Alpha Tau Medical Ltd 6-K, filed Nov 22, 2022
Alpha Tau Medical Ltd. (DRTS)
About this 6-K
Alpha Tau Medical Ltd filed this 6-K on November 22, 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 November 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 November 22, 2022, Alpha Tau Medical Ltd. (Nasdaq: DRTS) (the “Company”) issued a press release titled “Alpha Tau Medical Announces Third 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 and (ii) consolidated statement of operations 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 November 22, 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: November 22, 2022 | By: | /s/ Uzi Sofer |
| Uzi Sofer | ||
| Chief Executive Officer | ||
Exhibit 99.1
Alpha Tau Medical Announces Third Quarter 2022 Financial Results and Provides Corporate Update
JERUSALEM, November 22, 2022 - 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 third quarter 2022 financial results and provided a corporate update.
"Alpha Tau remained active in the third quarter, as we continued preparations for our upcoming U.S. pivotal study in recurrent cutaneous squamous cell carcinoma and laid the groundwork for exploration of our Alpha DaRT oncology treatment platform across a broad set of applications," said Alpha Tau CEO Uzi Sofer. "At the same time, we have remained highly visible through a series of scientific publications and presentations to discuss our Alpha DaRT treatment. In anticipation of pivotal study data and a potential U.S. launch, we are actively preparing for our global commercialization efforts, having brought the highly experienced Peter Melnyk into the role of Chief Commercial Officer, while we continue to ramp up manufacturing capacity across the world. Peter will focus on prelaunch activities across the U.S. and international markets to help prepare for future reimbursement and commercialization efforts. In parallel, we continue to initiate a number of feasibility trials in internal organs and develop new delivery technologies for Alpha DaRT to expand its use in patients underserved by current treatments. With all of this activity, we remain well capitalized and focused on efficient operations as we continue to execute on our strategic plans."
Recent Corporate Highlights:
| · | Peter Melnyk, a former member of Alpha Tau’s Board of Directors, assumed the full-time position of Alpha Tau’s Chief Commercial Officer. |
| · | Two landmark pre-clinical studies demonstrating significant potential synergies between the Alpha DaRT treatment and standard-of-care immunotherapy, chemotherapy and anti-angiogenic therapy were published in major peer-reviewed journals. |
| o | Study on combination with anti-PD1 therapy published by International Journal of Radiation Oncology, Biology, Physics, known in the field as the Red Journal, the official journal of the American Society for Radiation Oncology (ASTRO). |
| o | Study on combinations with chemotherapy and anti-angiogenic therapy in human glioblastoma multiforme xenografts published by Frontiers in Oncology, in its Radiation Oncology section. |
| · | Medicines and Healthcare products Regulatory Agency of the United Kingdom approved clinical trial in squamous cell carcinoma of the vulva at Addenbrookes Hospital in Cambridge. |
| · | Health Canada approved the addition of Jewish General Hospital in Montreal as a second site in the Company’s clinical trial in advanced pancreatic cancer. |
| · | Dr. Christopher Barker of Memorial Sloan Kettering Cancer Center presented at the ASTRO 2022 Annual Meeting on results of the Company’s U.S. pilot feasibility study completed earlier in 2022. |
| · | Investigators at The University of Texas MD Anderson Cancer Center presented a poster at the Radiation Research Society’s 2022 Annual Meeting on tumor growth delay and immune stimulation using the Alpha DaRT in treating 4T1 murine triple-negative breast cancer tumors. |
Upcoming Anticipated Milestones
| · | Expecting first patient treated in U.S. multi-center pivotal trial in recurrent cutaneous SCC around year-end 2022. |
| · | Targeting recruitment in the Canadian feasibility trial in pancreatic tumors to begin around year-end 2022. |
| · | Planning to begin an Israeli feasibility trial in pancreatic tumors in the first quarter of 2023. |
| · | Planned submission of Alpha DaRT pivotal trial results in head and neck SCC to Japan’s regulatory authority, PMDA, around year-end 2022, for marketing approval. |
| · | Targeting Health Canada approval for initiation of liver cancer feasibility trial by the first quarter of 2023. |
Financial results for the third quarter ended September 30, 2022
R&D expenses for the quarter ended September 30, 2022 were $4.8 million, compared to $3.0 million for the same period in 2021, primarily due to increased R&D headcount, costs associated with our U.S. multi-center pivotal study and other clinical studies, and increased share-based compensation costs and accrual of other compensation expenses.
Marketing expenses for the quarter ended September 30, 2022 were $0.2 million, compared to $0.1 million for the same period in 2021.
G&A expenses for the quarter ended September 30, 2022 were $2.3 million, compared to $0.5 million for the same period in 2021, primarily due to increased professional fees (including D&O insurance), share-based compensation, advisors and other expenses associated with being a public company, and accrual of other compensation expenses.
