-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) (NASDAQ: 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.
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.
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CONSOLIDATED BALANCE SHEETS
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LIABILITIES AND SHAREHOLDERS' EQUITY
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Warrants to convertible Preferred shares
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
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
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to ordinary shareholders, basic and diluted*)
*) Prior period results have been retroactively adjusted to reflect the 1: 0.905292 stock split effected on March 7, 2022.
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Supplemental disclosures of cash flow information:
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SOURCE Alpha Tau Medical
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