Alpha Tau Medical Ltd 6-K, filed May 26, 2022
Alpha Tau Medical Ltd. (DRTS)
About this 6-K
Alpha Tau Medical Ltd filed this 6-K on May 26, 2022.
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 May 2022
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 x Form 40-F ¨
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ¨
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ¨
CONTENTS
On May 26, 2022, Alpha Tau Medical Ltd. (Nasdaq: DRTS) (the “Company”) issued a press release titled “Alpha Tau Medical Announces First Quarter 2022 Financial Results and Provides Corporate Update.” A copy of this press release is attached to this Form 6-K as Exhibit 99.1.
Other than as indicated below, the information in this Report on Form 6-K, including in Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise set forth herein or as shall be expressly set forth by specific reference in such a filing.
The financial information contained in the (i) consolidated balance sheets, (ii) consolidated statement of operations and (iii) consolidated statement of cash flows included in the press release attached as Exhibit 99.1 to this Report on Form 6-K is hereby incorporated by reference into the Company’s Registration Statement on Form S-8 (File No. 333-264169).
EXHIBIT INDEX
|
Exhibit No. |
Description | |
| 99.1 | Press release dated May 26, 2022. | |
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: May 26, 2022 | By: | /s/ Uzi Sofer |
| Uzi Sofer | ||
| Chief Executive Officer | ||
Exhibit 99.1
Alpha Tau Medical Announces First Quarter 2022 Financial Results and Provides Corporate Update
-Debuted as publicly-traded oncology company in March 2022 under symbol DRTS while raising approximately $104 million in gross proceeds-
-Targeted start of U.S. multi-center pivotal trial in skin cancers in the middle of 2022-
JERUSALEM, May 26, 2022 /PRNewswire/ -- Alpha Tau Medical Ltd. (Nasdaq: DRTS and DRTSW), ("Alpha Tau" or the “Company”), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT™, reported first quarter 2022 financial results and provided a corporate update.
"2022 is an important year for the Company, as we look to initiate a number of important clinical trials across large global markets, including our first U.S. pivotal trial as well as trials in internal organs such as the prostate," commented Alpha Tau CEO Uzi Sofer. "The first quarter of 2022 already saw us reach a number of meaningful milestones, including our first U.S. data read out and our debut as a public company traded on NASDAQ under symbol “DRTS.” We are also working in parallel to expand our manufacturing capabilities and to strengthen our supply chain in the U.S., Israel, and Asia, as part of the expansion of our clinical trial activities and future commercialization."
First quarter 2022 Corporate Highlights:
| · | Reported results in January 2022 from the first pilot multi-center study of Alpha DaRT in the United States, led by Memorial Sloan Kettering Cancer Center. In this trial of malignant skin and soft tissue cancer patients, a complete response, as measured by RECIST criteria, was observed in all ten out of ten tumors treated (100%), with no product-related serious adverse events reported. Alongside these data, a 98% overall response rate was observed in a pooled analysis of superficial tumors treated that reached their efficacy endpoint measurement by quarter end, across the Company’s various trials. | |
| · | Completed patient recruitment in the Company’s Japanese pivotal trial in head and neck cancer, with data submission targeted for the second half of 2022. | |
| · | Entered into a sponsored research agreement with investigators at The University of Texas MD Anderson Cancer Center in January 2022 to evaluate the combination of Alpha DaRT with DNA-repair inhibitors and immune checkpoint inhibitors for the treatment of breast tumors. | |
| · | Completed its business combination in March 2022 with Healthcare Capital Corp., a special purpose acquisition company, together with a concurrent Private Investment in Public Equity (PIPE) financing, raising a total of approximately $104 million in gross proceeds, and commenced trading of its shares and warrants on the Nasdaq Capital Market under the symbols “DRTS” and “DRTSW”, respectively. | |
| · | Appointed Ruth (Ruti) Alon to its Board of Directors in March 2022. Ms. Alon brings a wealth of healthcare experience and serves on the boards of multiple private and public companies in the sector. |
Upcoming 2022 Milestone Targets Include:
| · | First Israeli patient in the prostate cancer feasibility trial in the second quarter of 2022. | |
| · | Initiation of multi-center pivotal U.S. trial in skin cancers in the middle of 2022. | |
| · | Recruitment in the Canadian feasibility trial in pancreatic tumors to begin in the second half of 2022. | |
| · | Submission of Alpha DaRT pivotal trial in head and neck cancer to Japan’s PMDA in the second half of 2022 for marketing authorization. |
Financial results for the first quarter ended March 31, 2022
R&D expenses for the quarter ended March 31, 2022 were $5.2 million, compared to $2.2 million for the same period in 2021, primarily due to increased R&D activity and increased share-based compensation costs.
