Alpha Tau Medical Ltd 6-K, filed Aug 14, 2024
Alpha Tau Medical Ltd. (DRTS)
About this 6-K
Alpha Tau Medical Ltd filed this 6-K on August 14, 2024.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
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
Commission File Number: 001-41316
(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, 2024. |
| ● | Exhibit 99.2. Operating and Financial Review and Prospects in connection the Interim Consolidated Financial Statements for the six months ended June 30, 2024. |
The Interim Consolidated Financial Statements of Alpha Tau Medical Ltd. as of June 30, 2024 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, 2024 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, 333-264306 and 333-274457) and Form S-8 (File Nos. 333-264169, 333-270406 and 333-277733).
1
EXHIBIT INDEX
| Exhibit No. | Description | |
| 99.1 | Interim Consolidated Financial Statements as of June 30, 2024. | |
| 99.2 | Operating and Financial Review and Prospects in connection the Interim Consolidated Financial Statements for the six months ended June 30, 2024. | |
| 101 | The following financial information from Alpha Tau Medical Ltd.’s Report on Form 6-K, formatted in XBRL (eXtensible Business Reporting Language): (i) Interim Consolidated Balance Sheets as of June 30, 2024 and December 31, 2023; (ii) Interim Consolidated Statements of Operations for the six months ended June 30, 2024 and 2023; (iii) Interim Consolidated Statements of Changes in Shareholders’ Equity for the six months ended June 30, 2024 and 2023; (iv) Interim Consolidated Statements of Cash Flows for the six months ended June 30, 2024 and 2023; and (v) Notes to the Interim Consolidated Financial Statements. | |
| 104 | Cover Page Interactive Data File (embedded within the inline XBRL document). |
2
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 14, 2024 | 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, 2024
U.S. DOLLARS IN THOUSANDS
UNAUDITED
INDEX
ALPHA TAU MEDICAL LTD.
INTERIM CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands
| December 31, | June 30, | |||||||||
| 2023 | 2024 | |||||||||
| Note | Audited | Unaudited | ||||||||
| ASSETS | ||||||||||
| CURRENT ASSETS: | ||||||||||
| Cash and cash equivalents | $ | $ | ||||||||
| Short-term deposits | ||||||||||
| Restricted deposits | ||||||||||
| Prepaid expenses and other receivables | ||||||||||
| Total current assets | ||||||||||
| LONG-TERM ASSETS: | ||||||||||
| Long term prepaid expenses | ||||||||||
| Property and equipment, net | ||||||||||
| Right-of-use asset | 3 | |||||||||
| Total long-term assets | ||||||||||
| Total assets | $ | $ | ||||||||
The accompanying notes are an integral part of the interim consolidated financial statements.
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ALPHA TAU MEDICAL LTD.
INTERIM CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands
| December 31, | June 30, | |||||||||
| 2023 | 2024 | |||||||||
| Note | Audited | Unaudited | ||||||||
| LIABILITIES AND SHAREHOLDERS’ EQUITY | ||||||||||
| CURRENT LIABILITIES: | ||||||||||
| Trade payables | $ | $ | ||||||||
| Other payables and accrued expenses | ||||||||||
| Current maturities of operating lease liabilities | 3 | |||||||||
| Total current liabilities | ||||||||||
| LONG-TERM LIABILITIES: | ||||||||||
| Long-term loan | 4 | |||||||||
| Warrants liability | 5 | |||||||||
| Operating lease liabilities | 3 | |||||||||
| Total long-term liabilities | ||||||||||
| Total liabilities | ||||||||||
| COMMITMENTS AND CONTINGENCIES | 7 | |||||||||
| SHAREHOLDERS’ EQUITY: | 8 | |||||||||
| Ordinary shares of -par value per share – Authorized: | ||||||||||
| Additional paid-in capital | ||||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||||
| Total shareholders’ equity | ||||||||||
| Total liabilities and shareholders’ equity | $ | $ | ||||||||
The accompanying notes are an integral part of the interim consolidated financial statements.
