Term Restricted shares are valued at the fair value of shares on the date of grant. |
Basic and Diluted Net Loss per Share | Basic and Diluted Net Loss per Share Basic loss per share is computed by dividing the net loss by the weighted average number of shares of Common Stock outstanding during the period. Diluted loss per share is computed by dividing the net loss by the weighted average number of shares of Common Stock outstanding together with the number of additional shares of Common Stock that would have been outstanding if all potentially dilutive shares of Common Stock had been issued. Diluted net loss per share is the same as basic net loss per share in periods when the effects of potentially dilutive shares of Common Stock are anti-dilutive. |
Business combinations | Business combinations The Company accounts for business combinations by applying the provisions of ASC 805, Business Combination (“ASC 805”) and allocates the fair value of the purchase consideration to the tangible and intangible assets acquired and liabilities assumed based on their estimated fair values. The excess of the fair value of purchase consideration over the fair value of these identifiable assets and liabilities is recorded as goodwill. When determining the fair value of assets acquired and liabilities assumed, management makes significant estimates and assumptions, especially with respect to intangible assets. Acquisition-related expenses are expensed as incurred. |
Goodwill and acquired intangible assets | Goodwill and acquired intangible assets Goodwill and acquired intangible assets recorded in the Company’s financial statements result from both business combinations. Goodwill represents the excess of the purchase price in a business combination over the fair value of identifiable tangible and intangible assets acquired and liabilities assumed. Goodwill is not amortized as it is estimated to have an indefinite life. As such, goodwill is subject to an annual impairment test. The Company allocates goodwill to reporting units based on the expected benefit from the business combination. Reporting units are evaluated when changes in the Company’s operating structure occur, and if necessary, goodwill is reassigned using a relative fair value allocation approach. The Company operates in one operating segment, and this segment is the only reporting unit. ASC 350, Intangibles—Goodwill and Other During the last quarter of 2023, the Company experienced a significant decline in the stock price, which might suggest the fair value of the reporting unit is less than its carrying amount. However, when the Company performed its annual goodwill impairment test on December 31, 2023, it was noted that the reporting unit have a negative carrying amount. The Company concluded that no goodwill impairment should be recorded since after performing a quantitative test, the reporting unit’s fair value is not less than its carrying amount. Separately acquired intangible assets are measured on initial recognition at cost including directly attributable costs. Intangible assets acquired in a business combination are measured at fair value at the acquisition date. Acquired identifiable finite-lived intangible assets are amortized on a straight-line basis over the estimated useful life of the respective asset. Each period the Company evaluates the estimated remaining useful lives of its intangible assets and whether events or changes in circumstances warrant a revision to the remaining period of amortization. Acquired indefinite-lived intangible assets are not amortized but are tested for impairment at least annually or more frequently if events or changes in circumstances indicate that the intangible asset may be impaired. |
Segment Information | Segment Information Financial information is available for evaluation by the chief operating decision maker, the Company’s Chief Executive Officer, in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business in one operating segment. Operating segments are defined as components of an enterprise in which separate financial information is evaluated regularly by the chief operating decision maker in deciding how to allocate resources and assessing performance. The geographical regions of the Company’s intangible assets are as follows: Schedule of Geographical Region of Long-Lived Assets 2023 2022 Year ended December 31, December 31, 2023 2022 Israel 3,800 - United States 98 - Total 3,898 - Total intangible assets 3,898 - The geographical regions of the Company’s long lived asset including rights of use are as follows: Year ended Year ended December 31, December 31, 2023 2022 Israel 600 2,392 United States 42 30 Total 642 2,422 Total rights of use of assets and property and equipment 642 2,422 A ll Schedule of Geographical Region of Revenues |
Revenue Recognition | Revenue Recognition The Company recognizes revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers, which applies to all contracts with customers. Under Topic 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of Topic 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. At contract inception, once the contract is determined to be within the scope of Topic 606, the Company assesses the goods or services promised within the contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. Customer option to acquire additional goods or services gives rise to a performance obligation in the contract only if the option provides a material right to the customer that it would not receive without entering into that contract. In a contract with multiple performance obligations, the Company develop estimates and assumptions that require judgment to determine the underlying stand-alone selling price for each performance obligation, which determines how the transaction price is allocated among the performance obligations. The Company evaluates each performance obligation to determine if it can be satisfied at a point in time or over time. Revenue is recognized when control of the promised goods or services is transferred to the customers, in an amount that reflects the consideration the Company expect to be entitled to receive in exchange for those goods or services. |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements In June 2016, the FASB issued ASU No. 2016-13 (Topic 326), Financial Instruments—Credit Losses: Measurement of Credit Losses on Financial Instruments, which replaces the existing incurred loss impairment model with an expected credit loss model and requires a financial asset measured at amortized cost to be presented at the net amount expected to be collected. The new guidance was effective for the Company on January 1, 2023 and the adoption did not have a material impact on the Company’s consolidated financial statements. |
Recently Issued Accounting Pronouncements Not Yet Adopted | Recently Issued Accounting Pronouncements Not Yet Adopted In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which requires public entities to disclose information about their reportable segments’ significant expenses and other segment items on an interim and annual basis. Public entities with a single reportable segment are required to apply the disclosure requirements in ASU 2023-07, as well as all existing segment disclosures and reconciliation requirements in ASC 280 on an interim and annual basis. ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, and for interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact of adopting ASU 2023-07. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which requires public entities, on an annual basis, to provide disclosure of specific categories in the rate reconciliation, as well as disclosure of income taxes paid disaggregated by jurisdiction. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact of adopting ASU 2023-09. |
Significant Accounting Polici_3
Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Schedule of Property and Equipment Estimated Useful Lives | Property and equipment are stated at cost, less accumulated depreciation. Depreciation is calculated on a straight-line basis over the estimated useful lives of the related assets, at the following annual rates: Schedule of Property and Equipment Estimated Useful Lives Computers and Software 33 % Lab Equipment 15 % Office Furniture and Equipment 7 9 % |
Schedule of Geographical Region of Long-Lived Assets | Schedule of Geographical Region of Long-Lived Assets 2023 2022 Year ended December 31, December 31, 2023 2022 Israel 3,800 - United States 98 - Total 3,898 - Total intangible assets 3,898 - The geographical regions of the Company’s long lived asset including rights of use are as follows: Year ended Year ended December 31, December 31, 2023 2022 Israel 600 2,392 United States 42 30 Total 642 2,422 Total rights of use of assets and property and equipment 642 2,422 |
Schedule of Geographical Region of Revenues | A ll Schedule of Geographical Region of Revenues |
Mergers (Tables)
Mergers (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Ayala Pharmaceuticals Inc [Member] | |
Business Acquisition [Line Items] | |
Schedule of fair value of Intangible Assets Acquired | The following sets forth the fair value of acquired identifiable assets and assumed liabilities of former Advaxis which includes adjustments to reflect the fair value of intangible assets acquired (in thousands) as of January 19, 2023: Schedule of fair value of Intangible Assets Acquired Amounts Cash and cash equivalents $ 22,539 Prepaid expenses and other current assets 300 Property and equipment, net 34 Intangible assets 130 Operating right-of-use asset 5 Other assets 11 Goodwill Total assets 23,019 SAFE liability Common stock warrant liability (203 ) Other current liabilities and trade payables (2,714 ) Total liabilities (2,917 ) Net assets acquired $ 20,102 |
Biosight Ltd. [Member] | |
Business Acquisition [Line Items] | |
Schedule of fair value of Intangible Assets Acquired | The following sets forth the fair value of acquired identifiable assets and assumed liabilities of Biosight which includes to reflect the fair value of intangible assets acquired (in thousands) as of October 18, 2023: Schedule of fair value of Intangible Assets Acquired Amounts Cash and cash equivalents $ 1,909 Fixed Assets, net 64 Prepaid expenses and other current assets 89 Intangible assets 3,800 Goodwill 4,500 Total assets 10,363 Side Letter Agreement Liability (685 ) SAFE liability (1,068 ) Other current liabilities and trade payables (3,096 ) Total liabilities (4,849 ) Net assets acquired $ 5,514 |
Schedule of Pro Forma Financial Information | The following unaudited table provides certain pro forma financial information for the Company as if the January 2023 Merger and the Biosight Merger occurred on January 1, 2022 (in thousands except per share amounts): Schedule of Pro Forma Financial Information Year Year ended ended December 31, December 31, 2023 2022* Unaudited Unaudited Revenue $ 13 $ 942 Net loss $ (57,344 ) $ (63,011 ) * The pro forma amounts above are derived from historical numbers of the Company, Old Ayala and Biosight. The results of operations for the year ended December 31, 2022 include the operations of the Company for the period from November 1, 2022 to October 31, 2023 which was the fiscal year 2022 prior to the change in the Company’s fiscal year end from October 31 to December 31, which change was effected in January 2023. There are no such adjustments for Biosight as the fiscal year ended on December 31, 2023. |
Property and Equipment, net (Ta
Property and Equipment, net (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment, Net | Property and Equipment, net consists of the following: Schedule of Property and Equipment, Net December 31, December 31, 2023 2022 (in thousands) Cost: Computers and Software $ 60 $ 73 Lab Equipment 95 296 Office Furniture and Equipment 92 146 Leasehold Improvements 1,105 1,105 Property and Equipment, Gross 1,352 1,620 Less: Accumulated Depreciation 812 660 Property and Equipment, Net $ 540 $ 960 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Leases | |
Schedule of Lease Liabilities and ROU Assets | Upon adoption, the Company recognized lease liabilities and corresponding ROU assets, adjusted for the accrued rent and remaining lease incentives received on the adoption date, as follows: Schedule of Lease Liabilities and ROU Assets ROU assets Lease liabilities January 1, 2022 ROU Lease liabilities Offices $ 1,448 $ 2,020 Cars 302 267 Total operating leases $ 1,750 $ 2,287 |
Schedule of Operating Right of Use Assets and Lease Liabilities | The Company has the following operating ROU assets and lease liabilities: Schedule of Operating Right of Use Assets and Lease Liabilities December 31, 2023 ROU assets Lease liabilities Offices $ 42 $ 134 Cars 60 41 Total operating leases $ 102 $ 175 December 31, 2022 ROU Lease liabilities Offices $ 1,273 $ 1,612 Cars 189 139 Total operating leases $ 1,462 $ 1,751 December 31, 2023 December 31, 2022 Lease liabilities Lease Current lease liabilities $ 166 $ 419 Non-current lease liabilities 9 1,332 Total lease liabilities $ 175 $ 1,751 |
Schedule of Lease Costs | The following table summarizes the lease costs recognized in the consolidated statement of operations: Schedule of Lease Costs December 31, 2023 December 31, 2022 Operating lease cost $ 457 $ 442 Variable lease cost 19 10 Total lease cost $ 476 $ 452 |
Schedule of Future Payments Operating Lease Liabilities | The following table summarizes the future payments of the Company for its operating lease liabilities: Schedule of Future Payments Operating Lease Liabilities December 31, 2023 2024 171 2025 9 Total undiscounted lease payments $ 180 Less: Interest (5 ) Total lease liabilities - operating $ 175 |
Goodwill and intangible asset_2
Goodwill and intangible assets, net (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Goodwill | The following table represents the changes in the carrying amounts of the Company’s total goodwill: Schedule of Goodwill Carrying Amount Balance as of December 31, 2022 - Addition from acquisitions 4,500 Balance as of December 31, 2023 4,500 |
Schedule of Intangible Assets | Schedule of Intangible Assets December 31, 2023 December 31, 2023 Unamortized Amortized Cost: In Process Technology $ 3,800 $ 130 Less - accumulated amortization - 32 Intangible assets, net $ 3,800 $ 98 |
Schedule of Amortization Expenses | Estimated amortization expense for the years ended: Schedule of Amortization Expenses 2024 $ 33 2025 33 2026 32 2027 - Thereafter 3,800 Total $ 3,898 |
Common Stock Purchase Warrant_2
Common Stock Purchase Warrants and Warrant Liability (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Common Stock Purchase Warrants And Warrant Liability | |
Schedule Of Warrants Outstanding | Schedule Of Warrants Outstanding Number of Shares Underlying Exercise Price Warrants Expiration Date Type of Financing $ 2.79 879 September 2024 September 2018 Public Offering $ 224.00 4,092 July 2024 July 2019 Public Offering $ 28.00 57,230 November 2025 November 2020 Public Offering $ 56.00 140,552 April 2026 April 2021 Registered Direct Offering (Accompanying Warrants) $ 56.00 175,065 5 years April 2021 Private Placement (Private Placement Warrants) $ 96.58 87,453 * February 2024 February 2021 Private Placement (issued by Old Ayala) $ 0.34 22,500,500 ** November 2028 November 17, 2023 Financing Grand Total 22,965,771 Shares Weighted Avg. Exercise Price Weighted Avg. Remaining Contractual Life in Years Aggregate Intrinsic Value Outstanding and Exercisable Warrants at December. 31 2022 337,320 $ 25.08 1.14 $ 144,083 Merged Warrants 377,818 $ 53.45 Issued as part of November 17 financing 22,500,500 $ 0.34 Exercised (249,867 ) $ 0.05 Outstanding Warrants at December 31, 2023 22,965,771 $ 1.58 4.84 $ 7,537,668 Exercisable Warrants at December 31, 2023 22,790,706 $ 1.15 4.84 $ 7,537,668 * Exercise price and warrant numbers have been retroactively adjusted for the impact of the January 2023 Merger, see note 1. ** See details under Warrant Liability Senior Convertible Notes for information on the exercise price |
