0001213900-22-015423 | 10-K | XBRL Viewer | Ayala Pharmaceuticals INC

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Consolidated Balance Sheets - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
Current Assets:
Cash and Cash Equivalents	$ 36,982	$ 42,025
Short-Term Restricted Bank Deposits	122	90
Trade Receivables		681
Prepaid Expenses and Other Current Assets	2,636	1,444
Total Current Assets	39,740	44,240
Long-Term Assets:
Other Assets	267	305
Property and Equipment, Net	1,120	1,283
Total Long-Term Assets	1,387	1,588
Total Assets	41,127	45,828
Current Liabilities:
Trade Payables	3,214	3,726
Other Accounts Payables	3,258	3,151
Total Current Liabilities	6,472	6,877
Long-Term Liabilities:
Long-Term Rent Liability	497	553
Total Long-Term Liabilities	497	553
Stockholders’ Equity:
Common Stock of $0.01 par value per share; 200,000,000 shares authorized at December 31, 2021 and 2020; 14,080,383 and 12,824,463 shares issued at December 31, 2021 and 2020, respectively; 13,956,035 and 12,728,446 shares outstanding at December 31, 2021 and 2020, Respectively.	139	128
Additional Paid-in Capital	145,160	109,157
Accumulated Deficit	(111,141)	(70,887)
Total Stockholders’ Equity	34,158	38,398
Total Liabilities and Stockholders’ Equity	$ 41,127	$ 45,828

Consolidated Balance Sheets (Parentheticals) - $ / shares	Dec. 31, 2021	Dec. 31, 2020
Statement of Financial Position [Abstract]
Common stock par value (in Dollars per share)	$ 0.01	$ 0.01
Common stock, shares authorized	200,000,000	200,000,000
Common Stock, shares issued	14,080,383	12,824,463
Common Stock, shares outstanding	13,956,035	12,728,446

Consolidated Statements of Operations - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Income Statement [Abstract]
Revenue from License Agreement	$ 3,506	$ 3,708
Cost of Revenue	(3,506)	(3,708)
Gross Profit
Research and Development	29,941	22,406
General and Administrative	9,277	7,371
Operating Loss	(39,218)	(29,777)
Financial income (expenses), net	(260)	56
Loss before taxes on income	(39,478)	(29,721)
Taxes on Income	(776)	(425)
Net Loss	$ (40,254)	$ (30,146)
Net Loss per Share attributable to Common Stockholders, Basic and Diluted (in Dollars per share)	$ (2.8)	$ (3.06)
Weighted Average Shares Used to Compute Net Loss per Share, Basic and Diluted (in Shares)	14,398,905	9,860,610

Statement of Changes In Stockholders’ Equity - USD ($)
$ in Thousands

Convertible Preferred Stock Series A

Preferred Stock

Convertible Preferred Stock Series B

Preferred Stock

Parent [Member]

Common Stock

Additional Paid-in Capital

Accumulated Deficit

Total

Balance at Dec. 31, 2019

$ 23,823

$ 29,550

$ 53,373

$ 51

$ 1,770

$ (40,741)

$ (38,920)

Balance (in Shares) at Dec. 31, 2019

3,679,778

3,750,674

4,998,874

Conversion of Preferred Stock into Common stock

$ (23,823)

$ (29,550)

(53,373)

$ 37

53,336

53,373

Conversion of Preferred Stock into Common stock (in Shares)

(3,679,778)

(3,750,674)

3,715,222

Issuance of Common Stock, Initial Public Offering, net of Issuance Cost of $2,730

$ 39

52,202

52,241

Issuance of Common Stock, Initial Public Offering, net of Issuance Cost of $2,730 (in Shares)

3,940,689

Exercise of Stock Options

$ 1

280

281

Exercise of Stock Options (in Shares)

54,999

Stock Based Compensation

^[1]

1,569

Stock Based Compensation (in Shares)

18,662

Net Loss

(30,146)

Balance at Dec. 31, 2020

$ 128

109,157

(70,887)

38,398

Balance (in Shares) at Dec. 31, 2020

12,728,446

Proceeds from Issuance of common stock and warrants, net of issuance cost of $1,724

$ 3

23,259

23,262

Proceeds from Issuance of common stock and warrants, net of issuance cost of $1,724 (in Shares)

333,333

Proceeds from Issuance of common stock net of issuance cost of $438

$ 8

9,959

9,967

Proceeds from Issuance of common stock net of issuance cost of $438 (in Shares)

827,094

Exercise of Stock Options

^[1]

101

$ 101

Exercise of Stock Options (in Shares)

18,328

Stock Based Compensation

^[1]

2,684

$ 2,684

Stock Based Compensation (in Shares)

48,834

Net Loss

(40,254)

Balance at Dec. 31, 2021

$ 139

$ 145,160

$ (111,141)

$ 34,158

Balance (in Shares) at Dec. 31, 2021

13,956,035

[1]	Represents an amount lower than $1.

Statement of Changes In Stockholders’ Equity (Parentheticals) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Statement of Stockholders' Equity [Abstract]
Issuance of Common Stock, Initial public offering net of issuance costs		$ 2,730
Issuance of shares and warrants, net of Issuance Cost	$ 1,724
Net of issuance cost	$ 438

Statements of Consolidated Cash Flows - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Cash Flows from Operating Activities:
Net Loss	$ (40,254)	$ (30,146)
Shared Based Compensation	2,684	1,569
Depreciation	168	182
Increase in Prepaid Expenses and other Assets	(1,174)	(1,029)
Decrease (Increase) in trade receivables	681	(212)
Increase in Trade Payables	(512)	451
Increase in other Accounts Payable	51	1,644
Net Cash used in Operating Activities	(38,356)	(27,541)
Cash Flows from Investing Activities:
Proceeds from Maturities of Long-Term Deposits		226
Purchase of Property and Equipment	(5)	(45)
Net Cash provided by (used in) Investing Activities	(5)	181
Cash Flows from Financing Activities:
Exercise of Stock Options	101	281
Issuance of shares and warrants, net	23,262
Proceeds from Issuance of Shares, net	9,967	52,641
Net Cash provided by Financing Activities	33,330	52,922
Increase (Decrease) in Cash and Cash Equivalents and Restricted Cash	(5,031)	25,562
Cash and Cash Equivalents and Restricted Cash at Beginning of the Year	42,370	16,808
Cash and Cash Equivalents and Restricted Cash at End of the Year	37,339	42,370
Supplemental Disclosure of Non-Cash Financing Activities
Non-cash Deferred Offering Costs		400
Cash Received for Interest	12	58
Cash Paid for Income Taxes	209	300
Cash Received for Income Taxes	32
Cash and Cash Equivalents	36,982	42,025
Restricted Cash	122	90
Restricted Cash in Other Assets	235	255
Cash and Cash Equivalents and Restricted Cash at End of the Year	$ 37,339	$ 42,370

General

12 Months Ended

Dec. 31, 2021

Accounting Policies [Abstract]

General

General

Ayala Pharmaceuticals, Inc. (the “Company”) was incorporated in November 2017. The Company is a clinical stage oncology company dedicated to developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations. The Company’s current portfolio of product candidates, AL101 and AL102, target the aberrant activation of the Notch pathway with gamma secretase inhibitors.

In 2017, the Company entered into an exclusive worldwide license agreement with respect to AL101 and AL102. See note 5.

The Company’s lead product candidates, AL101 and AL102, have completed preclinical and Phase 1 studies. AL102 is currently being evaluated in a pivotal Phase 2/3 trial (RINGSIDE) in patients with Desmoids tumors and is being evaluated in a Phase 1 clinical trial in combination with Novartis’ BMCA targeting agent, WVT078, in Patients with relapsed/refractory Multiple Myeloma. AL101 is currently being evaluated in a Phase 2 trial (ACCURACY) in patients with recurrent/metastatic adenoid cystic carcinoma (“R/M ACC”) bearing Notch-activating mutations is ongoing.

The Company has a wholly-owned Israeli subsidiary, Ayala-Oncology Israel Ltd. (the “Subsidiary”), which was incorporated in November 2017.

Initial Public Offering and Other Transactions

On May 12, 2020, the Company completed the sale of shares of its common stock in its IPO. In connection with the IPO, the Company issued and sold 3,940,689 shares of its common stock, par value $0.01 per share (“Common Stock”) including 274,022 shares associated with the partial exercise on June 4, 2020 of the underwriters’ option to purchase additional shares, at a price to the public of $15.00 per share, resulting in net proceeds to the Company of approximately $52.2 million after deducting underwriting discounts and commissions and offering expenses payable by the Company. All shares issued and sold were registered pursuant to a registration statement on Form S-1 (File No. 333-236942), as amended, declared effective by the U.S. Securities and Exchange Commission (the “Commission”) on May 7, 2020.

In connection with the IPO, the Company effected a one-for-two reverse stock split of its Common Stock which became effective on May 4, 2020. Upon the closing of the IPO, all of the outstanding shares of Series A preferred stock and Series B preferred stock automatically converted into an aggregate of 3,715,222 shares of Common Stock. Subsequent to the closing of the IPO, there were no preferred shares outstanding.