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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, | ||||||||||
| 2023 | 2024 | |||||||||
| Note | Unaudited | |||||||||
| Research and development, net | $ | $ | ||||||||
| Marketing expenses | ||||||||||
| General and administrative | ||||||||||
| Total operating loss | ||||||||||
| Financial expenses (income), net | 9 | ( | ) | |||||||
| Loss before taxes on income | ||||||||||
| Tax on income | ||||||||||
| Net loss | ||||||||||
| Net comprehensive loss | $ | $ | ||||||||
| $ | ( | ) | $ | ( | ) | |||||
The accompanying notes are an integral part of the interim consolidated financial statements.
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ALPHA TAU MEDICAL LTD.
INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY
U.S. dollars in thousands (except share and per share data)
| Additional | Total | |||||||||||||||||||
| Ordinary shares | paid-in | Accumulated | shareholders’ | |||||||||||||||||
| Shares | Amount | capital | deficit | equity | ||||||||||||||||
| Balances as of January 1, 2023 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| Issuance of ordinary shares upon exercise of warrants | ||||||||||||||||||||
| Issuance of ordinary shares upon exercise of share options | ||||||||||||||||||||
| Vesting of RSUs | ||||||||||||||||||||
| Share-based compensation | - | |||||||||||||||||||
| Net loss | - | ( | ) | ( | ) | |||||||||||||||
| Balances as of June 30, 2023 (unaudited) | $ | $ | $ | ( | ) | $ | ||||||||||||||
| Additional | Total | |||||||||||||||||||
| Ordinary shares | paid-in | Accumulated | shareholders’ | |||||||||||||||||
| Shares | Amount | capital | deficit | equity | ||||||||||||||||
| Balances as of January 1, 2024 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| Issuance of ordinary shares upon exercise of share options | ||||||||||||||||||||
| Vesting of RSUs | ||||||||||||||||||||
| Share-based compensation | - | |||||||||||||||||||
| Net loss | - | ( | ) | ( | ) | |||||||||||||||
| Balances as of June 30, 2024 (unaudited) | $ | $ | $ | ( | ) | $ | ||||||||||||||
The accompanying notes are an integral part of the interim consolidated unaudited financial statements.
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ALPHA TAU MEDICAL LTD.
INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S. dollars in thousands
| Six months ended June 30, | ||||||||
| 2023 | 2024 | |||||||
| Unaudited | ||||||||
| Cash flows from operating activities: | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation | ||||||||
| Share-based compensation | ||||||||
| Non-cash financial expenses (income), net | ( | ) | ||||||
| Increase in prepaid expenses and other receivables | ( | ) | ( | ) | ||||
| (Increase) decrease in long term prepaid expenses | ( | ) | ||||||
| Increase (decrease) in trade payables | ( | ) | ||||||
| Increase (decrease) in other payables and accrued expenses | ( | ) | ||||||
| Change in the fair value of Warrants Liabilities | ||||||||
| Change in operating lease liabilities | ( | ) | ( | ) | ||||
| Change in operating lease right-of-use assets | ||||||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| Cash flows from investing activities: | ||||||||
| Investment in short-term deposits | ( | ) | ( | ) | ||||
| Proceeds from short-term deposits | ||||||||
| Purchase of property and equipment | ( | ) | ( | ) | ||||
| Net cash provided by investing activities | ||||||||
| Cash flows from financing activities: | ||||||||
| Proceeds from exercise of options | ||||||||
| Net cash provided by financing activities | ||||||||
| Effect of exchange rate changes on cash, cash equivalents and restricted cash | ( | ) | ||||||
| Decrease in cash, cash equivalents and restricted cash | ( | ) | ( | ) | ||||
| Cash, cash equivalents and restricted cash at beginning of period | ||||||||
| Cash, cash equivalents and restricted cash at end of period | $ | $ | ||||||
| Supplemental disclosures of cash flow information: | ||||||||
| Income tax payments | $ | $ | ||||||
| Interest received | $ | $ | ||||||
| Interest paid | $ | $ | ||||||
| Operating lease liabilities arising from obtaining right of use assets | $ | $ | ||||||
The accompanying notes are an integral part of the interim consolidated financial statements.