Marketing expenses for the quarter ended March 31, 2022 were $0.2 million, compared to $0.2 million for the same period in 2021.
G&A expenses for the quarter ended March 31, 2022 were $3.3 million, compared to $0.4 million for the same period in 2021, primarily due to costs associated with the merger with Healthcare Capital Corp., increased professional fees and share-based compensation.
Financial expenses, net, for the quarter ended March 31, 2022 were $17.0 million, compared to $9.0 million for the same period in 2021, primarily due to an increase in the revaluation of warrants.
For the quarter ended March 31, 2022, the Company had a net loss of $25.7 million, or ($0.54) per share, compared to a loss of $11.7 million, or ($0.29) per share, in the same period in 2021.
Balance Sheet Highlights
As of March 31, 2022, the Company had cash and cash equivalents, restricted cash and short term deposits in the amount of $107.0 million, compared to $31.9 million on December 31, 2021. In addition, incremental proceeds of approximately $13 million from the original PIPE were received after March 31, 2022. The Company expects that this cash balance will be sufficient to fund operations for at least two years.
In addition, the Company's Board of Directors approved a program for the buyback of the Company's publicly traded warrants in an amount of up to $3 million. Repurchases may be started or suspended at any time without prior notice, depending on market conditions and other factors.
About Alpha DaRT™
Alpha DaRT™ (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral insertion of radium-224 impregnated seeds. When the radium decays, its short-lived daughters are released from the seed, and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.
About Alpha Tau Medical, Ltd.
Founded in 2016, Alpha Tau is an Israeli medical device company that focuses on research, development, and potential commercialization of the Alpha DaRT for the treatment of solid tumors. The technology was initially developed by Prof. Itzhak Kelson and Prof. Yona Keisari from Tel Aviv University.
Forward-Looking Statements
This press release includes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. When used herein, words including "anticipate," "being," "will," "plan," "may," "continue," and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Alpha Tau's current expectations and various assumptions. Alpha Tau believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Alpha Tau may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation: (i) Alpha Tau's ability to receive regulatory approval for its Alpha DaRT technology or any future products or product candidates; (ii) Alpha Tau's limited operating history; (iii) Alpha Tau's incurrence of significant losses to date; (iv) Alpha Tau's need for additional funding and ability to raise capital when needed; (v) Alpha Tau's limited experience in medical device discovery and development; (vi) Alpha Tau's dependence on the success and commercialization of the Alpha DaRT technology; (vii) the failure of preliminary data from Alpha Tau's clinical studies to predict final study results; (viii) failure of Alpha Tau's early clinical studies or preclinical studies to predict future clinical studies; (ix) Alpha Tau's ability to enroll patients in its clinical trials; (x) undesirable side effects caused by Alpha Tau's Alpha DaRT technology or any future products or product candidates; (xi) Alpha Tau's exposure to patent infringement lawsuits; (xii) Alpha Tau's ability to comply with the extensive regulations applicable to it; (xiii) the ability to meet Nasdaq's listing standards; (xiv) costs related to being a public company; (xv) changes in applicable laws or regulations; (xix) impacts from the COVID-19 pandemic; and the other important factors discussed under the caption "Risk Factors" in Alpha Tau's Annual Report on Form 20-F filed with the SEC on March 28, 2022, and other filings that Alpha Tau may make with the United States Securities and Exchange Commission. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While Alpha Tau may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing Alpha Tau's views as of any date subsequent to the date of this press release.