On February 19, 2021, the Company entered into a Securities Purchase Agreement (the “2021 Purchase Agreement”) with the purchasers named therein (the “Investors”). Pursuant to the 2021 Purchase Agreement, the company agreed to sell (i) an aggregate of 333,333 shares of our common stock (the “Private Placement Shares”), par value $0.01 per share, together with warrants to purchase an aggregate of 116,666 shares of its Common Stock with an exercise price of $18.10 per share (the “Common Warrants”), for an aggregate purchase price of $4,999,995.00 and (ii) pre-funded warrants to purchase an aggregate of 1,333,333 shares of its Common Stock with an exercise price of $0.01 per share (the “Pre-Funded Warrants” and collectively with the Common Warrants, the “Private Placement Warrants”), together with an aggregate of 466,666 Common Warrants, for an aggregate purchase price of $19,986,661.67 (collectively, the “Private Placement”). The Private Placement closed on February 23, 2021.

In June 2021, the Company entered into an Open Market Sales Agreement, or the Sales Agreement, with Jefferies LLC, or Jefferies, as sales agent, pursuant to which the Company may, from time to time, issue and sell Common Stock with an aggregate value of up to $200.0 million in “at-the-market” offerings, under its Registration Statement on Form S-3 (File No. 333-256792) filed with the SEC on June 4, 2021 (the “ATM”). Sales of Common Stock, if any, pursuant to the Sales Agreement, may be made in sales deemed to be an “at the market offering” as defined in Rule 415(a) of the Securities Act, including sales made directly through The Nasdaq Global Market or on any other existing trading market for its Common Stock. Pursuant to the Sales Agreement, during the year ended December 31, 2021, the Company sold a total of 827,094 shares of Common Stock for total gross proceeds of approximately $10.4 million.

Going Concern

The Company has incurred recurring losses since inception as a research and development organization and has an accumulated deficit of $111.1 million as of December 31, 2021. For the year ended December 31, 2021, the Company used $38.4 million of cash in operations. The Company has relied on its ability to fund its operations through public and private equity financings. The Company expects operating losses and negative cash flows to continue at significant levels in the future as it continues its clinical trials. As of December 31, 2021, the Company had approximately $37.3 million in cash and cash equivalents and restricted cash, which, without additional funding, the Company believes will not be sufficient to meet its obligations within the next twelve months from the date of issuance of these consolidated financial statements. The Company plans to continue to fund its operations through public or private debt and equity financings, but there can be no assurances that such financing will continue to be available to the Company on satisfactory terms, or at all. 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 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, 2021 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

12 Months Ended

Dec. 31, 2021

Accounting Policies [Abstract]

Significant Accounting Policies

Significant Accounting Policies

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 bank deposits

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 fair value. Short-term restricted bank deposits 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:

Computers and Software	33	%
Lab Equipment	15	%
Office Furniture and Equipment	7	%

Leasehold improvements are amortized on a straight-line basis over the shorter of the assets’ estimated useful life or the remaining term of the lease.

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 may not be recoverable. If indicators of impairment exist and the undiscounted future cash flows that the assets are expected to generate are less than the carrying value of the assets, the Company reduces the carrying amount of the assets through an impairment charge, to their estimated fair values. During the years ended December 31, 2021, and 2020, no impairment indicators have been identified.

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 $0.3 million and $0.2 million for the year ended December 31, 2021 and 2020, respectively.

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, 2021, and 2020, the Company has matched 100% of all employee contributions, up to 6% of the employee’s base salary.

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 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.

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.

Acquired In-Process Research and Development

In an asset acquisition, the initial costs of rights to in-process research and development projects acquired are expensed as R&D in the consolidated statements of operations unless the in-process research and development has an alternative future use. In a business combination, the fair value of in-process research and development is capitalized as an indefinite-lived intangible asset, regardless of whether the in-process research and development asset has an alternative future use.

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. In instances where payments made to CROs exceed the level of services provided and result in a prepayment of the research and development expenses. For reoccurring services fees, the Company calculates the time period over which services will be performed and the level of effort to be expanded in each period. If the actual timing of the performance of services varies from the calculation, the Company adjusts the accrual or amount of prepaid expenses accordingly. Non-refundable advance payments for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received rather than when the payment is made.

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. As of December 31, 2021, and 2020, the Company is not a party to any litigation that could have a material adverse effect on the Company’s business, financial position, results of operations or cash flows.

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.

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.

Company’s trade receivables are from one customer as of December 31, 2021, and December 31, 2020. In addition, the potential risk of loss with any one counterparty resulting from this type of credit risk is monitored on an ongoing basis. The Company grants credit of 45 days to this one customer.

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. Share price is estimated based on third party valuation (see also Note 9). 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, 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 The expected option term is calculated for options granted to employees and directors using the “simplified” method. Under this approach, the expected term is presumed to be the midpoint between the weighted average vesting term and the contractual term of the option. The simplified method makes the assumption that the employee will exercise share options evenly over the period when the share options are vested and ending on the date when the share options expire. The expected option term for options granted to non-employees is based on the contractual term. Changes in the determination of each of the inputs can affect the fair value of the share options granted and the results of operations of the Company.

Restricted shares are value as fair value of shares on 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.

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.

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 must 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.

In December 2018, the Company entered into an Evaluation Option to acquire License Agreement (the “Novartis Agreement”) with Novartis International Pharmaceutical Limited (“Novartis”) for which the company is paid for its research and development costs. For additional details regarding the Novartis Agreement, refer to Note 5.

The Company concluded that there is one distinct performance obligation under the Novartis Agreement: Research and development services, obligation which is satisfied over time.

Revenue associated with the research and development services in the amount of $3.5 million and $3.7 million was recognized in 2021 and 2020 respectively.

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 incurred from the total estimated expenses. The Company periodically reviews and updates its estimates, when appropriate, which may adjust revenue recognized for the period. The transaction price to be recognized as revenue under the Novartis Agreement consists of the reimbursable research and development costs.

Recently Issued Accounting Pronouncements Not Yet Adopted

As an “emerging growth company,” the Jumpstart Our Business Startups Act (“JOBS Act”) allows the Company to delay adoption of new or revised accounting pronouncements applicable to public companies until such pronouncements are made applicable to private companies. The Company has elected to use this extended transition period under the JOBS Act. The adoption dates discussed below reflects this election.

In February 2016, the FASB issued ASU 2016-02—Leases, requiring the recognition of lease assets and liabilities on the balance sheet. The standard: (a) clarifies the definition of a lease; (b) requires a dual approach to lease classification similar to current lease classifications; and (c) causes lessees to recognize leases on the balance sheet as a lease liability with a corresponding right-of-use asset for leases with a lease-term of more than 12 months. The standard will be effective for the Company for fiscal years beginning after December 15, 2021. The Company is currently evaluating the impact of adopting this new guidance on its financial statements.

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 guidance will be effective for the Company for fiscal years beginning after December 15, 2022. Early adoption is permitted. The Company is currently evaluating the effect that ASU 2016-13 will have on its consolidated financial statements and related disclosures.

In August 2020, the FASB issued ASU 2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”). The final guidance issued by the FASB for convertible instruments eliminates two of the three models in ASC 470-20 that require separate accounting for embedded conversion features. Separate accounting is still required in certain cases. Additionally, among other changes, the guidance eliminates some of the conditions for equity classification in ASC 815-40-25 for contracts in an entity’s own equity. The guidance also requires entities to use the if-converted method for all convertible instruments in the diluted earnings per share calculation and include the effect of share settlement for instruments that may be settled in cash or shares, except for certain liability-classified share-based payment awards. ASU 2020-06 is effective for fiscal years beginning after December 15, 2023, and interim periods within those fiscal years. The Company is currently evaluating the potential impact of this guidance on its consolidated financial statements.

Property and Equipment, net

12 Months Ended

Dec. 31, 2021

Property, Plant and Equipment [Abstract]

Property and Equipment, net

Property and Equipment, net

Property and Equipment, net consists of the following:

	December 31,		December 31,
	2021		2020
	(in thousands)
Cost:
Computers and Software	$	73	$	73
Lab Equipment		294		293
Office Furniture and Equipment		146		142
Leasehold Improvements		1,105		1,105
		1,618		1,613
Less: Accumulated Depreciation		498		330
Property and Equipment, Net	$	1,120	$	1,283

Depreciation expenses for the years ended December 31, 2021, and 2020 was approximately $168 and $182, respectively.

Other account payables

12 Months Ended

Dec. 31, 2021

Payables and Accruals [Abstract]

Other account payables

Other account payables

Other account payables consist of the following:

	December 31,		December 31,
	2021		2020
	(in thousands)
Accrued Professional Fees	$	291	$	657
Accrued Research and Development Expenses		56		101
Tax Provision		1,150		780
Accrued Payroll and Employee Benefits		1,761		1,613
Total Accrued Expenses	$	3,258	$	3,151

Commitments and Contingent Liabilities

12 Months Ended

Dec. 31, 2021

Commitments and Contingencies Disclosure [Abstract]

Commitments and Contingent Liabilities

Commitments and Contingent Liabilities

Lease

The Subsidiary rents its facilities under an operating lease agreement, which expired in November 2019.