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| ALPHA TAU MEDICAL LTD. |
| NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS |
| U.S. dollars in thousands (except share and per share data) |
NOTE 1:- GENERAL
| a. | Company description: |
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
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 (“HCCC”), a Delaware corporation and special purpose acquisition company (“SPAC”), and Archery Merger Sub Inc., a wholly-owned subsidiary of the Company (“Merger Sub”), pursuant to which Merger Sub merged with and into HCCC (the “Merger”). The Merger was consummated on March 7, 2022, with HCCC becoming a wholly-owned subsidiary of the Company and the Company became a Nasdaq listed publicly traded company on March 8, 2022.
In July 2022, HCCC was dissolved.
| 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 is 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.
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| 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.)
As of June 30, 2024,
the Company had cash, cash equivalents, short-term deposits and restricted deposits of $
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, 2023 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, 2023.
The significant accounting policies disclosed in the Company’s audited 2023 consolidated financial statements and notes thereto have been applied consistently to these unaudited interim consolidated financial statements. Results for the six-month period ended June 30, 2024 are not necessarily indicative of results that may be expected for the year ending December 31, 2024.
| b. | Use of estimates for the preparation of financial statements: |
The preparation of the unaudited interim consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. On an ongoing basis, the Company’s management evaluates estimates, including those related to fair values of warrants, fair values of share-based awards, deferred taxes, and contingent liabilities. Such estimates are based on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities.
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| 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.)
| c. | Restricted cash: |
Restricted cash is primarily invested
in bank deposit and is used as security for the Company’s lease commitments.
| June 30, | ||||||||
| 2023 | 2024 | |||||||
| Unaudited | ||||||||
| Cash and cash equivalents, as reported on the balance sheets | $ | $ | ||||||
| Restricted cash, as reported on the balance sheets | ||||||||
| Cash, cash equivalents, and restricted cash, as reported in the statements of cash flows | $ | $ | ||||||
| d. | 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.
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| 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 Public and Private Warrants assumed during the Merger (see also note 5) 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,
2023 and June 30, 2024, the Company has
In addition, as
of December 31, 2023 and June 30, 2024 the Company has
| 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.
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| 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, short-term deposits, restricted deposits, prepaid expenses and other receivables, long term prepaid expenses, 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.
| Six months ended June 30, | ||||||||
| 2023 | 2024 | |||||||
| Unaudited | ||||||||
| Operating lease cost | $ | $ | ||||||
| Variable lease cost | ||||||||
| Total net lease costs | $ | $ | ||||||
| As of | ||||||||
| December 31, 2023 | June 30, 2024 | |||||||
| Audited | Unaudited | |||||||
| Operating lease ROU assets | $ | $ | ||||||
| Operating lease liabilities, current | $ | $ | ||||||
| Operating lease liabilities, long-term | $ | $ | ||||||
| Weighted average remaining lease term (in years) | ||||||||
| Weighted average discount rate | % | % | ||||||
| Operating leases | ||||
| Unaudited | ||||
| 2024 | $ | |||
| 2025 | ||||
| 2026 | ||||
| 2027 | ||||
| 2028 | ||||
| 2029 and thereafter | ||||
| Total undiscounted lease payments | ||||
| Less: imputed interest | ||||
| Present value of lease liabilities | $ | |||
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| ALPHA TAU MEDICAL LTD. |
| NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS |
| U.S. dollars in thousands (except share and per share data) |
NOTE 4:- LONG-TERM LOAN
In connection with financing the acquisition
of a long-term leasehold on a plot of land in the Har Hotzvim Industrial Park in Jerusalem, the Company entered into agreements with Bank
Leumi Le-Israel BM (the “Lender”), for: 1) a letter of credit in the amount of approximately NIS
The long-term loan matures in a bullet
payment due in September 2025, subject to any extensions as may be agreed with the Lender, and bears monthly interest at a spread of
The Company chose to use these financing instruments to close the acquisition of the long-term leasehold, pending its exploration of comprehensive long-term financing alternatives for the development of the land into a larger headquarters for the Company.