Financial income, net, for the quarter ended September 30, 2022 was $4.7 million, compared to financial expense, net of $1.2 million for the same period in 2021, primarily due to the remeasurement of warrants and interest income on cash balances.
For the quarter ended September 30, 2022, the Company had a net loss of $2.6 million, or ($0.04) per share, compared to a loss of $4.8 million, or ($0.12) per share, in the same period in 2021.
Balance Sheet Highlights
As of September 30, 2022, the Company had cash and cash equivalents, restricted cash and short-term deposits in the amount of $108.5 million, compared to $31.9 million on December 31, 2021. The Company expects that this cash balance will be sufficient to fund operations for at least two years.
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 delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources 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 filed on form 20-F 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
| September 30, | December 31, | |||||||
| 2022 | 2021 | |||||||
| Unaudited | Audited | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 5,930 | $ | 23,236 | ||||
| Restricted cash | 792 | 618 | ||||||
| Short-term deposits | 101,735 | 8,080 | ||||||
| Prepaid expenses and other receivables | 2,869 | 707 | ||||||
| Total current assets | 111,326 | 32,641 | ||||||
| LONG-TERM ASSETS: | ||||||||
| Long term prepaid expenses | 393 | 2,028 | ||||||
| Property and equipment, net | 7,647 | 7,546 | ||||||
| Total long-term assets | 8,040 | 9,574 | ||||||
| Total assets | $ | 119,366 | $ | 42,215 | ||||
CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands (except share and per share data)
| September 30, | December 31, | |||||||
| 2022 | 2021 | |||||||
| Unaudited | Audited | |||||||
| LIABILITIES, CONVERTIBLE PREFERRED SHARES AND SHAREHOLDERS' DEFICIENCY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Trade payables | $ | 1,310 | $ | 1,203 | ||||
| Other payables and accrued expenses | 2,043 | 3,202 | ||||||
| Total current liabilities | 3,353 | 4,405 | ||||||
| LONG-TERM LIABILITIES: | ||||||||
| Warrants liability | 8,757 | - | ||||||
| Warrants to Convertible Preferred shares | - | 18,623 | ||||||
| Total liabilities | 12,110 | 23,028 | ||||||
| Convertible preferred shares of no-par value per share – Authorized: 0 and 25,348,176 shares as of September 30, 2022 and December 31, 2021, respectively; Issued and outstanding: 0 and 13,739,186 shares as of September 30, 2022 and December 31, 2021, respectively | - | 53,964 | ||||||
| SHAREHOLDERS' DEFICIENCY: | ||||||||
| Ordinary shares of no-par value per share – Authorized: 362,116,800 and 72,423,360 shares as of September 30, 2022 and December 31, 2021, respectively; Issued and outstanding : 69,011,550 and 40,528,913 shares as of September 30, 2022 and December 31, 2021, respectively | - | - | ||||||
| Additional paid-in capital | 190,462 | 18,063 | ||||||
| Accumulated deficit | (83,206 | ) | (52,840 | ) | ||||
| Total shareholders' equity (deficiency) | 107,256 | (34,777 | ) | |||||
| Total liabilities, Convertible Preferred shares and shareholders' equity (deficiency) | $ | 119,366 | $ | 42,215 | ||||
CONSOLIDATED STATEMENTS OF OPERATIONS
U.S. dollars in thousands (except share and per share data)
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Unaudited | ||||||||||||||||
| Research and development, net | $ | 4,827 | $ | 3,032 | $ | 15,510 | $ | 8,218 | ||||||||
| Marketing expenses | 248 | 102 | 577 | 356 | ||||||||||||
| General and administrative | 2,283 | 500 | 8,064 | 1,273 | ||||||||||||
| Total operating loss | 7,358 | 3,634 | 24,151 | 9,847 | ||||||||||||
| Financial (income) expenses, net | (4,744 | ) | 1,168 | 6,198 | 13,622 | |||||||||||
| Loss before taxes on income | 2,614 | 4,802 | 30,349 | 23,469 | ||||||||||||
| Income tax expense (benefit) | 9 | (5 | ) | 17 | 21 | |||||||||||
| Net loss | 2,623 | 4,797 | 30,366 | 23,490 | ||||||||||||
| Net comprehensive loss | $ | 2,623 | $ | 4,797 | $ | 30,366 | $ | 23,490 | ||||||||
| Net loss per share attributable to Ordinary shareholders, basic and diluted | $ | 0.04 | $ | 0.12 | $ | 0.49 | $ | 0.58 | ||||||||
| Weighted-average shares used in computing net loss per share attributable to Ordinary shareholders, basic and diluted | 68,798,251 | 40,515,336 | 61,654,800 | 40,513,766 | ||||||||||||