Cover
Cover - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 11, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Sep. 30, 2023 | |
Document Fiscal Period Focus | Q3 | |
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 Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 10,751,792 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | |
CURRENT ASSETS: | |||
Cash and cash equivalents | $ 2,123 | $ 2,408 | |
Short-term restricted bank deposits | 102 | 110 | |
Trade receivables | 234 | ||
Prepaid expenses and other current assets | 2,327 | 436 | |
Total current assets | 4,552 | 3,188 | |
LONG-TERM ASSETS: | |||
Deferred issuance costs | 1,953 | ||
Operating lease right of use asset | 1,276 | 1,462 | |
Intangible assets, net | 107 | ||
Property and equipment, net | 845 | 960 | |
Other assets | 201 | 206 | |
Total long-term assets | 2,429 | 4,581 | |
Total assets | 6,981 | 7,769 | |
CURRENT LIABILITIES: | |||
Trade payable | 5,056 | 4,080 | |
Operating lease liabilities | 480 | 419 | |
Accrued expenses | 1,556 | 551 | |
Accrued payroll and employee benefits | 1,231 | 994 | |
Other accounts payable | 204 | 169 | |
Total current liabilities | 8,527 | 6,213 | |
LONG TERM LIABILITIES: | |||
Long-term warrant liability | 65 | ||
Convertible Note | 2,068 | ||
Uncertain tax position | 1,630 | 1,323 | |
Long-term operating lease liabilities | 932 | 1,332 | |
Total long-term liabilities | 4,695 | 2,655 | |
STOCKHOLDERS’ EQUITY (DEFICIENCY): | |||
Common Stock of $0.001 par value per share; 170,000,000 and 37,480,000 shares authorized on September 30, 2023 (unaudited) and on December 31, 2022, respectively; 4,838,322 and 2,775,906 shares issued and on September 30, 2023 (unaudited) and December 31, 2022, respectively; 4,788,091 and 2,695,067 shares outstanding on September 30, 2023 (unaudited) and December 31, 2022, respectively. | [1] | 5 | 3 |
Additional paid-in capital | [1] | 166,307 | 148,052 |
Accumulated deficit | (172,553) | (149,154) | |
Total stockholders’ equity (deficiency) | (6,241) | (1,099) | |
Total liabilities and stockholders’ equity (deficiency) | $ 6,981 | $ 7,769 | |
[1]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 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Common stock, par value, per share | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 170,000,000 | 37,480,000 |
Common stock, shares, issued | 4,838,322 | 2,775,906 |
Common stock, shares, outstanding | 4,788,091 | 2,695,067 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | ||
Income Statement [Abstract] | |||||
Revenues from licensing agreement and others | $ 91 | $ 13 | $ 587 | ||
Cost of services | (91) | (13) | (497) | ||
Gross profit | 90 | ||||
Operating expenses: | |||||
Research and development | 5,683 | 7,199 | 18,671 | 20,282 | |
General and administrative | 1,448 | 2,881 | 8,815 | 7,586 | |
Operating loss | (7,131) | (10,080) | (27,486) | (27,778) | |
Financial (loss) income, net | (143) | 1 | 72 | 41 | |
Loss before income tax | (7,274) | (10,079) | (27,414) | (27,737) | |
Taxes on income | (65) | (106) | 4,015 | (509) | |
Net loss | $ (7,339) | $ (10,185) | $ (23,399) | $ (28,246) | |
Net Loss per share attributable to common stockholders, basic | $ (1.53) | $ (3.51) | $ (5.03) | $ (9.81) | |
Net loss per share, basic and diluted | $ (1.53) | $ (3.51) | $ (5.03) | $ (9.81) | |
Weighted average common shares outstanding, basic | [1],[2] | 4,784,474 | 2,901,478 | 4,648,599 | 2,879,465 |
Weighted average common shares outstanding, diluted | [1],[2] | 4,784,474 | 2,901,478 | 4,648,599 | 2,879,465 |
[1]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[2]Exercise price and warrant numbers of Old Ayala’s warrants have been retroactively adjusted for the impact of the January 2023 Merger, see note 1 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Changes in Stockholders' Equity (Deficiency) (Unaudited) - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid-in Capital [Member] | [1] | Retained Earnings [Member] | Total | ||
Beginning balance, value at Dec. 31, 2021 | $ 3 | [1] | $ 145,296 | $ (111,141) | $ 34,158 | ||
Stock-based compensation, shares at Dec. 31, 2021 | [1] | 2,615,360 | |||||
Vested restricted shares | [1] | ||||||
Vested restricted shares, shares | [1] | 6,658 | |||||
Share based compensation | [1] | 1,914 | 1,914 | ||||
Stock-based compensation, shares | [1] | ||||||
Proceeds from issuance of common stock, net of issuance cost of $3 | [1],[2] | 512 | 512 | ||||
Stock-based compensation, shares | [1] | 58,172 | |||||
Net loss | [1] | (28,246) | (28,246) | ||||
Ending balance, value at Sep. 30, 2022 | $ 3 | [1] | 147,722 | (139,387) | 8,338 | ||
Stock-based compensation, shares at Sep. 30, 2022 | [1] | 2,680,190 | |||||
Beginning balance, value at Jun. 30, 2022 | $ 3 | [1] | 146,738 | (129,202) | 17,539 | ||
Stock-based compensation, shares at Jun. 30, 2022 | [1] | 2,620,716 | |||||
Vested restricted shares | [1] | ||||||
Vested restricted shares, shares | [1] | 2,220 | |||||
Share based compensation | [1] | 516 | 516 | ||||
Stock-based compensation, shares | [1] | ||||||
Proceeds from issuance of common stock, net of issuance cost of $3 | [1],[2] | 468 | 468 | ||||
Stock-based compensation, shares | [1] | 57,254 | |||||
Net loss | [1] | (10,185) | (10,185) | ||||
Ending balance, value at Sep. 30, 2022 | $ 3 | [1] | 147,722 | (139,387) | 8,338 | ||
Stock-based compensation, shares at Sep. 30, 2022 | [1] | 2,680,190 | |||||
Beginning balance, value at Dec. 31, 2022 | $ 3 | [1] | 148,052 | (149,154) | (1,099) | ||
Stock-based compensation, shares at Dec. 31, 2022 | [1] | 2,695,067 | |||||
Vested restricted shares | [1] | ||||||
Vested restricted shares, shares | [1] | 30,882 | |||||
Share based compensation | [1] | 1,308 | $ 1,308 | ||||
Stock-based compensation, shares | [1] | ||||||
Stock-based compensation, shares | 0.1874 | ||||||
Net loss | [1] | (23,399) | $ (23,399) | ||||
Issuance of shares upon January 2023 Merger, net of issuance costs of $3,153 | $ 2 | [1] | 16,947 | 16,949 | |||
Stock-based compensation, shares | [1] | 2,062,143 | |||||
Ending balance, value at Sep. 30, 2023 | $ 5 | [1] | 166,307 | (172,553) | (6,241) | ||
Stock-based compensation, shares at Sep. 30, 2023 | [1] | 4,788,092 | |||||
Beginning balance, value at Jun. 30, 2023 | $ 5 | [1] | 166,218 | (165,214) | 1,009 | ||
Stock-based compensation, shares at Jun. 30, 2023 | [1] | 4,779,826 | |||||
Vested restricted shares | [1] | ||||||
Vested restricted shares, shares | [1] | 8,266 | |||||
Share based compensation | [1] | 89 | 89 | ||||
Stock-based compensation, shares | [1] | ||||||
Net loss | [1] | (7,339) | (7,339) | ||||
Ending balance, value at Sep. 30, 2023 | $ 5 | [1] | $ 166,307 | $ (172,553) | $ (6,241) | ||
Stock-based compensation, shares at Sep. 30, 2023 | [1] | 4,788,092 | |||||
[1]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[2]Represents an amount lower than $1. |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Changes in Stockholders' Equity (Unaudited) (Parenthetical) $ in Thousands | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
Statement of Stockholders' Equity [Abstract] | |
Merger, net of issuance costs | $ 3,153 |
Condensed Consolidated Statem_4
Condensed Consolidated Statement of Cash Flows (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (23,399) | $ (28,246) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Shared based compensation | 1,308 | 1,914 |
Depreciation and Amortization | 143 | 121 |
Asset write-downs | 28 | |
Remeasurement of long term warrant liability | (138) | |
Remeasurement of convertible note | 68 | |
Loss from exchange rate fluctuation | 26 | |