For the six month period ended June
30, 2024, the Company recorded interest expenses and currency exchange income in amount of $
NOTE 5:- WARRANTS LIABILITY
In March 2022, in conjunction with the Merger with HCCC, the Company issued
As
of June 30, 2024, a total of
As
of June 30, 2024, a total of
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 $ |
| ● | Upon not less than |
| ● | If, and only if, the closing price of the Ordinary shares
equals or exceeds $ |
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| ALPHA TAU MEDICAL LTD. |
| NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS |
| U.S. dollars in thousands (except share and per share data) |
NOTE 5:- WARRANTS LIABILITY (Cont.)
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
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
NOTE 6:- FAIR VALUE MEASUREMENTS
| December 31, 2023 | ||||||||||||
| Level 1 | Level 2 | Level 3 | ||||||||||
| (Unaudited) | ||||||||||||
| Warrants Liability – Public Warrants | $ | $ | $ | |||||||||
| Warrant Liability – Private Warrants | ||||||||||||
| Total | $ | $ | $ | |||||||||
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| ALPHA TAU MEDICAL LTD. |
| NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS |
| U.S. dollars in thousands (except share and per share data) |
NOTE 6:- FAIR VALUE MEASUREMENTS (Cont.)
| June 30, 2024 | ||||||||||||
| Level 1 | Level 2 | Level 3 | ||||||||||
| (Unaudited) | ||||||||||||
| Warrants Liability – Public Warrants | $ | $ | $ | |||||||||
| Warrant Liability – Private Warrants | ||||||||||||
| Total | $ | $ | $ | |||||||||
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.
| June 30, 2024 | ||||
| Unaudited | ||||
| Beginning of period | $ | |||
| Change in fair value | ( | ) | ||
| End of period | $ | |||
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| ALPHA TAU MEDICAL LTD. |
| NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS |
| U.S. dollars in thousands (except share and per share data) |
NOTE 7:- COMMITMENTS AND CONTINGENT LIABILITIES
| a. | Guarantees in the amount of $ |
| 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 $ |
In addition,
under the intellectual property purchase agreement with Althera, the Company assumed all of Althera’s liabilities towards the IIA totaling
$
| c. | Under the February 2, 2016 intellectual property purchase agreement with Althera, the Company is obligated
to pay Althera a fixed rate of |
| 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 |
| 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 |
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| ALPHA TAU MEDICAL LTD. |
| NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS |
| U.S. dollars in thousands (except share and per share data) |
NOTE 7:- COMMITMENTS AND CONTINGENT LIABILITIES (Cont.)
| 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 |
| g. | On December 1, 2020, the Company entered into a clinical trial agreement with Cambridge University Hospitals
NHS Trust, wherein Cambridge will receive |
| 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 8:- SHAREHOLDERS’ EQUITY
| a. | Ordinary shares: |
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
| b. | Share option plans: |
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
As of June 30,
2024,
- 16 -
| ALPHA TAU MEDICAL LTD. |
| NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS |
| U.S. dollars in thousands (except share and per share data) |
NOTE 8:- SHAREHOLDERS’ EQUITY (Cont.)