In January 2019, the Company 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 with finance in in the amount of approximately $0.5 million paid in arrears for of leasehold improvements. The financing was recorded as a Long-Term Rent Liability. The minimum rental payments under operating leases as of December 31, 2021, are as follows (in thousands):

Year ended December 31,	(in thousands)
2022		360
2023		360
2024		120
	$	840

The Subsidiary obtained a bank guarantee in the amount of approximately $0.2 million for its new office lease agreement.

The subsidiary leasing expense for the years ended December 2021 and 2020 was $0.3 million and $0.3 million, respectively.

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.

Under the BMS License Agreement, the Company is obligated to use commercially reasonable efforts to develop at least one BMS Licensed Product. The Company has 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. The Company has 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.

As consideration of the rights granted by BMS to the Company under the BMS License Agreement, the Company paid BMS a payment of $6 million and issued to BMS 1,125,929 shares of Series A Preferred Stock valued at approximately $7.3 million. The payment and transfer of intellectual property occurred in November 2017 at the time the BMS License Agreement was executed (the “Effective Date”).

The Company is required to pay BMS payments upon the achievement of certain development or regulatory milestone events of up to $95 million in the aggregate with respect to the first BMS Licensed Compound to achieve each such event and up to $47 million in the aggregate with respect to each additional BMS Licensed Compound to achieve each such event. The Company is also obligated to pay BMS payments of up to $50 million in the aggregate for each BMS Licensed Product that achieves certain sales-based milestone events and tiered royalties on net sales of each BMS Licensed Product by the Company or its affiliates or sublicensees at rates ranging from a high single-digit to low teen percentage, depending on the total annual worldwide net sales of each such Licensed Product. If the Company sublicenses or assigns any rights to the licensed patents, the BMS Licensed Compounds and/or the BMS Licensed Products, the Company is required to share with BMS a portion of all consideration received from such sublicense or assignment, ranging from a mid-teen to mid-double-digit percentage, depending on the development stage of the most advanced BMS Licensed Compound or BMS Licensed Product that is subject to the applicable sublicense or assignment, but such portion may be reduced based on the milestone or royalty payments that are payable by the Company to BMS under the BMS License Agreement.

Under the terms of the BMS Agreement, the Company was obligated to issue to BMS additional shares of preferred stock as would be required for BMS to maintain its 8% equity ownership in Company, subject to certain exceptions. This right terminated upon the closing of the sale of the Company’s Series B Preferred Stock. The Company estimates the fair value of this anti-dilution commitment using the probability weighted expected return method (“PWERM”). At the date of BMS Agreement, the Company recorded liability associated with the anti-dilution right in the amount of approximately $0.5 million, according to its fair value. For the year ended December 31, 2018, the Company recorded an income of approximately $0.5 million for the reassessment of the liability, within financial income, net, in the consolidated statement of operations.

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.

The BMS License Agreement remains in effect, on a country-by-country and BMS Licensed Product-by-BMS Licensed Product basis, until the expiration of royalty obligations with respect to a given BMS Licensed Product in the applicable country. Royalties are paid on a country-by-country and BMS Licensed Product-by-BMS Licensed Product basis from the first commercial sale of a particular BMS Licensed Product in a country until the latest of

10 years after the first commercial sale of such BMS Licensed Product in such country, (b) when such BMS Licensed Product is no longer covered by a valid claim in the licensed patent rights in such country, or (c) the expiration of any regulatory or marketing exclusivity for such BMS Licensed Product in such country. Any inventions, and related patent rights, invented solely by either party pursuant to activities conducted under the BMS License Agreement shall be solely owned by such party, and any inventions, and related patent rights, conceived of jointly by the Company and BMS pursuant to activities conducted under the BMS License Agreement shall be jointly owned by the Company and BMS, with BMS’s rights thereto included in the Company’s exclusive license. The Company has the first right—with reasonable consultation with, or participation by, BMS—to prepare, prosecute, maintain and enforce the licensed patents, at the Company’s expense.

BMS has the right to terminate the BMS License Agreement in its entirety upon written notice to the Company (a) for insolvency-related events involving the Company, (b) for the Company’s material breach of the BMS License Agreement if such breach remains uncured for a defined period of time, for the Company’s failure to fulfill its obligations to develop or commercialize the BMS Licensed Compounds and/or BMS Licensed Products not remedied within a defined period of time following written notice by BMS, or (d) if the Company or its affiliates commence any action challenging the validity, scope, enforceability or patentability of any of the licensed patent rights. The Company has the right to terminate the BMS License Agreement for convenience upon prior written notice to BMS, the length of notice dependent on whether a BMS Licensed Project has received regulatory approval, (b) upon immediate written notice to BMS for insolvency-related events involving BMS, (c) for BMS’s material breach of the BMS License Agreement if such breach remains uncured for a defined period of time, or (d) on a BMS Licensed Compound-by-BMS Licensed Compound and/or BMS Licensed Product-by-BMS Licensed Product basis upon immediate written notice to BMS if the Company reasonably determine that there are unexpected safety and public health issues relating to the applicable BMS Licensed Compounds and/or BMS Licensed Products.

Upon termination of the BMS License Agreement in its entirety by the Company for convenience or by BMS, the Company grants an exclusive, non-transferable, sublicensable, worldwide license to BMS under certain of its patent rights that are necessary to develop, manufacture or commercialize BMS Licensed Compounds or BMS Licensed Products. In exchange for such license, BMS must pay the Company a low single-digit percentage royalty on net sales of the BMS Licensed Compounds and/or BMS Licensed Products by it or its affiliates, licensees or sublicensees, provided that the termination occurred after a specified developmental milestone for such BMS Licensed Compounds and/ or BMS Licensed Products.

Option and License Agreement with Novartis International Pharmaceutical Ltd.

In December 2018, the Company entered into an evaluation, option and license agreement, or the Novartis Option Agreement, with Novartis International Pharmaceutical Limited, or Novartis, pursuant to which Novartis agreed to conduct certain studies to evaluate AL102 in combination with its B-cell maturation antigen, or BCMA, therapies in multiple myeloma, and the Company agreed to supply AL102 for such studies. All supply and development costs associated with such evaluation studies are fully borne by Novartis.

Under the Novartis Option Agreement, the Company granted Novartis an exclusive option to obtain an exclusive (including as to the Company and its affiliates), sublicensable (subject to certain terms and conditions), worldwide license and sublicense (as applicable) under certain patent rights and know-how controlled by the Company (including applicable patent rights and know-how that are licensed from BMS pursuant to the BMS License Agreement) to research, develop, manufacture (subject to the Company’s non-exclusive right to manufacture and supply AL102 or the Novartis Licensed Product for Novartis) and commercialize AL102 or any pharmaceutical product containing AL102 as the sole active ingredient, or the Novartis Licensed Product, for the diagnosis, prophylaxis, treatment, or prevention of multiple myeloma in humans. The Company also granted Novartis the right of first negotiation for the license rights to conduct development or commercialization activities with respect to the use of AL102 for indications other than multiple myeloma. Additionally, from the exercise by Novartis of its option until the termination of the Novartis Option Agreement, the Company may not, either itself or through its affiliates or any other third parties, directly or indirectly research, develop or commercialize certain BCMA-related compounds for the treatment of multiple myeloma.

According to the agreement, Novartis shall pay the Company a low eight figure option exercise fee in order to exercise its option and activate its license, upon which the Company will be eligible to receive development, regulatory and commercial milestone payments of up to $245 million in the aggregate and tiered royalties on net sales of Novartis Licensed Products by Novartis or its affiliates or sublicensees at rates ranging from a mid-single-digit to low double-digit percentage, depending on the total annual worldwide net sales of Novartis Licensed Products. Royalties will be paid on a country-by-country and Novartis Licensed Product-by-Novartis

Licensed Product basis from the first commercial sale of a particular Novartis Licensed Product in a country until the latest of (a) 10 years after the first commercial sale of such Novartis Licensed Product in such country, (b) when such Novartis Licensed Product is no longer covered by a valid claim in the licensed patent rights in such country, or (c) the expiration of any regulatory or marketing exclusivity for such Novartis Licensed Product in such country. Contemporaneously with the Novartis Option Agreement, the Company entered into a stock purchase agreement and associated investment agreements, or the SPA, with Novartis’ affiliate, Novartis Institutes for BioMedical Research, Inc., or NIBRI, pursuant to which NIBRI acquired a $10 million equity stake in the Company.

Novartis shall own any inventions, and related patent rights, invented solely by it or jointly with the Company in connection with activities conducted pursuant to the Novartis Option Agreement. The Company will maintain first right to prosecute and maintain any patents licensed to Novartis, both before and after its exercise of its option. The Company maintain the first right to defend and enforce its patents prior to Novartis’s exercise of its option, upon which Novartis gains such right with respect to patents included in the license.

The option granted to Novartis will remain in effect until the earlier of (a) 60 days following the last visit of the last subject in the evaluation studies, the termination of the Novartis Option Agreement, or (c) 36 months following the delivery by the Company to Novartis of sufficient amounts of clinical evaluation materials to conduct the anticipated clinical studies. The Novartis Option Agreement remains in effect until such time as no Novartis Licensed Product is being developed or commercialized by Novartis, its affiliates, or sublicensees (including distributors or commercial partners), unless terminated earlier. The Company has the right to terminate the Novartis Option Agreement (a) for Novartis’s material breach if such breach remains uncured for 60 days (such cure period shall be extended for an additional period during which Novartis is making good faith efforts to cure such breach) or (b) for Novartis’s failure to use commercially reasonable efforts to develop or commercialize AL102 and/or the Novartis Licensed Product not remedied within four months following written notice to Novartis. Novartis has the right to terminate the Novartis Option Agreement (a) in its entirety or on a country-by-country basis for convenience, upon 60 days written notice to us, (b) for Company’s material breach if such breach remains uncured for 60 days (such cure period shall be extended for an additional period during which Novartis is making good faith efforts to cure such breach) or (c) upon immediate written notice to the Company for insolvency-related events involving the Company.