(Increase) decrease in prepaid expenses and other assets | (1,590) | 1,106 |
Decrease (increase) in trade receivables | 234 | (129) |
Increase (decrease) in trade payables | 1,225 | (888) |
Decrease in operating lease right-of-use assets | 255 | 220 |
Decrease in operating lease liabilities | (409) | (568) |
Increase (decrease) in accrued expenses | (573) | 330 |
Increase (decrease) in accrued payroll and employee benefits | 197 | (618) |
Changes in uncertain tax position | 307 | 542 |
Increase (decrease)in other accounts payable | 35 | (126) |
Net cash used in operating activities | (22,283) | (26,342) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from issuance of shares, net of issuance cost of $3 | 512 | |
Proceeds from issuance of convertible note | 2,000 | |
Issuance of shares upon Merger, net of issuance costs | 20,001 | |
Net cash provided by financing activities | 22,001 | 512 |
Effect of exchange rate changes on cash, cash equivalents and restricted cash | (26) | |
Decrease in cash and cash equivalents and restricted cash | (308) | (25,830) |
Cash and cash equivalents and restricted cash at beginning of the period | 2,724 | 37,339 |
Cash and cash equivalents and restricted cash at end of the period | 2,416 | 11,509 |
SUPPLEMENTAL DISCLOSURE OF NON-CASH ACTIVITIES | ||
Lease liabilities arising from new right-of-use assets | 537 | |
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION | ||
Tax paid in cash | 286 | 182 |
Cash and cash equivalents | 2,123 | 11,195 |
Restricted bank deposits | 102 | 110 |
Restricted bank deposits in other assets | 191 | 204 |
Cash and cash equivalents and restricted cash at end of the period | $ 2,416 | $ 11,509 |
Condensed Consolidated Statem_5
Condensed Consolidated Statement of Cash Flows (Unaudited) (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended |
Sep. 30, 2022 | Sep. 30, 2022 | |
Statement of Cash Flows [Abstract] | ||
Common stock issuance cost | $ 3 | $ 3 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Pay vs Performance Disclosure [Table] | ||||
Net Income (Loss) Attributable to Parent | $ (7,339) | $ (10,185) | $ (23,399) | $ (28,246) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Sep. 30, 2023 | |
Insider Trading Arrangements [Line Items] | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
GENERAL
GENERAL | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
GENERAL | NOTE 1— GENERAL In these financial statements, unless otherwise stated or the context otherwise indicates, references to “New Ayala,” the “Company,” “we,” “us,” “our” and similar references refer 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 our company solely in the period prior to the January 2023 Merger. Prior to the January 2023 Merger, we were 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, we are 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. Our differentiated development approach is predicated on identifying and addressing tumorigenic drivers of cancer, through a combination of our bioinformatics platform and next-generation sequencing to deliver targeted therapies to underserved patient populations. Our current portfolio of product candidates, AL101 and AL102, targets the aberrant activation of the Notch pathway using gamma secretase inhibitors. Gamma secretase is the enzyme responsible for Notch activation and, when inhibited, turns off the Notch pathway activation. Aberrant activation of the Notch pathway has long been implicated in multiple solid tumor and hematological cancers and has often been associated with more aggressive cancers. In cancers, Notch is known to serve as a critical facilitator in processes such as cellular proliferation, survival, migration, invasion, drug resistance and metastatic spread, all of which contribute to a poorer patient prognosis. AL101 and AL102 are designed to address the underlying key drivers of tumor growth, and our initial Phase 2 clinical data of AL101 suggest that our approach may address shortcomings of existing treatment options. We believe that our novel product candidates, if approved, have the potential to transform treatment outcomes for patients suffering from rare and aggressive cancers. We also continue 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 In 2017, the Company entered into an exclusive worldwide license agreement with respect to AL101 and AL102. See note 5. Going Concern The Company has incurred recurring losses since inception as a research and development organization and has an accumulated deficit of $ 172.6 22.3 As of September 30, 2023, the Company had approximately $ 2.1 million in cash and cash equivalents, and had approximately $ 1.6 million, as of the date of filing of this Form 10-Q, following the completion of the financing transactions on November 17, 2023 (the “November 17 Financing”), as described below The Company has limited available cash resources and believes that its current resources will not, without additional funding, be sufficient to meet its current obligations on the date of issuance of these condensed consolidated financial statements, which are estimated at approximately $ 12 2 Management has evaluated different strategies to obtain the required funding for future operations, including through public or private debt and equity financings, but despite its efforts, the Company has been unsuccessful, other than the November 17 Financing, in securing additional capital to fund operations and otherwise satisfy creditor obligations. Obtaining additional funding is essential to provide sufficient cash flow to meet current operating requirements. There can be no assurances that such financing will become available to the Company on satisfactory terms, or at all. In addition to seeking to obtain additional financing, management and the Board are evaluating strategic alternatives that may be available. Should financing not be obtained, or another strategic alternative not consummated, management and the Board may consider other alternatives, including without limitation bankruptcy and liquidation of the Company or an assignment for the benefit of creditors. AYALA PHARMACEUTICALS, INC. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS NOTE 1—GENERAL (continued): During the three months ended September 30, 2023, the Company had a reduction in workforce in which the employment of approximately 30% If the Company is unable to obtain funding, the Company would be forced to delay, reduce, or eliminate its research and development programs, which could adversely affect its business prospects, 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. The unaudited condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern. Therefore, the unaudited condensed consolidated financial statements for the nine months ended September 30, 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. On November 17, 2023, the Company issued Senior Convertible Promissory Notes (collectively, the “Senior Convertible Notes”), in an aggregate amount of $ 4.0 0.001 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 preliminary 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 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 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 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 January 2023 Merger, which consist of the Patents and License agreements valued at $ 130 These intangible assets are classified as Level 3 measurements within the fair value hierarchy. AYALA PHARMACEUTICALS, INC. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS NOTE 1—GENERAL (continued): The following unaudited table provides certain pro forma financial information for the Company as if the January 2023 Merger occurred on January 1, 2022 (in thousands except per share amounts): SCHEDULE OF PRO FORMA FINANCIAL INFORMATION Nine months Nine months ended ended September 30, September 30, 2023 2022 * Unaudited Unaudited Revenue $ 13 $ 837 Net loss $ (23,583 ) $ (40,308 ) Three months Three months Ended ended September 30, September 30, 2023 2022* Unaudited Unaudited Revenue $ - $ 91 Net loss $ (7,992 ) $ (17,061 ) * The pro forma amounts above are derived from historical numbers of the Company and Old Ayala. The results of operations for the three and nine months ended September 30, 2022 include the operations of the Company for the period from May 1, 2022 to July 31, 2022 and November 1, 2021 to July 31, 2022, respectively which was the first nine months of fiscal year 2022 prior to the change in our fiscal year end from October 31 to December 31, which change was effected in January 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. Basis of Presentation The accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial information. Accordingly, they do not include all the information and notes required by GAAP for annual financial statements. In the opinion of management, all adjustments (of a normal recurring nature) considered necessary for a fair statement of the results for the interim periods presented have been included. Operating results for the interim period are not necessarily indicative of the results that may be expected for the full year. These unaudited condensed consolidated financial statements should be read in conjunction with the consolidated financial statements for the year ended December 31, 2022, included in the Annual Report on Form 10-K of Old Ayala filed for the year ended December 31, 2022 (the “Old Ayala 2022 Form 10-K”) with the Securities and Exchange Commission (the “SEC”) on March 31, 2023 and the Annual Report on Form 10-K of the Company filed for the year ended October 31, 2022 (the “Form 10-K”) with the SEC on February 10, 2023. The Company’s significant accounting policies have not changed materially from those included in note 2 of the Company’s consolidated financial statements for the year ended December 31, 2022, included in the Old Ayala 2022 Form 10-K and the Form 10-K, unless otherwise stated. Use of estimates The preparation of the unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates, judgments and assumptions that affect the amounts reported in the unaudited condensed 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 unaudited condensed consolidated financial statements. Actual results could differ from those estimates. AYALA PHARMACEUTICALS, INC. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS NOTE 1—GENERAL (continued): 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. 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 ANTI-DILUTIVE SECURITIES EXCLUDED FROM DILUTED NET LOSS PER SHARE For the Three Months Ended For the Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Net loss attributable to common stockholders, basic and diluted (7,339 ) (10,185 ) (23,399 ) (28,246 Weighted average common shares outstanding, basic and diluted* 4,784,474 2,901,478 4,648,599 2,879,465 Warrants 465,271 109,316 465,271 109,316 Stock options 110,860 213,997 110,860 213,997 Anti dilutive shares outstanding which were not included in the diluted calculation 576,131 323,313 576,131 323,313 Net loss per share attributable to common stockholders, basic and diluted $ (1.53 ) $ (3.51 ) $ (5.03 ) $ (9.81 ) See note 5 for condition of warrants. All of the Common Stock, exercise prices and per share data have been retroactively adjusted for the impact of the January 2023 Merger. The shares have been adjusted to the merger ratio of 0.1874 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. Restricted bank deposits, 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. Warrants liabilities and convertible note are stated at fair value on a recurring basis. 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. In October 2021, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2021-08, Accounting for Contract Assets and Contract Liabilities from Contracts with Customers (Topic 805). This ASU requires an acquirer in a business combination to recognize and measure contract assets and contract liabilities (deferred revenue) from acquired contracts using the revenue recognition guidance in Topic 606. At the acquisition date, the acquirer applies the revenue model as if it had originated the acquired contracts. The ASU is effective for annual periods beginning after December 15, 2022, including interim periods within those fiscal years. The Company adopt ASU 2021-08 on January 1, 2023, and will apply this new guidance to all business combinations consummated subsequent to this date. Currently, this ASU has no impact on the Company’s consolidated financial statements. AYALA PHARMACEUTICALS, INC. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS |
REVENUES
REVENUES | 9 Months Ended |
Sep. 30, 2023 | |
Revenue from Contract with Customer [Abstract] | |
REVENUES | NOTE 2— REVENUES The Company recognizes revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers, which applies to all contracts with customers. 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. 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 expects to be entitled to receive in exchange for those goods or services. In December 2018, the Company entered into an evaluation, option and license agreement (the “Novartis Agreement”) with Novartis International Pharmaceutical Limited (“Novartis”) for which the Company is paid for its research and development costs. The Company concluded that there is one distinct performance obligation under the Novartis Agreement: Research and development services, an obligation which is satisfied over time. Revenue associated with the research and development services in the amount of approximately $ 13 no Revenue associated with the research and development services in the amount of approximately $ 587 91 The Company concluded that progress towards completion of the research and development performance obligation related to the Novartis Agreement is best measured in an amount proportional to the expenses relative to the total estimated expenses. The Company periodically reviews and updates its estimates, when appropriate, which may adjust revenue recognized for the period. Most of the company’s revenues derive from the Novartis Agreement, for which revenues consist of reimbursable research and development costs. On June 2, 2022, Novartis informed the Company that Novartis does not intend to exercise its option to obtain an exclusive license for AL102, thereby terminating the agreement. AYALA PHARMACEUTICALS, INC. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS |
TAX
TAX | 9 Months Ended |
Sep. 30, 2023 | |
Income Tax Disclosure [Abstract] | |
TAX | NOTE 3— TAX The Company has reviewed the tax positions taken, or to be taken, in its tax returns for all tax years currently open to examination by a taxing authority. As of September 30, 2023 and December 31, 2022, the Company has recorded an uncertain tax position liability exclusive of interest and penalties of $ 1.6 1.3 103 79 SCHEDULE OF RECONCILIATION OF COMPANY’S UNRECOGNIZED TAX BENEFITS Nine months Year Ended ended September 30, December 31, 2023 2022 (In thousands) (In thousands) Uncertain tax position at the beginning of the period $ 1,323 $ 858 Additions for uncertain tax position of prior years (foreign exchange and interest) 35 36 Subtractions for tax positions of previous period (7 ) Additions for tax positions of current period 279 429 Uncertain tax position at the end of the period $ 1,630 $ 1,323 The Company files U.S. federal, various U.S. state and Israeli income tax returns. The associated tax filings remain subject to examination by applicable tax authorities for a certain length of time following the tax year to which those filings relate. In the United States and Israel, the 2018 and subsequent tax years remain subject to examination by the applicable taxing authorities as of September 30, 2023. In March 2023, the Company received $ 4.7 |