| Six months ended June 30, 2024 (unaudited) | ||||||||||||||||
| Number of options | Weighted average exercise price | Aggregate intrinsic value | Weighted average remaining contractual life (years) | |||||||||||||
| Outstanding at beginning of period | $ | $ | ||||||||||||||
| Granted | $ | |||||||||||||||
| Exercised | ( | ) | $ | |||||||||||||
| Forfeited and cancelled | ( | ) | $ | |||||||||||||
| Outstanding at end of period | $ | $ | ||||||||||||||
| Exercisable options | $ | $ | ||||||||||||||
| Number of RSU | ||||
| Outstanding at beginning of year | ||||
| Granted | ||||
| Vested | ( | ) | ||
| Forfeited and cancelled | ( | ) | ||
| Outstanding at end of period | ||||
| Six months ended June 30, | ||||||||
| 2023 | 2024 | |||||||
| Unaudited | ||||||||
| Research and development | $ | $ | ||||||
| Marketing expenses | ||||||||
| General and administrative | ||||||||
| Total share-based compensation expense | $ | $ | ||||||
As of June 30, 2024,
there were unrecognized compensation costs of $
- 17 -
| ALPHA TAU MEDICAL LTD. |
| NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS |
| U.S. dollars in thousands (except share and per share data) |
NOTE 8:- SHAREHOLDERS’ EQUITY (Cont.)
| c. | Warrants to investors: |
Upon completion of
the Merger, the
As of June 30, 2024,
a total of
| d. | Warrants to consultants: |
In April 2016,
NOTE 9:- FINANCIAL EXPENSES (INCOME), NET
| Six months ended June 30, | ||||||||
| 2023 | 2024 | |||||||
| Unaudited | ||||||||
| Financial expenses: | ||||||||
| Interest on loan | $ | $ | ||||||
| Remeasurement of warrants, net | ||||||||
| Others | ||||||||
| Total financial expenses | ||||||||
| Financial income: | ||||||||
| Foreign currency transaction income | ||||||||
| Interest from deposits | ||||||||
| Total financial income | ||||||||
| Financial expenses (income), net | $ | $ | ( | ) | ||||
- 18 -
| ALPHA TAU MEDICAL LTD. |
| NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS |
| U.S. dollars in thousands (except share and per share data) |
NOTE 10:- BASIC AND DILUTED NET LOSS PER SHARE
| Six months ended June 30, | ||||||||
| 2023 | 2024 | |||||||
| Unaudited | ||||||||
| Numerator: | ||||||||
| Net loss | $ | $ | ||||||
| Denominator: | ||||||||
| $ | $ | |||||||
For the six months
ended June 30, 2023 and 2024, 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, 2023, and 2024 the total weighted average number of shares related to outstanding
options and warrants excluded from the calculations of diluted net loss per share were
- - - - - - - - - - -
- 19 -
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, 2023 and 2024 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, 2023 appearing in our Annual Report on Form 20-F for the year ended December 31, 2023 (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.
| A. | Operating Results |
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. Following these initial positive results, we substantially expanded our clinical evaluations in later trials to a much wider patient population. Specifically, we initiated follow-on studies at multiple clinical sites in Israel and around the world, to evaluate Alpha DaRT in cancers of the skin, superficial soft tissue, or oral cavity, regardless of cell type, which includes SCC as well as basal cell carcinoma, melanoma, skin metastases, and others. 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 results of this study were published in an article in the JAMA Network Open journal in May 2023. 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 have also conducted an open-label multi-center pivotal clinical trial in Japan in recurrent head & neck cancer, whose endpoints exceeded the target endpoints for safety and efficacy. On the basis of this trial and following multiple pre-submission consultation meetings with Japan’s Pharmaceuticals and Medical Devices Agency, or PMDA, per common practice in Japan, we submitted a request to the PMDA in November 2023 for shonin pre-market approval of Alpha DaRT in patients with recurrent head & neck cancer, We anticipate a response to our submission in the fourth quarter of 2024. In August 2023, we announced that in long-term follow-up data from 81 lesions treated in 71 patients with unresectable, recurrent, or locally advanced head and neck or skin tumors treated Alpha DaRT across four prospective trials, we observed two-year actuarial local recurrence-free survival of 77% and no grade 2 or higher late toxicities. This data was published in an article in the Cancers journal in June 2024. In addition, we are conducting a first-in-woman study in the United Kingdom to evaluate the feasibility and safety study of Alpha DaRT for the treatment of new and recurrent squamous cell carcinoma of the vulva, using a similar approach to that used in superficial lesions of the skin, head or neck.