Fair Value Measurements

12 Months Ended

Dec. 31, 2021

Fair Value Disclosures [Abstract]

Fair Value Measurements

6. Fair Value Measurements

As of December 31, 2021, the Company had no financial liabilities measured at fair value.

The following tables summarize the fair value measurements of our financial instruments as of December 31, 2021:

	Fair Value Measurements at December 31, 2021
	Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)		Total
			($in thousands)
Cash equivalents:
Money market funds	$	32,900	$	—	$	—	$	32,900
Total cash equivalents	$	32,900	$	—	$	—	$	32,900

The following tables summarize the fair value measurements of our financial instruments as of December 31, 2020:

	Fair Value Measurements at December 31, 2020
	Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)		Total
			($in thousands)
Cash equivalents:
Money market funds	$	35,900	$	—	$	—	$	35,900
Total cash equivalents	$	35,900	$	—	$	—	$	35,900

- Definition

The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.

+ References + Details

Common Stock

12 Months Ended

Dec. 31, 2021

Common Stock [Abstract]

Common Stock

7. 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, 2021 and 2020.

On May 12, 2020, the Company completed the sale of shares of its Common Stock in its IPO. In connection with the IPO, the Company issued and sold 3,940,689 shares of Common Stock, including 274,022 shares associated with the partial exercise on June 4, 2020 of the underwriters’ option to purchase additional shares, at a price to the public of $15.00 per share, resulting in net proceeds to the Company of approximately $52.8 million after deducting underwriting discounts and commissions and estimated offering expenses payable by the Company. All shares issued and sold were registered pursuant to a registration statement on Form S-1 (File No. 333-236942), as amended, declared effective by the U.S. Securities and Exchange Commission (the “Commission”) on May 7, 2020.

In connection with the IPO, the Company effected a one-for-two reverse stock split of its Common Stock which became effective on May 4, 2020. Upon the closing of the IPO, all of the outstanding shares of Series A preferred stock and Series B preferred stock automatically converted into an aggregate of 3,715,222 shares of Common Stock . Subsequent to the closing of the IPO, there were no shares of preferred stock outstanding, and amended the authorized capital stock of the company to (i) 200,000,000 shares of Common Stock (ii) 10,000,000 shares of Preferred Stock.

On February 19, 2021, we entered into a Securities Purchase Agreement (the “2021 Purchase Agreement”) with the purchasers named therein (the “Investors”). Pursuant to the 2021 Purchase Agreement, we agreed to issue (i) an aggregate of 333,333 shares of our common stock (the “Private Placement Shares”), par value $0.01 per share, together with warrants to purchase an aggregate of 116,666 shares of our common stock with an exercise price of $18.10 per share (the “Common Warrants”), for an aggregate purchase price of $4,999,995.00 and (ii) pre-funded warrants to purchase an aggregate of 1,333,333 shares of our common stock with an exercise price of $0.01 per share (the “Pre-Funded Warrants” and collectively with the Common Warrants, the “Private Placement Warrants”), together with an aggregate of 466,666 Common Warrants, for an aggregate purchase price of $19,986,661.67 (collectively, the “Private Placement”). The Private Placement closed on February 23, 2021. The Company had issuance costs of approximately $1.715 million. The Private Placement closed on February 23, 2021. The warrants were classified as a component of permanent equity pursuant to ASC 480 “Distinguishing Liabilities from Equity” and ASC 815 “Derivatives and Hedging.” As of December 31, 2021, the 1,799,999 warrants are all outstanding.

In June 2021, we entered into an Open Market Sales Agreement, or the Sales Agreement, with Jefferies LLC, or Jefferies, as sales agent, pursuant to which we may, from time to time, issue and sell common stock with an aggregate value of up to $200.0 million in “at-the-market” offerings, under our Registration Statement on Form S-3 (File No. 333-256792) filed with the SEC on June 4, 2021 (the “ATM”). Sales of common stock, if any, pursuant to the Sales Agreement, may be made in sales deemed to be an “at the market offering” as defined in Rule 415(a) of the Securities Act, including sales made directly through The Nasdaq Global Market or on any other existing trading market for our common stock. Pursuant to the Sales Agreement, during the twelve months ended December 31, 2021, the Company issued a total of 827,094 shares of common stock for total gross proceeds of approximately $10.4 million.

Total shares of Common Stock reserved for issuance are summarized as follows:

	December 31,		December 31,
	2021		2020
Options Outstanding		900,789		695,674
Warrants for common shares of the company.		1,799,999
Shares available for future option grants		593,040		387,736
Total shares of Common Stock reserved for Issuance		3,293,828		1,083,410

Composition of Capital Stock:

December 31,
2021

December 31,
2020

Issued and

Authorized

outstanding

Authorized

outstanding

Shares of USD 0.01 par value:

Common Stock

200,000,000

13,956,035

200,000,000

12,728,446

Does not include 124,348 and 96,017 shares of restricted Common Stock issued but not outstanding in 2021 and 2020, respectively.

Stock-Based Plans

12 Months Ended

Dec. 31, 2021

Share-based Payment Arrangement [Abstract]

Stock-Based Plans

8. Stock-Based Plans

In 2017, the Company’s board of directors adopted the 2017 Stock Incentive Plan (the “Plan”). According to the Plan, share awards, including restricted stock, restricted stock units or other stock-based awards, or options to purchase shares may be granted to employees, directors, consultants and other service providers of the Company or any affiliate of the Company.

As of December 31, 2021, a total of 1,841,040 shares of Common Stock were authorized for issuance in accordance with the provisions of the 2017 Plan, of which 593,040 shares were then available for future awards (whether as share awards or as options to purchase shares of common stock of the Company). Each option granted under the Plan expires no later than 10 years from the date of grant. The options vest primarily over four to five years of employment.

The following table set forth the parameters used in the computation of the fair value of options granted to employees:

	Year ended
	December 31,
	2021			2020
Expected volatility		80	%		80	%
Expected dividends		0	%		0	%
Expected term (in years)		6.34			6.34
Risk free rate		0.50%-1.08	%		0.47%-2.03	%

Expected Volatility:

As the Company was privately owned in part of 2020, there was not sufficient historical volatility for the expected term of the stock options. Therefore, the Company used an average historical share price volatility based on an analysis of reported data for a peer group of comparable publicly traded companies which were selected based upon industry similarities.

Expected term (years):

Expected term represents the period that the Company’s option grants are expected to be outstanding. There is not sufficient historical share exercise data to calculate the expected term of the stock options. Therefore, the Company elected to utilize the simplified method to value option grants. Under this approach, the weighted-average expected life is presumed to be the average of the shortest vesting term and the contractual term of the option.

Risk-free interest rate:

The Company determined the risk-free interest rate by using a weighted-average equivalent to the expected term based on the U.S. Treasury yield curve in effect as of the date of grant.

Expected dividend yield:

The Company does not anticipate paying any dividends in the foreseeable future.

The Company recorded stock-based compensation for the period indicated as follows (in thousands):

	Year ended		Year ended
	December 31,		December 31,
	2021		2020
Research and Development	$	1,097	$	509
General and Administrative		1,587		1,060
Total Stock-Based Compensation	$	2,684	$	1,569

The Company recognizes compensation expenses for the value of its awards granted based on the accelerated method over the requisite service period of each of the awards.

A summary of the Company’s stock option activity granted to employees under the Plan is as follows:

	Year ended December 31, 2021
	Number of			Weighted average exercise		Weighted average remaining contractual term		Aggregate intrinsic
	options			price		(in years)		value

Outstanding at Beginning of Year		695,674		$	6.07		7.25	$	1,695,276
Granted		295,470			10.99
Exercised		(18,328	)		5.50			$	55,133
Forfeited		(70,527	)		9.78
Expired		(1,500	)		5.10
Outstanding, December 31, 2021		900,789		$	7.41		7.78	$	991,878
Exercisable Options, December 31, 2021		476,303		$	5.93		7.12	$	1,230,643

The weighted-average grant date per-share fair value of stock options granted during 2021 and 2020 was $7.98 and $6.07, respectively. The aggregate intrinsic value of stock options exercised during the year ended December 31, 2021 and 2020 was $55 and $280, respectively. As of December 31, 2021, there was approximately $ 1.1 million of total unrecognized compensation cost related to non-vested stock-based compensation arrangements granted under the Plan. That cost is expected to be recognized over a weighted-average period of 0.93 years.

Company’s restricted shares:

In February 2018, the Company granted 83,165 restricted shares to an employee and an officer of the Company. In the case of the officer, the restricted shares vest over two years starting November 15, 2017, and in the case of the other employee, the restricted shares vest over four years starting November 15, 2017.

In December 2019, the Company granted 59,597 restricted shares to two officers of the Company. The restricted shares vest over four years starting December 24, 2019.