COMMON STOCK PURCHASE WARRANTS
COMMON STOCK PURCHASE WARRANTS AND WARRANT LIABILITY | 9 Months Ended |
Sep. 30, 2023 | |
Common Stock Purchase Warrants And Warrant Liability | |
COMMON STOCK PURCHASE WARRANTS AND WARRANT LIABILITY | NOTE 4 – 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 September 30, 2023, there were 465,271 290,206 2.79 224.00 337,320 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) Grand Total 465,271 * Exercise price and warrant numbers of Old Ayala’s warrants have been retroactively adjusted for the impact of the January 2023 Merger, see note 1 AYALA PHARMACEUTICALS, INC. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS NOTE 4 – COMMON STOCK PURCHASE WARRANTS AND WARRANT LIABILITY (continued): As of September 30, 2023, the Company had 289,327 of its total 465,271 outstanding warrants classified as equity. As of December 31, 2022, all outstanding warrants were classified as equity. At issuance, equity warrants are recorded in additional paid-In capital. A summary of warrant activity was as follows (in thousands, except share and per share data): Weighted Average Weighted Remaining Average Contractual Life Aggregate Shares Exercise Price In Years Intrinsic Value Outstanding and exercisable warrants at December 31, 2022 337,320 $ 25.08 1.14 $ 86,613 Issuance of warrants upon January 2023 Merger 377,818 * 53.45 * Exercised (249,867 )* 0.05 * Outstanding warrants at September 30, 2023 465,271 * $ 61.56 * 3.15 $ - Exercisable warrants at September 30, 2023 290,206 $ 64.92 2.29 $ - * Exercise price and warrant numbers have been retroactively adjusted for the impact of the January 2023 Merger, see note 1. Shares Issued for Warrants Exercises During the nine months ended September 30, 2023, pre-funded warrant holders from the Old Ayala’s February 2019 Offering automatically net exercised 249,867 246,192 Warrant Liability 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 September 30, 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 September 30, 2023, the Company used the following inputs in its Black Scholes model: SCHEDULE OF ASSUMPTIONS USED IN WARRANT LIABILITY September 30, 2023 January 19, 2023 Exercise Price $ 55.73 $ 55.73 Stock Price $ 0.94 $ 2.95 Expected Term 4.98 4.98 Volatility % 128 % 117 % Risk Free Rate 4.60 % 3.60 % For the nine months ended September 30, 2023, the Company reported a gain of approximately $ 138 Convertible Note On August 7, 2023, the Company entered into a convertible note agreement (the “Note”) with ISRAEL BIOTECH FUND I, L.P. The Note provides for the borrowing by the Company of up to $ 2.0 15 65 On September 1, 2023 the company received the $ 2.0 The Company has elected the fair value option to measure the Note upon issuance, in accordance with ASC 825-10. Under the fair value option, the Note is 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). The Note was valued using a probability-weighted expected return model, which incorporated significant unobservable inputs such as the likelihood of a voluntary Note conversion (30% likelihood), the Note being held to maturity (30% likelihood) and the Note mandatory conversion in a PIPE (40% likelihood). This resulted in an implied borrowing rate of 37.8% was used as an input to the fair value measurement. In measuring the note for issued the Company used the following inputs: September 30, 2023 August 7, 2023 Stock price $ 0.94 $ 1.15 Interest rate 7.4 7.3 % Implied discount 48.8 % 40.6 % Volatility % 80.2 % 74.5 % Risk Free Rate 4.60 % 4.20 % For the nine months ended September 30, 2023, the Company reported change in fair value of not of approximately $ 68 AYALA PHARMACEUTICALS, INC. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE MEASUREMENTS | NOTE 5— FAIR VALUE MEASUREMENTS As of September 30, 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 September 30, 2023: SCHEDULE OF FAIR VALUE, ASSETS AND LIABILITIES MEASURED ON RECURRING BASIS Fair Value Measured at September 30, 2023 Level 1 Level 2 Level 3 Total Financial liabilities at fair value: Convertible note $ - $ - $ 2,068 $ 2,068 Long term warrant liability $ - $ - $ 65 $ 65 Total financial liabilities at fair value $ - $ - $ 2,133 $ 2,133 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 9 months ended For the 3 months ended Beginning balance - 67 Long term warrant assumed from Merger 203 - Proceed from issuance of loan $ 2,000 2,000 Revaluation recorded in financial income, net (70 ) 66 Ending balance 2,133 2,133 |
COMMITMENTS AND CONTINGENT LIAB
COMMITMENTS AND CONTINGENT LIABILITIES | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENT LIABILITIES | NOTE 6— COMMITMENTS AND CONTINGENT LIABILITIES In January 2019, the Company’s wholly owned Israeli subsidiary, Ayala-Oncology Israel Ltd. (the “Subsidiary”), signed a new lease agreement. The term of the lease is for 63 months and includes an option to extend the lease for an additional 60 months. As part of the agreement, the lessor also provided the Company an amount of approximately $ 0.5 The Subsidiary obtained a bank guarantee in the amount of approximately $ 191 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 36 65 The Company has the following operating ROU assets and lease liabilities: SCHEDULE OF OPERATING RIGHT OF USE ASSETS AND LEASE LIABILITIES September 30, 2023 ROU assets Lease liabilities Offices $ 1,179 $ 1,350 Cars 97 62 Total operating leases $ 1,276 $ 1,412 December 31, 2022 ROU assets Lease liabilities Offices $ 1,273 $ 1,612 Cars 189 139 Total operating leases $ 1,462 $ 1,751 September 30, December 31, 2023 2022 Lease liabilities Lease liabilities Current lease liabilities $ 480 $ 419 Non-current lease liabilities 932 1,332 Total lease liabilities $ 1,412 $ 1,751 The following table summarizes the lease costs recognized in the condensed consolidated statement of operations: SUMMARY OF LEASE COSTS For nine months For nine months ended ended September 30, September 30, 2023 2022 Operating lease cost $ 348 $ 341 Variable lease cost 6 10 Total lease cost $ 354 $ 351 For three months For three months ended ended September 30, September 30, 2023 2022 Operating lease cost $ 79 $ 120 Variable lease cost - - Total lease cost $ 79 $ 120 As of September 30, 2023, the weighted-average remaining lease term and weighted-average discount rate for operating leases are 2.7 7.4 AYALA PHARMACEUTICALS, INC. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS NOTE 6—COMMITMENTS AND CONTINGENT LIABILITIES (continued): The following table summarizes the future payments of the Company for its operating lease liabilities: SCHEDULE OF FUTURE PAYMENTS OF OPERATING LEASE LIABILITIES September 30, 2023 2023 (from October 1) $ 146 2024 380 2025 318 2026 308 2027 308 After 2027 411 Total undiscounted lease payments $ 1,871 Less: Interest 459 Total lease liabilities – operating $ 1,412 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”). AYALA PHARMACEUTICALS, INC. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS NOTE 6—COMMITMENTS AND CONTINGENT LIABILITIES (continued): 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”). At this time, the Company is unable to predict the likelihood of an unfavorable outcome with respect to the Complaint and the Demand Letters. |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 9 Months Ended |
