UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO SECTION 13A-16 OR 15D-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of August 2023
Commission File Number: 001-41316
Alpha Tau Medical Ltd.
(Exact Name of Registrant as Specified in Its
Charter)
Kiryat HaMada St. 5
Jerusalem, Israel 9777605
+972 (3) 577-4115
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form
40-F ☐
CONTENTS
The following documents are attached hereto
and incorporated by reference herein:
| ● | Exhibit 99.1. Interim Consolidated Financial Statements as of June 30, 2023. |
| ● | Exhibit 99.2. Operating and Financial Review and Prospects in connection the Interim Consolidated Financial
Statements for the six months ended June 30, 2023. |
The Interim Consolidated
Financial Statements of Alpha Tau Medical Ltd. as of June 30, 2023 attached as Exhibit 99.1 and the Operating Results and Financial Review
in connection with the Interim Consolidated Financial Statements of Alpha Tau Medical Ltd. for the six months ended June 30, 2023 attached
as Exhibit 99.2 to this Report on Form 6-K are hereby incorporated by reference into the Registrant’s Registration Statements on
Form F-3 (File Nos. 333-271073 and 333-264306) and Form S-8 (File Nos. 333-270406 and 333-264169).
EXHIBIT INDEX
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
ALPHA TAU MEDICAL LTD. |
|
|
|
Date: August 28, 2023 |
By: |
/s/ Uzi Sofer |
|
|
Uzi Sofer |
|
|
Chief Executive Officer |
3
Exhibit 99.1
ALPHA
TAU MEDICAL LTD.
INTERIM
CONSOLIDATED FINANCIAL STATEMENTS
AS
OF JUNE 30, 2023
U.S.
DOLLARS IN THOUSANDS
UNAUDITED
INDEX
ALPHA TAU MEDICAL LTD.
INTERIM
CONSOLIDATED BALANCE SHEETS
U.S. dollars
in thousands
| |
| | |
December 31, | | |
June 30, | |
| |
| | |
2022 | | |
2023 | |
| |
Note | | |
Audited | | |
Unaudited | |
ASSETS | |
| | |
| | |
| |
| |
| | |
| | |
| |
CURRENT ASSETS: | |
| | |
| | |
| |
Cash and cash equivalents | |
| | | |
$ | 5,836 | | |
$ | 855 | |
Restricted cash | |
| | | |
| 850 | | |
| 834 | |
Short-term deposits | |
| | | |
| 98,694 | | |
| 92,672 | |
Prepaid expenses and other receivables | |
| | | |
| 1,097 | | |
| 1,698 | |
| |
| | | |
| | | |
| | |
Total current assets | |
| | | |
| 106,477 | | |
| 96,059 | |
| |
| | | |
| | | |
| | |
LONG-TERM ASSETS: | |
| | | |
| | | |
| | |
Long term prepaid expenses | |
| | | |
| 391 | | |
| 441 | |
Property and equipment, net | |
| | | |
| 7,471 | | |
| 7,549 | |
Right-of-use asset | |
| 3 | | |
| 5,810 | | |
| 7,157 | |
| |
| | | |
| | | |
| | |
Total long-term assets | |
| | | |
| 13,672 | | |
| 15,147 | |
| |
| | | |
| | | |
| | |
Total assets | |
| | | |
$ | 120,149 | | |
$ | 111,206 | |
The
accompanying notes are an integral part of the interim consolidated financial statements.
ALPHA TAU MEDICAL LTD.
INTERIM
CONSOLIDATED BALANCE SHEETS
U.S. dollars
in thousands
| |
| | |
December 31, | | |
June 30, | |
| |
| | |
2022 | | |
2023 | |
| |
Note | | |
Audited | | |
Unaudited | |
| |
| | |
| | |
| |
LIABILITIES AND SHAREHOLDERS’ EQUITY | |
| | |
| | |
| |
| |
| | |
| | |
| |
CURRENT LIABILITIES: | |
| | |
| | |
| |
Trade payables | |
| | | |
| 1,423 | | |
| 1,789 | |
Other payables and accrued expenses | |
| | | |
| 2,246 | | |
| 2,781 | |
Current maturities of operating lease liabilities | |
| 3 | | |
| 669 | | |
| 846 | |
| |
| | | |
| | | |
| | |
Total current liabilities | |
| | | |
| 4,338 | | |
| 5,416 | |
| |
| | | |
| | | |
| | |
LONG-TERM LIABILITIES: | |
| | | |
| | | |
| | |
Warrants liability | |
| 5 | | |
| 5,630 | | |
| 7,794 | |
Operating lease liabilities | |
| 3 | | |
| 4,524 | | |
| 5,433 | |
| |
| | | |
| | | |
| | |
Total long-term liabilities | |
| | | |
| 10,154 | | |
| 13,227 | |
| |
| | | |
| | | |
| | |
Total liabilities | |
| | | |
| 14,492 | | |
| 18,643 | |
| |
| | | |
| | | |
| | |
COMMITMENTS AND CONTINGENCIES | |
| 6 | | |
| | | |
| | |
| |
| | | |
| | | |
| | |
SHAREHOLDERS’ EQUITY: | |
| 7 | | |
| | | |
| | |
Ordinary shares of no-par value per share – Authorized: 362,116,800 shares as of December 31, 2022 and June 30, 2023; Issued and outstanding: 69,105,000 and 69,373,135 shares as of December 31, 2022 and June 30, 2023, respectively | |
| | | |
| - | | |
| - | |
Additional paid-in capital | |
| | | |
| 192,259 | | |
| 196,045 | |
Accumulated deficit | |
| | | |
| (86,602 | ) | |
| (103,482 | ) |
| |
| | | |
| | | |
| | |
Total shareholders’ equity | |
| | | |
| 105,657 | | |
| 92,563 | |
| |
| | | |
| | | |
| | |
Total liabilities and shareholders’
equity | |
| | | |
$ | 120,149 | | |
$ | 111,206 | |
The
accompanying notes are an integral part of the interim consolidated financial statements.
ALPHA TAU MEDICAL LTD.
INTERIM
CONSOLIDATED STATEMENTS OF OPERATIONS
U.S. dollars
in thousands (except share and per share data)
| |
| | |
Six months ended June 30, | |
| |
Note | | |
2022 | | |
2023 | |
| |
| | |
Unaudited | |
| |
| | |
| | |
| |
Research and development, net | |
| | | |
$ | 10,683 | | |
$ | 12,261 | |
| |
| | | |
| | | |
| | |
Marketing expenses | |
| | | |
| 329 | | |
| 920 | |
| |
| | | |
| | | |
| | |
General and administrative | |
| | | |
| 5,781 | | |
| 3,631 | |
| |
| | | |
| | | |
| | |
Total operating loss | |
| | | |
| 16,793 | | |
| 16,812 | |
| |
| | | |
| | | |
| | |
Financial expenses, net | |
| 8 | | |
| 10,942 | | |
| 21 | |
| |
| | | |
| | | |
| | |
Loss before taxes on income | |
| | | |
| 27,735 | | |
| 16,833 | |
| |
| | | |
| | | |
| | |
Tax on income | |
| | | |
| 8 | | |
| 47 | |
| |
| | | |
| | | |
| | |
Net loss | |
| | | |
| 27,743 | | |
| 16,880 | |
| |
| | | |
| | | |
| | |
Net comprehensive loss | |
| | | |
$ | 27,743 | | |
$ | 16,880 | |
| |
| | | |
| | | |
| | |
Net loss per share, basic and diluted | |
| | | |
$ | (0.48 | ) | |
$ | (0.24 | ) |
| |
| | | |
| | | |
| | |
Weighted-average shares used in computing net loss per share, basic and diluted | |
| | | |
| 58,023,875 | | |
| 69,262,381 | |
The
accompanying notes are an integral part of the interim consolidated financial statements.
ALPHA TAU MEDICAL LTD.
INTERIM
CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY
U.S. dollars
in thousands (except share and per share data)
| |
Convertible | | |
| | |
| | |
Additional | | |
| | |
Total | |
| |
Preferred shares | | |
Ordinary shares | | |
paid-in | | |
Accumulated | | |
shareholders’ | |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
capital | | |
deficit | | |
equity | |
| |
| | |
| | |
| | |
| | |
| | |
| | |
| |
Balances as of January 1, 2022 | |
| 13,739,186 | | |
$ | 53,964 | | |
| 40,528,913 | | |
$ | - | | |
$ | 18,063 | | |
$ | (52,840 | ) | |
$ | (34,777 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Issuance of ordinary shares upon exercise of warrants | |
| - | | |
| - | | |
| 1,269,213 | | |
| - | | |
| 3,257 | | |
| - | | |
| 3,257 | |
Issuance of ordinary shares in connection with SPAC merger and PIPE financing | |
| - | | |
| - | | |
| 12,435,849 | | |
| - | | |
| 74,952 | | |
| - | | |
| 74,952 | |
Conversion of convertible preferred shares in connection with SPAC merger | |
| (13,739,186 | ) | |
| (53,964 | ) | |
| 14,270,797 | | |
| - | | |
| 53,964 | | |
| - | | |
| 53,964 | |
Conversion of Warrants to Convertible Preferred shares in connection with SPAC merger | |
| - | | |
| - | | |
| - | | |
| - | | |
| 35,170 | | |
| - | | |
| 35,170 | |
Vesting of RSUs | |
| - | | |
| - | | |
| 70,625 | | |
| - | | |
| - | | |
| - | | |
| - | |
Share-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| 3,445 | | |
| - | | |
| 3,445 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (27,743 | ) | |
| (27,743 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balances as of June 30, 2022 (unaudited) | |
| - | | |
$ | - | | |
| 68,575,397 | | |
$ | - | | |
$ | 188,851 | | |
$ | (80,583 | ) | |
$ | 108,268 | |
| |
Convertible | | |
| | |
| | |
Additional | | |
| | |
Total | |
| |
Preferred shares | | |
Ordinary shares | | |
paid-in | | |
Accumulated | | |
shareholders’ | |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
capital | | |
deficit | | |
equity | |
| |
| | |
| | |
| | |
| | |
| | |
| | |
| |
Balances as of January 1, 2023 | |
| - | | |
$ | - | | |
| 69,105,000 | | |
$ | - | | |
$ | 192,259 | | |
$ | (86,602 | ) | |
$ | 105,657 | |
| |
| | | |
| - | | |
| | | |
| | | |
| | | |
| | | |
| | |
Issuance of ordinary shares upon exercise of warrants | |
| - | | |
| - | | |
| 67,897 | | |
| - | | |
| - | | |
| - | | |
| - | |
Issuance of ordinary shares upon exercise of share options | |
| - | | |
| - | | |
| 2,500 | | |
| - | | |
| 2 | | |
| - | | |
| 2 | |
Vesting of RSUs | |
| - | | |
| - | | |
| 197,738 | | |
| | | |
| - | | |
| - | | |
| - | |
Share-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| 3,784 | | |
| - | | |
| 3,784 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (16,880 | ) | |
| (16,880 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balances as of June 30, 2023 (unaudited) | |
| - | | |
$ | - | | |
| 69,373,135 | | |
$ | - | | |
$ | 196,045 | | |
$ | (103,482 | ) | |
$ | 92,563 | |
The
accompanying notes are an integral part of the interim consolidated unaudited financial statements.
ALPHA TAU MEDICAL LTD.
INTERIM
CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S. dollars
in thousands
| |
Six months ended June 30, | |
| |
2022 | | |
2023 | |
| |
Unaudited | |
| |
| | |
| |
Cash flows from operating activities: | |
| | |
| |
| |
| | |
| |
Net loss | |
$ | (27,743 | ) | |
$ | (16,880 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Depreciation | |
| 475 | | |
| 512 | |
Share-based compensation | |
| 3,445 | | |
| 3,784 | |
Non-cash financial expenses (income), net | |
| (97 | ) | |
| 509 | |
Change in the fair value of Warrants Liabilities | |
| 11,105 | | |
| 2,164 | |
Increase in prepaid expenses and other receivables | |
| (2,443 | ) | |
| (601 | ) |
Decrease (increase) in long term prepaid expenses | |
| 1,821 | | |
| (50 | ) |
(Decrease) increase in trade payables | |
| (6 | ) | |
| 366 | |
(Decrease) increase in other payables and accrued expenses | |
| (1,885 | ) | |
| 535 | |
Change in operating lease liabilities | |
| - | | |
| (633 | ) |
Change in operating lease right-of-use assets | |
| - | | |
| 372 | |
| |
| | | |
| | |
Net cash used in operating activities | |
| (15,328 | ) | |
| (9,922 | ) |
| |
| | | |
| | |
Cash flows from investing activities: | |
| | | |
| | |
| |
| | | |
| | |
Investment in short-term deposits | |
| (100,000 | ) | |
| (98,431 | ) |
Redemption of short-term deposits | |
| 8,000 | | |
| 103,995 | |
Purchase of property and equipment | |
| (675 | ) | |
| (590 | ) |
| |
| | | |
| | |
Net cash (used in) provided by investing activities | |
| (92,675 | ) | |
| 4,974 | |
| |
| | | |
| | |
Cash flows from financing activities: | |
| | | |
| | |
| |
| | | |
| | |
Proceeds from exercise of warrants | |
| 3,257 | | |
| - | |
Proceeds from exercise of options | |
| - | | |
| 2 | |
Proceeds from SPAC merger and PIPE financing, net of transaction cost | |
| 93,543 | | |
| - | |
| |
| | | |
| | |
Net cash provided by financing activities | |
| 96,800 | | |
| 2 | |
| |
| | | |
| | |
Effect of exchange rate changes on cash, cash equivalents and restricted cash | |
| (288 | ) | |
| (51 | ) |
| |
| | | |
| | |
Decrease in cash, cash equivalents and restricted cash | |
| (11,491 | ) | |
| (4,997 | ) |
Cash, cash equivalents and restricted cash at beginning of period | |
| 23,854 | | |
| 6,686 | |
| |
| | | |
| | |
Cash, cash equivalents and restricted cash at end of period | |
$ | 12,363 | | |
$ | 1,689 | |
| |
| | | |
| | |
Supplemental disclosures of cash flow information: | |
| | | |
| | |
| |
| | | |
| | |
Income tax payments | |
$ | 2 | | |
$ | 13 | |
| |
| | | |
| | |
Interest received | |
$ | 50 | | |
$ | 2,394 | |
The
accompanying notes are an integral part of the interim consolidated financial statements.
ALPHA TAU MEDICAL LTD.
NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share
and per share data)
NOTE
1:- GENERAL
Alpha
Tau Medical Ltd. (“the Company”) is an Israeli clinical-stage oncology therapeutics company that focuses on research, development
and commercialization of Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) for the treatment of solid cancer. The Company was established
in November 2015 and began its operations in January 2016, and shortly thereafter acquired the full rights to the Alpha DaRT technology
from Althera Medical Ltd., (“Althera”), developed in 2003 at Tel Aviv University.
In
August 2017 the Company established a fully owned subsidiary in the United States - “Alpha Tau Medical Inc.” (“ATM Inc”).
ATM Inc began its activity in August 2018.
In
January 2018 the Company established a subsidiary in Japan “Alpha Tau Medical KK” (hereafter: ATM KK). ATM KK began its activity
in January 2018. Since July 2019, the Company holds 100% of ATM KK.
In
July 2019, the Company established a fully owned subsidiary in Canada “Alpha Tau Medical Canada Inc.” (hereafter: ATM Canada
Inc). ATM Canada Inc began its activity in March 2020.
| b. | Merger
with Healthcare Capital Corp: |
On
July 7, 2021, the Company entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Healthcare Capital
Corp., a Delaware corporation (“HCCC”), and Archery Merger Sub Inc., a Delaware corporation and wholly-owned subsidiary of
the Company (“Merger Sub”). As part of the completion of business combination on March 7, 2022 (the “Closing Date”),
the Merger Sub was merged with and into HCCC (the “Merger”), with HCCC surviving the merger as a wholly owned subsidiary of
the Company. In July 2022, HCCC was dissolved.
Each
of HCCC’s outstanding warrants to purchase one share of HCCC common stock, including both the HCCC warrants issued to public shareholders
in HCCC’s initial public offering (the “Public Warrants”) and the HCCC warrants issued in a private placement to HCCC’s
sponsors in HCCC’s initial public offering (the “Private Warrants”) (together, the “Warrants liability”),
were converted into the right to receive an equal number of warrants to purchase one Ordinary Share of the Company. A total of 15,891,984
warrants to purchase one Ordinary Share were issued to holders of HCCC warrants.
On
July 7, 2021, the Company entered into Subscription Agreements, together with a number of subsequent agreements since with certain
investors (the “PIPE Investors”) pursuant to which, among other things, the PIPE Investors agreed to purchase on the Closing
Date the Company’s ordinary shares at a price equal to $10.00 per share on the terms and subject to the conditions set forth in
the Subscription Agreements (the “PIPE Financing”). In connection with the closing of the Business Combination, the Company
consummated the sale of 9,251,006 ordinary shares for gross proceeds of $92,510 pursuant to the PIPE Financing.
Total
gross proceeds resulted from the Merger transaction were approximately $104,052 out of which total transaction costs amounted to approximately
$5,713. The transaction costs related to the Warrants liability in the amount of $817 were recognized as expenses in the Company’s
statement of operations for the period ended June 30, 2022. The residual amount was deducted of additional paid in capital.
ALPHA TAU MEDICAL LTD.
NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
NOTE
1:- GENERAL (Cont.)
| c. | The
Company’s activities since inception have consisted of performing research and development
activities. Successful completion of the Company’s development programs and, ultimately,
the attainment of profitable operations are dependent on future events, including, among
other things, its ability to secure financing; obtain further marketing approvals from regulatory
authorities; access potential markets; and build a sustainable customer base; attract, retain
and motivate qualified personnel; and develop strategic alliances. The Company’s operations
are funded by its shareholders and research and development grants and the Company intends
to seek further financing as well as make applications for further research and development
grants for continuing its operations. Although management believes that the Company will
be able to successfully fund its operations, there can be no assurance that the Company will
be able to do so or that the Company will ever operate profitably. |
The
Company expects to continue to incur substantial losses over the next several years during its clinical development phase. To fully execute
its business plan, the Company will need to complete registrational clinical studies and certain development activities as well as manufacture
the required clinical and commercial products in its manufacturing plants. Further, the Company will seek further regulatory approvals
prior to commercialization and the Company will need to establish sales, marketing and logistic infrastructures. These activities may
span many years and require substantial expenditures to complete and may ultimately be unsuccessful. Any delays in completing these activities
could adversely impact the Company.
As
of June 30, 2023, the Company had cash, cash equivalents, short-term deposits and restricted cash of $94,361. During the six months ended
June 30, 2023, the Company incurred a net loss of $16,880 and had negative cash flows from operating activities of $9,922. In addition,
the Company had an accumulated deficit of $103,482 on June 30, 2023. The Company believes that its existing capital resources will be
adequate to satisfy its expected liquidity requirements for at least two years.
NOTE
2:- SIGNIFICANT ACCOUNTING POLICIES
| a. | Unaudited interim consolidated financial statements: |
The
accompanying unaudited interim consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting
principles (“U.S. GAAP”) for interim financial information. In the opinion of management, the unaudited interim consolidated
financial statements include all adjustments necessary for a fair presentation.
The
balance sheet as of December 31, 2022 has been derived from the audited consolidated financial statements of the Company at that date
but does not include all information and footnotes required by U.S. GAAP for complete financial statements.
The
accompanying unaudited interim consolidated financial statements should be read in conjunction with the audited consolidated financial
statements and accompanying notes for the year ended December 31, 2022.
The
significant accounting policies disclosed in the Company’s audited 2022 consolidated financial statements and notes thereto have been
applied consistently to these unaudited interim consolidated financial statements. Results for the six months ended June 30, 2023 are
not necessarily indicative of results that may be expected for the year ending December 31, 2023.
ALPHA TAU MEDICAL LTD.
NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
NOTE
2:- SIGNIFICANT ACCOUNTING POLICIES (Cont.)
The
preparation of the unaudited interim consolidated financial statements in conformity with U.S. GAAP requires management to make estimates,
judgments and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities
at the date of the interim consolidated financial statements and the reported amounts of revenues and expenses during the reporting period.
The Company’s management believes that the estimates, judgments and assumptions used are reasonable based upon information available
at the time they are made. Actual results could differ from those estimates.
Restricted
cash is primarily invested in bank deposit and is used as security for the Company’s lease commitments. The following table provides
a reconciliation of the cash and cash equivalents balances reported on the balance sheets and the cash, cash equivalents and restricted
cash balances reported in the statements of cash flows:
| |
June 30, | |
| |
2022 | | |
2023 | |
| |
Unaudited | |
| |
| | |
| |
Cash and cash equivalents, as reported on the balance sheets | |
$ | 11,571 | | |
$ | 855 | |
Restricted cash, as reported on the balance sheets | |
| 792 | | |
| 834 | |
| |
| | | |
| | |
Cash, cash equivalents, and restricted cash, as reported in the statements of cash flows | |
$ | 12,263 | | |
$ | 1,689 | |
The
Company determines if an arrangement meets the definition of a lease at the inception of the lease.
Right-of-use
(“ROU”) assets represent the right to use an underlying asset for the lease term and lease liabilities represent the Company’s
obligation to make lease payments arising from the lease agreement. ROU assets are initially measured at amounts, which represents the
discounted present value of the lease payments over the lease, plus any initial direct costs incurred. The lease liability is initially
measured at lease commencement date based on the discounted present value of minimum lease payments over the lease term. The implicit
rate within the operating leases is generally not determinable, therefore the Company uses the Incremental Borrowing Rate (“IBR”)
based on the information available at commencement date in determining the present value of lease payments. The Company’s IBR was
estimated to approximate the interest rate for collateralized borrowing with similar terms and payments and in economic environments
where the leased asset was located.
Lease
term may include options to extend or terminate the lease when it is reasonably certain that the Company would exercise that option.
The Company elected to not recognize a lease liability ROU asset for leases with a term of twelve months or less. The Company also elected
the practical expedient to not separate lease and non-lease components for its leases.
Payments
under the Company’s lease agreements are primarily fixed; however, certain lease agreements contain variable payments, which are
expensed as incurred and not included in the operating lease ROU assets and liabilities.
Lease
expenses for lease payments are recognized on a straight-line basis over the lease term.
ALPHA TAU MEDICAL LTD.
NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
NOTE
2:- SIGNIFICANT ACCOUNTING POLICIES (Cont.)
| e. | Ordinary share warrants classification and measurement: |
The
Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s
specific terms and applicable authoritative guidance. The assessment considers whether the warrants are freestanding financial instruments,
meet the definition of a liability under ASC 480, are indexed to the Company’s own shares and whether the warrants are eligible
for equity classification under ASC 815-40. This assessment is conducted at the time of warrant issuance and as of each subsequent reporting
period end date while the warrants are outstanding.
Warrants
that meet all the criteria for equity classification, are required to be recorded as a component of additional paid-in capital. Warrants
that do not meet all the criteria for equity classification, are required to be recorded as liabilities at their initial fair value on
the date of issuance and remeasured to fair value through earnings at each balance sheet date thereafter.
The
Company has classified the SPAC warrants assumed during the Merger (both public and private) as a liability pursuant to ASC 815-40 since
the warrants do not meet the equity classification conditions. Accordingly, the Company measured the warrants at their fair value. The
warrants liability is subject to re-measurement at each balance sheet date until exercised, and any change in fair value is recognized
in our statement of comprehensive loss.
As
of December 31, 2022 and June 30, 2023, the Company has 2,391,857 and 2,323,960 warrants classified as equity.
In
addition, as of December 31, 2022 and June 30, 2023 the Company has 13,605,561 and 2,142,000 public and private warrants, respectively,
which are classified as a liability.
| f. | Fair value of financial instruments |
Fair
value is defined as the exchange price that would be received from the sale of an asset or paid to transfer a liability in the principal
or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date.
The Company measures financial assets and liabilities at fair value at each reporting period using a fair value hierarchy which requires
the Company to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value.
A
financial instrument’s classification within the fair value hierarchy is based upon the lowest level of input that is significant
to the fair value measurement. Three levels of inputs may be used to measure fair value:
Level
1 — quoted prices in active markets for identical assets or liabilities.
Level
2 — inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities;
quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for
substantially the full term of the assets or liabilities.
Level
3 — unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets
or liabilities.
ALPHA TAU MEDICAL LTD.
NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
NOTE
2:- SIGNIFICANT ACCOUNTING POLICIES (Cont.)
Financial
instruments consist among others of cash equivalents, restricted cash, other accounts receivable, trade payables, and other accounts
payable and accrued expenses. The estimated fair values of these financial instruments approximate their carrying value as presented,
due to their short-term maturities. We consider public warrant liabilities to be Level 1 and private warrants are measured at fair value
using Level 3 inputs.
NOTE
3:- LEASE
The
Company has entered into non-cancelable lease agreements for its offices and motor vehicles with lease periods expiring at various dates
through May 2035.
The
components of operating lease costs were as follows:
| |
Period ended June 30, 2023 | |
| |
Unaudited | |
| |
| |
Operating lease cost | |
$ | 475 | |
Variable lease cost | |
| 22 | |
| |
| | |
Total net lease costs | |
$ | 497 | |
Supplemental
balance sheet information related to operating leases is as follows:
| |
June 30, 2023 | |
| |
Unaudited | |
| |
| |
Operating lease ROU assets | |
$ | 7,157 | |
Operating lease liabilities, current | |
$ | 846 | |
Operating lease liabilities, long-term | |
$ | 5,433 | |
Weighted average remaining lease term (in years) | |
| 10.85 | |
Weighted average discount rate | |
| 5.10 | % |
Minimum
lease payments for the Company’s ROU assets over the remaining lease periods as of June 30, 2023, are as follows:
| |
Operating leases | |
| |
Unaudited | |
| |
| |
2023 | |
$ | 453 | |
2024 | |
| 849 | |
2025 | |
| 790 | |
2026 | |
| 689 | |
2027 and thereafter | |
| 5,562 | |
| |
| | |
Total undiscounted lease payments | |
| 8,343 | |
Less: imputed interest | |
| 2,064 | |
| |
| | |
Present value of lease liabilities | |
$ | 6,279 | |
ALPHA TAU MEDICAL LTD.
NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
NOTE
4:- WARRANTS LIABILITY
In
March 2022, in conjunction with the Merger with HCCC, the Company issued 13,749,986 warrants to the public shareholders of HCCC (the
“Public Warrants”) and 2,142,000 warrants to the sponsor of HCCC (the “Private Warrants”) in exchange for the
surrender and cancellation of an identical number of warrants exercisable into common stock of HCCC. The Public Warrants and the Private
Warrants may each be exercised into Ordinary shares of the Company within 5 years of the grant date, at an exercise price of $11.50,
and are subject to certain redemption provisions at the Company’s option.
As
of June 30, 2023, a total of 144,123 Public Warrants have been exercised into 144,123 ordinary shares of the Company.
As
of June 30, 2023, a total of 13,605,561 Public Warrants and 2,142,000 Private Warrants are outstanding.
Public
Warrants
Each
whole warrant will entitle the registered holder to purchase one Ordinary share. No fractional warrants will be issued and
only whole warrants will trade. No warrant will be exercisable and the Company will not be obligated to issue an Ordinary share upon
exercise of a warrant unless the Ordinary share issuable upon such warrant exercise has been registered, qualified or deemed to be exempt
under the securities laws of the state of residence of the registered holder of the warrants. In no event is the Company required to
net cash settle any warrant. During any period if the Company has failed to maintain an effective registration statement, warrant holders
will be able to, until such time there is an effective registration statement, exercise their warrants on a “cashless basis.”
Once
the warrants become exercisable, the Company may call the warrants for redemption:
| ● | In whole and not in part; |
| | |
| ● | At
a price of $0.01 per warrant; |
| | |
| ● | Upon
not less than 30 days’ prior written notice of redemption (the “30-day redemption
period”) to each warrant holder; and |
| | |
| ● | If,
and only if, the closing price of the Ordinary shares equals or exceeds $18.00 per share
(subject to standard adjustments) for any 20 trading days within a 30-trading
day period ending three business days before the Company sends to the notice of redemption
to the warrant holders. |
If
the Company calls the warrants for redemption for cash the Company’s management will have the option to require any holder that
wishes to exercise his, her or its warrant to do so on a “cashless basis.” If the Company’s management takes advantage
of this option, all holders of warrants would pay the exercise price by surrendering their warrants for that number of shares of Ordinary
shares equal to the quotient obtained by dividing (x) the product of the number of Ordinary shares underlying the warrants, multiplied
by the excess of the “fair market value” of Ordinary shares over the exercise price of the warrants by (y) the fair market
value. The “fair market value” will mean the average closing price of the Ordinary shares for the 10 trading days ending
on the third trading day prior to the date on which the notice of redemption is sent to the holders of warrants.
ALPHA TAU MEDICAL LTD.
NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
NOTE
4:- WARRANTS LIABILITY (Cont.)
Private
Warrants
Except
as described below, the Private Warrants have terms and provisions that are identical to those of the Public Warrants.
The
Private Warrants will not be redeemable by the combined company so long as they are held by the Sponsor or its permitted transferees.
The Sponsor, or its permitted transferees, has the option to exercise the Private Warrants on a cashless basis. If the Private Warrants
are held by someone other than the Sponsor or its permitted transferees, the Private Warrants will be redeemable by the combined company
and exercisable by such holders on the same basis as the Public Warrants. If holders of the Private Warrants elect to exercise them on
a cashless basis, they would pay the exercise price by surrendering their warrants for that number of Ordinary shares equal to the quotient
obtained by dividing (x) the product of the number of shares of Ordinary shares underlying the warrants, multiplied by the difference
between the exercise price of the warrants and the “fair market value” (defined below) by (y) the fair market value. The
“fair market value” means the average reported last sale price of the Ordinary shares for the 10 trading days ending on the
third trading day prior to the date on which the notice our warrant exercise is sent to the warrant agent.
NOTE
5:- FAIR VALUE MEASUREMENTS
The
following table presents information about the Company’s liabilities that are measured at fair value on a recurring basis as of
December 31, 2022 and June 30, 2023 and indicates the fair value hierarchy of the valuation inputs the Company utilized to
determine such fair value:
| |
December 31, 2022 | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
(Audited) | |
| |
| | |
| | |
| |
Warrants Liability – Public Warrants | |
$ | 3,403 | | |
$ | - | | |
$ | - | |
Warrant Liability – Private Warrants | |
| - | | |
| - | | |
| 2,227 | |
| |
| | | |
| | | |
| | |
Total | |
$ | 3,403 | | |
$ | - | | |
$ | 2,227 | |
| |
June 30, 2023 | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
(Unaudited) | |
| |
| | |
| | |
| |
Warrants Liability – Public Warrants | |
$ | 5,376 | | |
$ | - | | |
$ | - | |
Warrant Liability – Private Warrants | |
| - | | |
| - | | |
| 2,418 | |
| |
| | | |
| | | |
| | |
Total | |
$ | 5,376 | | |
$ | - | | |
$ | 2,418 | |
ALPHA TAU MEDICAL LTD.
NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
NOTE
5:- FAIR VALUE MEASUREMENTS (Cont.)
The
fair value of the Public Warrants is determined with reference to the prevailing market price for warrants that are trading on Nasdaq
under the ticker DRTSW.
The
Private warrants were valued using a Black Scholes Option Pricing Model, which is considered to be a Level 3 fair value measurement.
The Black Scholes model’s primary unobservable input utilized in determining the fair value of the Private warrants is the expected
volatility of the Ordinary shares. The expected volatility was implied from a blend of the Company’s own Ordinary share and Public
Warrant pricing, and 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.
The
Warrants to convertible preferred shares were converted into an identical number of warrants convertible into ordinary shares of the
Company. After conversion the converted warrants were valued using a Black Scholes Option Pricing Model. The Black Scholes model’s
primary unobservable input utilized in determining the fair value of the Warrants to convertible preferred shares is the expected volatility
of the Ordinary shares. The expected volatility was implied from the Company’s own Ordinary shares and Public Warrants pricing,
and 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.
There
were no transfers in or out of Level 3 from other levels in the fair value hierarchy.
The
change in the fair value of the Level 3 warrants liability is summarized below:
| |
June 30,
2023 | |
| |
Unaudited | |
| |
| |
Beginning of period | |
$ | 2,227 | |
Change in fair value | |
| 191 | |
| |
| | |
End of period | |
$ | 2,418 | |
NOTE
6:- COMMITMENTS AND CONTINGENT LIABILITIES
| a. | A guarantee in the amount of $609 was issued by a bank to secure the Company’s offices rent. In addition, a guarantee in the amount $225 was issued by a bank to the Commonwealth of Massachusetts, backed by a guarantee from the Company, to support the expansion of ATM Inc’s radioactive license in the State of Massachusetts. |
| b. | The Company has received royalty-bearing grants from the IIA to finance its research and development programs in Israel, through which the Company received IIA participation payments in the aggregate amount of $4,987 through June 30, 2023. In return, the Company is committed to pay IIA royalties at a rate of 3-3.5% of future sales of the developed products, up to 100% of the amount of grants received plus interest at LIBOR rate. Through June 30, 2023, no royalties have been paid or accrued. |
| | |
| | In
addition, under the intellectual property purchase agreement with Althera, the Company assumed all of Althera’s liabilities towards the
IIA totaling $474 of royalty-bearing grants received by Althera (plus accrued interest at LIBOR rate). The Company’s contingent royalty
liability to the IIA on June 30, 2023, including grants received by the Company, grants assumed from Althera and the associated
LIBOR interest accrued on all such grants, totaled $6,242. |
ALPHA TAU MEDICAL LTD.
NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
NOTE
6:- COMMITMENTS AND CONTINGENT LIABILITIES (Cont.)
| c. | Under the February 2, 2016 intellectual property purchase agreement with Althera, the Company is obligated to pay Althera a fixed rate of 2% (plus VAT) of Company’s future gross revenues (as defined in the agreement) that are derived from the purchased intellectual property, up to a maximum amount of $1,500 (plus VAT), in the aggregate, with the potential to set off against certain payments made by the Company to the IIA. |
| d. | The Company also entered into intellectual property agreements with Ramot at Tel Aviv University Ltd., the technology transfer company of Tel Aviv University (“Ramot”) on April 21, 2016 and July 14, 2016, all as amended on May 5, 2019, pursuant to which the Company is obligated to pay Ramot a fixed royalty of 2.5% on net sales of all of the Company’s products (as defined in the agreement) by the Company and its affiliates, with no set maximum. The royalty will be payable as of the first commercial sale (as defined in the agreement), until the later of: 15 years; or until the last to expire of the patents or patent applications from research developed at Tel Aviv University and assigned to the Company, on a country-by-country, product-by-product basis. The Company is also obligated to pay a 7% royalty (and in no event less than 0.65% of the net sales of Company products sold by the Company’s licensees in a given year) on any royalties or revenues received by the Company from its licensees. |
| e. | Under an Operations Partner Agreement between the Company and services provider HekaBio K.K. of May 21, 2019, the Company makes certain payments to HekaBio K.K. in exchange for consulting and administrative services in Japan, as well as payments upon the achievement of certain clinical and regulatory milestones. In addition, if HekaBio K.K. successfully assists the Company in obtaining regulatory marketing approval of the Company’s products in Japan, then the Company is to grant to HekaBio K.K. options to acquire 271,588 of the Company’s ordinary shares at a price of $4.42 each, and to pay HekaBio K.K. a royalty of 3.5% of the reimbursement price (as defined in the agreement) of such products in Japan and 10% of revenues received by the Company from distribution receipts (as defined in the agreement) for such products in Japan. As of June 30, 2023, no such options were granted. |
| f. | On November 18, 2018 and July 29, 2019, the Company entered into research and license agreements with BGN Technologies, the technology transfer company of Ben Gurion University (“BGN”), further amended on May 12, 2021, wherein the Company will wholly own any intellectual property that is developed jointly by Ben Gurion University and others (including the Company), and BGN will receive 0.75% royalties on all sales of the Company’s alpha radiation products, net of certain deductions and irrespective of the intellectual property underlying such sales, or 1.5% royalties on sales of products that contain intellectual property owned by Ben Gurion University, net of certain deductions. BGN will receive 4% of license revenues (as defined in the agreements) that relate to jointly developed intellectual property, and 8% of license revenues that relate to intellectual property developed solely by Ben Gurion University. The parties also agreed that the Company will continue to conduct research at Ben Gurion University for as long as the researchers wish to, and the parties have agreed on a research budget in good faith. |
| g. | On December 1, 2020, the Company entered into a clinical trial agreement with Cambridge University Hospitals NHS Trust, wherein Cambridge will receive 5% of any marginal increase in the Company’s net sales (all as defined in the agreement) generated on account of any patent or patent claim granted from the research performed in such trial, and 2% of the Company’s net sales (minus the aforementioned marginal increase payment) received for the treatment of Squamous Cell Carcinoma of the vulva, for three years from the date of first sale, world-wide. |
ALPHA TAU MEDICAL LTD.
NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
NOTE
6:- COMMITMENTS AND CONTINGENT LIABILITIES (Cont.)
| h. | On
August 16, 2022, the Company entered into a collaboration agreement with MIM Software, Inc.
(“MIM”) to provide treatment planning software for clinical sites using the Alpha
DaRT therapy. Under the terms of the agreement, the parties will collaborate on the use of
MIM’s software suite, including MIM Symphony® and MIMcloud®, for development
of new features and support for the Alpha DaRT across multiple potential indications, integration
into all clinical trials involving the Alpha DaRT, and bundling the MIM software with the
Alpha DaRT for future commercial sales in territories where the Alpha DaRT and MIM’s
software are both approved. The agreement contemplates certain payments to MIM to be agreed
between the parties upon initiating certain workstreams, as well as payments to MIM upon
commercial sale of the Alpha DaRT bundled with MIM’s software products. |
NOTE
7:- SHAREHOLDERS’ EQUITY
| a. | Ordinary share capital is composed as follows: |
| | |
December 31, 2022 | | |
June 30, 2023
(unaudited) | |
| | |
Authorized | | |
Issued and outstanding | | |
Authorized | | |
Issued and outstanding | |
| | |
Number of shares | |
| | |
| | | |
| | | |
| | | |
| | |
Ordinary shares of no-par value | | |
| 362,116,800 | | |
| 69,105,000 | | |
| 362,116,800 | | |
| 69,373,135 | |
The
Ordinary shares confer upon their holders the right to participate in the general meetings of the Company, to vote at such meetings (each
share represents one vote), and to participate in any distribution of dividends or any other distribution of the Company’s property,
including the distribution of surplus assets upon liquidation.
The
Company has authorized through its 2021 Share Incentive Plan (the “Plan”), an available pool of ordinary shares of the Company
from which to grant options, RSUs or other equity compensation to officers, directors, advisors, management and other key employees of
up to 18,192,586 Ordinary shares. The equity compensation granted generally has a four-year vesting period and expires ten years after
the date of grant, subject to the terms set forth in the Plan. Options granted under the Plan that are cancelled or forfeited before
expiration become available for future grant.
As
of June 30, 2023, 12,426,345 of the Company’s options are available for future grants.
ALPHA TAU MEDICAL LTD.
NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
NOTE
7:- SHAREHOLDERS’ EQUITY (Cont.)
A
summary of the status of options under the Plan as of June 30, 2023 and changes during the relevant period ended on that date is
presented below:
| |
Six months ended June 30, 2023 (unaudited) | |
| |
Number of options | | |
Weighted average exercise price | | |
Aggregate intrinsic value | | |
Weighted average remaining contractual life (years) | |
| |
| | |
| | |
| | |
| |
Outstanding at beginning of period | |
| 8,237,794 | | |
$ | 5.8 | | |
$ | 2,588 | | |
| 7.24 | |
Granted | |
| 3,185,111 | | |
$ | 3.4 | | |
| | | |
| | |
Exercised | |
| (2,500 | ) | |
$ | 1.1 | | |
| | | |
| | |
Forfeited and cancelled | |
| (41,292 | ) | |
$ | 9.9 | | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | |
Outstanding at end of period | |
| 11,379,113 | | |
$ | 5.1 | | |
$ | 7,709 | | |
| 7.5 | |
| |
| | | |
| | | |
| | | |
| | |
Exercisable options | |
| 5,838,956 | | |
$ | 4.5 | | |
$ | 4,934 | | |
| 5.9 | |
A
summary of the status of RSUs under the Plan as of June 30, 2023 and changes during the relevant period ended on that date is presented
below:
| |
Number of RSU | |
| |
| |
Outstanding at beginning of year | |
| 924,867 | |
Granted | |
| 391,724 | |
Forfeited and cancelled | |
| (12,820 | ) |
Vested | |
| (197,738 | ) |
| |
| | |
Outstanding on June 30, 2023 | |
| 1,106,033 | |
The
total equity-based compensation expense related to all of the Company’s equity-based awards recognized for the six months ended June 30,
2022 and 2023, was comprised as follows:
| |
Six months ended June 30, | |
| |
2022 | | |
2023 | |
| |
Unaudited | |
| |
| | |
| |
Research and development | |
$ | 2,260 | | |
$ | 2,536 | |
Marketing expenses | |
| 60 | | |
| 202 | |
General and administrative | |
| 1,125 | | |
| 1,046 | |
| |
| | | |
| | |
Total share-based compensation expense | |
$ | 3,445 | | |
$ | 3,784 | |
As
of June 30, 2023, there were unrecognized compensation costs of $19,510, which are expected to be recognized over a weighted average
period of approximately 2.62 years.
ALPHA TAU MEDICAL LTD.
NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
NOTE
7:- SHAREHOLDERS’ EQUITY (Cont.)
| 1. | In July 2019, as part of the investment round of HekaBio K.K, the investors received 651,067 warrants to ordinary shares with an exercise price of $5.04 to be exercised within 4 years from grant date. |
| 2. | In March 2022, in conjunction with the Merger with HCCC, the 3,880,777 warrants convertible into Preferred A Shares of the Company were converted into an identical number of warrants convertible into ordinary shares of the Company. The warrants are exercisable until September 2024 at an exercise price of $3.87. |
| | |
| | During
the six-month period ended June 30, 2022, a total of 1,509,176 of such warrants were exercised into 1,125,088 ordinary shares of the
Company. |
| | |
| | As
of June 30, 2023, a total of 2,323,960 such warrants are outstanding. |
| | |
| | The
warrants met all the criteria for equity classification and were reclassified as a component of additional paid-in capital. See also
note 2e and 6. |
| e. | Warrants
to consultants: |
In
March 2023, 67,897 warrants were exercised into 67,897 ordinary shares of no-par value, for no consideration.
NOTE
8:- FINANCIAL EXPENSES, NET
|
| |
Six months ended June 30, | |
|
| |
2022 | | |
2023 | |
|
| |
Unaudited | |
|
| |
| | |
| |
|
Financial expenses: | |
| | |
| |
|
| |
| | |
| |
|
Foreign currency transaction loss | |
$ | 260 | | |
$ | - | |
|
Remeasurement of warrants, net | |
| 11,105 | | |
| 2,164 | |
|
Others | |
| 13 | | |
| 11 | |
|
| |
| | | |
| | |
|
Total financial expenses | |
| 11,378 | | |
| 2,175 | |
|
| |
| | | |
| | |
|
Financial income: | |
| | | |
| | |
|
| |
| | | |
| | |
|
Foreign currency transaction income | |
| - | | |
| 220 | |
|
Interest from deposits | |
| 436 | | |
| 1,934 | |
|
| |
| | | |
| | |
|
Total financial income | |
| 436 | | |
| 2,154 | |
|
| |
| | | |
| | |
|
Financial expenses, net | |
$ | 10,942 | | |
$ | 21 | |
ALPHA TAU MEDICAL LTD.
NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
NOTE
9:- BASIC AND DILUTED NET LOSS PER SHARE
The
following table sets forth the computation of the Company’s basic and diluted net loss per Ordinary share:
| |
Six months ended June 30, | |
| |
2022 | | |
2023 | |
| |
Unaudited | |
Numerator: | |
| | |
| |
Net loss | |
$ | 27,743 | | |
$ | 16,880 | |
Denominator: | |
| | | |
| | |
Weighted-average shares used in computing net loss per Ordinary share, basic and diluted | |
| 58,023,875 | | |
| 69,262,381 | |
| |
| | | |
| | |
Net loss per Ordinary share, basic and diluted | |
$ | 0.48 | | |
$ | 0.24 | |
For
the six months ended June 30, 2022 and 2023, all outstanding options and warrants have been excluded from the calculation of the
diluted net loss per share since their effect was anti-dilutive. As of June 30, 2022, and 2023 the total weighted average number of shares
related to outstanding options and warrants excluded from the calculations of diluted net loss per share were 27,571,715 and 30,556,667,
respectively.
NOTE
10:- SUBSEQUENT EVENTS
In
Jul 2023, the Company accepted a long-term leasehold grant of 6,663 square meters (1.65 acres) of land from the Israel Land Authority
(“ILA”) following a positive recommendation by the Israeli Ministry of the Economy and Industry to grant the land directly
to the Company at a discounted cost. The cost of the leasehold will be determined in an assessment process currently underway between
the Company and the ILA.
-
- - - - - - - - - -
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Exhibit 99.2
Operating and Financial Review and Prospects
You should read the following discussion together
with the unaudited consolidated financial statements as of and for the six months ended June 30, 2022 and 2023 and related notes appearing
elsewhere in this Form 6-K, our audited consolidated financial statements and other financial information as of and for the year ended
December 31, 2022 appearing in our Annual Report on Form 20-F for the year ended December 31, 2022 (the “Annual Report”) and
Item 5—“Operating and Financial Review and Prospects” of the Annual Report. Except where the context otherwise requires
or where otherwise indicated in this discussion, the terms “Alpha Tau,” the “Company,” “we,” “us,”
“our,” “our company” and “our business” refer to Alpha Tau Medical Ltd. and its subsidiaries.
The statements in this discussion regarding
industry outlook, our expectations regarding our future performance, planned investments in our expansion into additional geographies,
research and development, sales and marketing and general and administrative functions, as well as other non-historical statements in
this discussion are forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended (the “Securities
Act”), Section 21E of the U.S. Securities Exchange Act of 1934, as amended (the “Exchange Act”) and the safe harbor
provisions of the U.S. Private Securities Litigation Reform Act of 1995. In some cases, these forward-looking statements can be identified
by words or phrases such as “may,” “might,” “will,” “could,” “would,” “should,”
“expect,” “plan,” “anticipate,” “intend,” “seek,” “believe,” “estimate,”
“predict,” “potential,” “continue,” “contemplate,” “possible” or similar words.
Our estimates and forward-looking statements
are mainly based on our current expectations and estimates of future events and trends which affect or may affect our business, operations
and industry. Although we believe that these estimates and forward-looking statements are based upon reasonable assumptions, they are
subject to numerous risks and uncertainties. These forward-looking statements are subject to a number of known and unknown risks, uncertainties,
other factors and assumptions, including the risks described in Item 3.D. “Key Information-Risk Factors” in our Annual Report.
The forward-looking statements made in this discussion relate only to events as of the date on which the statements are made. We undertake
no obligation to update any forward-looking statements made in this discussion to reflect events or circumstances after the date of this
discussion or to reflect new information or the occurrence of unanticipated events, except as required by law.
Overview
We are a clinical-stage oncology therapeutics company
focused on harnessing the innate relative biological effectiveness and short range of alpha particles for use as a localized radiation
therapy for solid tumors. Our proprietary Alpha DaRT technology is designed to utilize the specific therapeutic properties of alpha particles
while aiming to overcome, and even harness for potential benefit, the traditional shortcomings of alpha radiation’s limited range.
We believe that our Alpha DaRT technology has the potential to be broadly applicable across multiple targets and tumor types. We have
evaluated and continue to evaluate the feasibility, safety and efficacy of the Alpha DaRT technology for the treatment of superficial
lesions, i.e., tumors of the skin, head or neck, in multiple clinical trials conducted in clinical sites around the world. In a first-in-human
study of locally advanced and recurrent squamous cell carcinoma, or SCC, cancers of the skin and head and neck, efficacy was evaluated
in 28 tumors, and results showed that Alpha DaRT achieved 100% overall response rate and over 78% complete response rate. The Alpha DaRT
was generally well-tolerated, with limited local toxicity and no systemic toxicity. On the basis of this clinical trial as well as some
of our further clinical trials, we received marketing approval in Israel in August 2020 for the treatment of SCC of the skin or oral cavity
using the Alpha DaRT. In June 2021, the FDA granted the Alpha DaRT Breakthrough Device Designation for the treatment of patients with
SCC of the skin or oral cavity without curative standard of care. In October 2021, the FDA granted the Alpha DaRT a second Breakthrough
Device Designation, in treating recurrent Glioblastoma Multiforme, or GBM, as an adjunct to standard medical therapies or as a standalone
therapy after standard medical therapies have been exhausted. In the second half of 2021, we treated ten patients in the U.S. in a multi-center
pilot feasibility trial conducted at Memorial Sloan Kettering Cancer Center and four other U.S. clinical sites, to explore the feasibility
of delivering radiotherapy for malignant skin and superficial soft tissue tumors using Alpha DaRT. The study met its primary feasibility
endpoint, as all patients had successful delivery of radiation by Alpha DaRT. At approximately 12 weeks and 24 weeks after treatment,
all ten lesions treated demonstrated a complete response to treatment, with no product-related serious adverse events observed. We are
conducting a multi-center pivotal trial, which we refer to as the ReSTART trial, to explore the delivery of radiotherapy for up to 86
patients with recurrent cutaneous squamous cell carcinoma tumors using Alpha DaRT at up to 20 clinical sites around the United States
and selected other clinical sites outside the U.S. We anticipate completing recruitment of this trial in early 2024, and receiving results
of the trial in 2024 for potential submission to the FDA. If submitted and approved, we expect to commercialize our Alpha DaRT technology
first in the United States before other markets, including Israel, notwithstanding our existing marketing authorization in Israel (under
which we have not yet commercialized the product). We hold exclusive rights to our proprietary Alpha DaRT technology in our core markets,
including the United States and Europe.
While local radiation therapy has been a mainstay
of cancer therapy for years, it has been mostly limited to modalities utilizing beta or gamma emissions, which primarily destroy cells
through an indirect mechanism relying on oxygen and the generation of free radicals to cause single-strand DNA breaks. By contrast, alpha
radiation has hundreds of times the linear energy transfer rate of beta-emitters. Additionally, alpha particles’ heavier mass and
far shorter particle paths (less than 100 μm) relative to beta’s lighter mass and lengthier (up to 12 mm) path, have been shown
to destroy radioresistant cells in clinical studies – causing multiple, irreparable, double-strand DNA breaks and other cellular
damage upon direct impact – within a very short distance. Accordingly, we believe that alpha radiation has several significant potential
advantages for use in cancer radiotherapy, including a high relative biological efficiency (potentially enabling it to destroy tumor cells
with administration of lower levels of radiation), imperviousness to factors such as hypoxia, and a very well-defined range of travel
with limited collateral damage. Nonetheless, its use has also been limited precisely due to alpha’s extremely short particle range
in living tissue, as the range of less than 100 μm is insufficient to provide meaningful clinical utility.
The Alpha DaRT technology employs a series of radioactive
sources that are embedded with Radium-224 to enable a controlled, intratumoral release of alpha-emitting atoms which diffuse and decay
throughout the tumor, seeking to kill cancerous cells with localized precision, while penetrating deeper into the tumor than can otherwise
be reached by the limited ranges of the alpha particles themselves. Due to the inherent limited range of the alpha particles, we believe
that the Alpha DaRT technology has the potential to deliver powerful and localized precise killing impact to the tumor without damage
to surrounding healthy tissue. By combining the innate relative biological effectiveness and short range of alpha particles in a single-use
disposable form, we believe that the Alpha DaRT could address tumors that have otherwise demonstrated poor response to radiation therapy
or other standards of care, with the potential to apply to a wide range of tumors and clinical settings.
We
were incorporated in Israel in 2015 and our headquarters is located in Jerusalem, Israel. Our operations to date have been limited to
organizing and staffing our company, business planning, raising capital, developing our technology, acquiring and building our intellectual
property portfolio and conducting research and development activities, including pre-clinical studies and clinical trials, for our Alpha
DaRT technology. We do not have any products approved for sale in the United States and have not generated any revenue from product sales.