Schedule Of Assumptions Used In Warrant Liability | The Company used the following significant inputs in measuring the Secured Notes and Senior Convertible Notes : Schedule Of Assumptions Used In Warrant Liability December 31, November 17, August 7, Stock price $ 0.67 $ 0.77 $ 1.15 Interest rate 12.4 7.2 % 7.3 % Implied discount 47.7 % 75.2 % (32.4 )% Risk Free Rate 5.60 % 4.50 % 4.20 % In measuring the warrant liability for the warrants issued on November 17, 2023 at December 31, 2023, the Company used the following inputs in its Black Scholes model: December 31, 2023 November 17, 2023 Assumed Exercise Price $ 0.04 $ 0.05 Diluted Stock Price $ 0.26 $ 0.31 Expected Term 4.9 5.0 Volatility % 95.7 % 96.3 % Risk Free Rate 3.85 % 4.45 % In measuring the warrant liability for the warrants issued in the April 2021 Private Placement and September 2018 Public Offering at December 31, 2023, the Company used the following inputs in its Black Scholes model: December 31, 2023 January 19, 2023 Exercise Price $ 55.73 $ 55.73 Stock Price $ 0.67 $ 2.95 Expected Term 4.98 4.98 Volatility % 127 % 117 % Risk Free Rate 3.85 % 3.60 % |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis | As of December 31, 2022 the Company did not have any assets or liabilities carried at fair value on a recurring basis. The following table provide the liabilities carried at fair value measured on a recurring basis as of December 31, 2023: Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis Fair Value Measured at December 31, 2023 Level 1 Level 2 Level 3 Total Financial liabilities at fair value: Convertible note $ - - $ 8,141 $ 8,141 Side Letter Agreements - - 8,436 8,436 Long term warrant liability - - 6,057 6,057 Total financial liabilities at fair value $ - $ - $ 22,634 $ 22,634 |
Schedule of Fair Value Liabilities Measured on Recurring Basis | The changes in the fair value of the Company’s Level 3 financial liabilities, which are measured on a recurring basis are as follows (in thousands): Schedule of Fair Value Liabilities Measured on Recurring Basis For the year ended December 31, 2023 December 31, 2022 - Long term warrant assumed from January 2023 Merger 203 Proceed from issuance of Convertible Notes $ 2,000 Side Letter Agreement in connection with Biosight Merger 685 SAFE assumed from Biosight Merger 1,068 Conversion of of shares to SAFE (1,068 ) Proceed from issuance of Senior Convertible Notes 4,000 Remeasurement recorded in financial loss, net 15,746 December 31, 2023 22,634 |
Stock-Based Plans (Tables)
Stock-Based Plans (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Fair Value of Stock Options Granted | The following table set forth the parameters used in the computation of the fair value of options granted to employees: Schedule of Fair Value of Stock Options Granted Year ended December 31, 2023 2022 Expected volatility - % 80 % Expected dividends - % 0 % Expected term (in years) - 6.34 Risk free rate - % 0.98 3.53 % * no shares have been granted |
Schedule of Share Based Compensation Expense | The Company recorded stock-based compensation for the period indicated as follows (in thousands): Schedule of Share Based Compensation Expense Year ended Year ended December 31, December 31, 2023 2022 Research and Development $ 119 $ 717 General and Administrative 1,104 1,527 Total Stock-Based Compensation $ 1,223 $ 2,244 |
Schedule of Changes in Stock Option Plan | A summary of the Company’s stock option activity granted to employees under the Plan is as follows: Schedule of Changes in Stock Option Plan Year ended December 31, 2023 Weighted average Weighted remaining average contractual Aggregate Number of exercise term intrinsic options price (in years) value Outstanding at Beginning of Year 197,897 $ 38.34 6.10 $ - Assumed in advaxis merger 9,815 1,243.88 6.30 Granted - - - - Forfeited (6,539 ) 38.34 7.30 Expired (98,281 ) 38.91 5.92 Outstanding, December 31, 2023 102,892 $ 151.86 6.20 $ - Exercisable Options, December 31, 2023 90,596 $ 131.77 6.02 $ - |
Schedule of Summarizes Information Relating to Restricted Shares | The following table summarizes information relating to restricted shares, as well as changes to such awards during the fiscal years ended December 31, 2023 and 2022: Schedule of Summarizes Information Relating to Restricted Shares Year ended December 31, Weighted average Fair value on grant date Year ended December 31, Weighted average Fair value on grant date 2022 2023 Opening balance 23,303 $ 58.09 80,840 18.78 Forfeited (5,926 ) 16.67 (5,176 ) 10.67 Granted 84,997 10.42 - - Vested (21,534 ) 28.92 (58,607 ) 21.37 80,840 $ 18.78 17,057 - |
Taxes on Income (Tables)
Taxes on Income (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Schedule of Income Before Income Tax | The Company recorded loss from continuing operations, before taxes on income for the period indicated as follows (in thousands): Schedule of Income Before Income Tax Year ended Year ended December 31, December 31, 2023 2022 United States $ (49,912 ) $ (36,674 ) Israel (2,072 ) (755 ) Net loss before tax $ (51,984 ) $ (37,429 ) |
Schedule of Income Tax Expense | Income tax expense is summarized as follows (in thousands): Schedule of Income Tax Expense Year ended Year ended December 31, December 31, 2023 2022 Current: Domestic $ (4,335 ) $ 57 Foreign 423 527 Current Income tax expense $ (3,912 ) $ 584 Income tax expense $ (3,912 ) $ 584 |
Schedule of Tax Federal Statutory Rate | The effective income tax rate differed from the amount computed by applying the federal statutory rate to our loss before income taxes as follows: Schedule of Tax Federal Statutory Rate Year ended Year ended December, 31 December, 31 2023 2022 U.S. federal tax provision at statutory rate 21.00 % 21.00 % State and local tax, net of federal benefit 37.96 0.72 Foreign rate differences 0.03 (0.06 ) Non-deductible stock compensation (0.49 ) (1.26 ) Section 951A GILTI 0.00 0.00 Effect of other permanent differences (0.05 ) (0.01 ) Uncertain tax positions (0.81 ) (1.15 ) Change in valuation allowance (48.44 ) (25.51 ) Federal Tax Reform Rate Change 0.00 0.00 Tax Credits - 4.14 Provision to Return ( 1.68 ) 1.67 Other adjustments (0.01 ) (1.10 ) Effective tax rate 7.51 % (1.56 )% |
Schedule of Deferred Tax Assets | Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company’s deferred tax assets are as follows (in thousands): Schedule of Deferred Tax Assets 2023 2022 ($ in thousands) As of December 31, 2023 2022 Deferred tax assets: Federal net operating loss carry forwards $ 69,040 $ 27,592 Tax credit carry forwards 16,668 4,862 Intangible and other related assets 3,095 2,990 Research and Development Costs 36,632 3,074 Accrued expenses 169 72 Warrant and other fair value Liabilities 5,142 - Stock Based Compensation 4,782 - Lease Liability 460 410 Total deferred tax assets before valuation allowance 135,988 39,000 Valuation allowance (135,570 ) (38,652 ) Total deferred tax assets 418 348 Deferred tax liabilities: Right of Use Asset 418 348 Total deferred tax liabilities 418 348 Net deferred tax assets $ - $ - |
Schedule of Reconciliation of Company’s Unrecognized Tax Benefits | Schedule of Reconciliation of Company’s Unrecognized Tax Benefits 2023 2022 (in thousands) (in thousands) Uncertain tax position at the beginning of year $ 1,335 $ 858 Additions for uncertain tax position of prior years (foreign exchange and interest) 13 36 Additions for tax positions of current year 423 441 Uncertain tax position at the end of the year $ 1,771 $ 1,335 |
Net Loss Per Share Attributab_2
Net Loss Per Share Attributable to Common Stockholders (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Earnings Per Share [Abstract] | |
Schedule of Diluted Net Loss Per Share | The table below sets forth the number of potential shares of common stock that have been excluded from diluted net loss per share Schedule of Diluted Net Loss Per Share 2023 2022 For the year Ended December 31, 2023 2022 Net loss attributable to common stockholders, basic and diluted (48,072 ) (38,013 ) Weighted average common shares outstanding, basic and diluted* 6,019,063 2,895,130 Warrants 22,965,771 87,453 Stock options 102,892 197,897 Anti dilutive shares outstanding which were not included in the diluted calculation 23,068,663 285,350 Net loss per share attributable to common stockholders, basic and diluted $ (7.99 ) $ (13.13 ) |
