Full Press Release Details
Announces Second Quarter 2022 Financial Results and Provides Corporate Update
-Received FDA Conditional Investigational Device
Exemption (IDE), whose conditions have since been satisfied, to initiate a pivotal trial of Alpha DaRT in recurrent
cutaneous squamous cell carcinoma. The Company expects to treat its first patient in this study later in 2022-
first patient in a feasibility study evaluating the Alpha DaRT as a neoadjuvant therapy in patients with prostate cancer-
JERUSALEM, August 25, 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 second quarter 2022 financial results and provided a corporate update.
"We have made significant progress by gaining
conditional FDA approval, whose conditions have since been satisfied, for our pivotal trial IDE in SCC as well as treating our first
patient in a prostate cancer feasibility trial. We've seen overwhelming interest from leading clinical sites across the U.S. in
participating in our upcoming pivotal trial in SCC, and look forward to initiating that trial shortly. While making clinical progress,
we are thoughtfully expanding our pipeline from superficial cancers that only require a temporary Alpha DaRT implant, to more invasive
internal tumors like liver and prostate, and then finally to ones such as pancreatic cancer and GBM with the greatest unmet need. We've
made great strides in GBM in large animal studies, on the back of receipt of Breakthrough Device Designation for recurrent GBM from the
FDA," said Alpha Tau CEO Uzi Sofer. "In tandem, we have been preparing for global commercialization efforts by expanding
our manufacturing capabilities alongside our expanded radioactive licenses in Israel and in the U.S., as well as educating the medical
community on our technology via hands-on experience in our trials."
Recent Corporate Highlights:
Upcoming Anticipated 2022 Milestones
Financial results for the second
quarter ended June 30, 2022
R&D expenses for the
quarter ended June 30, 2022 were $5.4 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
expenses for the quarter ended June 30, 2022 were $0.1 million, compared to $0.1 million for the same period in 2021.
expenses for the quarter ended June 30, 2022 were $2.4 million, compared to $0.4 million for the same period in 2021,
primarily due to increased professional fees (including D&O insurance), share-based compensation, and costs (including bonuses) associated
with our financing transaction in the first quarter of 2022.
income, net, for the quarter ended June 30, 2022 was $6.0 million, compared to financial expense, net of $3.5 million for the same period
in 2021, primarily due to the remeasurement of warrants.
the quarter ended June 30, 2022, the Company had a net loss of $2.0 million, or ($0.03) per share, compared to a loss of $7.0
million, or ($0.17) per share, in the same period in 2021.
Balance Sheet Highlights
30, 2022, the Company had cash and cash equivalents, restricted cash and short term deposits in the amount of $112.8 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.
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
CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands
| June 30, | December 31, | |||||||
| 2022 | 2021 | |||||||
| Unaudited | Audited | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 11,571 | $ | 23,236 | ||||
| Restricted cash | 792 | 618 | ||||||
| Short-term deposits | 100,465 | 8,080 | ||||||
| Prepaid expenses and other receivables | 3,199 | 707 | ||||||
| Total current assets | 116,027 | 32,641 | ||||||
| LONG-TERM ASSETS: | ||||||||
| Long term prepaid expenses | 207 | 2,028 | ||||||
| Property and equipment, net | 7,746 | 7,546 | ||||||
| Total long-term assets | 7,953 | 9,574 | ||||||
| Total assets | $ | 123,980 | $ | 42,215 |
CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands (except share and per share data)
| June 30, | December 31, | |||||||
| 2022 | 2021 | |||||||
| Unaudited | Audited | |||||||
| LIABILITIES, CONVERTIBLE PREFERRED SHARES AND SHAREHOLDERS' EQUITY (DEFICIENCY) | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Trade payables | $ | 1,197 | $ | 1,203 | ||||
| Other payables and accrued expenses | 1,567 | 3,202 | ||||||
| Total current liabilities | 2,764 | 4,405 | ||||||
| LONG-TERM LIABILITIES: | ||||||||
| Warrants liability | 12,948 | - | ||||||
| Warrants to Convertible Preferred shares | - | 18,623 | ||||||
| Total liabilities | 15,712 | 23,028 | ||||||
| Convertible preferred shares of no-par value per share - Authorized: 25,348,176 shares as of June 30, 2022 and December 31, 2021; Issued and outstanding: 0 and 13,739,186 shares as of June 30, 2022 and December 31, 2021, respectively | - | 53,964 | ||||||
| SHAREHOLDERS' EQUITY (DEFICIENCY): | ||||||||
| Ordinary shares of no-par value per share - Authorized: 362,116,800 and 72,423,360 shares as of June 30, 2022 and December 31, 2021, respectively; Issued and outstanding: 68,575,397 and 40,528,913 shares as of June 30, 2022 and December 31, 2021, respectively | - | - | ||||||
| Additional paid-in capital | 188,851 | 18,063 | ||||||
| Accumulated deficit | (80,583 | ) | (52,840 | ) | ||||
| Total shareholders' equity (deficiency) | 108,268 | (34,777 | ) | |||||
| Total liabilities, Convertible Preferred shares and shareholders' equity (deficiency) | $ | 123,980 | $ | 42,215 |
CONSOLIDATED STATEMENTS OF OPERATIONS
U.S. dollars in thousands (except share and per share data)
| Three months ended June 30, | Six months ended June 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Unaudited | ||||||||||||||||
| Research and development, net | 5,448 | 2,997 | 10,683 | 5,186 | ||||||||||||
| Marketing expenses | 121 | 87 | 329 | 254 | ||||||||||||
| General and administrative | 2,443 | 394 | 5,781 | 773 | ||||||||||||
| Total operating loss | 8,012 | 3,478 | 16,793 | 6,213 | ||||||||||||
| Financial (income) expenses net | (6,019 | ) | 3,489 | 10,942 | 12,454 | |||||||||||
| Loss before taxes on income | 1,993 | 6,967 | 27,735 | 18,667 | ||||||||||||
| Tax on income | 6 | 15 | 8 | 26 | ||||||||||||
| Net loss | 1,999 | 6,982 | 27,743 | 18,693 | ||||||||||||
| Net comprehensive loss | 1,999 | 6,982 | 27,743 | 18,693 | ||||||||||||
| Net loss per share attributable to Ordinary shareholders, basic and diluted | 0.03 | 0.17 | 0.48 | 0.46 | ||||||||||||
| Weighted-average shares used in computing net loss per share attributable to Ordinary shareholders, basic and diluted | 68,427,180 | 40,515,336 | *) | 58,023,875 | 40,512,967 | *) |