Sep. 30, 2023 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | NOTE 7 – SUBSEQUENT EVENTS Merger with Biosight 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 (the “Biosight Merger”) with and into Biosight, which is now a wholly owned subsidiary of the Company. At completion of the Biosight Merger, Ayala’s then-current equity holders own approximately 45% 55% Based on the agreement, Ayala Pharmaceuticals, Inc. is the legal acquirer in the Merger. In addition, the Company considered ASC 805-10-55 to determine the accounting acquirer in the Merger. As the Company holds a majority of the members of the governing body of the combined Company, 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 Merger. The Company has accounted for the Merger as a business combination according to ASC 805 “Business Combinations”. Senior Convertible Notes On November 17, 2023, 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 has 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 4.0 7,500,000 |
GENERAL (Policies)
GENERAL (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Going Concern | Going Concern The Company has incurred recurring losses since inception as a research and development organization and has an accumulated deficit of $ 172.6 22.3 As of September 30, 2023, the Company had approximately $ 2.1 million in cash and cash equivalents, and had approximately $ 1.6 million, as of the date of filing of this Form 10-Q, following the completion of the financing transactions on November 17, 2023 (the “November 17 Financing”), as described below The Company has limited available cash resources and believes that its current resources will not, without additional funding, be sufficient to meet its current obligations on the date of issuance of these condensed consolidated financial statements, which are estimated at approximately $ 12 2 Management has evaluated different strategies to obtain the required funding for future operations, including through public or private debt and equity financings, but despite its efforts, the Company has been unsuccessful, other than the November 17 Financing, in securing additional capital to fund operations and otherwise satisfy creditor obligations. Obtaining additional funding is essential to provide sufficient cash flow to meet current operating requirements. There can be no assurances that such financing will become available to the Company on satisfactory terms, or at all. In addition to seeking to obtain additional financing, management and the Board are evaluating strategic alternatives that may be available. Should financing not be obtained, or another strategic alternative not consummated, management and the Board may consider other alternatives, including without limitation bankruptcy and liquidation of the Company or an assignment for the benefit of creditors. AYALA PHARMACEUTICALS, INC. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS NOTE 1—GENERAL (continued): During the three months ended September 30, 2023, the Company had a reduction in workforce in which the employment of approximately 30% If the Company is unable to obtain funding, the Company would be forced to delay, reduce, or eliminate its research and development programs, which could adversely affect its business prospects, 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. The unaudited condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern. Therefore, the unaudited condensed consolidated financial statements for the nine months ended September 30, 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. On November 17, 2023, the Company issued Senior Convertible Promissory Notes (collectively, the “Senior Convertible Notes”), in an aggregate amount of $ 4.0 0.001 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 preliminary 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 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 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 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 January 2023 Merger, which consist of the Patents and License agreements valued at $ 130 These intangible assets are classified as Level 3 measurements within the fair value hierarchy. AYALA PHARMACEUTICALS, INC. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS NOTE 1—GENERAL (continued): The following unaudited table provides certain pro forma financial information for the Company as if the January 2023 Merger occurred on January 1, 2022 (in thousands except per share amounts): SCHEDULE OF PRO FORMA FINANCIAL INFORMATION Nine months Nine months ended ended September 30, September 30, 2023 2022 * Unaudited Unaudited Revenue $ 13 $ 837 Net loss $ (23,583 ) $ (40,308 ) Three months Three months Ended ended September 30, September 30, 2023 2022* Unaudited Unaudited Revenue $ - $ 91 Net loss $ (7,992 ) $ (17,061 ) * The pro forma amounts above are derived from historical numbers of the Company and Old Ayala. The results of operations for the three and nine months ended September 30, 2022 include the operations of the Company for the period from May 1, 2022 to July 31, 2022 and November 1, 2021 to July 31, 2022, respectively which was the first nine months of fiscal year 2022 prior to the change in our fiscal year end from October 31 to December 31, which change was effected in January 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. |
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial information. Accordingly, they do not include all the information and notes required by GAAP for annual financial statements. In the opinion of management, all adjustments (of a normal recurring nature) considered necessary for a fair statement of the results for the interim periods presented have been included. Operating results for the interim period are not necessarily indicative of the results that may be expected for the full year. These unaudited condensed consolidated financial statements should be read in conjunction with the consolidated financial statements for the year ended December 31, 2022, included in the Annual Report on Form 10-K of Old Ayala filed for the year ended December 31, 2022 (the “Old Ayala 2022 Form 10-K”) with the Securities and Exchange Commission (the “SEC”) on March 31, 2023 and the Annual Report on Form 10-K of the Company filed for the year ended October 31, 2022 (the “Form 10-K”) with the SEC on February 10, 2023. The Company’s significant accounting policies have not changed materially from those included in note 2 of the Company’s consolidated financial statements for the year ended December 31, 2022, included in the Old Ayala 2022 Form 10-K and the Form 10-K, unless otherwise stated. |
Use of estimates | Use of estimates The preparation of the unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates, judgments and assumptions that affect the amounts reported in the unaudited condensed 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 unaudited condensed consolidated financial statements. Actual results could differ from those estimates. AYALA PHARMACEUTICALS, INC. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS NOTE 1—GENERAL (continued): |