To date, we have funded our operations primarily through private placements of ordinary and convertible preferred shares and funding from
government grants. From inception through June 30, 2023, we have raised an aggregate of $185,958 to fund our operations, of which $57,911
were gross proceeds from sales of our convertible preferred shares, $121,485 were gross proceeds from the issuance of ordinary shares
and $6,562 were gross proceeds from government grants, excluding government grants which are paid directly to partner institutions such
as hospitals and clinical trial sites.
We
have incurred significant net operating losses in every year since our inception and expect to continue to incur significant expenses
and increasing operating losses for the foreseeable future. Our net losses may fluctuate significantly from quarter to quarter and year
to year and could be substantial. Our net losses were $ 27,743 and $16,880 for the six months ended June 30, 2022 and June 30,
2023, respectively. As of June 30, 2023, we had an accumulated deficit of $103,482. We anticipate that our expenses will increase significantly
as we:
|
● |
conduct additional clinical trials of our Alpha DaRT technology; |
|
|
|
|
● |
continue to discover and develop additional product candidates; |
|
|
|
|
● |
construct manufacturing facilities and supply chain capabilities in multiple geographies of sufficient capacity to provide commercial quantities of our Alpha DaRT products and any other product candidates for which we may obtain marketing approval; |
|
|
|
|
● |
seek regulatory and marketing approvals for our Alpha DaRT technology and any other product candidates that successfully complete clinical trials, if any; |
|
|
|
|
● |
develop and execute launch strategies, and establish a sales, marketing and distribution infrastructure to commercialize our Alpha DaRT technology and any other products for which we may obtain regulatory approval in geographies in which we plan to commercialize our products ourselves; |
|
● |
maintain, expand and protect our intellectual property portfolio; |
|
|
|
|
● |
hire additional staff, including clinical, scientific, technical, regulatory operational, and financial personnel, to execute our business plan; and |
|
|
|
|
● |
add clinical, scientific, operational, financial and management information systems and personnel to support our product development and potential future commercialization efforts, and to enable us to operate as a public company. |
We
do not expect to generate revenue from product sales unless and until we successfully complete clinical development and obtain further
regulatory approvals for our Alpha DaRT technology. If we obtain regulatory approval for our Alpha DaRT technology or any other product
candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution.
Furthermore, we expect to continue to incur additional costs associated with operating as a public company. As a result, we will need
substantial additional funding to support our continuing operations and pursue our growth strategy. Until such time as we can generate
significant revenue from product sales, if ever, we expect to fund our operations through public or private equity or debt financings
or other sources, including strategic collaborations. We may, however, be unable to raise additional funds or enter into such other arrangements
when needed on favorable terms or at all. Our failure to raise capital or enter into such other arrangements as and when needed would
have a negative impact on our financial condition and our ability to develop our current product candidates, or any additional product
candidates, if developed.
Because
of the numerous risks and uncertainties associated with therapeutics product development, we are unable to accurately predict the timing
or amount of increased expenses or when or if we will be able to achieve or maintain profitability. Even if we are able to generate revenue
from product sales, we may not become profitable. If we fail to become profitable or are unable to sustain profitability on a continuing
basis, then we may be unable to continue our operations at planned levels and be forced to reduce or terminate our operations.
As
of June 30, 2023, we had cash and cash equivalents, restricted cash and short-term deposits totaling $94,361. We believe that our existing
cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements for at least two years.
We have based these estimates on assumptions that may prove to be imprecise, and we may use our available capital resources sooner than
we currently expect. See “Liquidity and Capital Resources” below. Because of the numerous risks and uncertainties associated
with the development of our Alpha DaRT technology and any future product candidates, and because the extent to which we may enter into
collaborations with third parties for product development is unknown, we are unable to estimate the amounts of increased capital outlays
and operating expenses associated with completing the research and development of our Alpha DaRT technology or any future potential product
candidates.
If
we raise additional funds through collaborations, strategic alliances, or licensing arrangements with third parties, we may have to relinquish
valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may
not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to
delay, limit, reduce, or terminate our product development programs or any future commercialization efforts or grant rights to develop
and market product candidates that we would otherwise prefer to develop and market ourselves.
Basis of presentation
Our
financial statements are prepared in accordance with accounting principles generally accepted in the United States, or U.S. GAAP. Unless
otherwise indicated, all dollar amounts are presented in thousands.
Financial Operations
Overview
Revenue
To
date, we have not generated any revenue from product sales and do not expect to generate any revenue from the sale of products in the
foreseeable future. If our development efforts for our Alpha DaRT technology or other product candidates are successful and result in
further regulatory approvals and successful commercialization efforts, we may generate revenue in the future from product sales. We cannot
predict if, when, or to what extent we will generate revenue from the commercialization and sale of our Alpha DaRT technology or any other
product candidates. We may never succeed in obtaining further regulatory approvals for our Alpha DaRT technology or any of our other product
candidates that we may develop in the future.
Operating Expenses
Our
operating expenses since inception have consisted solely of research and development costs, marketing expenses and general and administrative
costs.
Research
and development, net
Research
and development, net consist primarily of costs incurred for our research activities, including the development of and pursuit of further
regulatory approvals of our Alpha DaRT technology, which include:
|
● |
employee-related expenses, including salaries, benefits and share-based compensation expense for personnel engaged in research and development functions; |
|
● |
expenses incurred in connection with the preclinical and clinical development of our product candidates, including under agreements with CROs, investigative sites and consultants; |
|
● |
costs of manufacturing our product candidates or other material costs for use in our preclinical studies and clinical trials, including costs of raw materials, components, and other laboratory materials; |
|
● |
consulting and professional fees related to research and development activities; |
|
● |
facility costs and other allocated expenses, which include expenses for rent and maintenance of our facility, utilities, depreciation, overhead expenses and other supplies; and |
|
● |
registration and maintenance of our intellectual property portfolio. |
We
expense research and development costs as incurred.
Our
external research and development expenses consist primarily of costs such as fees paid to consultants, clinical sites, contractors and
CROs in connection with our preclinical and clinical development activities.
Because
the bulk of our research and development expenses are for internal personnel or for manufacture of our Alpha DaRT for use across our clinical
trials and pre-clinical studies, and the majority of our clinical trials and pre-clinical studies are led internally
rather than using external CROs, we are unable to allocate our research and development expenses on a program-by-program basis.
Grants
from the IIA are offset against research and development costs at the later of when grant receipt is assured or the expenses are incurred.
Research
and development activities are central to our business model. Product candidates in later stages of clinical development generally have
higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage
clinical trials. We expect that our research and development expenses will continue to increase for the foreseeable future as we initiate
additional clinical trials of our Alpha DaRT technology, scale our manufacturing processes, continue to discover and develop additional
components to the Alpha DaRT platform or other product candidates, and hire additional clinical and scientific personnel.
The
successful development of our Alpha DaRT technology and other potential future product candidates is highly uncertain. Accordingly, at
this time, we cannot reasonably estimate or know the nature, timing and costs of the efforts that will be necessary to complete the development
of these product candidates. We are also unable to predict when, if ever, we will generate revenue and material net cash inflows from
the commercialization and sale of any of our product candidates for which we have obtained or may obtain marketing approval. We may never
succeed in achieving further regulatory approvals for any of our product candidates. The duration, costs and timing of preclinical studies,
clinical trials and development of our product candidates will depend on a variety of factors, including:
|
● |
successful completion of clinical trials with safety, tolerability and efficacy profiles for our Alpha DaRT technology and any potential future product candidates that are satisfactory to the FDA or any comparable foreign regulatory authority; |
|
● |
approval of IDEs or comparable applications for Alpha DaRT technology and any potential future product candidate to commence planned or future clinical trials in the United States or foreign countries; |
|
● |
significant and changing government regulation and regulatory guidance; |
|
● |
timing and receipt of marketing approvals from applicable regulatory authorities; |
|
● |
successful construction of additional manufacturing facilities, or establishing arrangements with contract manufacturing organizations, or CMOs, for third-party clinical and commercial manufacturing, to obtain sufficient supply of our product candidates; |
|
● |
obtaining and maintaining patent and other intellectual property protection and regulatory exclusivity for our product candidates; |
|
● |
commercializing our Alpha DaRT technology and any potential future product candidate, if and when further approved, whether alone or in collaboration with others; |
|
● |
acceptance of the product, if and when approved, by patients, the medical community and third-party payors; |
|
● |
competition with other therapies; and |
|
● |
maintenance of a continued acceptable safety profile of Alpha DaRT technology and any potential future product candidate following approval. |
A
change in the outcome of any of these variables with respect to the development, manufacture or commercialization enabling activities
of any of our product candidates would significantly change the costs, timing and viability associated with the development of that product
candidate. For example, if the FDA or another regulatory authority were to require us to conduct clinical trials beyond those that we
anticipate will be required for the completion of clinical development of our Alpha DaRT technology and any potential future product candidate,
or if we experience significant delays in our clinical trials due to patient enrollment or other reasons, we would be required to expend
significant additional financial resources and time on the completion of clinical development.
Marketing expenses
Marketing
expenses consist primarily of salaries and other related costs, including share-based compensation, for personnel in marketing functions.
Marketing expenses also include direct and allocated facility-related costs as well as costs of participation in conferences and exhibitions,
licenses for marketing software, production of videos and marketing materials, and external consulting on product marketing or reimbursement.
We
expect that our marketing expenses will increase in the future to support continued marketing activities and potential commercialization
of our Alpha DaRT technology and any potential future product candidate. These increases will likely include increased costs related to
the hiring of additional personnel and fees to outside consultants, particularly if and when we initiate the hiring of a commercial team
or increase our pre-launch commercial activities.
General
and administrative expenses
General
and administrative expenses consist primarily of salaries and other related costs, including share-based compensation, for personnel in
executive, finance and administrative functions. General and administrative expenses also include direct and allocated facility-related
costs as well as professional fees for legal, consulting, investor and public relations, accounting, auditing, tax services and insurance
costs.
We
expect that our general and administrative expenses will increase in the future to support continued research and development activities
and potential commercialization of our Alpha DaRT technology and any potential future product candidate. These increases will likely include
increased costs related to the hiring of additional personnel and fees to outside consultants, attorneys and accountants, among other
expenses.
Additionally,
we expect to continue to incur increased expenses associated with being a public company, including costs of additional personnel, accounting,
audit, legal, regulatory and tax-related services associated with maintaining compliance with exchange listing and Securities
and Exchange Commission (“SEC”) requirements, director and officer insurance costs, and investor and public relations costs.
Financial
(income) expenses, net
Financial
(income) expenses, net, primarily consists of non-cash interest expense incurred on remeasurement of warrants, foreign currency
translation, bank charges and interest, and interest income earned on our cash and cash equivalents.
Results of Operations
The
following table summarizes our results of operations for the six months ended June 30, 2022 and 2023:
| |
Six Months Ended June 30, | | |
| | |
| |
| |
2022 | | |
2023 | | |
Change | | |
% Change | |
Operating expenses: | |
| | |
| | |
| | |
| |
Research and development, net | |
$ | 10,683 | | |
$ | 12,261 | | |
$ | 1,578 | | |
| 14.8 | % |
Marketing | |
| 329 | | |
| 920 | | |
| 591 | | |
| 179.6 | |
General and administrative | |
| 5,781 | | |
| 3,631 | | |
| (2,150 | ) | |
| (37.2 | ) |
Total operating expenses | |
$ | 16,793 | | |
$ | 16,812 | | |
$ | 19 | | |
| 0.1 | % |
Loss from operations: | |
| | | |
| | | |
| | | |
| | |
Financial expense, net | |
| 10,942 | | |
| 21 | | |
| (10,921 | ) | |
| (99.8 | ) |
Loss before taxes on income | |
| 27,735 | | |
| 16,833 | | |
| (10,902 | ) | |
| (39.3 | ) |
Tax on income | |
| 8 | | |
| 47 | | |
| 39 | | |
| 487.5 | |
Net loss | |
$ | 27,743 | | |
$ | 16,880 | | |
$ | (10,863 | ) | |
| (39.2 | )% |
Comparison of the Six Months Ended
June 30, 2022 and 2023
Research and development, net
Research
and development, net increased by $1,578 from $10,683 for the six months ended June 30, 2022 to $12,261 for the six months ended
June 30, 2023. The increase in research and development expense was primarily attributable to increased employee compensation and benefits,
including share-based compensation, increased operating costs, and increased pre-clinical study and clinical trial expenses particularly
in our U.S. multi-center pivotal trial, offset by lower expenses in Japan because of the completion of our clinical study in Japan last
year.
Marketing
expenses
Marketing
expense increased by $591 from $329 for the six months ended June 30, 2022 to $920 for the six months ended June 30, 2023. The
increase in marketing expenses was primarily attributable to increased employee compensation and benefits, including share-based compensation
and the hiring of our chief commercial officer.
General
and administrative
General
and administrative decreased by $2,150 from $5,781 for the six months ended June 30, 2022 to $3,631 for the six months ended
June 30, 2023. The decrease in general and administrative expenses was primarily due to decreased professional fees (including D&O
insurance), and one-time costs and bonuses associated with our financing transaction in the first quarter of 2022.
Financial
expense, net
Financial
expense, net decreased $10,921 from $10,942 for the six months ended June 30, 2022 to $21 for the year six months ended June
30, 2023. The decrease was primarily attributable to a decrease in revaluation of warrants, an increase in interest from bank deposits,
and changes in foreign exchange rates.
B. |
Liquidity and Capital Resources |
Sources of Liquidity
We
have funded our operations from inception through June 30, 2023 primarily through gross proceeds of $57,911 from sales of our convertible
preferred shares, $121,485 from the issuance of ordinary shares and $6,562 from government grants. The following table provides information
regarding our total cash and cash equivalents, restricted cash and short-term deposits for the periods presented:
| |
As of | |
| |
December 31, 2022 | | |
June 30, 2023 | |
Cash and cash equivalents | |
$ | 5,836 | | |
$ | 855 | |
Restricted cash | |
| 850 | | |
| 834 | |
Short-term deposits | |
| 98,694 | | |
| 92,672 | |
| |
$ | 105,380 | | |
$ | 94,361 | |
Cash Flows
The following table provides
information regarding our cash flows for the periods presented:
| |
Six months ended June 30, | |
| |
2022 | | |
2023 | |
Net cash used in operating activities | |
$ | (15,328 | ) | |
$ | (9,922 | ) |
Net cash (used in) provided by investing activities | |
| (92,675 | ) | |
| 4,974 | |
Net cash provided by financing activities | |
| 96,800 | | |
| 2 | |
Effect of exchange rate changes on cash, cash equivalents and restricted cash | |
| (288 | ) | |
| (51 | ) |
Decrease in cash, cash equivalents and restricted cash | |
$ | (11,491 | ) | |
$ | (4,997 | ) |
Net cash used in operating activities
The
cash used in operating activities resulted primarily from our net losses adjusted for non-cash charges and changes in components
of working capital. Net cash used in operating activities was $15,328 for the six months ended June 30, 2022, compared to $9,922
for the six months ended June 30, 2023. The decrease of $5,406 was primarily attributable to a decrease in net loss of $10,863 and
$2,420 increase in other payables and accrued expenses, offset by a decrease of $8,941 in the add-back of the change in fair value of
Warrants liabilities.
Net cash
provided from/ used in investing activities
Net
cash used in investing activities was $92,675 for the six months ended June 30, 2022 compared to net cash provided by investing activities
of $4,974 for the six months ended June 30, 2023. The increase in cash provided by investing activities of $97,649 was primarily
attributable to a $95,995 increase in redemption of bank deposits.
Net cash
provided by financing activities
Net
cash provided by financing activities was $96,800 for the six months ended June 30, 2022 compared to $2 for the six months ended
June 30, 2023. The decrease of $96,798 was primarily attributable to the $93,543 net proceeds of the SPAC merger and concurrent PIPE financing
in March 2022.
Effect
of exchange rate changes on cash, cash equivalents and restricted cash
The
effect of exchange rate changes on cash, cash equivalents and restricted cash was a decrease of $288 for the six months ended June
30, 2022 compared to a decrease of $51 for the six months ended June 30, 2023. The increase of $237 was primarily attributable to changes
in the exchange rate between the U.S. Dollar and the Israeli NIS.
C. |
Research and Development, Patents and Licenses, Etc. |
For a discussion of our research and development
policies, see “Research and Development” in Item 4.B. of our Annual Report and “Key Information—Risk
Factors—Risks Related To Our Incorporation and Location In Israel” in Item 3.D. of our Annual Report.
For
a description of our intellectual property, please see “Item 4.B” in our Annual Report under “—Intellectual
Property.
Other than as disclosed elsewhere in this report
or in the unaudited consolidated financial statements as of and for the six months ended June 30, 2022 and 2023 and related notes thereto,
or as described in Item 3.D. “Key Information—Risk Factors of our Annual Report, we are not aware of any trends,
uncertainties, demands, commitments or events that are reasonably likely to have a material effect on our total revenues, income, profitability,
liquidity or capital resources, or that caused the disclosed financial information to be not necessarily indicative of future operating
results or financial condition.
E. |
Critical Accounting Estimates |
We have provided a summary of our significant accounting
policies, estimates and judgments in Note 3 to our consolidated financial statements, which are included in our Annual Report. The
following critical accounting discussion pertains to accounting policies management believes are most critical to the portrayal of our
historical financial condition and results of operations and that require significant, difficult, subjective or complex judgments. Other
companies in similar businesses may use different estimation policies and methodologies, which may impact the comparability of our financial
condition, results of operations and cash flows to those of other companies.