We have also evaluated and continue to evaluate the feasibility, safety and efficacy of the Alpha DaRT technology for the treatment of solid tumors in internal organs, including the pancreas, prostate, brain, breast, lung and liver. We are currently conducting a safety and feasibility trial of Alpha DaRT treatment of advanced pancreatic cancer at two centers in Montreal, Canada, in addition to ongoing trials in Israel. In November 2023, we announced interim data from the first five patients treated in this trial, indicating successful delivery in all five cases and no product-associated serious adverse events. In addition, we reported that the first five patients received conservative partial tumor coverage, and in patients with higher radium-224 levels, increased tumor responses were observed, with the last three patients presenting two stable disease responses and one partial response at last measurement.
We have engaged with a number of prestigious medical and educational institutions and, as of July 1, 2024, have sixteen clinical studies ongoing worldwide across these two parallel strategies, of generating data in superficial tumors as well as conducting studies in other indications
Additionally, in our pre-clinical studies, we evaluated the Alpha DaRT on 20 tumor models (both human and mouse). Alpha DaRT sources were observed to have killed multiple types of mouse and human tumors in vivo. The intensity of the killing activity varied between tumor types, and was dependent on the ability of the radioactive atoms to diffuse inside the tumor and on the intrinsic sensitivity of the tissue to DNA damage induced by the radiation, but all tumor types showed responsiveness to Alpha DaRT, i.e., there was no observed resistance. We therefore believe that our technology may potentially be relevant for treatment across a broad range of tumors. We are currently focused on developing the Alpha DaRT for use in a number of potential applications, particularly in refractory or unresectable localized tumors which are not being adequately addressed by standard of care, tumor types with a high unmet need (such as pancreatic adenocarcinoma or glioblastoma multiforme), and metastatic tumors in combination with systemic therapies such as checkpoint inhibitors. We are also investigating the potential of the Alpha DaRT to elicit an immune response as observed in previous pre-clinical data, as well as anecdotal evidence of response from untreated tumors, or abscopal effects, which may have the potential to inhibit or even reduce metastases.
If 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.
2
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, 2024 we have raised an aggregate of $186,563 to fund our operations, of which $179,466 were gross proceeds from issuance of shares and $7,097 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 $16,880 and $15,350 for the six months ended June 30, 2023 and June 30, 2024, respectively. As of June 30, 2024, we had an accumulated deficit of $131,109. 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; |
3
| ● | 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, 2024, we had cash and cash equivalents, short-term deposits and restricted deposits totaling $74,146. 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.
4
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; |
5
| ● | 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 as we 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.
6
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 on loan, 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, 2023 and 2024:
| Six Months Ended June 30, | ||||||||||||||||
| 2023 | 2024 | Change | % Change | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development, net | $ | 12,261 | $ | 13,314 | $ | 1,053 | 8.6 | % | ||||||||
| Marketing | 920 | 1,133 | 213 | 23.2 | ||||||||||||
| General and administrative | 3,631 | 3,031 | (600 | ) | (16.5 | ) | ||||||||||
| Total operating expenses | $ | 16,812 | $ | 17,478 | $ | 666 | 4.0 | % | ||||||||
| Loss from operations: | ||||||||||||||||
| Financial expense (income), net | 21 | (2,132 | ) | (2,153 | ) | (10,252 | ) | |||||||||
| Loss before taxes on income | 16,833 | 15,346 | (1,487 | ) | (8.8 | ) | ||||||||||
| Tax on income | 47 | 4 | (43 | ) | (91.5 | ) | ||||||||||
| Net loss | $ | 16,880 | $ | 15,350 | $ | (1,530 | ) | (9.1 | )% | |||||||
Comparison of the Six Months Ended June 30, 2023 and 2024
Research and development, net
Research and development, net increased by $1,053 from $12,261 for the six months ended June 30, 2023 to $13,314 for the six months ended June 30, 2024. The increase in research and development expense was primarily attributable to increased employee compensation and benefits, including share-based compensation, increased costs of raw materials, and increased travel expenses related to our U.S. multi-center pivotal trial, offset by lower third-party contractor expenses.