Net Loss per Share | 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. 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 ANTI-DILUTIVE SECURITIES EXCLUDED FROM DILUTED NET LOSS PER SHARE For the Three Months Ended For the Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Net loss attributable to common stockholders, basic and diluted (7,339 ) (10,185 ) (23,399 ) (28,246 Weighted average common shares outstanding, basic and diluted* 4,784,474 2,901,478 4,648,599 2,879,465 Warrants 465,271 109,316 465,271 109,316 Stock options 110,860 213,997 110,860 213,997 Anti dilutive shares outstanding which were not included in the diluted calculation 576,131 323,313 576,131 323,313 Net loss per share attributable to common stockholders, basic and diluted $ (1.53 ) $ (3.51 ) $ (5.03 ) $ (9.81 ) See note 5 for condition of warrants. All of the Common Stock, exercise prices and per share data have been retroactively adjusted for the impact of the January 2023 Merger. The shares have been adjusted to the merger ratio of 0.1874 |
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. Restricted bank deposits, 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. Warrants liabilities and convertible note are stated at fair value on a recurring basis. |
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. In October 2021, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2021-08, Accounting for Contract Assets and Contract Liabilities from Contracts with Customers (Topic 805). This ASU requires an acquirer in a business combination to recognize and measure contract assets and contract liabilities (deferred revenue) from acquired contracts using the revenue recognition guidance in Topic 606. At the acquisition date, the acquirer applies the revenue model as if it had originated the acquired contracts. The ASU is effective for annual periods beginning after December 15, 2022, including interim periods within those fiscal years. The Company adopt ASU 2021-08 on January 1, 2023, and will apply this new guidance to all business combinations consummated subsequent to this date. Currently, this ASU has no impact on the Company’s consolidated financial statements. |
GENERAL (Tables)
GENERAL (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
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 preliminary 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 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 |
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 occurred on January 1, 2022 (in thousands except per share amounts): SCHEDULE OF PRO FORMA FINANCIAL INFORMATION Nine months Nine months ended ended September 30, September 30, 2023 2022 * Unaudited Unaudited Revenue $ 13 $ 837 Net loss $ (23,583 ) $ (40,308 ) Three months Three months Ended ended September 30, September 30, 2023 2022* Unaudited Unaudited Revenue $ - $ 91 Net loss $ (7,992 ) $ (17,061 ) * The pro forma amounts above are derived from historical numbers of the Company and Old Ayala. The results of operations for the three and nine months ended September 30, 2022 include the operations of the Company for the period from May 1, 2022 to July 31, 2022 and November 1, 2021 to July 31, 2022, respectively which was the first nine months of fiscal year 2022 prior to the change in our fiscal year end from October 31 to December 31, which change was effected in January 2023. |
SCHEDULE OF ANTI-DILUTIVE SECURITIES EXCLUDED FROM 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 ANTI-DILUTIVE SECURITIES EXCLUDED FROM DILUTED NET LOSS PER SHARE For the Three Months Ended For the Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Net loss attributable to common stockholders, basic and diluted (7,339 ) (10,185 ) (23,399 ) (28,246 Weighted average common shares outstanding, basic and diluted* 4,784,474 2,901,478 4,648,599 2,879,465 Warrants 465,271 109,316 465,271 109,316 Stock options 110,860 213,997 110,860 213,997 Anti dilutive shares outstanding which were not included in the diluted calculation 576,131 323,313 576,131 323,313 Net loss per share attributable to common stockholders, basic and diluted $ (1.53 ) $ (3.51 ) $ (5.03 ) $ (9.81 ) |
TAX (Tables)
TAX (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Income Tax Disclosure [Abstract] | |
SCHEDULE OF RECONCILIATION OF COMPANY’S UNRECOGNIZED TAX BENEFITS | SCHEDULE OF RECONCILIATION OF COMPANY’S UNRECOGNIZED TAX BENEFITS Nine months Year Ended ended September 30, December 31, 2023 2022 (In thousands) (In thousands) Uncertain tax position at the beginning of the period $ 1,323 $ 858 Additions for uncertain tax position of prior years (foreign exchange and interest) 35 36 Subtractions for tax positions of previous period (7 ) Additions for tax positions of current period 279 429 Uncertain tax position at the end of the period $ 1,630 $ 1,323 |
COMMON STOCK PURCHASE WARRANT_2
COMMON STOCK PURCHASE WARRANTS AND WARRANT LIABILITY (Tables) | 9 Months Ended |
Sep. 30, 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) Grand Total 465,271 * Exercise price and warrant numbers of Old Ayala’s warrants have been retroactively adjusted for the impact of the January 2023 Merger, see note 1 Weighted Average Weighted Remaining Average Contractual Life Aggregate Shares Exercise Price In Years Intrinsic Value Outstanding and exercisable warrants at December 31, 2022 337,320 $ 25.08 1.14 $ 86,613 Issuance of warrants upon January 2023 Merger 377,818 * 53.45 * Exercised (249,867 )* 0.05 * Outstanding warrants at September 30, 2023 465,271 * $ 61.56 * 3.15 $ - Exercisable warrants at September 30, 2023 290,206 $ 64.92 2.29 $ - * 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 WARRANT LIABILITY | In measuring the warrant liability for the warrants issued in the April 2021 Private Placement and September 2018 Public Offering at September 30, 2023, the Company used the following inputs in its Black Scholes model: SCHEDULE OF ASSUMPTIONS USED IN WARRANT LIABILITY September 30, 2023 January 19, 2023 Exercise Price $ 55.73 $ 55.73 Stock Price $ 0.94 $ 2.95 Expected Term 4.98 4.98 Volatility % 128 % 117 % Risk Free Rate 4.60 % 3.60 % September 30, 2023 August 7, 2023 Stock price $ 0.94 $ 1.15 Interest rate 7.4 7.3 % Implied discount 48.8 % 40.6 % Volatility % 80.2 % 74.5 % Risk Free Rate 4.60 % 4.20 % |
FAIR VALUE MEASUREMENTS (Tables
FAIR VALUE MEASUREMENTS (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
SCHEDULE OF FAIR VALUE, ASSETS AND LIABILITIES MEASURED ON RECURRING BASIS | As of September 30, 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 September 30, 2023: SCHEDULE OF FAIR VALUE, ASSETS AND LIABILITIES MEASURED ON RECURRING BASIS Fair Value Measured at September 30, 2023 Level 1 Level 2 Level 3 Total Financial liabilities at fair value: Convertible note $ - $ - $ 2,068 $ 2,068 Long term warrant liability $ - $ - $ 65 $ 65 Total financial liabilities at fair value $ - $ - $ 2,133 $ 2,133 |
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 9 months ended For the 3 months ended Beginning balance - 67 Long term warrant assumed from Merger 203 - Proceed from issuance of loan $ 2,000 2,000 Revaluation recorded in financial income, net (70 ) 66 Ending balance 2,133 2,133 |
COMMITMENTS AND CONTINGENT LI_2
COMMITMENTS AND CONTINGENT LIABILITIES (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
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 September 30, 2023 ROU assets Lease liabilities Offices $ 1,179 $ 1,350 Cars 97 62 Total operating leases $ 1,276 $ 1,412 December 31, 2022 ROU assets Lease liabilities Offices $ 1,273 $ 1,612 Cars 189 139 Total operating leases $ 1,462 $ 1,751 September 30, December 31, 2023 2022 Lease liabilities Lease liabilities Current lease liabilities $ 480 $ 419 Non-current lease liabilities 932 1,332 Total lease liabilities $ 1,412 $ 1,751 |