In May 2020, the Company granted 58,651 restricted shares to two officers of the Company. The restricted shares vest over four years starting May 7, 2020.

The following table summarizes information relating to restricted shares, as well as changes to such awards during the fiscal years ended December 31, 2021 and 2020:

	Year ended			Year ended
	December 31,			December 31,
	2021			2020
Outstanding at beginning of Year		101,929			65,847
Granted		71,253			58,651
Forfeited		—			(3,907	)
Vested		(48,834	)		(18,662	)
Outstanding at end of Year		124,348			101,929

The weighted average fair values at grant date of restricted shares granted for the years ended December 31, 2021 and 2020 was $11.26 and $15.00, per share respectively.

The total fair value of shares vested during each of 2021 and 2020 was approximately $0.2 million. As of December 31, 2021, the Company had approximately $1.8 million of unrecognized compensation expense related to non-vested restricted shares, expected to be recognized over a weighted average period of 1.73 years.

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

12 Months Ended

Dec. 31, 2021

Income Tax Disclosure [Abstract]

Taxes on Income

9. 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):

Year ended Year ended

December 31, December 31,

2021 2020

United States $ (39,018 ) $ (29,698 )

Israel (460 ) (23 )

Net loss before tax $ (39,478 ) $ (29,721 )

Income tax expense is summarized as follows (in thousands):

	Year ended		Year ended
	December 31,		December 31,
	2021		2020
Current:
Federal	$	—	$
State				—
Foreign		776		426

	$	776	$	426
Deferred:
Federal	$	—	$	—
State		—		—
Foreign		—		—
	$	—	$	—
Income tax expense	$	776	$	426

The effective income tax rate differed from the amount computed by applying the federal statutory rate to our loss before income taxes as follows:

	Year ended			Year ended
	December, 31			December, 31
	2021			2020
U.S. federal tax provision at statutory rate		21.00	%		21.00	%
State and local tax, net of federal benefit		4.01			4.64
Foreign rate differences		(0.09	)		(0.07	)
Non-deductible stock compensation		(1.43	)		(1.11	)
Section 951A GILTI		0.00			(0.85	)
Effect of other permanent differences		(0.07	)		(0.07	)
Uncertain tax positions		(0.66	)		(0.52	)
Change in valuation allowance		(34.39	)		(26.65	)
Federal Tax Reform Rate Change		0.00			0.00
Tax Credits		6.01			—
Provision to Return		3.95			—
Other adjustments		(0.30	)		2.20

Effective tax rate		(1.97	)%		(1.43	)%

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):

	As of			As of
	December 31,			December 31,
	2021			2020
Deferred tax assets:
Federal net operating loss carryforwards	$	22,614		$	12,752
Intangible assets		3,402			651
Accrued expenses		3,011			3,022
Other		169			—
Total deferred tax assets		29,196			16,425
Valuation allowance		(29,196	)		(16,425	)
Net deferred tax assets	$	—		$	—

As of December 31, 2021, the Company has provided a valuation allowance of approximately $29.2 million in respect of the Company’s deferred tax assets resulting from tax loss carryforwards and other temporary differences. Realization of deferred tax assets is dependent upon future earnings, if any, the time and amount of which are uncertain. As the Company is still in its development stage and has not yet generated revenues, it is more likely than not that sufficient taxable income will not be available for the tax losses to be utilized in the future. Therefore, a valuation allowance was recorded to reduce the deferred tax assets to their recoverable amounts.

Available Carryforward Tax Losses

As of December 31, 2021, we had net operating loss carryforwards, or NOLs, of $91.6 million for federal income tax purposes and $57.7 million for state income tax purposes, which may be available to offset our future taxable income, if any, and begin to expire in various amounts in 2037 and 2038, respectively, provided that NOLs generated in tax years ending after December 31, 2017 will not be subject to expiration. In general, under Sections 382 and 383 of the U.S. Internal Revenue Code of 1986, as amended, or the Code, a corporation that undergoes an “ownership change” is subject to limitations on its ability to use its pre-change NOLs to offset future taxable income. If the U.S. Internal Revenue Service challenges our determinations with respect to the existence of previous ownership changes or the effects thereof, or if we undergo an ownership change, our ability to use our NOLs could be limited by Section 382 of the Code. Future changes in our stock ownership, some of which are outside of our control, could also result in an ownership change under Sections 382 and 383 of the Code. In addition, for taxable years beginning after December 31, 2020, utilization of federal NOLs generated in tax years beginning after December 31, 2017 are limited to a maximum of 80% of the taxable income for such year, after taking into account utilization of NOLs generated in years beginning before January 1, 2018 and determined without regard to such NOL deduction. Furthermore, our ability to use NOLs of companies that we may acquire in the future may be subject to limitations. For these reasons, we may not be able to use a material portion of the NOLs, even if we attain profitability. The reduction of the corporate tax rate under recently-enacted U.S. tax legislation may cause a reduction in the economic benefit of our NOLs and other deferred tax assets available to us.

In addition, as of December 31, 2021, the Company had federal Orphan Drug research and development credit carryforwards of approximately $618 thousand and $33, respectively. If not utilized, the federal tax carryforwards which expire in 2039.

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, 2021, and 2020, the Company has recorded an uncertain tax position liability exclusive of interest and penalties of approximately $0.9 and $0.6 million, respectively. As of December 31, 2021, the Company has not accrued penalties for uncertain tax positions. A reconciliation of the Company’s unrecognized tax benefits is below:

	2021		2020
	(in thousands)		(in thousands)
Uncertain tax position at the beginning of year	$	581	$	424
Additions for uncertain tax position of prior years (foreign exchange and interest)		17		3
Additions for tax positions of current year		260		153
Uncertain tax position at the end of the year	$	858	$	581

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 2017, 2018, 2019, 2020 and 2021 for all tax jurisdictions.

Israel:

In December 2016, the Israeli Parliament approved the Economic Efficiency Law (Legislative Amendments for Applying the Economic Policy for the 2017 and 2018 Budget Years) which reduces the corporate income tax rate from 25% to 24% effective from January 1, 2017, and to 23% effective from January 1, 2018.

The Israeli corporate income tax rate was 23% in 2021 and 2020. Income not eligible for Preferred Enterprise benefits is taxed at the regular corporate tax rates as described above.

- Definition

The entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section 50
-Paragraph 21
-URI http://asc.fasb.org/extlink&oid=121826272&loc=d3e32857-109319

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section S99
-Paragraph 2
-Subparagraph (SAB Topic 11.C)
-URI http://asc.fasb.org/extlink&oid=122134291&loc=d3e330215-122817

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section 50
-Paragraph 17
-Subparagraph (b)
-URI http://asc.fasb.org/extlink&oid=121826272&loc=d3e32809-109319

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SAB TOPIC 6.I.5.Q1)
-URI http://asc.fasb.org/extlink&oid=122134291&loc=d3e330036-122817

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section 50
-Paragraph 14
-URI http://asc.fasb.org/extlink&oid=121826272&loc=d3e32705-109319

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 270
-Section 50
-Paragraph 1
-URI http://asc.fasb.org/extlink&oid=6424409&loc=d3e44925-109338

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-URI http://asc.fasb.org/topic&trid=2144680

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 30
-Section 50
-Paragraph 2
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=6424122&loc=d3e41874-109331

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 235
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(h)(2))
-URI http://asc.fasb.org/extlink&oid=120395691&loc=d3e23780-122690

+ Details

Net Loss Per Share Attributable to Common Stockholders

12 Months Ended

Dec. 31, 2021

Earnings Per Share [Abstract]

Net Loss Per Share Attributable to Common Stockholders

10. 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):

	Year ended		Year ended
	December 31, 2021		December 31, 2020
Numerator:
Net loss	$	40,254	$	30,146
Denominator:
Weighted-average number of shares used to compute net loss per share, basic and diluted		14,398,905		9,860,610

The calculation of basic and diluted Loss Per Share includes 1,333,333 and 1,155,555 weighted average warrants with an exercise price of $0.01 for the year ended December 31, 2021, respectively.

The following potentially dilutive common stock equivalents have been excluded from the calculation of diluted net loss per share for the period presented due to their anti-dilutive effect: 466,666 shares of common stock and 900,789 options outstanding to purchase common stock as of December 31, 2021.

The following potentially dilutive common stock equivalents have been excluded from the calculation of diluted net loss per share for the period presented due to their anti-dilutive effect: 3,679,778 shares of Series A Preferred Stock, and 3,750,674 shares of Series B Preferred Stock, that were converted on IPO and 695,674 options outstanding to purchase common stock as of December 31, 2020.

Accounting Policies, by Policy (Policies)

12 Months Ended

Dec. 31, 2021

Accounting Policies [Abstract]

Use of Estimates

Use of Estimates:

Consolidated Financial Statements in U.S. Dollars

Consolidated Financial Statements in U.S. Dollars

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 bank deposits

Cash and Cash Equivalents and Short-term restricted bank deposits

Property and Equipment, Net

Property and Equipment, Net

Computers and Software	33	%
Lab Equipment	15	%
Office Furniture and Equipment	7	%

Leasehold improvements are amortized on a straight-line basis over the shorter of the assets’ estimated useful life or the remaining term of the lease.