Marketing expenses
Marketing expense increased by $213 from $920 for the six months ended June 30, 2023 to $1,133 for the six months ended June 30, 2024. The increase in marketing expenses was primarily attributable to increased employee compensation and benefits, including share-based compensation, and increased marketing activities.
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General and administrative
General and administrative decreased by $600 from $3,631 for the six months ended June 30, 2023 to $3,031 for the six months ended June 30, 2024. The decrease in general and administrative expenses was primarily due to decreased professional fees (including D&O insurance and legal expenses), offset by increased travel expenses and increased employee compensation and benefits, including share-based compensation.
Financial expense, net
Financial expense, net decreased $2,153 from $21 for the six months ended June 30, 2023 to $(2,132) for the six months ended June 30, 2024. 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, offset by an interest on long-term loan.
| B. | Liquidity and Capital Resources |
Sources of Liquidity
We have funded our operations from inception through June 30, 2024 primarily through gross proceeds of $179,466 from issuance of our shares and $7,097 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, 2023 | June 30, 2024 | |||||||
| Cash and cash equivalents | $ | 12,657 | $ | 2,763 | ||||
| Short-term deposits | 69,131 | 68,268 | ||||||
| Restricted deposits | 3,152 | 3,115 | ||||||
| $ | 84,940 | $ | 74,146 | |||||
Cash Flows
The following table provides information regarding our cash flows for the periods presented:
| Six months ended June 30, | ||||||||
| 2023 | 2024 | |||||||
| Net cash used in operating activities | $ | (9,922 | ) | $ | (12,803 | ) | ||
| Net cash provided by investing activities | 4,974 | 2,886 | ||||||
| Net cash provided by financing activities | 2 | 25 | ||||||
| Effect of exchange rate changes on cash, cash equivalents and restricted cash | (51 | ) | 18 | |||||
| Decrease in cash, cash equivalents and restricted cash | $ | (4,997 | ) | $ | (9,894 | ) | ||
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 $9,922 for the six months ended June 30, 2023, compared to $12,803 for the six months ended June 30, 2024. The increase of $2,881 was primarily attributable to a decrease in net loss of $1,530 and a $1,083 increase of share-based compensation, offset by a $2,808 increase in non-cash financial income, net, a $924 decrease in trade payables, a $599 decrease in other payables and accrued expenses, and a $1,706 decrease in the add-back of the change in fair value of Warrants liabilities.
Net cash provided by investing activities
Net cash provided by investing activities was $4,974 for the six months ended June 30, 2023, compared to net cash provided by investing activities of $2,866 for the six months ended June 30, 2024. The decrease in cash provided by investing activities of $2,108 was primarily attributable to a $68,931 decrease in proceeds from bank deposits, offset by a decrease of $71,513 investments into bank deposits and a $474 decrease in purchase of property and equipment.
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Net cash provided by financing activities
Net cash provided by financing activities was $2 for the six months ended June 30, 2023 compared to $25 for the six months ended June 30, 2024. The increase of $23 was attributable to exercise of options.
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 $51 for the six months ended June 30, 2023 compared to an increase of $18 for the six months ended June 30, 2024. The increase of $69 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.
| D. | Trend Information |
Other than as disclosed elsewhere in this Form 6-K or in the unaudited consolidated financial statements as of and for the six months ended June 30, 2023 and 2024 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.
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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. |
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Public and Private Warrants
In March 2022, in conjunction with the Merger with HCCC, the Company issued 13,749,984 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, 2024, no Public or Private Warrants were exercised. As of June 30, 2024, 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 by considering the prevailing market price of the Public Warrants as well as 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 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.
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