SUMMARY OF LEASE COSTS | The following table summarizes the lease costs recognized in the condensed consolidated statement of operations: SUMMARY OF LEASE COSTS For nine months For nine months ended ended September 30, September 30, 2023 2022 Operating lease cost $ 348 $ 341 Variable lease cost 6 10 Total lease cost $ 354 $ 351 For three months For three months ended ended September 30, September 30, 2023 2022 Operating lease cost $ 79 $ 120 Variable lease cost - - Total lease cost $ 79 $ 120 |
SCHEDULE OF FUTURE PAYMENTS OF OPERATING LEASE LIABILITIES | The following table summarizes the future payments of the Company for its operating lease liabilities: SCHEDULE OF FUTURE PAYMENTS OF OPERATING LEASE LIABILITIES September 30, 2023 2023 (from October 1) $ 146 2024 380 2025 318 2026 308 2027 308 After 2027 411 Total undiscounted lease payments $ 1,871 Less: Interest 459 Total lease liabilities – operating $ 1,412 |
SCHEDULE OF FAIR VALUE OF INTAN
SCHEDULE OF FAIR VALUE OF INTANGIBLE ASSETS ACQUIRED (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Jan. 19, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Cash and cash equivalents | $ 22,539 | |
Prepaid expenses and other current assets | 300 | |
Property and equipment, net | 34 | |
Intangible assets | $ 130 | 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 |
SCHEDULE OF PRO FORMA FINANCIAL
SCHEDULE OF PRO FORMA FINANCIAL INFORMATION (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2023 | Sep. 30, 2022 | [1] | Sep. 30, 2023 | Sep. 30, 2022 | [1] | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||||
Revenue | $ 91 | $ 13 | $ 837 | |||
Net loss | $ (7,992) | $ (17,061) | $ (23,583) | $ (40,308) | ||
[1]The pro forma amounts above are derived from historical numbers of the Company and Old Ayala. The results of operations for the three and nine months ended September 30, 2022 include the operations of the Company for the period from May 1, 2022 to July 31, 2022 and November 1, 2021 to July 31, 2022, respectively which was the first nine months of fiscal year 2022 prior to the change in our fiscal year end from October 31 to December 31, which change was effected in January 2023. |
SCHEDULE OF ANTI-DILUTIVE SECUR
SCHEDULE OF ANTI-DILUTIVE SECURITIES EXCLUDED FROM DILUTED NET LOSS PER SHARE (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | ||
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||||
Net loss | $ (7,339) | $ (10,185) | $ (23,399) | $ (28,246) | |
Weighted average common shares outstanding, basic | [1],[2] | 4,784,474 | 2,901,478 | 4,648,599 | 2,879,465 |
Weighted average common shares outstanding, diluted | [1],[2] | 4,784,474 | 2,901,478 | 4,648,599 | 2,879,465 |
Warrants | 465,271,000 | 109,316,000 | 465,271,000 | 109,316,000 | |
Stock options | 110,860,000 | 213,997,000 | 110,860,000 | 213,997,000 | |
Anti dilutive shares outstanding which were not included in the diluted calculation | 576,131,000 | 323,313,000 | 576,131,000 | 323,313,000 | |
Net Loss per share attributable to common stockholders, basic | $ (1.53) | $ (3.51) | $ (5.03) | $ (9.81) | |
Net Loss per share attributable to common stockholders, diluted | $ (1.53) | $ (3.51) | $ (5.03) | $ (9.81) | |
[1]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[2]Exercise price and warrant numbers of Old Ayala’s warrants have been retroactively adjusted for the impact of the January 2023 Merger, see note 1 |
GENERAL (Details Narrative)
GENERAL (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | ||||||
Sep. 30, 2023 | Sep. 30, 2022 | Nov. 17, 2023 | Aug. 07, 2023 | Jan. 19, 2023 | Dec. 31, 2022 | Oct. 18, 2022 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Accumulated deficit | $ 172,553 | $ 149,154 | |||||
Net cash used in operating activities | 22,283 | $ 26,342 | |||||
Cash and Cash Equivalents, at Carrying Value | 2,123 | $ 11,195 | 2,408 | ||||
Reduced value | 1,600 | ||||||
Available cash resources | 12,000 | ||||||
Convertible note | $ 2,068 | $ 2,000 | |||||
Reduction in workforce percentage | 30% | ||||||
Common stock, par value | $ 0.001 | $ 0.001 | |||||
Stock issued during period, shares, new issues | 0.1874 | ||||||
Intangible assets | $ 130 | $ 130 | |||||
Common shares merger ratio | 0.1874 | ||||||
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 | 62.50% | ||||||
Senior Convertible Promissory Note [Member] | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Aggregate amount | $ 4,000 | ||||||
Share price | $ 0.001 | ||||||
Senior Convertible Promissory Note [Member] | Subsequent Event [Member] | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Aggregate amount | $ 4,000 | ||||||
Share price | $ 0.001 |
REVENUES (Details Narrative)
REVENUES (Details Narrative) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Revenue from Contract with Customer [Abstract] | ||||
Revenues | $ 91 | $ 13 | $ 587 |
SCHEDULE OF RECONCILIATION OF C
SCHEDULE OF RECONCILIATION OF COMPANY’S UNRECOGNIZED TAX BENEFITS (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | ||
Uncertain tax position at the beginning of the period | $ 1,323 | $ 858 |
Additions for uncertain tax position of prior years (foreign exchange and interest) | 35 | 36 |
Subtractions for tax positions of previous period | (7) | |
Additions for tax positions of current period | 279 | 429 |
Uncertain tax position at the end of the period | $ 1,630 | $ 1,323 |
TAX (Details Narrative)
TAX (Details Narrative) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2023 | Dec. 31, 2022 | Mar. 31, 2023 | |
Income Tax Disclosure [Abstract] | |||
Uncertain tax position liability | $ 1,600 | $ 1,300 | |
Interest related to uncertain tax positions | $ 103 | $ 79 | |
Proceeds form sale of discontinued operation | $ 4,700 |
SCHEDULE OF WARRANTS OUTSTANDIN
SCHEDULE OF WARRANTS OUTSTANDING (Details) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2023 | Dec. 31, 2022 | ||
Offsetting Assets [Line Items] | |||
Number of shares underlying warrants | 465,271 | ||
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 and exercisable warrants | 1 year 1 month 20 days | ||
Aggregate Intrinsic Value, Outstanding and exercisable | $ 86,613 | ||
Warrants, Issuance of warrants upon merger | [1] | 377,818 | |
Weighted Average Exercise Price, Issuance of warrants upon merger | [1] | $ 53.45 | |
Warrants, Exercised | [1] | (249,867) | |
Weighted Average Exercise Price, Exercised | [1] | $ 0.05 | |
Outstanding warrants, shares | [1] | 465,271 | |
Weighted Average Exercise Price, Outstanding warrants | [1] | $ 61.56 | |
Weighted Average Remaining Contractual Life In Years, Outstanding warrants | 3 years 1 month 24 days | ||
Aggregate Intrinsic Value, Outstanding | |||
Exercisable warrants, shares | 290,206 | ||
Weighted Average Exercise Price, Exercisable warrants | $ 64.92 | ||
Weighted Average Remaining Contractual Life In Years, Exercisable warrants | 2 years 3 months 14 days | ||
Aggregate Intrinsic Value, Exercisable | |||
Exercise Price Range One [Member] | |||
Offsetting Assets [Line Items] | |||
Exercise price | $ 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 | $ 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 | $ 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 | $ 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 | $ 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 Six [Member] | |||
Offsetting Assets [Line Items] | |||
Exercise price | $ 96.58 | ||
Number of shares underlying warrants | [2] | 87,453 | |
Expected term | February 2024 | ||
Type of financing | February 2021 Private Placement (issued by Old Ayala) | ||