Related parties (Tables)
Related parties (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Related Party Transactions [Abstract] | |
Schedule of Related Party Transactions | Schedule of Related Party Transactions b. The following related party balances are included in the consolidated balance sheets: 2023 2022 December 31, 2023 2022 Convertible Loan (1) $ 8,007 $ - Long-term warrant liability (1) $ 5,915 - Side Letter Agreement liabilities $ 8,175 $ - Accrued expenses (2) $ 118 $ 69 c. The following related party transactions are included in the consolidated statements of income (loss): 2023 2022 Year ended December 31, 2023 2022 Financial expenses (income), net (1) $ 8,351 $ - General and Administrative (2) $ 128 $ 65 (1) In August and November 2023, the Company entered into Convertible Note agreement. See note 8. (2) For director fees to members of Israel Biotech Fund I, L.P., Israel Biotech Fund II, L.P., Arkin Bio Ventures L.P. (3) In November 2023, the Company entered into the Side Letter Agreement. See note 8. |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Prepaid Expenses And Other Current Assets | |
Schedule of Prepaid Expenses and Other Current Assets | Schedule of Prepaid Expenses and Other Current Assets 2023 2022 December 31, 2023 2022 Prepaid Insurances $ 2,144 $ 431 Short-term restricted bank deposits 330 110 Other Assets 172 5 Total $ 2,646 $ 546 |
Finance expenses net (Tables)
Finance expenses net (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Finance Expenses Net | |
Schedule of Finance Expenses Net | Schedule of Finance Expenses Net 2023 2022 December 31, 2023 2022 Remeasurement of long-term warrant liability $ 5,854 $ - Remeasurement of Side Letter Agreements 7,751 - Remeasurement of convertible note 2,141 - Others (28 ) (74 ) Total $ 15,718 $ (74 ) |
General (Details Narrative)
General (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||||||
Mar. 25, 2024 | Mar. 25, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | Mar. 01, 2024 | Feb. 27, 2024 | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Stock Issued During Period, Shares, New Issues | 0.1874 | ||||||
Common Stock, Par or Stated Value Per Share | $ 0.001 | $ 0.001 | |||||
Cash in operations | $ 29,485 | $ 34,510 | |||||
Net loss | 48,072 | 38,013 | |||||
Cash and cash equivalents | 4,882 | 2,408 | |||||
Current liabilities | 25,018 | 6,201 | |||||
Accumulated deficit | 197,226 | $ 149,154 | |||||
Common Stock [Member] | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Stock Issued During Period, Shares, New Issues | [1] | 58,172 | |||||
Net loss | [1] | ||||||
Asset Purchase Agreement [Member] | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Payments to Acquire Businesses, Gross | $ 16,000 | ||||||
Payment for contingent consideration liability operating activities | $ 3,000 | ||||||
Subsequent Event [Member] | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Cash | $ 13,000 | ||||||
Convertible Debt | $ 2,000 | $ 2,000 | |||||
Subsequent Event [Member] | Common Stock [Member] | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Stock Issued During Period, Shares, Purchase of Assets | 2,175,489 | ||||||
Subsequent Event [Member] | Asset Purchase Agreement [Member] | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Payments to Acquire Businesses, Gross | $ 20,000 | ||||||
Deposits | $ 4,000 | ||||||
Common Stock, Par or Stated Value Per Share | $ 0.0001 | ||||||
Subsequent Event [Member] | Asset Purchase Agreement [Member] | Maximum [Member] | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Payments to Acquire Businesses, Gross | $ 37,500 | ||||||
Subsequent Event [Member] | Asset Purchase Agreement [Member] | Common Stock [Member] | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Stock Issued During Period, Shares, New Issues | 2,175,489 | ||||||
[1]All of the Common Stock and per share data have been retroactively adjusted and Additional paid in Capital to adjust for common stock amount, for the impact of the January 2023 merger between Old Ayala, Inc. (f/k/a Ayala Pharmaceuticals, Inc.) and Ayala Pharmaceutical, Inc.(f/k/a Advaxis, Inc.). See note 1 |
Schedule of Property and Equipm
Schedule of Property and Equipment Estimated Useful Lives (Details) | Dec. 31, 2023 |
Computer Equipment [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Salvage Value, Percentage | 33% |
Equipment [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Salvage Value, Percentage | 15% |
Office Equipment [Member] | Minimum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Salvage Value, Percentage | 7% |
Office Equipment [Member] | Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Salvage Value, Percentage | 9% |
Schedule of Geographical Region
Schedule of Geographical Region of Long-Lived Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Total intangible assets | $ 3,898 | |
Total rights of use of assets and property and equipment | 642 | 2,422 |
ISRAEL | ||
Total intangible assets | 3,800 | |
Total rights of use of assets and property and equipment | 600 | 2,392 |
UNITED STATES | ||
Total intangible assets | 98 | |
Total rights of use of assets and property and equipment | $ 42 | $ 30 |
Significant Accounting Polici_4
Significant Accounting Policies (Details Narrative) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | ||
Property, Plant and Equipment [Line Items] | |||
Severance costs | $ 0.2 | $ 0.3 | |
Percentage of employee contributions | 100% | 100% | |
Percentage of employee's base salary | 6% | 6% | |
Short term leases | 12 months | ||
Expected dividend yield | [1] | 0% | |
Minimum [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Remainning term percent | 10% | ||
Maximum [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Remainning term percent | 50% | ||
Leasehold Improvements [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Property, Plant and Equipment, Salvage Value, Percentage | 10% | ||
[1]no shares have been granted |
Schedule of fair value of Intan
Schedule of fair value of Intangible Assets Acquired (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Oct. 18, 2023 | Jan. 19, 2023 |
Business Acquisition [Line Items] | |||
Intangible assets | $ 130 | ||
Ayala Pharmaceuticals Inc [Member] | |||
Business Acquisition [Line Items] | |||
Cash and cash equivalents | $ 22,539 | ||
Prepaid expenses and other current assets | 300 | ||
Fixed Assets, net | 34 | ||
Intangible assets | 130 | ||
Operating right-of-use asset | 5 | ||
Other assets | 11 | ||
Total assets | 23,019 | ||
Common stock warrant liability | (203) | ||
Other current liabilities and trade payables | (2,714) | ||
Total liabilities | (2,917) | ||
Net assets acquired | $ 20,102 | ||
Biosight Ltd. [Member] | |||
Business Acquisition [Line Items] | |||
Cash and cash equivalents | $ 1,909 | ||
Prepaid expenses and other current assets | 89 | ||
Fixed Assets, net | 64 | ||
Intangible assets | 3,800 | ||
Goodwill | 4,500 | ||
Total assets | 10,363 | ||
SAFE liability | (1,068) | ||
Other current liabilities and trade payables | (3,096) | ||
Total liabilities | (4,849) | ||
Net assets acquired | 5,514 | ||
Side Letter Agreement Liability | $ (685) |
Schedule of Pro Forma Financial
Schedule of Pro Forma Financial Information (Details) - Biosight Ltd. [Member] - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | [1] | |
Business Acquisition [Line Items] | |||
Revenue | $ 13 | $ 942 | |
Net loss | $ (57,344) | $ (63,011) | |
[1]The pro forma amounts above are derived from historical numbers of the Company, Old Ayala and Biosight. The results of operations for the year ended December 31, 2022 include the operations of the Company for the period from November 1, 2022 to October 31, 2023 which was the fiscal year 2022 prior to the change in the Company’s fiscal year end from October 31 to December 31, which change was effected in January 2023. There are no such adjustments for Biosight as the fiscal year ended on December 31, 2023. |