Maintenance and repair costs are expensed as incurred.

Impairment of Long-Lived Assets

Impairment of Long-Lived Assets

Accrued Post-Employment Benefit

Accrued Post-Employment Benefit

Fair Value of Financial Instruments

Fair Value of Financial Instruments:

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 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.

Research and Development

Research and Development

Acquired In-Process Research and Development

Acquired In-Process Research and Development

Clinical Trial Costs

Clinical Trial Costs

Patent Costs

Patent Costs

Contingent Liabilities

Contingent Liabilities

Income Taxes

Income Taxes

Concentrations of Credit Risk

Concentrations of Credit Risk

Stock-Based Compensation

Stock-Based Compensation

Expected volatility

Expected volatility

Expected Dividend Yield

Expected Dividend Yield

The Company has historically not paid dividends and has no foreseeable plans to pay dividends, 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.

Restricted shares are value as fair value of shares on date of grant.

Basic and Diluted Net Loss per Share

Basic and Diluted Net Loss per Share

Segment Information

Segment Information

Revenue Recognition

Revenue Recognition

(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.

The Company evaluates each performance obligation to determine if it can be satisfied at a point in time or over time.

The Company concluded that there is one distinct performance obligation under the Novartis Agreement: Research and development services, obligation which is satisfied over time.

Revenue associated with the research and development services in the amount of $3.5 million and $3.7 million was recognized in 2021 and 2020 respectively.

Recently Issued Accounting Pronouncements Not Yet Adopted

Recently Issued Accounting Pronouncements Not Yet Adopted

Significant Accounting Policies (Tables)

12 Months Ended

Dec. 31, 2021

Accounting Policies [Abstract]

Schedule of property and equipment

Computers and Software	33	%
Lab Equipment	15	%
Office Furniture and Equipment	7	%

Property and Equipment, net (Tables)

12 Months Ended

Dec. 31, 2021

Property, Plant and Equipment [Abstract]

Schedule of property and Equipment, net

	December 31,		December 31,
	2021		2020
	(in thousands)
Cost:
Computers and Software	$	73	$	73
Lab Equipment		294		293
Office Furniture and Equipment		146		142
Leasehold Improvements		1,105		1,105
		1,618		1,613
Less: Accumulated Depreciation		498		330
Property and Equipment, Net	$	1,120	$	1,283

Other account payables (Tables)

12 Months Ended

Dec. 31, 2021

Payables and Accruals [Abstract]

Schedule of other account payables

	December 31,		December 31,
	2021		2020
	(in thousands)
Accrued Professional Fees	$	291	$	657
Accrued Research and Development Expenses		56		101
Tax Provision		1,150		780
Accrued Payroll and Employee Benefits		1,761		1,613
Total Accrued Expenses	$	3,258	$	3,151

Commitments and Contingent Liabilities (Tables)

12 Months Ended

Dec. 31, 2021

Commitments and Contingencies Disclosure [Abstract]

Schedule of the company signed a new lease agreement

Year ended December 31,	(in thousands)
2022		360
2023		360
2024		120
	$	840

Fair Value Measurements (Tables)

12 Months Ended

Dec. 31, 2021

Fair Value Disclosures [Abstract]

Schedule of fair value measurements

	Fair Value Measurements at December 31, 2021
	Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)		Total
			($in thousands)
Cash equivalents:
Money market funds	$	32,900	$	—	$	—	$	32,900
Total cash equivalents	$	32,900	$	—	$	—	$	32,900

	Fair Value Measurements at December 31, 2020
	Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)		Total
			($in thousands)
Cash equivalents:
Money market funds	$	35,900	$	—	$	—	$	35,900
Total cash equivalents	$	35,900	$	—	$	—	$	35,900

Common Stock (Tables)

12 Months Ended

Dec. 31, 2021

Common Stock [Abstract]

Schedule of total shares of common stock reserved for issuance

	December 31,		December 31,
	2021		2020
Options Outstanding		900,789		695,674
Warrants for common shares of the company.		1,799,999
Shares available for future option grants		593,040		387,736
Total shares of Common Stock reserved for Issuance		3,293,828		1,083,410

Schedule of composition of capital stock

December 31,
2021

December 31,
2020

Issued and

Authorized

outstanding

Authorized

outstanding

Shares of USD 0.01 par value:

Common Stock

200,000,000

13,956,035

200,000,000

12,728,446

Does not include 124,348 and 96,017 shares of restricted Common Stock issued but not outstanding in 2021 and 2020, respectively.

Stock-Based Plans (Tables)

12 Months Ended

Dec. 31, 2021

Share-based Payment Arrangement [Abstract]

Schedule of fair value of options granted to employees

	Year ended
	December 31,
	2021			2020
Expected volatility		80	%		80	%
Expected dividends		0	%		0	%
Expected term (in years)		6.34			6.34
Risk free rate		0.50%-1.08	%		0.47%-2.03	%

Schedule of stock-based compensation

	Year ended		Year ended
	December 31,		December 31,
	2021		2020
Research and Development	$	1,097	$	509
General and Administrative		1,587		1,060
Total Stock-Based Compensation	$	2,684	$	1,569

Schedule of stock option activity granted to employees

	Year ended December 31, 2021
	Number of			Weighted average exercise		Weighted average remaining contractual term		Aggregate intrinsic
	options			price		(in years)		value

Outstanding at Beginning of Year		695,674		$	6.07		7.25	$	1,695,276
Granted		295,470			10.99
Exercised		(18,328	)		5.50			$	55,133
Forfeited		(70,527	)		9.78
Expired		(1,500	)		5.10
Outstanding, December 31, 2021		900,789		$	7.41		7.78	$	991,878
Exercisable Options, December 31, 2021		476,303		$	5.93		7.12	$	1,230,643

Schedule of summarizes information relating to restricted shares

	Year ended			Year ended
	December 31,			December 31,
	2021			2020
Outstanding at beginning of Year		101,929			65,847
Granted		71,253			58,651
Forfeited		—			(3,907	)
Vested		(48,834	)		(18,662	)
Outstanding at end of Year		124,348			101,929

Taxes on Income (Tables)

12 Months Ended

Dec. 31, 2021

Income Tax Disclosure [Abstract]

Schedule of loss from continuing operations, before taxes on income

	Year ended			Year ended
	December 31,			December 31,
	2021			2020
United States	$	(39,018	)	$	(29,698	)
Israel		(460	)		(23	)
Net loss before tax	$	(39,478	)	$	(29,721	)

Schedule of income tax expense

	Year ended		Year ended
	December 31,		December 31,
	2021		2020
Current:
Federal	$	—	$
State				—
Foreign		776		426

	$	776	$	426
Deferred:
Federal	$	—	$	—
State		—		—
Foreign		—		—
	$	—	$	—
Income tax expense	$	776	$	426

Schedule of the effective income tax rate differed from the amount applying the federal statutory rate

	Year ended			Year ended
	December, 31			December, 31
	2021			2020
U.S. federal tax provision at statutory rate		21.00	%		21.00	%
State and local tax, net of federal benefit		4.01			4.64
Foreign rate differences		(0.09	)		(0.07	)
Non-deductible stock compensation		(1.43	)		(1.11	)
Section 951A GILTI		0.00			(0.85	)
Effect of other permanent differences		(0.07	)		(0.07	)
Uncertain tax positions		(0.66	)		(0.52	)
Change in valuation allowance		(34.39	)		(26.65	)
Federal Tax Reform Rate Change		0.00			0.00
Tax Credits		6.01			—
Provision to Return		3.95			—
Other adjustments		(0.30	)		2.20

Effective tax rate		(1.97	)%		(1.43	)%

Schedule of deferred income taxes the carrying amounts of assets and liabilities

	As of			As of
	December 31,			December 31,
	2021			2020
Deferred tax assets:
Federal net operating loss carryforwards	$	22,614		$	12,752
Intangible assets		3,402			651
Accrued expenses		3,011			3,022
Other		169			—
Total deferred tax assets		29,196			16,425
Valuation allowance		(29,196	)		(16,425	)
Net deferred tax assets	$	—		$	—

Schedule of unrecognized tax benefits

	2021		2020
	(in thousands)		(in thousands)
Uncertain tax position at the beginning of year	$	581	$	424
Additions for uncertain tax position of prior years (foreign exchange and interest)		17		3
Additions for tax positions of current year		260		153
Uncertain tax position at the end of the year	$	858	$	581

Net Loss Per Share Attributable to Common Stockholders (Tables)

12 Months Ended

Dec. 31, 2021

Earnings Per Share [Abstract]

Schedule of the loss per share

	Year ended		Year ended
	December 31, 2021		December 31, 2020
Numerator:
Net loss	$	40,254	$	30,146
Denominator:
Weighted-average number of shares used to compute net loss per share, basic and diluted		14,398,905		9,860,610

