- Positive interim safety and feasibility data from pancreatic cancer study in
- ReSTART
- Submitted PMDA application for recurrent Head and Neck cancer in
- Entered into long-term lease for a second facility in the
- Cash, deposits and restricted deposits balance of $84.9 million, with anticipated runway for at least two years -
“2023 was an incredibly productive year, as we launched our ReSTART pivotal
Recent Corporate Highlights:
- In October, the Company announced that it had entered into a long-term lease agreement for a standalone building of over 14,000 rentable square feet in
Hudson, NH , with the intention of erecting the Company’s secondU.S. manufacturing site, alongside its first site in nearbyLawrence, MA. - In October, the Company announced that Dr.
Stephen Hahn , a former commissioner of theU.S. Food and Drug Administration (“FDA”) and a distinguished expert in the field of radiation oncology and translational clinical research, joined itsScientific Advisory Board . - In November, the Company announced that Japan’s
Pharmaceuticals and Medical Devices Agency (“PMDA”) accepted Alpha Tau’s submission requesting shonin pre-market approval ofAlpha DaRT in patients with recurrent head and neck cancer, following multiple pre-submission consultation meetings with the PMDA per common practice inJapan . - In November, the Company announced interim results from treatment of the first five patients in the Company’s safety and feasibility trial in
Montreal, Canada , examining the use ofAlpha DaRT to treat advanced pancreatic cancer. The Alpha DaRT procedure was deemed technically successful in all five cases, withAlpha DaRT sources successfully inserted into the target tumors. There were no reported serious adverse events deemed related to the product, and the only reported adverse events deemed possibly related to the product were of severity grade 1 (mild). In addition, despite the conservative and gradual step-up of tumor coverage from minimal initial levels, three of the five patients demonstrated stable disease responses at four weeks after treatment, and one was upgraded to partial response at 69 days after treatment.
Upcoming Milestones
- Planning treatment of the first patient in the Canadian liver metastases safety and feasibility trial in H1 2024. The trial is currently open for recruitment; for more information please see here: https://www.clinicaltrials.gov/study/NCT05829291
- Planning treatment of the first patient in the Israeli recurrent lung cancer safety and feasibility trial in H1 2024. The trial is currently open for recruitment; for more information please see here: https://www.clinicaltrials.gov/study/NCT05632913
- Targeting first brain cancer treatment in H2 2024.
- Targeting completion of patient recruitment in the ReSTART pivotal
U.S. multi-center trial in recurrent cutaneous squamous cell carcinoma in H2 2024. For more information please see here: https://www.clinicaltrials.gov/study/NCT05323253 - Targeting completion of patient recruitment in the Canadian advanced inoperable pancreatic cancer study in
Montreal in H2 2024. For more information please see here: https://www.clinicaltrials.gov/study/NCT04002479 - Anticipating response from PMDA in
Japan by year-end 2024 for pre-market approval forAlpha DaRT in patients with recurrent head and neck cancer.
Financial results for the full year ended
R&D expenses for the year ended December 31, 2023 were $26.4 million, compared to $20.9 million in 2022, due to increased employee headcount, compensation and benefits, including share-based compensation, increased operating costs, and increased pre-clinical study and clinical trial expenses, particularly in our
Marketing expenses for the year ended December 31, 2023 were $1.9 million, compared to $1.0 million for 2022 due to increased employee compensation and benefits, including share-based compensation, and the hiring of our chief commercial officer.
G&A expenses for the year ended December 31, 2023 were $7.3 million, compared to $10.3 million for 2022, due to to decreased professional fees (including D&O insurance), and costs associated with our financing transaction in the first quarter of 2022.
Financial expenses (income), net, for the year ended
For the year ended December 31, 2023, the Company had a net loss of $29.2 million, or
Balance Sheet Highlights
As of December 31, 2023, the Company had cash and cash equivalents, restricted cash and deposits in the amount of
About Alpha DaRT™
About
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.
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
Investor Relations Contact:
IR@alphatau.com
CONSOLIDATED BALANCE SHEETS | |||||||
U.S. dollars in thousands | |||||||
2022 | 2023 | ||||||
ASSETS | |||||||
CURRENT ASSETS: | |||||||
Cash and cash equivalents | $ | 5,836 | $ | 12,657 | |||
Restricted cash | 850 | - | |||||
Short-term deposits | 98,694 | 69,131 | |||||
Restricted deposits | - | 3,152 | |||||
Prepaid expenses and other receivables | 1,097 | 816 | |||||
Total current assets | 106,477 | 85,756 | |||||
LONG-TERM ASSETS: | |||||||
Long term prepaid expenses | 391 | 471 | |||||
Property and equipment, net | 7,471 | 12,798 | |||||
Operating lease right-of-use assets | 5,810 | 8,363 | |||||
Total long-term assets | 13,672 | 21,632 | |||||
Total assets | $ | 120,149 | $ | 107,388 | |||
CONSOLIDATED BALANCE SHEETS | |||||||
U.S. dollars in thousands (except share and per share data) | |||||||
2022 | 2023 | ||||||
LIABILITIES AND SHAREHOLDERS’ EQUITY | |||||||
CURRENT LIABILITIES: | |||||||
Trade payables | $ | 1,423 | $ | 2,566 | |||
Other payables and accrued expenses | 2,246 | 3,474 | |||||
Current maturities of operating lease liabilities | 669 | 1,062 | |||||
Total current liabilities | 4,338 | 7,102 | |||||
LONG-TERM LIABILITIES: | |||||||
Long-term loan | - | 5,610 | |||||
Warrants liability | 5,630 | 3,597 | |||||
Operating lease liabilities | 4,524 | 6,604 | |||||
Total long-term liabilities | 10,154 | 15,811 | |||||
Total liabilities | 14,492 | 22,913 | |||||
COMMITMENTS AND CONTINGENCIES | |||||||
SHAREHOLDERS' EQUITY: | |||||||
Ordinary shares of no-par value per share – Authorized: 362,116,800 shares as of | - | - | |||||
Additional paid-in capital | 192,259 | 200,234 | |||||
Accumulated deficit | (86,602 | ) | (115,759 | ) | |||
Total shareholders' equity | 105,657 | 84,475 | |||||
Total liabilities and shareholders' equity | $ | 120,149 | $ | 107,388 | |||
CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||
U.S. dollars in thousands (except share and per share data) | |||||||||||
Year ended | |||||||||||
2021 | 2022 | 2023 | |||||||||
Research and development, net | $ | 11,447 | $ | 20,890 | $ | 26,424 | |||||
Marketing expenses | 482 | 974 | 1,924 | ||||||||
General and administrative | 1,861 | 10,272 | 7,332 | ||||||||
Total operating loss | 13,790 | 32,136 | 35,680 | ||||||||
Financial expenses (income), net | 13,474 | 1,606 | (6,539 | ) | |||||||
Loss before taxes on income | 27,264 | 33,742 | 29,141 | ||||||||
Tax on income | 7 | 20 | 16 | ||||||||
Net loss | 27,271 | 33,762 | 29,157 | ||||||||
Net comprehensive loss | $ | 27,271 | $ | 33,762 | $ | 29,157 | |||||
Net loss per share, basic and diluted | $ | (0.67 | ) | $ | (0.53 | ) | $ | (0.42 | ) | ||
Weighted-average shares used in computing net loss per share, basic and diluted | 40,534,697* | 63,534,875 | 69,377,922 | ||||||||
* Prior period results have been retroactively adjusted to reflect the 1: 0.905292 stock split effected on
Source:
2024 GlobeNewswire, Inc., source