Mergers (Details Narrative)
Mergers (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |||
Dec. 31, 2023 | Oct. 18, 2023 | Dec. 31, 2022 | Oct. 18, 2022 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Common stock, par value | $ 0.001 | $ 0.001 | ||
Stock issued during period, shares, new issues | 0.1874 | |||
Intangible assets | $ 130 | |||
Goodwill | 4,500 | |||
Transaction cost | 1,000 | |||
Merger Agreement [Member] | Merger Sub Inc and Ayala Pharmaceuticals Inc [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Percentage of outstanding shares | 37.50% | |||
Merger Agreement [Member] | Ayala Pharmaceuticals Inc [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Percentage of outstanding shares | 55% | 62.50% | ||
Merger Agreement [Member] | Merger with Biosight Ltd. [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Percentage of outstanding shares | 45% | |||
Patents And License Agreements [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Intangible assets | $ 3,800 |
Schedule of Property and Equi_2
Schedule of Property and Equipment, Net (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] | ||
Property and Equipment, Gross | $ 1,352 | $ 1,620 |
Less: Accumulated Depreciation | 812 | 660 |
Property and Equipment, Net | 540 | 960 |
Computer Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and Equipment, Gross | 60 | 73 |
Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and Equipment, Gross | 95 | 296 |
Furniture and Fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and Equipment, Gross | 92 | 146 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and Equipment, Gross | $ 1,105 | $ 1,105 |
Property and Equipment, net (De
Property and Equipment, net (Details Narrative) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation expense | $ 334 | $ 162 |
Write down to assets | $ 145 |
Schedule of Lease Liabilities a
Schedule of Lease Liabilities and ROU Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Mar. 31, 2023 | Dec. 31, 2022 | Jan. 01, 2022 |
Property, Plant and Equipment [Line Items] | ||||
ROU assets | $ 102 | $ 65 | $ 1,462 | $ 1,750 |
Lease liabilities | 175 | $ 65 | 1,751 | 2,287 |
Offices [Member] | ||||
Property, Plant and Equipment [Line Items] | ||||
ROU assets | 42 | 1,273 | 1,448 | |
Lease liabilities | 134 | 1,612 | 2,020 | |
Cars [Member] | ||||
Property, Plant and Equipment [Line Items] | ||||
ROU assets | 60 | 189 | 302 | |
Lease liabilities | $ 41 | $ 139 | $ 267 |
Schedule of Operating Right of
Schedule of Operating Right of Use Assets and Lease Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Mar. 31, 2023 | Dec. 31, 2022 | Jan. 01, 2022 |
Property, Plant and Equipment [Line Items] | ||||
Operating right-of-use asset | $ 102 | $ 65 | $ 1,462 | $ 1,750 |
Total lease liabilities | 175 | $ 65 | 1,751 | 2,287 |
Current lease liabilities | 166 | 419 | ||
Non-current lease liabilities | 9 | 1,332 | ||
Offices [Member] | ||||
Property, Plant and Equipment [Line Items] | ||||
Operating right-of-use asset | 42 | 1,273 | 1,448 | |
Total lease liabilities | 134 | 1,612 | 2,020 | |
Cars [Member] | ||||
Property, Plant and Equipment [Line Items] | ||||
Operating right-of-use asset | 60 | 189 | 302 | |
Total lease liabilities | $ 41 | $ 139 | $ 267 |
Schedule of Lease Costs (Detail
Schedule of Lease Costs (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Leases | ||
Operating lease cost | $ 457 | $ 442 |
Variable lease cost | 19 | 10 |
Total lease cost | $ 476 | $ 452 |
Schedule of Future Payments Ope
Schedule of Future Payments Operating Lease Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Mar. 31, 2023 | Dec. 31, 2022 | Jan. 01, 2022 |
Leases | ||||
2024 | $ 171 | |||
2025 | 9 | |||
Total undiscounted lease payments | 180 | |||
Less: Interest | (5) | |||
Total lease liabilities - operating | $ 175 | $ 65 | $ 1,751 | $ 2,287 |
Leases (Details Narrative)
Leases (Details Narrative) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended | ||||||
Mar. 31, 2023 | Mar. 25, 2023 | Mar. 25, 2021 | Sep. 30, 2021 | Dec. 31, 2023 | Dec. 31, 2022 | Jan. 01, 2022 | Jan. 31, 2019 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Lease term | 63 months | |||||||
Renewal term | 60 months | |||||||
Lease hold improvements | $ 500 | |||||||
Payments of rent | $ 36 | $ 29 | ||||||
Lessee finance lease renewal term date | Mar. 31, 2025 | Mar. 31, 2023 | ||||||
Operating lease right of use asset | 65 | $ 102 | $ 1,462 | $ 1,750 | ||||
Operating lease liability | $ 65 | 175 | $ 1,751 | $ 2,287 | ||||
Gain on termination of lease | $ 238 | |||||||
Weighted average remaining lease term | 8 months 12 days | |||||||
Weighted average discount rate percent | 14.16% | |||||||
Office Lease Agreement [Member] | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
[custom:BankGuaranteeAmount-0] | $ 200 |
Schedule of Goodwill (Details)
Schedule of Goodwill (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2023 USD ($) | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Balance as of December 31, 2022 | |
Addition from acquisitions | 4,500 |
Balance as of December 31, 2023 | $ 4,500 |
Schedule of Intangible Assets (
Schedule of Intangible Assets (Details) $ in Thousands | Dec. 31, 2023 USD ($) |
Impairment Effects on Earnings Per Share [Line Items] | |
In Process Technology | $ 3,800 |
Intangible assets, net | 3,898 |
Indefinite-Lived Intangible Assets [Member] | |
Impairment Effects on Earnings Per Share [Line Items] | |
In Process Technology | 3,800 |
Less - accumulated amortization | |
Intangible assets, net | 3,800 |
Finite-Lived Intangible Assets [Member] | |
Impairment Effects on Earnings Per Share [Line Items] | |
In Process Technology | 130 |
Less - accumulated amortization | 32 |
Intangible assets, net | $ 98 |
Schedule of Amortization Expens
Schedule of Amortization Expenses (Details) $ in Thousands | Dec. 31, 2023 USD ($) |
Goodwill and Intangible Assets Disclosure [Abstract] | |
2024 | $ 33 |
2025 | 33 |
2026 | 32 |
2027 | |
Thereafter | 3,800 |
Total | $ 3,898 |
Goodwill and intangible asset_3
Goodwill and intangible assets, net (Details Narrative) $ in Thousands | 12 Months Ended |
Dec. 31, 2023 USD ($) | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Amortization expense | $ 32 |
Commitments and Contingent Li_2
Commitments and Contingent Liabilities (Details Narrative) - USD ($) | 1 Months Ended | 12 Months Ended | |||
Nov. 30, 2017 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2010 | Mar. 06, 2024 | |
Loss Contingencies [Line Items] | |||||
Revenue | $ 13,000 | $ 692,000 | |||
Milestone payments | 600,000 | ||||
Settlement agreement | 200,000 | ||||
Subsequent Event [Member] | |||||
Loss Contingencies [Line Items] | |||||
Warrants to purchase up | 15,000,000 | ||||
Cancer Field [Member] | |||||
Loss Contingencies [Line Items] | |||||
certain milestone payments | 2,500,000 | ||||
Strategic Fields [Member] | |||||
Loss Contingencies [Line Items] | |||||
certain milestone payments | $ 1,000,000 | ||||
BMS License Agreement [Member] | |||||
Loss Contingencies [Line Items] | |||||
Paid development or regulatory milestone events | $ 95,000,000 | ||||
Aggregate additional milestone amount | 47,000,000 | ||||
Payment to sales based milestone events | $ 50,000,000 | ||||
License Agreement [Member] | |||||
Loss Contingencies [Line Items] | |||||
Royalty rate percentage | 2.50% | ||||
Revenue | $ 250,000,000 | ||||
Increase in royalty rate percentage | 2.75% | ||||
Sales milestone | $ 40,000,000 | ||||
Advance royalties | 775,000 | ||||
Maintenance fee | $ 100,000 | ||||
License Agreement [Member] | Minimum [Member] | |||||
Loss Contingencies [Line Items] | |||||
Revenue | 250,000,000 | ||||
License Agreement [Member] | Maximum [Member] | |||||
Loss Contingencies [Line Items] | |||||
Revenue | $ 2,000,000,000 |
Schedule Of Warrants Outstandin