Recently Issued and
Adopted Accounting Pronouncements
A
description of recently issued accounting pronouncements that may potentially impact our financial position, results of operations or
cash flows is disclosed in note 2 to our consolidated financial statements included in our Annual Report.
Critical Accounting
Policies and Use of Estimates
Our
management’s discussion and analysis of financial condition and results of operations is based on our consolidated financial statements,
which have been prepared in accordance with U.S. GAAP. The preparation of these financial statements requires us to make estimates and
judgments that affect the reported amounts of assets, liabilities and expenses and the disclosure of contingent assets and liabilities
in our consolidated financial statements during the reporting periods. These items are monitored and analyzed by us for changes in facts
and circumstances, and material changes in these estimates could occur in the future. We base our estimates on historical experience,
known trends and events, and on various other factors that we believe are reasonable under the circumstances, the results of which form
the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Changes
in estimates are reflected in reported results for the period in which they become known. Actual results may differ materially from these
estimates under different assumptions or conditions.
While
our significant accounting policies are described in more detail in the notes to our consolidated financial statements appearing in our
Annual Report, we believe the following accounting policies used in the preparation of our consolidated financial statements require the
most significant judgments and estimates.
Share-Based Compensation
We
account for share based compensation in accordance with ASC No. 718, “Compensation - Stock Compensation” that requires companies
to estimate the fair value of equity-based payment awards on the date of grant using an option-pricing model. We recognize compensation
expenses for the value of our awards granted based on the straight-line attribution method over the requisite service period of each of
the awards. We recognize forfeitures of awards as they occur.
For
graded vesting awards with no market or performance conditions, we recognize the related share-based compensation expense on a straight-line
basis over the requisite service period of the awards. For awards with performance conditions the share-based compensation expense is
recognized if and when we conclude that it is probable that the performance condition will be achieved and where the performance condition
awards include graded vesting, the share-based compensation expense is recognized based on the accelerated method. We reassess the probability
of vesting at each reporting period for awards with performance conditions and adjust compensation cost based on our probability assessment.
We
selected the Black-Scholes option-pricing model as the most appropriate fair value method for our option awards. The option-pricing model
requires a number of assumptions, of which the most significant are the share price, volatility and the expected option term.
These assumptions and
estimates were determined as follows:
|
1) |
Expected term - The expected term of options granted is based on historical experience and represents the period of time that options granted are expected to be outstanding. There is not sufficient historical share exercise data to calculate the expected term of the share options. We determine the expected term using the simplified method. The simplified method deems the term to be the average of the time-to-vesting and the contractual life of the options. |
|
2) |
Expected volatility - Since we have a limited trading history of our Ordinary shares, there is not sufficient historical volatility for the expected term of the share options. The expected volatility is derived from a mix of the implied volatility of our publicly traded warrants as well as the average historical share volatilities of several unrelated public companies within our industry that we consider to be comparable to our own business over a period equivalent to the option’s expected term. |
|
3) |
Risk-free interest rate - We 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. |
|
4) |
Expected dividend yield – We do not anticipate paying any dividends in the foreseeable future. Thus, we used 0% as our expected dividend yield. |
|
5) |
Fair value of Ordinary shares – Our Ordinary shares have a limited history of being publicly traded. In determining the fair value of ordinary shares, the board of directors considered the grant date fair value for share-based awards as of the closing price of our ordinary shares on NASDAQ on the date of grant. |
Public and Private
Warrants
In
March 2022, in conjunction with the Merger with HCCC, the Company issued 13,749,986 warrants to the public shareholders of HCCC (the
“Public Warrants”) and 2,142,000 warrants to the sponsor of HCCC (the “Private Warrants”) in exchange for the
surrender and cancellation of an identical number of warrants exercisable into common stock of HCCC. The Public Warrants and the Private
Warrants may each be exercised into Ordinary shares of the Company within 5 years of the grant date, at an exercise price of $11.50,
and are subject to certain redemption provisions at the Company’s option.
During
the six months ended June 30, 2023, no Public or Private Warrants were exercised. As of June 30, 2023, a total of 13,605,561 Public
Warrants and 2,142,000 Private Warrants are outstanding.
The
fair value of the Public Warrants is determined with reference to the prevailing market price for warrants that are trading on Nasdaq
under the ticker DRTSW.
The
Private warrants were valued using a Black Scholes Option Pricing Model, which is considered to be a Level 3 fair value measurement.
The Black Scholes model’s primary unobservable input utilized in determining the fair value of the Private warrants is the expected
volatility of the Ordinary shares. The expected volatility was implied from a blend of the Company’s own Ordinary share and Public
Warrant pricing, and 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.
Emerging Growth Company
Status
The
Jumpstart Our Business Startups Act of 2012, or the JOBS Act, permits an “emerging growth company” such as us to take advantage
of an extended transition period to comply with new or revised accounting standards applicable to public companies until those standards
would otherwise apply to private companies.
We
are in the process of evaluating the benefits of relying on other exemptions and reduced reporting requirements under the JOBS Act. Subject
to certain conditions, as an emerging growth company we intend to rely on certain of these exemptions, including exemptions from the requirement
to provide an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section 404(b) of
the Sarbanes-Oxley Act and from any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory
audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements,
known as the auditor discussion and analysis. We will remain an emerging growth company until the earlier of: (i) the last day of the
fiscal year in which we have total annual gross revenues of $1.235 billion or more; (ii) the date on which we have issued more
than $1 billion in nonconvertible debt during the previous three years; (iii) the date on which we are deemed to be a large
accelerated filer under the rules of the SEC; or (iv) December 31, 2027.
10
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v3.23.2
Interim Consolidated Balance Sheets - USD ($) $ in Thousands |
Jun. 30, 2023 |
Dec. 31, 2022 |
CURRENT ASSETS: |
|
|
Cash and cash equivalents |
$ 855
|
$ 5,836
|
Restricted cash |
834
|
850
|
Short-term deposits |
92,672
|
98,694
|
Prepaid expenses and other receivables |
1,698
|
1,097
|
Total current assets |
96,059
|
106,477
|
LONG-TERM ASSETS: |
|
|
Long term prepaid expenses |
441
|
391
|
Property and equipment, net |
7,549
|
7,471
|
Right-of-use asset |
7,157
|
5,810
|
Total long-term assets |
15,147
|
13,672
|
Total assets |
111,206
|
120,149
|
CURRENT LIABILITIES: |
|
|
Trade payables |
1,789
|
1,423
|
Other payables and accrued expenses |
2,781
|
2,246
|
Current maturities of operating lease liabilities |
846
|
669
|
Total current liabilities |
5,416
|
4,338
|
LONG-TERM LIABILITIES: |
|
|
Warrants liability |
7,794
|
5,630
|
Operating lease liabilities |
5,433
|
4,524
|
Total long-term liabilities |
13,227
|
10,154
|
Total liabilities |
18,643
|
14,492
|
COMMITMENTS AND CONTINGENCIES |
|
|
SHAREHOLDERS’ EQUITY: |
|
|
Ordinary shares of no-par value per share – Authorized: 362,116,800 shares as of December 31, 2022 and June 30, 2023; Issued and outstanding: 69,105,000 and 69,373,135 shares as of December 31, 2022 and June 30, 2023, respectively |
|
|
Additional paid-in capital |
196,045
|
192,259
|
Accumulated deficit |
(103,482)
|
(86,602)
|
Total shareholders’ equity |
92,563
|
105,657
|
Total liabilities and shareholders’ equity |
$ 111,206
|
$ 120,149
|
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v3.23.2
Interim Consolidated Balance Sheets (Parentheticals) - $ / shares
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Statement of Financial Position [Abstract] |
|
|
Ordinary shares of no-par value per share (in Dollars per share) |
|
|
Ordinary shares, Authorized |
362,116,800
|
362,116,800
|
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69,373,135
|
69,105,000
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69,373,135
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69,105,000
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v3.23.2
Interim Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Income Statement [Abstract] |
|
|
Research and development, net |
$ 12,261
|
$ 10,683
|
Marketing expenses |
920
|
329
|
General and administrative |
3,631
|
5,781
|
Total operating loss |
16,812
|
16,793
|
Financial expenses, net |
21
|
10,942
|
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16,833
|
27,735
|
Tax on income |
47
|
8
|
Net loss |
16,880
|
27,743
|
Net comprehensive loss |
$ 16,880
|
$ 27,743
|
Net loss per share, basic (in Dollars per share) |
$ (0.24)
|
$ (0.48)
|
Weighted-average shares used in computing net loss per share, basic (in Shares) |
69,262,381
|
58,023,875
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v3.23.2
Interim Consolidated Statements of Changes in Shareholders’ Equity - USD ($) $ in Thousands |
Convertible Preferred shares |
Ordinary shares |
Additional paid-in capital |
Accumulated deficit |
Total |
Balance at Dec. 31, 2021 |
$ 53,964
|
|
$ 18,063
|
$ (52,840)
|
$ (34,777)
|
Balance (in Shares) at Dec. 31, 2021 |
13,739,186
|
40,528,913
|
|
|
|
Issuance of ordinary shares upon exercise of warrants |
|
|
3,257
|
|
3,257
|
Issuance of ordinary shares upon exercise of warrants (in Shares) |
|
1,269,213
|
|
|
|
Issuance of ordinary shares in connection with SPAC merger and PIPE financing |
|
|
74,952
|
|
74,952
|
Issuance of ordinary shares in connection with SPAC merger and PIPE financing (in Shares) |
|
12,435,849
|
|
|
|
Conversion of convertible preferred shares in connection with SPAC merger |
$ (53,964)
|
|
53,964
|
|
53,964
|
Conversion of convertible preferred shares in connection with SPAC merger (in Shares) |
(13,739,186)
|
14,270,797
|
|
|
|
Conversion of Warrants to Convertible Preferred shares in connection with SPAC merger |
|
|
35,170
|
|
35,170
|
Vesting of RSUs |
|
|
|
|
|
Vesting of RSUs (in Shares) |
|
70,625
|
|
|
|
Share-based compensation |
|
|
3,445
|
|
3,445
|
Net loss |
|
|
|
(27,743)
|
(27,743)
|
Balance at Jun. 30, 2022 |
|
|
188,851
|
(80,583)
|
108,268
|
Balance (in Shares) at Jun. 30, 2022 |
|
68,575,397
|
|
|
|
Balance at Dec. 31, 2022 |
|
|
192,259
|
(86,602)
|
105,657
|
Balance (in Shares) at Dec. 31, 2022 |
|
69,105,000
|
|
|
|
Issuance of ordinary shares upon exercise of warrants |
|
|
|
|
|
Issuance of ordinary shares upon exercise of warrants (in Shares) |
|
67,897
|
|
|
|
Issuance of ordinary shares upon exercise of share options |
|
|
2
|
|
2
|
Issuance of ordinary shares upon exercise of share options (in Shares) |
|
2,500
|
|
|
|
Vesting of RSUs |
|
|
|
|
|
Vesting of RSUs (in Shares) |
|
197,738
|
|
|
|
Share-based compensation |
|
|
3,784
|
|
3,784
|
Net loss |
|
|
|
(16,880)
|
(16,880)
|
Balance at Jun. 30, 2023 |
|
|
$ 196,045
|
$ (103,482)
|
$ 92,563
|
Balance (in Shares) at Jun. 30, 2023 |
|
69,373,135
|
|
|
|
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v3.23.2
Interim Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Cash flows from operating activities: |
|
|
Net loss |
$ (16,880)
|
$ (27,743)
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
Depreciation |
512
|
475
|
Share-based compensation |
3,784
|
3,445
|
Non-cash financial expenses (income), net |
509
|
(97)
|
Change in the fair value of Warrants Liabilities |
2,164
|
11,105
|
Increase in prepaid expenses and other receivables |
(601)
|
(2,443)
|
Decrease (increase) in long term prepaid expenses |
(50)
|
1,821
|
(Decrease) increase in trade payables |
366
|
(6)
|
(Decrease) increase in other payables and accrued expenses |
535
|
(1,885)
|
Change in operating lease liabilities |
(633)
|
|
Change in operating lease right-of-use assets |
372
|
|
Net cash used in operating activities |
(9,922)
|
(15,328)
|
Cash flows from investing activities: |
|
|
Investment in short-term deposits |
(98,431)
|
(100,000)
|
Redemption of short-term deposits |
103,995
|
8,000
|
Purchase of property and equipment |
(590)
|
(675)
|
Net cash (used in) provided by investing activities |
4,974
|
(92,675)
|
Cash flows from financing activities: |
|
|
Proceeds from exercise of warrants |
|
3,257
|
Proceeds from exercise of options |
2
|
|
Proceeds from SPAC merger and PIPE financing, net of transaction cost |
|
93,543
|
Net cash provided by financing activities |
2
|
96,800
|
Effect of exchange rate changes on cash, cash equivalents and restricted cash |
(51)
|
(288)
|
Decrease in cash, cash equivalents and restricted cash |
(4,997)
|
(11,491)
|
Cash, cash equivalents and restricted cash at beginning of period |
6,686
|
23,854
|
Cash, cash equivalents and restricted cash at end of period |
1,689
|
12,363
|
Supplemental disclosures of cash flow information: |
|
|
Income tax payments |
13
|
2
|
Interest received |
$ 2,394
|
$ 50
|
X |
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v3.23.2
General
|
6 Months Ended |
Jun. 30, 2023 |
General [Abstract] |
|
GENERAL |
NOTE
1:- GENERAL
Alpha
Tau Medical Ltd. (“the Company”) is an Israeli clinical-stage oncology therapeutics company that focuses on research, development
and commercialization of Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) for the treatment of solid cancer. The Company was established
in November 2015 and began its operations in January 2016, and shortly thereafter acquired the full rights to the Alpha DaRT technology
from Althera Medical Ltd., (“Althera”), developed in 2003 at Tel Aviv University.
In
August 2017 the Company established a fully owned subsidiary in the United States - “Alpha Tau Medical Inc.” (“ATM Inc”).
ATM Inc began its activity in August 2018.
In
January 2018 the Company established a subsidiary in Japan “Alpha Tau Medical KK” (hereafter: ATM KK). ATM KK began its activity
in January 2018. Since July 2019, the Company holds 100% of ATM KK.
In
July 2019, the Company established a fully owned subsidiary in Canada “Alpha Tau Medical Canada Inc.” (hereafter: ATM Canada
Inc). ATM Canada Inc began its activity in March 2020.
| b. | Merger
with Healthcare Capital Corp: |
On
July 7, 2021, the Company entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Healthcare Capital
Corp., a Delaware corporation (“HCCC”), and Archery Merger Sub Inc., a Delaware corporation and wholly-owned subsidiary of
the Company (“Merger Sub”). As part of the completion of business combination on March 7, 2022 (the “Closing Date”),
the Merger Sub was merged with and into HCCC (the “Merger”), with HCCC surviving the merger as a wholly owned subsidiary of
the Company. In July 2022, HCCC was dissolved.
Each
of HCCC’s outstanding warrants to purchase one share of HCCC common stock, including both the HCCC warrants issued to public shareholders
in HCCC’s initial public offering (the “Public Warrants”) and the HCCC warrants issued in a private placement to HCCC’s
sponsors in HCCC’s initial public offering (the “Private Warrants”) (together, the “Warrants liability”),
were converted into the right to receive an equal number of warrants to purchase one Ordinary Share of the Company. A total of 15,891,984
warrants to purchase one Ordinary Share were issued to holders of HCCC warrants.
On
July 7, 2021, the Company entered into Subscription Agreements, together with a number of subsequent agreements since with certain
investors (the “PIPE Investors”) pursuant to which, among other things, the PIPE Investors agreed to purchase on the Closing
Date the Company’s ordinary shares at a price equal to $10.00 per share on the terms and subject to the conditions set forth in
the Subscription Agreements (the “PIPE Financing”). In connection with the closing of the Business Combination, the Company
consummated the sale of 9,251,006 ordinary shares for gross proceeds of $92,510 pursuant to the PIPE Financing.
Total
gross proceeds resulted from the Merger transaction were approximately $104,052 out of which total transaction costs amounted to approximately
$5,713. The transaction costs related to the Warrants liability in the amount of $817 were recognized as expenses in the Company’s
statement of operations for the period ended June 30, 2022. The residual amount was deducted of additional paid in capital.
| c. | The
Company’s activities since inception have consisted of performing research and development
activities. Successful completion of the Company’s development programs and, ultimately,
the attainment of profitable operations are dependent on future events, including, among
other things, its ability to secure financing; obtain further marketing approvals from regulatory
authorities; access potential markets; and build a sustainable customer base; attract, retain
and motivate qualified personnel; and develop strategic alliances. The Company’s operations
are funded by its shareholders and research and development grants and the Company intends
to seek further financing as well as make applications for further research and development
grants for continuing its operations. Although management believes that the Company will
be able to successfully fund its operations, there can be no assurance that the Company will
be able to do so or that the Company will ever operate profitably. |
The
Company expects to continue to incur substantial losses over the next several years during its clinical development phase. To fully execute
its business plan, the Company will need to complete registrational clinical studies and certain development activities as well as manufacture
the required clinical and commercial products in its manufacturing plants. Further, the Company will seek further regulatory approvals
prior to commercialization and the Company will need to establish sales, marketing and logistic infrastructures. These activities may
span many years and require substantial expenditures to complete and may ultimately be unsuccessful. Any delays in completing these activities
could adversely impact the Company.