General (Details) - USD ($) $ / shares in Units, $ in Thousands				1 Months Ended		12 Months Ended
	Jun. 04, 2020	May 12, 2020	May 04, 2020	Jun. 30, 2021	Feb. 19, 2021	Dec. 31, 2021	Dec. 31, 2020
General (Details) [Line Items]
Common stock shares associated (in Shares)		3,940,689
Net proceeds	$ 52,200
Aggregate shares of common stock (in Shares)			3,715,222
Securities purchase agreements, description					(i) an aggregate of 333,333 shares of our common stock (the “Private Placement Shares”), par value $0.01 per share, together with warrants to purchase an aggregate of 116,666 shares of its Common Stock with an exercise price of $18.10 per share (the “Common Warrants”), for an aggregate purchase price of $4,999,995.00 and (ii) pre-funded warrants to purchase an aggregate of 1,333,333 shares of its Common Stock with an exercise price of $0.01 per share (the “Pre-Funded Warrants” and collectively with the Common Warrants, the “Private Placement Warrants”), together with an aggregate of 466,666 Common Warrants, for an aggregate purchase price of $19,986,661.67 (collectively, the “Private Placement”). The Private Placement closed on February 23, 2021.
Aggregate value				$ 200,000
Total number of shares (in Shares)						827,094
Goss proceeds						$ 10,400
Accumulated deficit						(111,141)	$ (70,887)
Cash in operations						(38,356)	$ (27,541)
Cash and cash equivalents and restricted bank deposits						$ 37,300
IPO [Member]
General (Details) [Line Items]
Shares of common stock (in Shares)		3,940,689
Per share value (in Dollars per share)	$ 15	$ 0.01
Common stock shares associated (in Shares)		274,022
Net proceeds		$ 52,800

Significant Accounting Policies (Details) - USD ($) $ in Millions	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Accounting Policies [Abstract]
Severance costs	$ 0.3	$ 0.2
Employee contributions, percentage	100.00%
Employee’s base salary, percentage	6.00%
Largest benefit likelihood, percentage	50.00%
Expected dividend yield	0.00%
Research and development services	$ 3.5	$ 3.7

Significant Accounting Policies (Details) - Schedule of property and equipment	Dec. 31, 2021
Computers and Software [Member]
Significant Accounting Policies (Details) - Schedule of property and equipment [Line Items]
Estimated useful lives	33.00%
Lab Equipment [Member]
Significant Accounting Policies (Details) - Schedule of property and equipment [Line Items]
Estimated useful lives	15.00%
Office Furniture and Equipment [Member]
Significant Accounting Policies (Details) - Schedule of property and equipment [Line Items]
Estimated useful lives	7.00%

Property and Equipment, net (Details) - USD ($)	Dec. 31, 2021	Dec. 31, 2020
Property, Plant and Equipment [Abstract]
Depreciation expense	$ 168	$ 182

Property and Equipment, net (Details) - Schedule of property and Equipment, net - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
Cost:
Property, Plant and Equipment, Gross	$ 1,618	$ 1,613
Less: Accumulated Depreciation	498	330
Property and Equipment, Net	1,120	1,283
Computers and Software [Member]
Cost:
Property, Plant and Equipment, Gross	73	73
Lab Equipment [Member]
Cost:
Property, Plant and Equipment, Gross	294	293
Office Furniture and Equipment [Member]
Cost:
Property, Plant and Equipment, Gross	146	142
Leasehold Improvements [Member]
Cost:
Property, Plant and Equipment, Gross	$ 1,105	$ 1,105

Other account payables (Details) - Schedule of other account payables - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Schedule of other account payables [Abstract]
Accrued Professional Fees	$ 291	$ 657
Accrued Research and Development Expenses	56	101
Tax Provision	1,150	780
Accrued Payroll and Employee Benefits	1,761	1,613
Total Accrued Expenses	$ 3,258	$ 3,151

Commitments and Contingent Liabilities (Details) - USD ($) $ in Millions	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Commitments and Contingent Liabilities (Details) [Line Items]
Operating lease option to extend terms	The term of the lease is for 63 months and includes an option to extend the lease for an additional 60 months.
Bank guarantee obtained for lease agreement.	$ 0.2
Leasing expense	$ 0.3	$ 0.3
Percentage of equity ownership	8.00%
BMS agreement, description	This right terminated upon the closing of the sale of the Company’s Series B Preferred Stock. The Company estimates the fair value of this anti-dilution commitment using the probability weighted expected return method (“PWERM”). At the date of BMS Agreement, the Company recorded liability associated with the anti-dilution right in the amount of approximately $0.5 million, according to its fair value. For the year ended December 31, 2018, the Company recorded an income of approximately $0.5 million for the reassessment of the liability, within financial income, net, in the consolidated statement of operations.
License Agreement [Member]
Commitments and Contingent Liabilities (Details) [Line Items]
Leasehold improvements	$ 0.5
License Agreement [Member] \| BMS [Member]
Commitments and Contingent Liabilities (Details) [Line Items]
Collaborative arrangement, milestone payments liability .	95.0
Collaborative arrangement, additional milestone payments	47.0
Collaborative arrangements sales based milestone amount payable	$ 50.0
Term of license agreement	10 years
BMS License Agreement [Member]
Commitments and Contingent Liabilities (Details) [Line Items]
Payments	$ 6.0
Preferred stock valued	$ 7.3
Option And License Agreement [Member] \| Novartis International Pharmaceutical Ltd. [Member]
Commitments and Contingent Liabilities (Details) [Line Items]
Term of license agreement	10 years
Milestone payment receivable	$ 245.0
Period before which breach shall be cured by the company	60 days
Period for which license option granted shall remain uncured	36 months
Period before which breach shall be cured by the company	60 days
Notice period for the termination of the agreement	60 days
Period for which license option granted shall remain effective	60 days
Stock purchase agreement and associated investment agreements [Member] \| Novartis International Pharmaceutical Ltd. [Member]
Commitments and Contingent Liabilities (Details) [Line Items]
Stock shares issued during the period new issues value	$ 10.0

Commitments and Contingent Liabilities (Details) - Schedule of the company signed a new lease agreement $ in Thousands	Dec. 31, 2021 USD ($)
Schedule of the company signed a new lease agreement [Abstract]
2022	$ 360
2023	360
2024	120
Total	$ 840

Fair Value Measurements (Details) - Schedule of fair value measurements - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Cash equivalents:
Total cash equivalents	$ 32,900	$ 35,900
Money Market Funds [Member]
Cash equivalents:
Total cash equivalents	32,900	35,900
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member]
Cash equivalents:
Total cash equivalents	32,900	35,900
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] \| Money Market Funds [Member]
Cash equivalents:
Total cash equivalents	32,900	35,900
Significant Other Observable Inputs (Level 2) [Member]
Cash equivalents:
Total cash equivalents
Significant Other Observable Inputs (Level 2) [Member] \| Money Market Funds [Member]
Cash equivalents:
Total cash equivalents
Significant Unobservable Inputs (Level 3) [Member]
Cash equivalents:
Total cash equivalents
Significant Unobservable Inputs (Level 3) [Member] \| Money Market Funds [Member]
Cash equivalents:
Total cash equivalents

Common Stock (Details) - USD ($)			1 Months Ended		12 Months Ended
Common Stock (Details) - USD ($)	Jun. 04, 2020	May 12, 2020	Feb. 19, 2021	May 31, 2020	Dec. 31, 2021	Dec. 31, 2020	Jun. 30, 2021
Common Stock (Details) [Line Items]
Shares issued		3,940,689
Partial exercise shares		274,022
Net proceeds (in Dollars)	$ 52,200,000
Conversion of aggregate common stock shares		3,715,222
Common stock, per share (in Dollars per share)					$ 0.01	$ 0.01
Issuance costs (in Dollars)			$ 1,715,000
Outstanding shares			1,799,999
Aggregate of common stock value (in Dollars)							$ 200,000,000
Total common stock shares					827,094
Gross proceeds of common stock (in Dollars)					$ 10,400,000
Restricted Common Stock				58,651	124,348	96,017
Common Stock [Member]
Common Stock (Details) [Line Items]
Shares issued		200,000,000
Preferred Stock [Member]
Common Stock (Details) [Line Items]
Shares issued		10,000,000
IPO [Member]
Common Stock (Details) [Line Items]
Shares issued		274,022
Price, per share (in Dollars per share)		$ 15
Net proceeds (in Dollars)		$ 52,800,000
Private Placement [Member]
Common Stock (Details) [Line Items]
Aggregate of common stock shares			333,333
Common stock, per share (in Dollars per share)			$ 0.01
Aggregate purchase price (in Dollars)			$ 19,986,661.67
Aggregate of common warrants shares			466,666
Common Warrants [Member]
Common Stock (Details) [Line Items]
Aggregate of common stock shares			116,666
Common stock exercise price (in Dollars per share)			$ 18.1
Aggregate purchase price (in Dollars)			$ 4,999,995
Pre-Funded Warrants [Member]
Common Stock (Details) [Line Items]
Aggregate of common stock shares			1,333,333
Common stock exercise price (in Dollars per share)			$ 0.01

Common Stock (Details) - Schedule of total shares of common stock reserved for issuance - shares	Dec. 31, 2021	Dec. 31, 2020
Schedule of total shares of common stock reserved for issuance [Abstract]
Options Outstanding	900,789	695,674
Warrants for common shares of the company	1,799,999
Shares available for future option grants	593,040	387,736
Total shares of Common Stock reserved for Issuance	3,293,828	1,083,410

Common Stock (Details) - Schedule of composition of capital stock - Common Stock [Member] - shares

Dec. 31, 2021

Dec. 31, 2020

Common Stock (Details) - Schedule of composition of capital stock [Line Items]

Authorized

200,000,000

Issued and outstanding

^[1]

13,956,035

12,728,446

[1]	Does not include 124,348 and 96,017 shares of restricted Common Stock issued but not outstanding in 2021 and 2020, respectively.