Schedule Of Warrants Outstanding (Details) | 12 Months Ended | |
Dec. 31, 2023 $ / shares shares | ||
Offsetting Assets [Line Items] | ||
Number of shares underlying warrants | 22,965,771 | |
Exercise Price Range One [Member] | ||
Offsetting Assets [Line Items] | ||
Exercise price | $ / shares | $ 2.79 | |
Number of shares underlying warrants | 879 | |
Expected term | September 2024 | |
Type of financing | September 2018 Public Offering | |
Exercise Price Range Two [Member] | ||
Offsetting Assets [Line Items] | ||
Exercise price | $ / shares | $ 224 | |
Number of shares underlying warrants | 4,092 | |
Expected term | July 2024 | |
Type of financing | July 2019 Public Offering | |
Exercise Price Range Three [Member] | ||
Offsetting Assets [Line Items] | ||
Exercise price | $ / shares | $ 28 | |
Number of shares underlying warrants | 57,230 | |
Expected term | November 2025 | |
Type of financing | November 2020 Public Offering | |
Exercise Price Range Four [Member] | ||
Offsetting Assets [Line Items] | ||
Exercise price | $ / shares | $ 56 | |
Number of shares underlying warrants | 140,552 | |
Expected term | April 2026 | |
Type of financing | April 2021 Registered Direct Offering (Accompanying Warrants) | |
Exercise Price Range Five [Member] | ||
Offsetting Assets [Line Items] | ||
Exercise price | $ / shares | $ 56 | |
Number of shares underlying warrants | 175,065 | |
Expected term | 5 years after the date such warrants become exercisable, if ever | |
Type of financing | April 2021 Private Placement (Private Placement Warrants) | |
Expected term | 5 years | |
Exercise Price Range Seven [Member] | ||
Offsetting Assets [Line Items] | ||
Exercise price | $ / shares | $ 96.58 | |
Number of shares underlying warrants | 87,453 | [1] |
Expected term | February 2024 | |
Type of financing | February 2021 Private Placement (issued by Old Ayala) | |
Exercise Price Range Six [Member] | ||
Offsetting Assets [Line Items] | ||
Exercise price | $ / shares | $ 0.34 | |
Number of shares underlying warrants | 22,500,500 | [2] |
Expected term | November 2028 | |
Type of financing | November 17, 2023 Financing | |
[1]Exercise price and warrant numbers have been retroactively adjusted for the impact of the January 2023 Merger, see note 1.[2]See details under Warrant Liability Senior Convertible Notes for information on the exercise price |
SCHEDULE OF WARRANTS OUTSTAND_2
SCHEDULE OF WARRANTS OUTSTANDING (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | ||
Common Stock Purchase Warrants And Warrant Liability | |||
Warrants, Outstanding and exercisable warrants | 337,320 | ||
Weighted Average Exercise Price, Outstanding and exercisable warrants | $ 25.08 | ||
Weighted Average Remaining Contractual Life In Years, Outstanding warrants | 4 years 10 months 2 days | 1 year 1 month 20 days | |
Aggregate Intrinsic Value, Outstanding and exercisable | $ 144,083 | ||
Merged warrants | [1] | 377,818 | |
Weighted Average Exercise Price, Merged warrants | [1] | $ 53.45 | |
Warrants, Issuance of warrants upon merger | 22,500,500 | ||
Weighted Average Exercise Price, Issuance of warrants upon merger | $ 0.34 | ||
Warrants, Exercised | [1] | (249,867) | |
Weighted Average Exercise Price, Exercised | [1] | $ 0.05 | |
Outstanding warrants, shares | [1] | 22,965,771 | |
Weighted Average Exercise Price, Outstanding warrants | [1] | $ 1.58 | |
Aggregate Intrinsic Value, Outstanding | $ 7,537,668 | ||
Exercisable warrants, shares | 22,790,706 | ||
Weighted Average Exercise Price, Exercisable warrants | $ 1.15 | ||
Weighted Average Remaining Contractual Life In Years, Exercisable warrants | 4 years 10 months 2 days | ||
Aggregate Intrinsic Value, Exercisable | $ 7,537,668 | ||
[1]Exercise price and warrant numbers have been retroactively adjusted for the impact of the January 2023 Merger, see note 1. |
Schedule Of Assumptions Used In
Schedule Of Assumptions Used In Warrant Liability (Details) | Dec. 31, 2023 $ / shares | Nov. 17, 2023 $ / shares | Aug. 07, 2023 $ / shares |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||
Stock Price | $ 0.67 | $ 0.77 | $ 1.15 |
Measurement Input, Interest Rate [Member] | |||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||
Stock Price | 12.4 | 7.2 | 7.3 |
Measurement Input, Discount Rate [Member] | |||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||
Stock Price | 47.7 | 75.2 | (32.4) |
Measurement Input, Risk Free Interest Rate [Member] | |||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||
Stock Price | 5.60 | 4.50 | 4.20 |
SCHEDULE OF ASSUMPTIONS USED _2
SCHEDULE OF ASSUMPTIONS USED IN WARRANT LIABILITY (Details) | Dec. 31, 2023 $ / shares | Nov. 17, 2023 $ / shares | Aug. 07, 2023 $ / shares | Jan. 19, 2023 $ / shares |
Stock Price | $ 0.67 | $ 0.77 | $ 1.15 | |
Warrant Liability [Member] | Private Placement [Member] | ||||
Exercise Price | 0.04 | 0.05 | ||
Stock Price | $ 0.26 | $ 0.31 | ||
Warrant Liability [Member] | Private Placement [Member] | Measurement Input, Expected Term [Member] | ||||
Expected term | 4 years 10 months 24 days | 5 years | ||
Warrant Liability [Member] | Private Placement [Member] | Measurement Input, Price Volatility [Member] | ||||
Measurement input percentage | 95.7 | 96.3 | ||
Warrant Liability [Member] | Private Placement [Member] | Measurement Input, Risk Free Interest Rate [Member] | ||||
Measurement input percentage | 3.85 | 4.45 | ||
Warrant Liability One [Member] | Private Placement [Member] | ||||
Exercise Price | $ 55.73 | $ 55.73 | ||
Stock Price | $ 0.67 | $ 2.95 | ||
Warrant Liability One [Member] | Private Placement [Member] | Measurement Input, Expected Term [Member] | ||||
Expected term | 4 years 11 months 23 days | 4 years 11 months 23 days | ||
Warrant Liability One [Member] | Private Placement [Member] | Measurement Input, Price Volatility [Member] | ||||
Measurement input percentage | 127 | 117 | ||
Warrant Liability One [Member] | Private Placement [Member] | Measurement Input, Risk Free Interest Rate [Member] | ||||
Measurement input percentage | 3.85 | 3.60 |
Common Stock Purchase Warrant_3
Common Stock Purchase Warrants and Warrant Liability (Details Narrative) - USD ($) | 12 Months Ended | |||||
Nov. 17, 2023 | Aug. 07, 2023 | Dec. 31, 2023 | Sep. 11, 2023 | Dec. 31, 2022 | ||
Number of warrant shares | 22,965,771 | |||||
Number of issuance of shares | 22,500,500 | |||||
Warrant exchanges of shares | [1] | 249,867 | ||||
Aggregate amount | $ 4 | |||||
Gain on fair value of warrant liability | $ 6,000,000 | |||||
Loss on fair value of liability | $ 7,200,000 | |||||
Par value per share | $ 0.001 | $ 0.001 | ||||
Side Agreement And Reinvestment Rights [Member] | ||||||
Uninvested amount | $ 1,800,000 | |||||
Share discount percentage | 35% | |||||
September Side Agreement [Member] | ||||||
Other expenses | $ 2,200,000 | |||||
April Private Placement [Member] | ||||||
Gain on fair value of warrant liability | 161,000 | |||||
Senior Convertible Promissory Note [Member] | ||||||
Share price | $ 0.001 | |||||
Debt instrument description | (i) 50% of the Common Stock’s price per share as of market close on November 16, 2023 and (ii) 50% of the Common Stock’s price per share as of the close of market on the Trading Day immediately prior to the date of the Notice of Conversion, subject to certain adjustments. In connection with the issuance of the Senior Convertible Notes, the Company issued to the noteholders warrants to purchase an aggregate of 15,000,000 shares of the Common Stock with an exercise price equal to the lower of (A) 50% of the Common Stock’s price per share as of market close on November 16, 2023 and (ii) 50% of the Common Stock’s price per share as of the close of market on the Trading Day immediately prior to the date of the Notice of Exercise of the warrant, subject to adjustment, which exercise may be on a cashless basis | |||||
Debt instrument additional amount | $ 4 | |||||
Senior Convertible Promissory Note [Member] | November Side Agreement [Member] | ||||||
Convertible debt | $ 1,458,000 | |||||
Senior Convertible Promissory Note [Member] | September Side Agreement [Member] | ||||||