As
of June 30, 2023, the Company had cash, cash equivalents, short-term deposits and restricted cash of $94,361. During the six months ended
June 30, 2023, the Company incurred a net loss of $16,880 and had negative cash flows from operating activities of $9,922. In addition,
the Company had an accumulated deficit of $103,482 on June 30, 2023. The Company believes that its existing capital resources will be
adequate to satisfy its expected liquidity requirements for at least two years.
|
X |
- DefinitionThe entire disclosure for the nature of an entity's business, major products or services, principal markets including location, and the relative importance of its operations in each business and the basis for the determination, including but not limited to, assets, revenues, or earnings. For an entity that has not commenced principal operations, disclosures about the risks and uncertainties related to the activities in which the entity is currently engaged and an understanding of what those activities are being directed toward.
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v3.23.2
Significant Accounting Policies
|
6 Months Ended |
Jun. 30, 2023 |
Accounting Policies [Abstract] |
|
SIGNIFICANT ACCOUNTING POLICIES |
NOTE
2:- SIGNIFICANT ACCOUNTING POLICIES
| a. | Unaudited interim consolidated financial statements: |
The
accompanying unaudited interim consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting
principles (“U.S. GAAP”) for interim financial information. In the opinion of management, the unaudited interim consolidated
financial statements include all adjustments necessary for a fair presentation.
The
balance sheet as of December 31, 2022 has been derived from the audited consolidated financial statements of the Company at that date
but does not include all information and footnotes required by U.S. GAAP for complete financial statements.
The
accompanying unaudited interim consolidated financial statements should be read in conjunction with the audited consolidated financial
statements and accompanying notes for the year ended December 31, 2022.
The
significant accounting policies disclosed in the Company’s audited 2022 consolidated financial statements and notes thereto have been
applied consistently to these unaudited interim consolidated financial statements. Results for the six months ended June 30, 2023 are
not necessarily indicative of results that may be expected for the year ending December 31, 2023.
The
preparation of the unaudited interim consolidated financial statements in conformity with U.S. GAAP requires management to make estimates,
judgments and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities
at the date of the interim consolidated financial statements and the reported amounts of revenues and expenses during the reporting period.
The Company’s management believes that the estimates, judgments and assumptions used are reasonable based upon information available
at the time they are made. Actual results could differ from those estimates.
Restricted
cash is primarily invested in bank deposit and is used as security for the Company’s lease commitments. The following table provides
a reconciliation of the cash and cash equivalents balances reported on the balance sheets and the cash, cash equivalents and restricted
cash balances reported in the statements of cash flows:
| |
June 30, | |
| |
2022 | | |
2023 | |
| |
Unaudited | |
| |
| | |
| |
Cash and cash equivalents, as reported on the balance sheets | |
$ | 11,571 | | |
$ | 855 | |
Restricted cash, as reported on the balance sheets | |
| 792 | | |
| 834 | |
| |
| | | |
| | |
Cash, cash equivalents, and restricted cash, as reported in the statements of cash flows | |
$ | 12,263 | | |
$ | 1,689 | |
The
Company determines if an arrangement meets the definition of a lease at the inception of the lease.
Right-of-use
(“ROU”) assets represent the right to use an underlying asset for the lease term and lease liabilities represent the Company’s
obligation to make lease payments arising from the lease agreement. ROU assets are initially measured at amounts, which represents the
discounted present value of the lease payments over the lease, plus any initial direct costs incurred. The lease liability is initially
measured at lease commencement date based on the discounted present value of minimum lease payments over the lease term. The implicit
rate within the operating leases is generally not determinable, therefore the Company uses the Incremental Borrowing Rate (“IBR”)
based on the information available at commencement date in determining the present value of lease payments. The Company’s IBR was
estimated to approximate the interest rate for collateralized borrowing with similar terms and payments and in economic environments
where the leased asset was located.
Lease
term may include options to extend or terminate the lease when it is reasonably certain that the Company would exercise that option.
The Company elected to not recognize a lease liability ROU asset for leases with a term of twelve months or less. The Company also elected
the practical expedient to not separate lease and non-lease components for its leases.
Payments
under the Company’s lease agreements are primarily fixed; however, certain lease agreements contain variable payments, which are
expensed as incurred and not included in the operating lease ROU assets and liabilities.
Lease
expenses for lease payments are recognized on a straight-line basis over the lease term.
| e. | Ordinary share warrants classification and measurement: |
The
Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s
specific terms and applicable authoritative guidance. The assessment considers whether the warrants are freestanding financial instruments,
meet the definition of a liability under ASC 480, are indexed to the Company’s own shares and whether the warrants are eligible
for equity classification under ASC 815-40. This assessment is conducted at the time of warrant issuance and as of each subsequent reporting
period end date while the warrants are outstanding.
Warrants
that meet all the criteria for equity classification, are required to be recorded as a component of additional paid-in capital. Warrants
that do not meet all the criteria for equity classification, are required to be recorded as liabilities at their initial fair value on
the date of issuance and remeasured to fair value through earnings at each balance sheet date thereafter.
The
Company has classified the SPAC warrants assumed during the Merger (both public and private) as a liability pursuant to ASC 815-40 since
the warrants do not meet the equity classification conditions. Accordingly, the Company measured the warrants at their fair value. The
warrants liability is subject to re-measurement at each balance sheet date until exercised, and any change in fair value is recognized
in our statement of comprehensive loss.
As
of December 31, 2022 and June 30, 2023, the Company has 2,391,857 and 2,323,960 warrants classified as equity.
In
addition, as of December 31, 2022 and June 30, 2023 the Company has 13,605,561 and 2,142,000 public and private warrants, respectively,
which are classified as a liability.
| f. | Fair value of financial instruments |
Fair
value is defined as the exchange price that would be received from the sale of an asset or paid to transfer a liability in the principal
or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date.
The Company measures financial assets and liabilities at fair value at each reporting period using a fair value hierarchy which requires
the Company to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value.
A
financial instrument’s classification within the fair value hierarchy is based upon the lowest level of input that is significant
to the fair value measurement. Three levels of inputs may be used to measure fair value:
Level
1 — quoted prices in active markets for identical assets or liabilities.
Level
2 — inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities;
quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for
substantially the full term of the assets or liabilities.
Level
3 — unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets
or liabilities. Financial
instruments consist among others of cash equivalents, restricted cash, other accounts receivable, trade payables, and other accounts
payable and accrued expenses. The estimated fair values of these financial instruments approximate their carrying value as presented,
due to their short-term maturities. We consider public warrant liabilities to be Level 1 and private warrants are measured at fair value
using Level 3 inputs.
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v3.23.2
Lease
|
6 Months Ended |
Jun. 30, 2023 |
Lease [Abstract] |
|
LEASE |
NOTE
3:- LEASE
The
Company has entered into non-cancelable lease agreements for its offices and motor vehicles with lease periods expiring at various dates
through May 2035.
The
components of operating lease costs were as follows:
| |
Period ended June 30, 2023 | |
| |
Unaudited | |
| |
| |
Operating lease cost | |
$ | 475 | |
Variable lease cost | |
| 22 | |
| |
| | |
Total net lease costs | |
$ | 497 | |
Supplemental
balance sheet information related to operating leases is as follows:
| |
June 30, 2023 | |
| |
Unaudited | |
| |
| |
Operating lease ROU assets | |
$ | 7,157 | |
Operating lease liabilities, current | |
$ | 846 | |
Operating lease liabilities, long-term | |
$ | 5,433 | |
Weighted average remaining lease term (in years) | |
| 10.85 | |
Weighted average discount rate | |
| 5.10 | % |
Minimum
lease payments for the Company’s ROU assets over the remaining lease periods as of June 30, 2023, are as follows:
| |
Operating leases | |
| |
Unaudited | |
| |
| |
2023 | |
$ | 453 | |
2024 | |
| 849 | |
2025 | |
| 790 | |
2026 | |
| 689 | |
2027 and thereafter | |
| 5,562 | |
| |
| | |
Total undiscounted lease payments | |
| 8,343 | |
Less: imputed interest | |
| 2,064 | |
| |
| | |
Present value of lease liabilities | |
$ | 6,279 | |
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v3.23.2
Warrants Liability
|
6 Months Ended |
Jun. 30, 2023 |
Warrants Liability Abstract |
|
WARRANTS LIABILITY |
NOTE
4:- WARRANTS LIABILITY
In
March 2022, in conjunction with the Merger with HCCC, the Company issued 13,749,986 warrants to the public shareholders of HCCC (the
“Public Warrants”) and 2,142,000 warrants to the sponsor of HCCC (the “Private Warrants”) in exchange for the
surrender and cancellation of an identical number of warrants exercisable into common stock of HCCC. The Public Warrants and the Private
Warrants may each be exercised into Ordinary shares of the Company within 5 years of the grant date, at an exercise price of $11.50,
and are subject to certain redemption provisions at the Company’s option.
As
of June 30, 2023, a total of 144,123 Public Warrants have been exercised into 144,123 ordinary shares of the Company.
As
of June 30, 2023, a total of 13,605,561 Public Warrants and 2,142,000 Private Warrants are outstanding.
Public
Warrants
Each
whole warrant will entitle the registered holder to purchase one Ordinary share. No fractional warrants will be issued and
only whole warrants will trade. No warrant will be exercisable and the Company will not be obligated to issue an Ordinary share upon
exercise of a warrant unless the Ordinary share issuable upon such warrant exercise has been registered, qualified or deemed to be exempt
under the securities laws of the state of residence of the registered holder of the warrants. In no event is the Company required to
net cash settle any warrant. During any period if the Company has failed to maintain an effective registration statement, warrant holders
will be able to, until such time there is an effective registration statement, exercise their warrants on a “cashless basis.”
Once
the warrants become exercisable, the Company may call the warrants for redemption:
| ● | In whole and not in part; |
| | |
| ● | At
a price of $0.01 per warrant; |
| | |
| ● | Upon
not less than 30 days’ prior written notice of redemption (the “30-day redemption
period”) to each warrant holder; and |
| | |
| ● | If,
and only if, the closing price of the Ordinary shares equals or exceeds $18.00 per share
(subject to standard adjustments) for any 20 trading days within a 30-trading
day period ending three business days before the Company sends to the notice of redemption
to the warrant holders. |
If
the Company calls the warrants for redemption for cash the Company’s management will have the option to require any holder that
wishes to exercise his, her or its warrant to do so on a “cashless basis.” If the Company’s management takes advantage
of this option, all holders of warrants would pay the exercise price by surrendering their warrants for that number of shares of Ordinary
shares equal to the quotient obtained by dividing (x) the product of the number of Ordinary shares underlying the warrants, multiplied
by the excess of the “fair market value” of Ordinary shares over the exercise price of the warrants by (y) the fair market
value. The “fair market value” will mean the average closing price of the Ordinary shares for the 10 trading days ending
on the third trading day prior to the date on which the notice of redemption is sent to the holders of warrants. Private
Warrants
Except
as described below, the Private Warrants have terms and provisions that are identical to those of the Public Warrants.
The
Private Warrants will not be redeemable by the combined company so long as they are held by the Sponsor or its permitted transferees.
The Sponsor, or its permitted transferees, has the option to exercise the Private Warrants on a cashless basis. If the Private Warrants
are held by someone other than the Sponsor or its permitted transferees, the Private Warrants will be redeemable by the combined company
and exercisable by such holders on the same basis as the Public Warrants. If holders of the Private Warrants elect to exercise them on
a cashless basis, they would pay the exercise price by surrendering their warrants for that number of Ordinary shares equal to the quotient
obtained by dividing (x) the product of the number of shares of Ordinary shares underlying the warrants, multiplied by the difference
between the exercise price of the warrants and the “fair market value” (defined below) by (y) the fair market value. The
“fair market value” means the average reported last sale price of the Ordinary shares for the 10 trading days ending on the
third trading day prior to the date on which the notice our warrant exercise is sent to the warrant agent.
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v3.23.2
Fair Value Measurements
|
6 Months Ended |
Jun. 30, 2023 |
Fair Value Measurements [Abstract] |
|
FAIR VALUE MEASUREMENTS |
NOTE
5:- FAIR VALUE MEASUREMENTS
The
following table presents information about the Company’s liabilities that are measured at fair value on a recurring basis as of
December 31, 2022 and June 30, 2023 and indicates the fair value hierarchy of the valuation inputs the Company utilized to
determine such fair value:
| |
December 31, 2022 | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
(Audited) | |
| |
| | |
| | |
| |
Warrants Liability – Public Warrants | |
$ | 3,403 | | |
$ | - | | |
$ | - | |
Warrant Liability – Private Warrants | |
| - | | |
| - | | |
| 2,227 | |
| |
| | | |
| | | |
| | |
Total | |
$ | 3,403 | | |
$ | - | | |
$ | 2,227 | |
| |
June 30, 2023 | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
(Unaudited) | |
| |
| | |
| | |
| |
Warrants Liability – Public Warrants | |
$ | 5,376 | | |
$ | - | | |
$ | - | |
Warrant Liability – Private Warrants | |
| - | | |
| - | | |
| 2,418 | |
| |
| | | |
| | | |
| | |
Total | |
$ | 5,376 | | |
$ | - | | |
$ | 2,418 | |
The
fair value of the Public Warrants is determined with reference to the prevailing market price for warrants that are trading on Nasdaq
under the ticker DRTSW.
The
Private warrants were valued using a Black Scholes Option Pricing Model, which is considered to be a Level 3 fair value measurement.
The Black Scholes model’s primary unobservable input utilized in determining the fair value of the Private warrants is the expected
volatility of the Ordinary shares. The expected volatility was implied from a blend of the Company’s own Ordinary share and Public
Warrant pricing, and 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.
The
Warrants to convertible preferred shares were converted into an identical number of warrants convertible into ordinary shares of the
Company. After conversion the converted warrants were valued using a Black Scholes Option Pricing Model. The Black Scholes model’s
primary unobservable input utilized in determining the fair value of the Warrants to convertible preferred shares is the expected volatility
of the Ordinary shares. The expected volatility was implied from the Company’s own Ordinary shares and Public Warrants pricing,
and 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.
There
were no transfers in or out of Level 3 from other levels in the fair value hierarchy.
The
change in the fair value of the Level 3 warrants liability is summarized below:
| |
June 30,
2023 | |
| |
Unaudited | |
| |
| |
Beginning of period | |
$ | 2,227 | |
Change in fair value | |
| 191 | |
| |
| | |
End of period | |
$ | 2,418 | |
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v3.23.2
Commitments and Contingent Liabilities
|
6 Months Ended |
Jun. 30, 2023 |
Commitments and Contingent Liabilities [Abstract] |
|
COMMITMENTS AND CONTINGENT LIABILITIES |
NOTE
6:- COMMITMENTS AND CONTINGENT LIABILITIES
| a. | A guarantee in the amount of $609 was issued by a bank to secure the Company’s offices rent. In addition, a guarantee in the amount $225 was issued by a bank to the Commonwealth of Massachusetts, backed by a guarantee from the Company, to support the expansion of ATM Inc’s radioactive license in the State of Massachusetts. |
| b. | The Company has received royalty-bearing grants from the IIA to finance its research and development programs in Israel, through which the Company received IIA participation payments in the aggregate amount of $4,987 through June 30, 2023. In return, the Company is committed to pay IIA royalties at a rate of 3-3.5% of future sales of the developed products, up to 100% of the amount of grants received plus interest at LIBOR rate. Through June 30, 2023, no royalties have been paid or accrued. |
| | |
| | In
addition, under the intellectual property purchase agreement with Althera, the Company assumed all of Althera’s liabilities towards the
IIA totaling $474 of royalty-bearing grants received by Althera (plus accrued interest at LIBOR rate). The Company’s contingent royalty
liability to the IIA on June 30, 2023, including grants received by the Company, grants assumed from Althera and the associated
LIBOR interest accrued on all such grants, totaled $6,242. |
| c. | Under the February 2, 2016 intellectual property purchase agreement with Althera, the Company is obligated to pay Althera a fixed rate of 2% (plus VAT) of Company’s future gross revenues (as defined in the agreement) that are derived from the purchased intellectual property, up to a maximum amount of $1,500 (plus VAT), in the aggregate, with the potential to set off against certain payments made by the Company to the IIA. |
| d. | The Company also entered into intellectual property agreements with Ramot at Tel Aviv University Ltd., the technology transfer company of Tel Aviv University (“Ramot”) on April 21, 2016 and July 14, 2016, all as amended on May 5, 2019, pursuant to which the Company is obligated to pay Ramot a fixed royalty of 2.5% on net sales of all of the Company’s products (as defined in the agreement) by the Company and its affiliates, with no set maximum. The royalty will be payable as of the first commercial sale (as defined in the agreement), until the later of: 15 years; or until the last to expire of the patents or patent applications from research developed at Tel Aviv University and assigned to the Company, on a country-by-country, product-by-product basis. The Company is also obligated to pay a 7% royalty (and in no event less than 0.65% of the net sales of Company products sold by the Company’s licensees in a given year) on any royalties or revenues received by the Company from its licensees. |
| e. | Under an Operations Partner Agreement between the Company and services provider HekaBio K.K. of May 21, 2019, the Company makes certain payments to HekaBio K.K. in exchange for consulting and administrative services in Japan, as well as payments upon the achievement of certain clinical and regulatory milestones. In addition, if HekaBio K.K. successfully assists the Company in obtaining regulatory marketing approval of the Company’s products in Japan, then the Company is to grant to HekaBio K.K. options to acquire 271,588 of the Company’s ordinary shares at a price of $4.42 each, and to pay HekaBio K.K. a royalty of 3.5% of the reimbursement price (as defined in the agreement) of such products in Japan and 10% of revenues received by the Company from distribution receipts (as defined in the agreement) for such products in Japan. As of June 30, 2023, no such options were granted. |
| f. | On November 18, 2018 and July 29, 2019, the Company entered into research and license agreements with BGN Technologies, the technology transfer company of Ben Gurion University (“BGN”), further amended on May 12, 2021, wherein the Company will wholly own any intellectual property that is developed jointly by Ben Gurion University and others (including the Company), and BGN will receive 0.75% royalties on all sales of the Company’s alpha radiation products, net of certain deductions and irrespective of the intellectual property underlying such sales, or 1.5% royalties on sales of products that contain intellectual property owned by Ben Gurion University, net of certain deductions. BGN will receive 4% of license revenues (as defined in the agreements) that relate to jointly developed intellectual property, and 8% of license revenues that relate to intellectual property developed solely by Ben Gurion University. The parties also agreed that the Company will continue to conduct research at Ben Gurion University for as long as the researchers wish to, and the parties have agreed on a research budget in good faith. |
| g. | On December 1, 2020, the Company entered into a clinical trial agreement with Cambridge University Hospitals NHS Trust, wherein Cambridge will receive 5% of any marginal increase in the Company’s net sales (all as defined in the agreement) generated on account of any patent or patent claim granted from the research performed in such trial, and 2% of the Company’s net sales (minus the aforementioned marginal increase payment) received for the treatment of Squamous Cell Carcinoma of the vulva, for three years from the date of first sale, world-wide. |
| h. | On
August 16, 2022, the Company entered into a collaboration agreement with MIM Software, Inc.