Investor Relations Contact:
IR@alphatau.com
CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands
March
31, | December
31, | |||||||
| Unaudited | Audited | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 98,071 | $ | 23,236 | ||||
| Restricted cash | 837 | 618 | ||||||
| Short-term deposits | 8,092 | 8,080 | ||||||
| Prepaid expenses and other receivables | 4,204 | 707 | ||||||
| Total current assets | 111,204 | 32,641 | ||||||
| LONG-TERM ASSETS: | ||||||||
| Long term prepaid expenses | 223 | 2,028 | ||||||
| Property and equipment, net | 7,613 | 7,546 | ||||||
| Total long-term assets | 7,836 | 9,574 | ||||||
| Total assets | $ | 119,040 | $ | 42,215 | ||||
CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands
| March 31, 2022 | December 31, 2021 | |||||||
| Unaudited | Audited | |||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Trade Payables | $ | 3,829 | $ | 1,203 | ||||
| Other payables and accrued expenses | 2,467 | 3,202 | ||||||
| Total current liabilities | 6,296 | 4,405 | ||||||
| LONG-TERM LIABILITIES: | ||||||||
| Warrants liability | 18,755 | - | ||||||
| Warrants to convertible Preferred shares | - | 18,623 | ||||||
| Total liabilities | 25,051 | 23,028 | ||||||
| Convertible Preferred shares of
no-par value per share – Authorized: 25,348,176 shares as of December 31, 2021; Issued and outstanding: 0 and 13,739,186 shares as of March 31, 2022 and December 31, 2021, respectively | - | 53,964 | ||||||
| SHAREHOLDERS' DEFICENCY: | ||||||||
| Share capital | ||||||||
| Ordinary Shares of no-par value per
share - Authorized: 362,116,800 and 72,423,360 shares as of March 31, 2022 and December 31, 2021, respectively; Issued and outstanding: 66,973,188 and 40,528,913 shares as of March 31, 2022 and December 31, 2021, respectively | - | - | ||||||
| Additional paid-in capital | 172,573 | 18,063 | ||||||
| Accumulated deficit | (78,584 | ) | (52,840 | ) | ||||
| Total shareholders' equity (deficiency) | 93,989 | (34,777 | ) | |||||
| Total liabilities and shareholders' equity (deficiency) | $ | 119,040 | $ | 42,215 | ||||
CONSOLIDATED STATEMENTS OF OPERATIONS
U.S. dollars in thousands (except share and per share data)
| Three months ended March 31, | ||||||||
| 2022 | 2021 | |||||||
| Unaudited | ||||||||
| Research and development, net | $ | 5,235 | $ | 2,189 | ||||
| Marketing expenses | 208 | 167 | ||||||
| General and administrative expenses | 3,338 | 379 | ||||||
| Total operating loss | 8,781 | 2,735 | ||||||
| Financial expenses, net | 16,961 | 8,965 | ||||||
| Loss before taxes on income | 25,742 | 11,700 | ||||||
| Tax on income | 2 | 11 | ||||||
| Net loss | 25,744 | 11,711 | ||||||
| Net comprehensive loss | $ | 25,744 | $ | 11,711 | ||||
| Net loss per share, basic and diluted | $ | (0.54 | ) | $ | (0.29 | ) | ||
| Weighted-average shares used in computing net loss per share attributable to ordinary shareholders, basic and diluted*) | 47,504,979 | 40,510,572 | ||||||
*) Prior period results have been retroactively adjusted to reflect the 1: 0.905292 stock split effected on March 7, 2022.
CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S. dollars in thousands
Three
months ended | ||||||||
| 2022 | 2021 | |||||||
| Unaudited | ||||||||
| Cash flows from operating activities: | ||||||||
| Net loss | $ | (25,744 | ) | $ | (11,711 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation | 231 | 164 | ||||||
| Share-based compensation | 1,982 | 145 | ||||||
| Increase in prepaid expenses and other receivables | (3,447 | ) | (307 | ) | ||||
| Decrease (increase) in long term prepaid expenses | 1,805 | (30 | ) | |||||
| Remeasurement of warrants to convertible preferred shares | 16,911 | 8,462 | ||||||
| Financial expenses, net | 36 | 479 | ||||||
| Increase in trade payables | 2,626 | 72 | ||||||
| Decrease in other payables and accrued expenses | (985 | ) | (402 | ) | ||||
| Net cash used in operating activities | (6,585 | ) | (3,128 | ) | ||||
| Cash flows from investing activities: | ||||||||
| Purchase of property and equipment | (298 | ) | (609 | ) | ||||
| Net cash used in investing activities | (298 | ) | (609 | ) | ||||
| Cash flows from financing activities: | ||||||||
| Proceeds from exercise of warrants | 1,350 | - | ||||||
| Proceeds from exercise of options | - | 1 | ||||||
| Proceeds from SPAC merger and PIPE financing, net of transaction cost | 80,635 | - | ||||||
| Net cash provided by financing activities | 81,985 | 1 | ||||||
| Effect of exchange rate changes on cash, equivalents and restricted cash | (48 | ) | (564 | ) | ||||
| Increase (decrease) in cash, cash equivalents and restricted cash | 75,054 | (4,300 | ) | |||||
| Cash, cash equivalents and restricted cash at beginning of period | 23,854 | 16,174 | ||||||
| Cash, cash equivalents and restricted cash at end of period | $ | 98,908 | $ | 11,874 | ||||
| Supplemental disclosures of cash flow information: | ||||||||
| Income tax payments | $ | - | $ | 40 | ||||
| Interest received | $ | - | $ | 4 | ||||
Non-cash activities: | ||||||||
| Receivables from exercise of options to ordinary shares | $ | - | $ | 20 | ||||