Warrants and rights outstanding | 349,000 | |||||
Senior Secured Convertible Notes [Member] | ||||||
Debt Instrument, Issued, Principal | $ 2,000,000 | |||||
Senior Convertible Debt [Member] | ||||||
Short term debt | 4,000,000 | |||||
Debt fair value | 6,600,000 | |||||
Secure debt | 600,000 | |||||
Adjustments of warrants | $ 7,100,000 | |||||
Convertible Debt [Member] | ||||||
Number of issuance of shares | 22,500,500 | |||||
Minimum [Member] | ||||||
Shares authorized | 170,000,000 | |||||
Maximum [Member] | ||||||
Shares authorized | 300,000,000 | |||||
Maximum [Member] | November Side Agreement [Member] | ||||||
Convertible debt | $ 4,000,000 | |||||
Warrant [Member] | ||||||
Number of warrant shares | 22,790,706 | |||||
Warrant exchanges of shares | 249,867 | |||||
Warrant [Member] | Minimum [Member] | ||||||
Warrant exercise price per share | $ 0.34 | |||||
Warrant [Member] | Maximum [Member] | ||||||
Warrant exercise price per share | $ 224 | |||||
Common Stock [Member] | ||||||
Number of warrant shares | 337,320 | |||||
Warrant exchanges of shares | 246,192 | |||||
Common Stock [Member] | Minimum [Member] | ||||||
Warrant exercise price per share | $ 0.05 | |||||
Common Stock [Member] | Maximum [Member] | ||||||
Warrant exercise price per share | $ 96.58 | |||||
Equity Warrants [Member] | ||||||
Number of warrant shares | 289,327 | |||||
Class of Warrant or Right, Outstanding | 22,965,771 | |||||
Warrant Liability [Member] | Minimum [Member] | ||||||
Warrant exercise price per share | $ 2.79 | |||||
Warrant Liability [Member] | Maximum [Member] | ||||||
Warrant exercise price per share | $ 1,800 | |||||
[1]Exercise price and warrant numbers have been retroactively adjusted for the impact of the January 2023 Merger, see note 1. |
Schedule of Fair Value, Assets
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis (Details) | Dec. 31, 2023 USD ($) |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Total financial liabilities at fair value | $ 22,634 |
Private Placement [Member] | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Convertible note | 8,141 |
Side Letter Agreements | 8,436 |
Total financial liabilities at fair value | 6,057 |
Fair Value, Inputs, Level 1 [Member] | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Total financial liabilities at fair value | |
Fair Value, Inputs, Level 1 [Member] | Private Placement [Member] | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Convertible note | |
Side Letter Agreements | |
Total financial liabilities at fair value | |
Fair Value, Inputs, Level 2 [Member] | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Total financial liabilities at fair value | |
Fair Value, Inputs, Level 2 [Member] | Private Placement [Member] | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Convertible note | |
Side Letter Agreements | |
Total financial liabilities at fair value | |
Fair Value, Inputs, Level 3 [Member] | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Total financial liabilities at fair value | 22,634 |
Fair Value, Inputs, Level 3 [Member] | Private Placement [Member] | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Convertible note | 8,141 |
Side Letter Agreements | 8,436 |
Total financial liabilities at fair value | $ 6,057 |
Schedule of Fair Value Liabilit
Schedule of Fair Value Liabilities Measured on Recurring Basis (Details) - Fair Value, Recurring [Member] - Fair Value, Inputs, Level 3 [Member] $ in Thousands | 12 Months Ended |
Dec. 31, 2023 USD ($) | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
December 31, 2022 | |
Long term warrant assumed from January 2023 Merger | 203 |
Proceed from issuance of Convertible Notes | 2,000 |
Side Letter Agreement in connection with Biosight Merger | 685 |
SAFE assumed from Biosight Merger | 1,068 |
Conversion of of shares to SAFE | (1,068) |
Proceed from issuance of Senior Convertible Notes | 4,000 |
Remeasurement recorded in financial loss, net | 15,746 |
December 31, 2023 | $ 22,634 |
Common Stock (Details Narrative
Common Stock (Details Narrative) - shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Equity [Abstract] | ||
Number of shares restricted | 39,452 | 80,839 |
Schedule of Fair Value of Stock
Schedule of Fair Value of Stock Options Granted (Details) | 12 Months Ended | |||
Dec. 31, 2023 | Dec. 31, 2022 | |||
Share-Based Payment Arrangement [Abstract] | ||||
Expected volatility | [1] | 80% | ||
Expected dividends | [1] | 0% | ||
Expected term | 6 years 4 months 2 days | |||
Risk free interest rate | [1] | |||
Risk free interest rate | 0.98% | |||
Risk free interest rate | 3.53% | |||
[1]no shares have been granted |
Schedule of Share Based Compens
Schedule of Share Based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share-based compensation expense | $ 1,223 | $ 2,244 |
Research and Development Expense [Member] | ||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share-based compensation expense | 119 | 717 |
General and Administrative Expense [Member] | ||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share-based compensation expense | $ 1,104 | $ 1,527 |
Schedule of Changes in Stock Op
Schedule of Changes in Stock Option Plan (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | ||
Shares Outstanding, Beginning Balance | 197,897 | |
Weighted Average Exercise Price, Outstanding, Beginning | $ 38.34 | |
Weighted Average Remaining Contractual Life In Years, Outstanding, Ending balance | 6 years 2 months 12 days | 6 years 1 month 6 days |
Aggregate Intrinsic Value, Beginning | ||
Shares, Assumed in advaxis merger | 9,815 | |
Weighted Average Exercise Price, Assumed in advaxis merger | $ 1,243.88 | |
Weighted Average Remaining Contractual Life In Years, Merger | 6 years 3 months 18 days | |
Shares, Granted | ||
Weighted Average Exercise Price, Granted | ||
Shares, Forfeited | (6,539) | |
Weighted Average Exercise Price, Forfeited | $ 38.34 | |
Weighted Average Remaining Contractual Life In Years, Forfeited | 7 years 3 months 18 days | |
Shares, Expired | (98,281) | |
Weighted Average Exercise Price, Expired | $ 38.91 | |
Weighted Average Remaining Contractual Life In Years, Expired | 5 years 11 months 1 day | |
Shares, Outstanding, Ending Balance | 102,892 | 197,897 |
Weighted Average Exercise Price, Outstanding, Ending | $ 151.86 | $ 38.34 |
Aggregate Intrinsic Value, Ending | ||
Shares, Vested and Exercisable | 90,596 | |
Weighted Average Exercise Price, Vested and Exercisable | $ 131.77 | |
Weighted Average Remaining Contractual Life In Years, Vested and Exercisable | 6 years 7 days | |
Aggregate Intrinsic Value, Vested and Exercisable |
Schedule of Summarizes Informat
Schedule of Summarizes Information Relating to Restricted Shares (Details) - Restricted Stock [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Beginning balance | 80,840 | 23,303 |
Weighted average fairvale on grant date, beginning balance | $ 18.78 | $ 58.09 |
Forfeited | (5,176) | (5,926) |
Weighted average fairvale on grant date, forfeited | $ 10.67 | $ 16.67 |
Granted | 84,997 | |
Weighted average fairvale on grant date, granted | $ 10.42 | |
Vested | (58,607) | (21,534) |
Weighted average fairvale on grant date, vested | $ 21.37 | $ 28.92 |
Ending balance | 17,057 | 80,840 |
Weighted average fairvale on grant date, beginning balance | $ 18.78 |
Stock-Based Plans (Details Narr
Stock-Based Plans (Details Narrative) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 12 Months Ended | ||
Aug. 31, 2022 | May 31, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Stock issued during period, shares, new issues | 0.1874 | |||
Options outstanding | 102,892 | 197,897 | ||
Restricted Stock [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Fair value, grant | $ 0 | $ 2 | ||
Restricted shares granted | 84,997 | |||
Restricted Stock [Member] | Officers and Employees [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Restricted shares granted | 80,050 | |||
Vesting period | 3 years | |||
Restricted Stock [Member] | Employees [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Restricted shares granted | 4,947 | |||