(“MIM”) to provide treatment planning software for clinical sites using the Alpha
DaRT therapy. Under the terms of the agreement, the parties will collaborate on the use of
MIM’s software suite, including MIM Symphony® and MIMcloud®, for development
of new features and support for the Alpha DaRT across multiple potential indications, integration
into all clinical trials involving the Alpha DaRT, and bundling the MIM software with the
Alpha DaRT for future commercial sales in territories where the Alpha DaRT and MIM’s
software are both approved. The agreement contemplates certain payments to MIM to be agreed
between the parties upon initiating certain workstreams, as well as payments to MIM upon
commercial sale of the Alpha DaRT bundled with MIM’s software products. |
|
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- DefinitionThe entire disclosure for commitments and contingencies.
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v3.23.2
Shareholders’ Equity
|
6 Months Ended |
Jun. 30, 2023 |
Stockholders' Equity Note [Abstract] |
|
SHAREHOLDERS’ EQUITY |
NOTE
7:- SHAREHOLDERS’ EQUITY
| a. | Ordinary share capital is composed as follows: |
| | |
December 31, 2022 | | |
June 30, 2023
(unaudited) | |
| | |
Authorized | | |
Issued and outstanding | | |
Authorized | | |
Issued and outstanding | |
| | |
Number of shares | |
| | |
| | | |
| | | |
| | | |
| | |
Ordinary shares of no-par value | | |
| 362,116,800 | | |
| 69,105,000 | | |
| 362,116,800 | | |
| 69,373,135 | |
The
Ordinary shares confer upon their holders the right to participate in the general meetings of the Company, to vote at such meetings (each
share represents one vote), and to participate in any distribution of dividends or any other distribution of the Company’s property,
including the distribution of surplus assets upon liquidation.
The
Company has authorized through its 2021 Share Incentive Plan (the “Plan”), an available pool of ordinary shares of the Company
from which to grant options, RSUs or other equity compensation to officers, directors, advisors, management and other key employees of
up to 18,192,586 Ordinary shares. The equity compensation granted generally has a four-year vesting period and expires ten years after
the date of grant, subject to the terms set forth in the Plan. Options granted under the Plan that are cancelled or forfeited before
expiration become available for future grant.
As
of June 30, 2023, 12,426,345 of the Company’s options are available for future grants. A
summary of the status of options under the Plan as of June 30, 2023 and changes during the relevant period ended on that date is
presented below:
| |
Six months ended June 30, 2023 (unaudited) | |
| |
Number of options | | |
Weighted average exercise price | | |
Aggregate intrinsic value | | |
Weighted average remaining contractual life (years) | |
| |
| | |
| | |
| | |
| |
Outstanding at beginning of period | |
| 8,237,794 | | |
$ | 5.8 | | |
$ | 2,588 | | |
| 7.24 | |
Granted | |
| 3,185,111 | | |
$ | 3.4 | | |
| | | |
| | |
Exercised | |
| (2,500 | ) | |
$ | 1.1 | | |
| | | |
| | |
Forfeited and cancelled | |
| (41,292 | ) | |
$ | 9.9 | | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | |
Outstanding at end of period | |
| 11,379,113 | | |
$ | 5.1 | | |
$ | 7,709 | | |
| 7.5 | |
| |
| | | |
| | | |
| | | |
| | |
Exercisable options | |
| 5,838,956 | | |
$ | 4.5 | | |
$ | 4,934 | | |
| 5.9 | |
A
summary of the status of RSUs under the Plan as of June 30, 2023 and changes during the relevant period ended on that date is presented
below:
| |
Number of RSU | |
| |
| |
Outstanding at beginning of year | |
| 924,867 | |
Granted | |
| 391,724 | |
Forfeited and cancelled | |
| (12,820 | ) |
Vested | |
| (197,738 | ) |
| |
| | |
Outstanding on June 30, 2023 | |
| 1,106,033 | |
The
total equity-based compensation expense related to all of the Company’s equity-based awards recognized for the six months ended June 30,
2022 and 2023, was comprised as follows:
| |
Six months ended June 30, | |
| |
2022 | | |
2023 | |
| |
Unaudited | |
| |
| | |
| |
Research and development | |
$ | 2,260 | | |
$ | 2,536 | |
Marketing expenses | |
| 60 | | |
| 202 | |
General and administrative | |
| 1,125 | | |
| 1,046 | |
| |
| | | |
| | |
Total share-based compensation expense | |
$ | 3,445 | | |
$ | 3,784 | |
As
of June 30, 2023, there were unrecognized compensation costs of $19,510, which are expected to be recognized over a weighted average
period of approximately 2.62 years.
| 1. | In July 2019, as part of the investment round of HekaBio K.K, the investors received 651,067 warrants to ordinary shares with an exercise price of $5.04 to be exercised within 4 years from grant date. |
| 2. | In March 2022, in conjunction with the Merger with HCCC, the 3,880,777 warrants convertible into Preferred A Shares of the Company were converted into an identical number of warrants convertible into ordinary shares of the Company. The warrants are exercisable until September 2024 at an exercise price of $3.87. |
| | |
| | During
the six-month period ended June 30, 2022, a total of 1,509,176 of such warrants were exercised into 1,125,088 ordinary shares of the
Company. |
| | |
| | As
of June 30, 2023, a total of 2,323,960 such warrants are outstanding. |
| | |
| | The
warrants met all the criteria for equity classification and were reclassified as a component of additional paid-in capital. See also
note 2e and 6. |
| e. | Warrants
to consultants: |
In
March 2023, 67,897 warrants were exercised into 67,897 ordinary shares of no-par value, for no consideration.
|
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v3.23.2
Financial Expenses, Net
|
6 Months Ended |
Jun. 30, 2023 |
Financial Expenses, Net [Abstract] |
|
FINANCIAL EXPENSES, NET |
NOTE
8:- FINANCIAL EXPENSES, NET
|
| |
Six months ended June 30, | |
|
| |
2022 | | |
2023 | |
|
| |
Unaudited | |
|
| |
| | |
| |
|
Financial expenses: | |
| | |
| |
|
| |
| | |
| |
|
Foreign currency transaction loss | |
$ | 260 | | |
$ | - | |
|
Remeasurement of warrants, net | |
| 11,105 | | |
| 2,164 | |
|
Others | |
| 13 | | |
| 11 | |
|
| |
| | | |
| | |
|
Total financial expenses | |
| 11,378 | | |
| 2,175 | |
|
| |
| | | |
| | |
|
Financial income: | |
| | | |
| | |
|
| |
| | | |
| | |
|
Foreign currency transaction income | |
| - | | |
| 220 | |
|
Interest from deposits | |
| 436 | | |
| 1,934 | |
|
| |
| | | |
| | |
|
Total financial income | |
| 436 | | |
| 2,154 | |
|
| |
| | | |
| | |
|
Financial expenses, net | |
$ | 10,942 | | |
$ | 21 | |
|
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v3.23.2
Basic and Diluted Net Loss Per Share
|
6 Months Ended |
Jun. 30, 2023 |
Basic and Diluted Net Loss Per Share [Abstract] |
|
BASIC AND DILUTED NET LOSS PER SHARE |
NOTE
9:- BASIC AND DILUTED NET LOSS PER SHARE
The
following table sets forth the computation of the Company’s basic and diluted net loss per Ordinary share:
| |
Six months ended June 30, | |
| |
2022 | | |
2023 | |
| |
Unaudited | |
Numerator: | |
| | |
| |
Net loss | |
$ | 27,743 | | |
$ | 16,880 | |
Denominator: | |
| | | |
| | |
Weighted-average shares used in computing net loss per Ordinary share, basic and diluted | |
| 58,023,875 | | |
| 69,262,381 | |
| |
| | | |
| | |
Net loss per Ordinary share, basic and diluted | |
$ | 0.48 | | |
$ | 0.24 | |
For
the six months ended June 30, 2022 and 2023, all outstanding options and warrants have been excluded from the calculation of the
diluted net loss per share since their effect was anti-dilutive. As of June 30, 2022, and 2023 the total weighted average number of shares
related to outstanding options and warrants excluded from the calculations of diluted net loss per share were 27,571,715 and 30,556,667,
respectively.
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v3.23.2
Subsequent Events
|
6 Months Ended |
Jun. 30, 2023 |
Subsequent Events [Abstract] |
|
SUBSEQUENT EVENTS |
NOTE
10:- SUBSEQUENT EVENTS
In
Jul 2023, the Company accepted a long-term leasehold grant of 6,663 square meters (1.65 acres) of land from the Israel Land Authority
(“ILA”) following a positive recommendation by the Israeli Ministry of the Economy and Industry to grant the land directly
to the Company at a discounted cost. The cost of the leasehold will be determined in an assessment process currently underway between
the Company and the ILA.
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v3.23.2
Accounting Policies, by Policy (Policies)
|
6 Months Ended |
Jun. 30, 2023 |
Accounting Policies [Abstract] |
|
Unaudited interim consolidated financial statements |
| a. | Unaudited interim consolidated financial statements: |
The
accompanying unaudited interim consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting
principles (“U.S. GAAP”) for interim financial information. In the opinion of management, the unaudited interim consolidated
financial statements include all adjustments necessary for a fair presentation. The
balance sheet as of December 31, 2022 has been derived from the audited consolidated financial statements of the Company at that date
but does not include all information and footnotes required by U.S. GAAP for complete financial statements. The
accompanying unaudited interim consolidated financial statements should be read in conjunction with the audited consolidated financial
statements and accompanying notes for the year ended December 31, 2022. The
significant accounting policies disclosed in the Company’s audited 2022 consolidated financial statements and notes thereto have been
applied consistently to these unaudited interim consolidated financial statements. Results for the six months ended June 30, 2023 are
not necessarily indicative of results that may be expected for the year ending December 31, 2023.
|
Use of estimates |
The
preparation of the unaudited interim consolidated financial statements in conformity with U.S. GAAP requires management to make estimates,
judgments and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities
at the date of the interim consolidated financial statements and the reported amounts of revenues and expenses during the reporting period.
The Company’s management believes that the estimates, judgments and assumptions used are reasonable based upon information available
at the time they are made. Actual results could differ from those estimates.
|
Restricted cash |
Restricted
cash is primarily invested in bank deposit and is used as security for the Company’s lease commitments. The following table provides
a reconciliation of the cash and cash equivalents balances reported on the balance sheets and the cash, cash equivalents and restricted
cash balances reported in the statements of cash flows:
| |
June 30, | |
| |
2022 | | |
2023 | |
| |
Unaudited | |
| |
| | |
| |
Cash and cash equivalents, as reported on the balance sheets | |
$ | 11,571 | | |
$ | 855 | |
Restricted cash, as reported on the balance sheets | |
| 792 | | |
| 834 | |
| |
| | | |
| | |
Cash, cash equivalents, and restricted cash, as reported in the statements of cash flows | |
$ | 12,263 | | |
$ | 1,689 | |
|
Leases |
The
Company determines if an arrangement meets the definition of a lease at the inception of the lease. Right-of-use
(“ROU”) assets represent the right to use an underlying asset for the lease term and lease liabilities represent the Company’s
obligation to make lease payments arising from the lease agreement. ROU assets are initially measured at amounts, which represents the
discounted present value of the lease payments over the lease, plus any initial direct costs incurred. The lease liability is initially
measured at lease commencement date based on the discounted present value of minimum lease payments over the lease term. The implicit
rate within the operating leases is generally not determinable, therefore the Company uses the Incremental Borrowing Rate (“IBR”)
based on the information available at commencement date in determining the present value of lease payments. The Company’s IBR was
estimated to approximate the interest rate for collateralized borrowing with similar terms and payments and in economic environments
where the leased asset was located. Lease
term may include options to extend or terminate the lease when it is reasonably certain that the Company would exercise that option.
The Company elected to not recognize a lease liability ROU asset for leases with a term of twelve months or less. The Company also elected
the practical expedient to not separate lease and non-lease components for its leases. Payments
under the Company’s lease agreements are primarily fixed; however, certain lease agreements contain variable payments, which are
expensed as incurred and not included in the operating lease ROU assets and liabilities. Lease
expenses for lease payments are recognized on a straight-line basis over the lease term.
|
Ordinary share warrants classification and measurement |
| e. | Ordinary share warrants classification and measurement: |
The
Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s
specific terms and applicable authoritative guidance. The assessment considers whether the warrants are freestanding financial instruments,
meet the definition of a liability under ASC 480, are indexed to the Company’s own shares and whether the warrants are eligible
for equity classification under ASC 815-40. This assessment is conducted at the time of warrant issuance and as of each subsequent reporting
period end date while the warrants are outstanding. Warrants
that meet all the criteria for equity classification, are required to be recorded as a component of additional paid-in capital. Warrants
that do not meet all the criteria for equity classification, are required to be recorded as liabilities at their initial fair value on
the date of issuance and remeasured to fair value through earnings at each balance sheet date thereafter. The
Company has classified the SPAC warrants assumed during the Merger (both public and private) as a liability pursuant to ASC 815-40 since
the warrants do not meet the equity classification conditions. Accordingly, the Company measured the warrants at their fair value. The
warrants liability is subject to re-measurement at each balance sheet date until exercised, and any change in fair value is recognized
in our statement of comprehensive loss. As
of December 31, 2022 and June 30, 2023, the Company has 2,391,857 and 2,323,960 warrants classified as equity. In
addition, as of December 31, 2022 and June 30, 2023 the Company has 13,605,561 and 2,142,000 public and private warrants, respectively,
which are classified as a liability.
|
Fair value of financial instruments |
| f. | Fair value of financial instruments |
Fair
value is defined as the exchange price that would be received from the sale of an asset or paid to transfer a liability in the principal
or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date.
The Company measures financial assets and liabilities at fair value at each reporting period using a fair value hierarchy which requires
the Company to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. A
financial instrument’s classification within the fair value hierarchy is based upon the lowest level of input that is significant
to the fair value measurement. Three levels of inputs may be used to measure fair value: Level
1 — quoted prices in active markets for identical assets or liabilities. Level
2 — inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities;
quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for
substantially the full term of the assets or liabilities. Level
3 — unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets
or liabilities. Financial
instruments consist among others of cash equivalents, restricted cash, other accounts receivable, trade payables, and other accounts
payable and accrued expenses. The estimated fair values of these financial instruments approximate their carrying value as presented,
due to their short-term maturities. We consider public warrant liabilities to be Level 1 and private warrants are measured at fair value
using Level 3 inputs.
|
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v3.23.2
Significant Accounting Policies (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Accounting Policies [Abstract] |
|
Schedule of Cash, Cash Equivalents and Restricted Cash Balances Reported in the Statements of Cash Flows |
The following table provides
a reconciliation of the cash and cash equivalents balances reported on the balance sheets and the cash, cash equivalents and restricted
cash balances reported in the statements of cash flows:
| |
June 30, | |
| |
2022 | | |
2023 | |
| |
Unaudited | |
| |
| | |
| |
Cash and cash equivalents, as reported on the balance sheets | |
$ | 11,571 | | |
$ | 855 | |
Restricted cash, as reported on the balance sheets | |
| 792 | | |
| 834 | |
| |
| | | |
| | |
Cash, cash equivalents, and restricted cash, as reported in the statements of cash flows | |
$ | 12,263 | | |
$ | 1,689 | |
|
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v3.23.2
Lease (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Lease [Abstract] |
|
Schedule of Operating Lease Costs |
The
components of operating lease costs were as follows:
| |
Period ended June 30, 2023 | |
| |
Unaudited | |
| |
| |
Operating lease cost | |
$ | 475 | |
Variable lease cost | |
| 22 | |
| |
| | |
Total net lease costs | |
$ | 497 | |
|
Schedule of Supplemental Balance Sheet Information Related to Operating Leases |
Supplemental
balance sheet information related to operating leases is as follows:
| |
June 30, 2023 | |
| |
Unaudited | |
| |
| |
Operating lease ROU assets | |
$ | 7,157 | |
Operating lease liabilities, current | |
$ | 846 | |
Operating lease liabilities, long-term | |
$ | 5,433 | |
Weighted average remaining lease term (in years) | |
| 10.85 | |
Weighted average discount rate | |
| 5.10 | % |
|
Schedule of Minimum Lease Payments |
Minimum
lease payments for the Company’s ROU assets over the remaining lease periods as of June 30, 2023, are as follows:
| |
Operating leases | |
| |
Unaudited | |
| |
| |
2023 | |
$ | 453 | |
2024 | |
| 849 | |
2025 | |
| 790 | |
2026 | |
| 689 | |
2027 and thereafter | |
| 5,562 | |
| |
| | |
Total undiscounted lease payments | |
| 8,343 | |
Less: imputed interest | |
| 2,064 | |
| |
| | |
Present value of lease liabilities | |
$ | 6,279 | |
|
X |
- DefinitionTabular disclosure of condensed balance sheet, including, but not limited to, balance sheets of consolidated entities and consolidation eliminations.