[1]Exercise price and warrant numbers have been retroactively adjusted for the impact of the January 2023 Merger, see note 1.[2]Exercise price and warrant numbers of Old Ayala’s warrants 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) | Sep. 30, 2023 $ / shares | Aug. 07, 2023 $ / shares | Jan. 19, 2023 $ / shares |
Stock Price | $ 0.94 | $ 1.15 | |
Measurement Input, Price Volatility [Member] | |||
Measurement input percentage | 80.2 | 74.5 | |
Measurement Input, Risk Free Interest Rate [Member] | |||
Measurement input percentage | 4.60 | 4.20 | |
Warrant Liability [Member] | Private Placement [Member] | |||
Exercise Price | $ 55.73 | $ 55.73 | |
Stock Price | $ 0.94 | $ 2.95 | |
Warrant Liability [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 [Member] | Private Placement [Member] | Measurement Input, Price Volatility [Member] | |||
Measurement input percentage | 128 | 117 | |
Warrant Liability [Member] | Private Placement [Member] | Measurement Input, Risk Free Interest Rate [Member] | |||
Measurement input percentage | 4.60 | 3.60 |
COMMON STOCK PURCHASE WARRANT_3
COMMON STOCK PURCHASE WARRANTS AND WARRANT LIABILITY (Details Narrative) $ / shares in Units, $ in Thousands | 9 Months Ended | |||||
Sep. 01, 2023 USD ($) | Sep. 30, 2023 USD ($) $ / shares shares | Sep. 30, 2022 USD ($) | Aug. 07, 2023 USD ($) $ / shares | Dec. 31, 2022 $ / shares shares | ||
Exercisable warrants to purchase | shares | 465,271 | |||||
Warrant exchanges of shares | shares | [1] | 249,867 | ||||
Par value per share | $ / shares | $ 0.001 | $ 0.001 | ||||
Gain on fair value of warrant liability | $ | $ 138 | |||||
Proceeds from convertible debt | $ | $ 2,000 | |||||
Unobservable measurement input, uncertainty, description | The Note was valued using a probability-weighted expected return model, which incorporated significant unobservable inputs such as the likelihood of a voluntary Note conversion (30% likelihood), the Note being held to maturity (30% likelihood) and the Note mandatory conversion in a PIPE (40% likelihood). This resulted in an implied borrowing rate of 37.8% was used as an input to the fair value measurement. | |||||
Stock Price | $ / shares | $ 0.94 | $ 1.15 | ||||
Change in fair value | $ | $ 68 | |||||
Measurement Input, Interest Rate [Member] | ||||||
Stock Price | 7.4 | 7.3 | ||||
Measurement Input, Discount Rate [Member] | ||||||
Stock Price | 48.8 | 40.6 | ||||
Measurement Input, Price Volatility [Member] | ||||||
Stock Price | 80.2 | 74.5 | ||||
Measurement Input, Risk Free Interest Rate [Member] | ||||||
Stock Price | 4.60 | 4.20 | ||||
Israel Biotech Fund Ilp [Member] | ||||||
Convertible debt | $ | $ 2,000 | |||||
Investmentst | $ | $ 15,000 | |||||
Interest rate percentage | 65% | |||||
Proceeds from convertible debt | $ | $ 2,000 | |||||
Minimum [Member] | ||||||
Shares authorized | shares | 170,000,000 | |||||
Maximum [Member] | ||||||
Shares authorized | shares | 300,000,000 | |||||
Warrant [Member] | ||||||
Exercisable warrants to purchase | shares | 290,206 | |||||
Warrant exchanges of shares | shares | 249,867 | |||||
Warrant [Member] | Minimum [Member] | ||||||
Warrant exercise price per share | $ / shares | $ 2.79 | |||||
Warrant [Member] | Maximum [Member] | ||||||
Warrant exercise price per share | $ / shares | $ 224 | |||||
Common Stock [Member] | ||||||
Exercisable warrants to purchase | shares | 337,320 | |||||
Warrant exchanges of shares | shares | 246,192 | |||||
Common Stock [Member] | Minimum [Member] | ||||||
Warrant exercise price per share | $ / shares | $ 0.05 | |||||
Common Stock [Member] | Maximum [Member] | ||||||
Warrant exercise price per share | $ / shares | $ 96.58 | |||||
Warrant Liability [Member] | Minimum [Member] | ||||||
Warrant exercise price per share | $ / shares | $ 2.79 | |||||
Warrant Liability [Member] | Maximum [Member] | ||||||
Warrant exercise price per share | $ / shares | $ 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) | Sep. 30, 2023 USD ($) |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Total financial liabilities at fair value | $ 2,133 |
Private Placement [Member] | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Convertible note | 2,068 |
Total financial liabilities at fair value | 65 |
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 | |
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 | |
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 | 2,133 |
Fair Value, Inputs, Level 3 [Member] | Private Placement [Member] | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Convertible note | 2,068 |
Total financial liabilities at fair value | $ 65 |
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] - USD ($) | 3 Months Ended | 9 Months Ended |
Sep. 30, 2023 | Sep. 30, 2023 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Beginning balance | $ 67 | |
Long term warrant assumed from Merger | 203 | |
Proceed from issuance of loan | 2,000 | 2,000 |
Revaluation recorded in financial income, net | 66 | (70) |
Ending balance | $ 2,133 | $ 2,133 |
SCHEDULE OF OPERATING RIGHT OF
SCHEDULE OF OPERATING RIGHT OF USE ASSETS AND LEASE LIABILITIES (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] | ||
Operating right-of-use asset | $ 1,276 | $ 1,462 |
Total lease liabilities | 1,412 | 1,751 |
Current lease liabilities | 480 | 419 |
Non-current lease liabilities | 932 | 1,332 |
Officer [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Operating right-of-use asset | 1,179 | 1,273 |
Total lease liabilities | 1,350 | 1,612 |
Cars [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Operating right-of-use asset | 97 | 189 |
Total lease liabilities | $ 62 | $ 139 |
SUMMARY OF LEASE COSTS (Details
SUMMARY OF LEASE COSTS (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | ||||
Operating lease cost | $ 79 | $ 120 | $ 348 | $ 341 |
Variable lease cost | 6 | 10 | ||
Total lease cost | $ 79 | $ 120 | $ 354 | $ 351 |
SCHEDULE OF FUTURE PAYMENTS OF
SCHEDULE OF FUTURE PAYMENTS OF OPERATING LEASE LIABILITIES (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Commitments and Contingencies Disclosure [Abstract] | ||
2023 (from October 1) | $ 146 | |
2024 | 380 | |
2025 | 318 | |
2026 | 308 | |
2027 | 308 | |
After 2027 | 411 | |
Total undiscounted lease payments | 1,871 | |
Less: Interest | 459 | |
Total lease liabilities – operating | $ 1,412 | $ 1,751 |
COMMITMENTS AND CONTINGENT LI_3
COMMITMENTS AND CONTINGENT LIABILITIES (Details Narrative) - USD ($) $ in Thousands | 1 Months Ended | 9 Months Ended | ||
Mar. 25, 2023 | Mar. 25, 2021 | Sep. 30, 2021 | Sep. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | ||||
Loan from lessor | $ 500 | |||
Bank guarantee amount | 191 | |||
Lease and rental expense | $ 36 | $ 29 | ||
Lease to extending term date | March 31, 2023 | |||
Operating lease right of use asset and lease liabilities | $ 65 | |||
Weighted average remaining lease term | 2 years 8 months 12 days | |||
Weighted average discount rate percent | 7.40% |
SUBSEQUENT EVENTS (Details Narr
SUBSEQUENT EVENTS (Details Narrative) | Nov. 17, 2023 USD ($) Integer $ / shares | Jul. 26, 2023 |
Senior Convertible Promissory Note [Member] | ||
Subsequent Event [Line Items] | ||
Aggregate amount | $ 4,000,000 | |
Share price | $ / shares | $ 0.001 | |
Senior Convertible Promissory Note [Member] | Subsequent Event [Member] | ||
Subsequent Event [Line Items] | ||
Aggregate amount | $ 4,000,000 | |
Share price | $ / shares | $ 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 has 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 | |
Debt instrument share | Integer | 7,500,000 | |
Ayala Pharmaceuticals Inc [Member] | ||
Subsequent Event [Line Items] | ||
Ownership percentage | 45% | |
Biosight Merger [Member] | ||
Subsequent Event [Line Items] | ||
Ownership percentage | 55% |