Vesting period | 4 years | |||
2015 Plan [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Stock issued during period, shares, new issues | 81,248 | |||
Shares available for issuance | 69,513 | |||
January 2023 Merger [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Restricted shares issued and outstanding | 117,360 | |||
Options outstanding | 107,623 | |||
Stock Option Plan [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Fair value, grant | $ 5.74 | |||
Unrecognized cost | $ 0.1 | |||
Vesting period | 1 year 1 month 20 days |
Schedule of Income Before Incom
Schedule of Income Before Income Tax (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | ||
United States | $ (49,912) | $ (36,674) |
Israel | (2,072) | (755) |
Net loss before tax | $ (51,984) | $ (37,429) |
Schedule of Income Tax Expense
Schedule of Income Tax Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Operating Loss Carryforwards [Line Items] | ||
Current Income tax expense | $ (3,912) | $ 584 |
Income tax expense | (3,912) | 584 |
Domestic Tax Authority [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Domestic | (4,335) | 57 |
Foreign Tax Authority [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Foreign | $ 423 | $ 527 |
Schedule of Tax Federal Statuto
Schedule of Tax Federal Statutory Rate (Details) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | ||
U.S. federal tax provision at statutory rate | 21% | 21% |
State and local tax, net of federal benefit | 37.96% | 0.72% |
Foreign rate differences | 0.03% | (0.06%) |
Non-deductible stock compensation | (0.49%) | (1.26%) |
Section 951A GILTI | 0% | 0% |
Effect of other permanent differences | (0.05%) | (0.01%) |
Uncertain tax positions | (0.81%) | (1.15%) |
Change in valuation allowance | (48.44%) | (25.51%) |
Federal Tax Reform Rate Change | 0% | 0% |
Tax Credits | 4.14% | |
Provision to Return | 1.68% | 1.67% |
Other adjustments | (0.01%) | (1.10%) |
Effective tax rate | 7.51% | (1.56%) |
Schedule of Deferred Tax Assets
Schedule of Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Income Tax Disclosure [Abstract] | ||
Federal net operating loss carry forwards | $ 69,040 | $ 27,592 |
Tax credit carry forwards | 16,668 | 4,862 |
Intangible and other related assets | 3,095 | 2,990 |
Research and Development Costs | 36,632 | 3,074 |
Accrued expenses | 169 | 72 |
Warrant and other fair value Liabilities | 5,142 | |
Stock Based Compensation | 4,782 | |
Lease Liability | 460 | 410 |
Total deferred tax assets before valuation allowance | 135,988 | 39,000 |
Valuation allowance | (135,570) | (38,652) |
Total deferred tax assets | 418 | 348 |
Right of Use Asset | 418 | 348 |
Total deferred tax liabilities | 418 | 348 |
Net deferred tax assets |
Schedule of Reconciliation of C
Schedule of Reconciliation of Company’s Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | ||
Uncertain tax position at the beginning of year | $ 1,335 | $ 858 |
Additions for uncertain tax position of prior years (foreign exchange and interest) | 13 | 36 |
Additions for tax positions of current year | 423 | 441 |
Uncertain tax position at the end of the year | $ 1,771 | $ 1,335 |
Taxes on Income (Details Narrat
Taxes on Income (Details Narrative) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2018 | |
Operating Loss Carryforwards [Line Items] | |||
Income tax description | (i) a permanent reduction to the statutory federal corporate income tax rate from 35% (top rate) to 21% (flat rate) effective for tax years beginning after December 31, 2017 (ii) a new tax deduction in the amount of 37.5% of “foreign derived intangible income” that effectively reduces the federal corporate tax on certain qualified foreign derived sales/licenses/leases and service income in excess of a base amount to 13.125% (as compared to the regular corporate income tax rate of 21%); (iii) stricter limitation on the tax deductibility of business interest expense; (iv) a shift of the U.S. taxation of multinational corporations from a tax on worldwide income to a territorial system (along with certain rules designed to prevent erosion of the U.S. income tax base) (v) a one-time deemed repatriation tax on accumulated offshore earnings held in cash and illiquid assets, with the latter taxed at a lower rate and (vi) an expansion of the U.S. controlled foreign corporation (“CFC”) anti deferral starting with the CFC’s first tax year beginning in 2018 intended to tax in the U.S. “global intangible low-taxed income” (“GILTI”) | ||
Valuation allowance | $ 135,570 | $ 38,652 | |
Net operating loss carry-forward | 214,900 | ||
Income tax penalties expense | $ 1,800 | $ 1,300 | |
Tax credit percent | 4.14% | ||
Israel Tax Authority [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Tax credit percent | 23% | 23% | |
Research and Development Expense [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carry-forward | $ 11,400 | $ 190,500 |
Schedule of Diluted Net Loss Pe
Schedule of Diluted Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Earnings Per Share [Abstract] | ||
Net loss attributable to common stockholders, basic | $ (48,072) | $ (38,013) |
Net loss attributable to common stockholders, diluted | $ (48,072) | $ (38,013) |
Weighted average common shares outstanding, basic | 6,019,063 | 2,895,130 |
Weighted average common shares outstanding, diluted | 6,019,063 | 2,895,130 |
Warrants | 22,965,771 | 87,453 |
Stock options | 102,892 | 197,897 |
Anti dilutive shares outstanding which were not included in the diluted calculation | 23,068,663 | 285,350 |
Net loss per share attributable to common stockholders, basic | $ (7.99) | $ (13.13) |
Net loss per share attributable to common stockholders, diluted | $ (7.99) | $ (13.13) |
Schedule of Related Party Trans
Schedule of Related Party Transactions (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | ||
Related Party Transaction [Line Items] | |||
Convertible Loan | [1] | $ 8,141 | |
Long-term warrant liability | [1] | 6,057 | |
General and Administrative | 12,185 | 9,742 | |
Related Party [Member] | |||
Related Party Transaction [Line Items] | |||
Financial expenses (income), net | [2] | 8,351 | |
General and Administrative | [3] | 128 | 65 |
Related Party [Member] | |||
Related Party Transaction [Line Items] | |||
Convertible Loan | [2] | 8,007 | |
Long-term warrant liability | [2] | 5,915 | |
Side Letter Agreement liabilities | 8,175 | ||
Accrued expenses | [3] | $ 118 | $ 69 |
[1]Received from related party see note 14.[2]In August and November 2023, the Company entered into Convertible Note agreement. See note 8.[3]For director fees to members of Israel Biotech Fund I, L.P., Israel Biotech Fund II, L.P., Arkin Bio Ventures L.P. |
Related parties (Details Narrat
Related parties (Details Narrative) | 12 Months Ended |
Dec. 31, 2023 | |
Three Affiliated Directors [Member] | |
Related party Transaction | 75% |
Arkin Bio Ventures LP [Member] | |
Related party Transaction | 20% |
Schedule of Prepaid Expenses an
Schedule of Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Prepaid Expenses And Other Current Assets | ||
Prepaid Insurances | $ 2,144 | $ 431 |
Short-term restricted bank deposits | 330 | 110 |
Other Assets | 172 | 5 |
Total | $ 2,646 | $ 546 |
Schedule of Finance Expenses Ne
Schedule of Finance Expenses Net (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Finance Expenses Net | ||
Remeasurement of long-term warrant liability | $ 5,854 | |
Remeasurement of Side Letter Agreements | 7,751 | |
Remeasurement of convertible note | 2,141 | |
Others | (28) | (74) |
Total | $ 15,718 | $ (74) |
Subsequent Events (Details Narr
Subsequent Events (Details Narrative) - Subsequent Event [Member] - USD ($) $ in Thousands | Mar. 21, 2024 | Feb. 27, 2024 | Feb. 07, 2024 | Mar. 06, 2024 |
Subsequent Event [Line Items] | ||||
Financing notes converted into shares | 15,456,432 | |||
Shares exercised | 22,500,500 | |||
Cash less exercise option | 15,280,123 | |||
Additional fund | $ 2,000 | |||
Purchase of shares | 15,000,000 | |||
Repayments of Debt | $ 200 |