Stock-Based Plans (Details) - USD ($)		1 Months Ended				12 Months Ended
Stock-Based Plans (Details) - USD ($)	May 07, 2020	May 31, 2020	Dec. 24, 2019	Feb. 28, 2018	Nov. 15, 2017	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Stock-Based Plans (Details) [Line Items]
Options to purchase shares						593,040
Option granted						10 years
Fair value of stock options granted						$ 7.98	$ 6.07
Aggregate intrinsic value of stock options exercised						$ 55	$ 280
Non-vested stock-based compensation						1,100,000
Restricted shares term	4 years		4 years		4 years	11 months 4 days
Restricted shares		58,651				124,348	96,017
Restricted shares								59,597
Restricted shares granted, per share						$ 11.26	$ 15
Fair value of shares vested						200,000	200,000
Unrecognized compensation expense						$ 1,800,000
Weighted average maturity period						1 year 8 months 23 days
Maximum [Member]
Stock-Based Plans (Details) [Line Items]
Options vest primarily						4 years
Minimum [Member]
Stock-Based Plans (Details) [Line Items]
Options vest primarily						5 years
Common Stock [Member]
Stock-Based Plans (Details) [Line Items]
Common stock, shares authorized						1,841,040
Employee Stock [Member]
Stock-Based Plans (Details) [Line Items]
Restricted shares				83,165

Stock-Based Plans (Details) - Schedule of fair value of options granted to employees	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Stock-Based Plans (Details) - Schedule of fair value of options granted to employees [Line Items]
Expected volatility	80.00%	80.00%
Expected dividends	0.00%	0.00%
Expected term (in years)	6 years 4 months 2 days	6 years 4 months 2 days
Minimum [Member]
Stock-Based Plans (Details) - Schedule of fair value of options granted to employees [Line Items]
Risk free rate	0.50%	0.47%
Maximum [Member]
Stock-Based Plans (Details) - Schedule of fair value of options granted to employees [Line Items]
Risk free rate	1.08%	2.03%

Stock-Based Plans (Details) - Schedule of stock-based compensation - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Schedule of stock-based compensation [Abstract]
Research and Development	$ 1,097	$ 509
General and Administrative	1,587	1,060
Total Stock-Based Compensation	$ 2,684	$ 1,569

Stock-Based Plans (Details) - Schedule of stock option activity granted to employees $ / shares in Units, $ in Thousands	12 Months Ended
	Dec. 31, 2021 USD ($) $ / shares shares
Schedule of stock option activity granted to employees [Abstract]
Number of options Outstanding at Beginning of Year (in Shares) \| shares	695,674
Weighted average exercise price Outstanding at Beginning of Year	$ 6.07
Weighted average remaining contractual term (in years) Outstanding at Beginning of Year	7 years 3 months
Aggregate intrinsic value Outstanding at Beginning of Year (in Dollars) \| $	$ 1,695,276
Number of options Granted (in Shares) \| shares	295,470
Weighted average exercise price Granted	$ 10.99
Number of options Exercised (in Shares) \| shares	(18,328)
Weighted average exercise price Exercised	$ 5.5
Aggregate intrinsic value Exercised (in Dollars) \| $	$ 55,133
Number of options Forfeited (in Shares) \| shares	(70,527)
Weighted average exercise price Forfeited	$ 9.78
Number of options Expired (in Shares) \| shares	(1,500)
Weighted average exercise price Expired	$ 5.1
Number of options Outstanding End of Year (in Shares) \| shares	900,789
Weighted average exercise price Outstanding End of Year	$ 7.41
Weighted average remaining contractual term (in years) Outstanding End of Year	7 years 9 months 10 days
Aggregate intrinsic value Outstanding End of Year (in Dollars) \| $	$ 991,878
Number of options exercisable options, End of Year	$ 476,303
Weighted average exercise price exercisable options,End of Year	$ 5.93
Weighted average remaining contractual term (in years) exercisable options, End of Year	7 years 1 month 13 days
Aggregate intrinsic value exercisable options, End of Year (in Dollars) \| $	$ 1,230,643

Stock-Based Plans (Details) - Schedule of summarizes information relating to restricted shares - shares	Dec. 31, 2021	Dec. 31, 2020
Schedule of summarizes information relating to restricted shares [Abstract]
Outstanding at beginning of Year	101,929	65,847
Granted	71,253	58,651
Forfeited		(3,907)
Vested	(48,834)	(18,662)
Outstanding at end of Year	124,348	101,929

Taxes on Income (Details) - USD ($) $ in Thousands	1 Months Ended	12 Months Ended
Taxes on Income (Details) - USD ($) $ in Thousands	Dec. 22, 2017	Dec. 31, 2021	Dec. 31, 2020	Jan. 01, 2018	Jan. 01, 2017
Taxes on Income (Details) [Line Items]
Tax provisions, description	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”).
Valuation allowance		$ 29,200
Federal income tax		91,600
State income tax		$ 57,700
Taxable income, percentage		80.00%
Research and development credit carryforwards		$ 33
Interest and penalties		$ 900	$ 600
Income tax rate		23.00%	23.00%	23.00%
Maximum [Member]
Taxes on Income (Details) [Line Items]
Income tax rate					25.00%
Minimum [Member]
Taxes on Income (Details) [Line Items]
Income tax rate					24.00%
Federal Orphan Drug [Member]
Taxes on Income (Details) [Line Items]
Research and development credit carryforwards		$ 618

Taxes on Income (Details) - Schedule of loss from continuing operations, before taxes on income - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Taxes on Income (Details) - Schedule of loss from continuing operations, before taxes on income [Line Items]
Net loss before tax	$ (39,478)	$ (29,721)
United States [Member]
Taxes on Income (Details) - Schedule of loss from continuing operations, before taxes on income [Line Items]
Net loss before tax	(39,018)	(29,698)
Israel [Member]
Taxes on Income (Details) - Schedule of loss from continuing operations, before taxes on income [Line Items]
Net loss before tax	$ (460)	$ (23)

Taxes on Income (Details) - Schedule of income tax expense - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Current:
Federal
State
Foreign	776	426
Current, total	776	426
Deferred:
Federal
State
Foreign
Deferred, total
Income tax expense	$ 776	$ 426

Taxes on Income (Details) - Schedule of the effective income tax rate differed from the amount applying the federal statutory rate	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Schedule of the effective income tax rate differed from the amount applying the federal statutory rate [Abstract]
U.S. federal tax provision at statutory rate	21.00%	21.00%
State and local tax, net of federal benefit	4.01%	4.64%
Foreign rate differences	(0.09%)	(0.07%)
Non-deductible stock compensation	(1.43%)	(1.11%)
Section 951A GILTI	0.00%	(0.85%)
Effect of other permanent differences	(0.07%)	(0.07%)
Uncertain tax positions	(0.66%)	(0.52%)
Change in valuation allowance	(34.39%)	(26.65%)
Federal Tax Reform Rate Change	0.00%	0.00%
Tax Credits	6.01%
Provision to Return	3.95%
Other adjustments	(0.30%)	2.20%
Effective tax rate	(1.97%)	(1.43%)

Taxes on Income (Details) - Schedule of deferred income taxes the carrying amounts of assets and liabilities - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
Deferred tax assets:
Federal net operating loss carryforwards	$ 22,614	$ 12,752
Intangible assets	3,402	651
Accrued expenses	3,011	3,022
Other	169
Total deferred tax assets	29,196	16,425
Valuation allowance	(29,196)	(16,425)
Net deferred tax assets

Taxes on Income (Details) - Schedule of unrecognized tax benefits - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Schedule of unrecognized tax benefits [Abstract]
Uncertain tax position at the beginning of year	$ 581	$ 424
Additions for uncertain tax position of prior years (foreign exchange and interest)	17	3
Additions for tax positions of current year	260	153
Uncertain tax position at the end of the year	$ 858	$ 581

Net Loss Per Share Attributable to Common Stockholders (Details)	12 Months Ended
	Dec. 31, 2021 $ / shares shares
Net Loss Per Share Attributable to Common Stockholders (Details) [Line Items]
Weighted average shares basic	1,333,333
Weighted average shares diluted	1,155,555
Weighted average warrants price per share (in Dollars per share) \| $ / shares	$ 0.01
Antidilutive excluded shares	466,666
Stock options outstanding	900,789
IPO [Member]
Net Loss Per Share Attributable to Common Stockholders (Details) [Line Items]
Antidilutive excluded shares	695,674
Series A Preferred Stock [Member]
Net Loss Per Share Attributable to Common Stockholders (Details) [Line Items]
Antidilutive excluded shares	3,679,778
Series B Preferred Stock [Member]
Net Loss Per Share Attributable to Common Stockholders (Details) [Line Items]
Antidilutive excluded shares	3,750,674

Net Loss Per Share Attributable to Common Stockholders (Details) - Schedule of the loss per share - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Numerator:
Net loss	$ 40,254	$ 30,146
Denominator:
Weighted-average number of shares used to compute net loss per share, basic and diluted	14,398,905	9,860,610