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v3.23.2
Fair Value Measurements (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Fair Value Measurements [Abstract] |
|
Schedule of Fair Value Hierarchy of the Valuation Inputs the Company Utilized to Determine Such Fair Value |
The
following table presents information about the Company’s liabilities that are measured at fair value on a recurring basis as of
December 31, 2022 and June 30, 2023 and indicates the fair value hierarchy of the valuation inputs the Company utilized to
determine such fair value
| |
December 31, 2022 | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
(Audited) | |
| |
| | |
| | |
| |
Warrants Liability – Public Warrants | |
$ | 3,403 | | |
$ | - | | |
$ | - | |
Warrant Liability – Private Warrants | |
| - | | |
| - | | |
| 2,227 | |
| |
| | | |
| | | |
| | |
Total | |
$ | 3,403 | | |
$ | - | | |
$ | 2,227 | |
| |
June 30, 2023 | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
(Unaudited) | |
| |
| | |
| | |
| |
Warrants Liability – Public Warrants | |
$ | 5,376 | | |
$ | - | | |
$ | - | |
Warrant Liability – Private Warrants | |
| - | | |
| - | | |
| 2,418 | |
| |
| | | |
| | | |
| | |
Total | |
$ | 5,376 | | |
$ | - | | |
$ | 2,418 | |
|
Schedule of Fair Value of the Level 3 Warrants Liability |
The
change in the fair value of the Level 3 warrants liability is summarized below
| |
June 30,
2023 | |
| |
Unaudited | |
| |
| |
Beginning of period | |
$ | 2,227 | |
Change in fair value | |
| 191 | |
| |
| | |
End of period | |
$ | 2,418 | |
|
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v3.23.2
Shareholders’ Equity (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Stockholders' Equity Note [Abstract] |
|
Schedule of Ordinary Share Capital |
Ordinary share capital is composed as follows:
| | |
December 31, 2022 | | |
June 30, 2023
(unaudited) | |
| | |
Authorized | | |
Issued and outstanding | | |
Authorized | | |
Issued and outstanding | |
| | |
Number of shares | |
| | |
| | | |
| | | |
| | | |
| | |
Ordinary shares of no-par value | | |
| 362,116,800 | | |
| 69,105,000 | | |
| 362,116,800 | | |
| 69,373,135 | |
|
Schedule of Options and Changes |
A
summary of the status of options under the Plan as of June 30, 2023 and changes during the relevant period ended on that date is
presented below:
| |
Six months ended June 30, 2023 (unaudited) | |
| |
Number of options | | |
Weighted average exercise price | | |
Aggregate intrinsic value | | |
Weighted average remaining contractual life (years) | |
| |
| | |
| | |
| | |
| |
Outstanding at beginning of period | |
| 8,237,794 | | |
$ | 5.8 | | |
$ | 2,588 | | |
| 7.24 | |
Granted | |
| 3,185,111 | | |
$ | 3.4 | | |
| | | |
| | |
Exercised | |
| (2,500 | ) | |
$ | 1.1 | | |
| | | |
| | |
Forfeited and cancelled | |
| (41,292 | ) | |
$ | 9.9 | | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | |
Outstanding at end of period | |
| 11,379,113 | | |
$ | 5.1 | | |
$ | 7,709 | | |
| 7.5 | |
| |
| | | |
| | | |
| | | |
| | |
Exercisable options | |
| 5,838,956 | | |
$ | 4.5 | | |
$ | 4,934 | | |
| 5.9 | |
|
Schedule of the Status of RSUs |
A
summary of the status of RSUs under the Plan as of June 30, 2023 and changes during the relevant period ended on that date is presented
below:
| |
Number of RSU | |
| |
| |
Outstanding at beginning of year | |
| 924,867 | |
Granted | |
| 391,724 | |
Forfeited and cancelled | |
| (12,820 | ) |
Vested | |
| (197,738 | ) |
| |
| | |
Outstanding on June 30, 2023 | |
| 1,106,033 | |
|
Schedule of Total Equity-Based Compensation Expense |
The
total equity-based compensation expense related to all of the Company’s equity-based awards recognized for the six months ended June 30,
2022 and 2023, was comprised as follows:
| |
Six months ended June 30, | |
| |
2022 | | |
2023 | |
| |
Unaudited | |
| |
| | |
| |
Research and development | |
$ | 2,260 | | |
$ | 2,536 | |
Marketing expenses | |
| 60 | | |
| 202 | |
General and administrative | |
| 1,125 | | |
| 1,046 | |
| |
| | | |
| | |
Total share-based compensation expense | |
$ | 3,445 | | |
$ | 3,784 | |
|
X |
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v3.23.2
Financial Expenses, Net (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Financial Expenses, Net [Abstract] |
|
Schedule of Financial Expenses, Net |
FINANCIAL EXPENSES, NET
|
| |
Six months ended June 30, | |
|
| |
2022 | | |
2023 | |
|
| |
Unaudited | |
|
| |
| | |
| |
|
Financial expenses: | |
| | |
| |
|
| |
| | |
| |
|
Foreign currency transaction loss | |
$ | 260 | | |
$ | - | |
|
Remeasurement of warrants, net | |
| 11,105 | | |
| 2,164 | |
|
Others | |
| 13 | | |
| 11 | |
|
| |
| | | |
| | |
|
Total financial expenses | |
| 11,378 | | |
| 2,175 | |
|
| |
| | | |
| | |
|
Financial income: | |
| | | |
| | |
|
| |
| | | |
| | |
|
Foreign currency transaction income | |
| - | | |
| 220 | |
|
Interest from deposits | |
| 436 | | |
| 1,934 | |
|
| |
| | | |
| | |
|
Total financial income | |
| 436 | | |
| 2,154 | |
|
| |
| | | |
| | |
|
Financial expenses, net | |
$ | 10,942 | | |
$ | 21 | |
|
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v3.23.2
Basic and Diluted Net Loss Per Share (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Basic and Diluted Net Loss Per Share [Abstract] |
|
Schedule of Basic and Diluted Net Loss Per Ordinary Share |
The
following table sets forth the computation of the Company’s basic and diluted net loss per Ordinary share:
| |
Six months ended June 30, | |
| |
2022 | | |
2023 | |
| |
Unaudited | |
Numerator: | |
| | |
| |
Net loss | |
$ | 27,743 | | |
$ | 16,880 | |
Denominator: | |
| | | |
| | |
Weighted-average shares used in computing net loss per Ordinary share, basic and diluted | |
| 58,023,875 | | |
| 69,262,381 | |
| |
| | | |
| | |
Net loss per Ordinary share, basic and diluted | |
$ | 0.48 | | |
$ | 0.24 | |
|
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v3.23.2
General (Details) - USD ($) $ / shares in Units, $ in Thousands |
6 Months Ended |
|
|
Jun. 30, 2023 |
Jun. 30, 2022 |
Jul. 07, 2021 |
Jan. 31, 2018 |
General (Details) [Line Items] |
|
|
|
|
Ownership percentage |
|
|
|
100.00%
|
Purchase of warrants (in Shares) |
15,891,984
|
|
|
|
Sale of ordinary shares (in Shares) |
|
9,251,006
|
|
|
Gross proceeds |
|
$ 104,052
|
|
|
Transaction cost |
|
5,713
|
|
|
Short-term deposits and restricted cash |
$ 94,361
|
|
|
|
Net loss amount |
16,880
|
|
|
|
Operating activity |
9,922
|
|
|
|
Accumulated deficit |
$ 103,482
|
|
|
|
Liquidity requirements |
2 years
|
|
|
|
Warrants Liability [Member] |
|
|
|
|
General (Details) [Line Items] |
|
|
|
|
Transaction cost |
|
817
|
|
|
PIPE Investor [Member] |
|
|
|
|
General (Details) [Line Items] |
|
|
|
|
Price per share (in Dollars per share) |
|
|
$ 10
|
|
PIPE Financing [Member] |
|
|
|
|
General (Details) [Line Items] |
|
|
|
|
Gross proceeds |
|
$ 92,510
|
|
|
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v3.23.2
Significant Accounting Policies (Details) - shares
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Significant Accounting Policies (Details) [Line Items] |
|
|
Warrants classified as equity |
2,323,960
|
2,391,857
|
Public Warrants [Member] |
|
|
Significant Accounting Policies (Details) [Line Items] |
|
|
Warrants shares |
2,142,000
|
13,605,561
|
Private Warrants [Member] |
|
|
Significant Accounting Policies (Details) [Line Items] |
|
|
Warrants shares |
2,142,000
|
13,605,561
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v3.23.2
Significant Accounting Policies (Details) - Schedule of Cash, Cash Equivalents and Restricted Cash Balances Reported in the Statements of Cash Flows - USD ($) $ in Thousands |
Jun. 30, 2023 |
Jun. 30, 2022 |
Schedule Of Cash Cash Equivalents And Restricted Cash Balances Reported In The Statements Of Cash Flows [Abstract] |
|
|
Cash and cash equivalents, as reported on the balance sheets |
$ 855
|
$ 11,571
|
Restricted cash, as reported on the balance sheets |
834
|
792
|
Cash, cash equivalents, and restricted cash, as reported in the statements of cash flows |
$ 1,689
|
$ 12,263
|
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v3.23.2
Warrants Liability (Details) - $ / shares
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Jun. 30, 2022 |
Mar. 31, 2022 |
Warrants Liability (Details) [Line Items] |
|
|
|
|
Exercise price (in Dollars per share) |
$ 30,556,667
|
|
$ 27,571,715
|
|
Warrants outstanding |
2,323,960
|
2,391,857
|
|
|
Warrants for redemption description |
●In whole and not in part;
●At
a price of $0.01 per warrant;
●Upon
not less than 30 days’ prior written notice of redemption (the “30-day redemption
period”) to each warrant holder; and
●If,
and only if, the closing price of the Ordinary shares equals or exceeds $18.00 per share
(subject to standard adjustments) for any 20 trading days within a 30-trading
day period ending three business days before the Company sends to the notice of redemption
to the warrant holders.
|
|
|
|
Public Warrants [Member] |
|
|
|
|
Warrants Liability (Details) [Line Items] |
|
|
|
|
Number of warrants issued |
|
|
|
13,749,986
|
Term of warrants |
|
|
|
5 years
|
Exercise price (in Dollars per share) |
|
|
|
$ 11.5
|
Number of warrants exercised |
144,123
|
|
|
|
Ordinary shares |
144,123
|
|
|
|
Warrants outstanding |
13,605,561
|
|
|
|
Private Warrants [Member] |
|
|
|
|
Warrants Liability (Details) [Line Items] |
|
|
|
|
Number of warrants issued |
|
|
|
2,142,000
|
Warrants outstanding |
2,142,000
|
|
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v3.23.2
Fair Value Measurements (Details) - Schedule of Fair Value Hierarchy of the Valuation Inputs the Company Utilized to Determine Such Fair Value - USD ($) $ in Thousands |
Jun. 30, 2023 |
Dec. 31, 2022 |
Level 1 [Member] |
|
|
Fair Value Measurements (Details) - Schedule of Fair Value Hierarchy of the Valuation Inputs the Company Utilized to Determine Such Fair Value [Line Items] |
|
|
Warrants Liability – Public Warrants |
$ 5,376
|
$ 3,403
|
Warrant Liability – Private Warrants |
|
|
Total |
5,376
|
3,403
|
Level 2 [Member] |
|
|
Fair Value Measurements (Details) - Schedule of Fair Value Hierarchy of the Valuation Inputs the Company Utilized to Determine Such Fair Value [Line Items] |
|
|
Warrants Liability – Public Warrants |
|
|
Warrant Liability – Private Warrants |
|
|
Total |
|
|
Level 3 [Member] |
|
|
Fair Value Measurements (Details) - Schedule of Fair Value Hierarchy of the Valuation Inputs the Company Utilized to Determine Such Fair Value [Line Items] |
|
|
Warrants Liability – Public Warrants |
|
|
Warrant Liability – Private Warrants |
2,418
|
2,227
|
Total |
$ 2,418
|
$ 2,227
|
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Shareholders’ Equity (Details) $ / shares in Units, $ in Thousands |
1 Months Ended |
6 Months Ended |
|
|
Mar. 31, 2023
shares
|
Jul. 31, 2019
$ / shares
shares
|
Jun. 30, 2023
USD ($)
shares
|
Jun. 30, 2022
shares
|
Dec. 31, 2022
shares
|
Mar. 31, 2022
$ / shares
shares
|
Shareholders’ Equity (Details) [Line Items] |
|
|
|
|
|
|
Number of vote entitled |
|
|
1
|
|
|
|
Options shares |
|
|
12,426,345
|
|
|
|
Unrecognized compensation costs (in Dollars) | $ |
|
|
$ 19,510
|
|
|
|
Weighted average period |
|
|
2 years 7 months 13 days
|
|
|
|
Convertible warrants |
|
|
2,323,960
|
|
2,391,857
|
|
Exercised warrant |
67,897
|
|
|
|
|
|
Ordinary shares of no-par value |
67,897
|
|
|
|
|
|
Share Incentive Plan 2021 [Member] |
|
|
|
|
|
|
Shareholders’ Equity (Details) [Line Items] |
|
|
|
|
|
|
Options shares |
|
|
18,192,586
|
|
|
|
Option granted period |
|
|
10 years
|
|
|
|
Convertible Debt Securities [Member] |
|
|
|
|
|
|
Shareholders’ Equity (Details) [Line Items] |
|
|
|
|
|
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Exercise price per shares (in Dollars per share) | $ / shares |
|
|
|
|
|
$ 3.87
|
Convertible warrants |
|
|
|
|
|
3,880,777
|
HekaBio K K [Member] |
|
|
|
|
|
|
Shareholders’ Equity (Details) [Line Items] |
|
|
|
|
|
|
Options shares |
|
|
|
1,125,088
|
|
|
Issuance of warrant |
|
651,067
|
|
|
|
|
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|
$ 5.04
|
|
|
|
|
Grant date |
|
4 years
|
|
|
|
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Warrants exercised |
|
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|
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v3.23.2
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|
Jun. 30, 2023 |
Dec. 31, 2022 |
Schedule of Consolidated Financial Statements [Abstract] |
|
|
Authorized Ordinary shares of no-par value |
362,116,800
|
362,116,800
|
Issued and outstanding Ordinary shares of no-par value |
69,373,135
|
69,105,000
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v3.23.2
Shareholders’ Equity (Details) - Schedule of Options and Changes $ / shares in Units, $ in Thousands |
6 Months Ended |
Jun. 30, 2023
USD ($)
$ / shares
shares
|
Schedule of Options and Changes [Abstract] |
|
Number of options Forfeited and cancelled | shares |
(41,292)
|
Weighted average exercise price Forfeited and cancelled | $ / shares |
$ 9.9
|
Service providers [Member] |
|
Schedule of Options and Changes [Abstract] |
|
Number of options at the beginning of year | shares |
8,237,794
|
Weighted average exercise price Outstanding at beginning of year | $ / shares |
$ 5.8
|
Aggregate intrinsic value Outstanding at beginning of year | $ |
$ 2,588
|
Weighted average remaining contractual life (years) beginning of year |
7 years 2 months 26 days
|
Number of options Granted | shares |
3,185,111
|
Weighted average exercise price Granted | $ / shares |
$ 3.4
|
Number of options Exercised | shares |
(2,500)
|
Weighted average exercise price Exercised | $ / shares |
$ 1.1
|
Number of options Outstanding At the end of year | shares |
11,379,113
|
Weighted average exercise price Outstanding at end of year | $ / shares |
$ 5.1
|
Aggregate intrinsic value Outstanding at end of year | $ |
$ 7,709
|
Weighted average remaining contractual life (years) Outstanding at end of year |
7 years 6 months
|
Number of options Exercisable options | shares |
5,838,956
|
Weighted average exercise price Exercisable options | $ / shares |
$ 4.5
|
Aggregate intrinsic value Exercisable options | $ |
$ 4,934
|
Weighted average remaining contractual life (years) Exercisable options |
5 years 10 months 24 days
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Financial Expenses, Net (Details) - Schedule of Financial Expenses, Net - USD ($) $ in Thousands |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Financial expenses: |
|
|
Foreign currency transaction loss |
|
$ 260
|
Remeasurement of warrants, net |
2,164
|
11,105
|
Others |
11
|
13
|
Total financial expenses |
2,175
|
11,378
|
Financial income: |
|
|
Foreign currency transaction income |
220
|
|
Interest from deposits |
1,934
|
436
|
Total financial income |
2,154
|
436
|
Financial expenses, net |
$ 21
|
$ 10,942
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6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Numerator: |
|
|
Net loss |
$ 16,880
|
$ 27,743
|
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|
|
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69,262,381
|
58,023,875
|
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Alpha Tau Medical (NASDAQ:DRTS)
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