- Treated the first patient with advanced inoperable pancreatic cancer at
- 89% CR, two-year local recurrence-free survival of 77%, and no treatment-related grade 2 or higher late-onset toxicity reported from an analysis of four feasibility trials in 71 patients with unresectable skin and head and neck cancers -
- Former
- Cash, deposits & restricted deposits balance of
"This year has already seen tremendous progress, as we advance 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, has joined itsScientific Advisory Board . - In September, the first patient with advanced inoperable pancreatic cancer was treated with
Alpha DaRT at Hadassah Medical inJerusalem, Israel , in parallel to the Company’s ongoing safety and feasibility trial for the treatment of advanced inoperable pancreatic cancer currently underway inMontreal, Canada . - In August, Alpha Tau reported long-term safety and tumor control outcomes data for patients with unresectable, recurrent, or locally advanced head and neck or skin tumors treated with
Alpha DaRT across four prospective trials conducted at several international institutions. In this analysis, 81 lesions were treated in 71 patients. The median follow-up was 14 months (range: 2-51 months). A complete response (CR) was observed in 89% of treated lesions (n=72), 10% (n=8) demonstrated a partial response, and one patient was not evaluable. The two-year actuarial local recurrence-free survival (LRFS) rate was 77% [95% CI: 63–87%]. Twenty percent of patients developed treatment-related acute grade 2 toxicity (such as dermatitis radiation, local pain at the treatment site or pruritus), which subsequently resolved with conservative treatment; there were no grade 3 or higher related acute toxicities reported. There were no grade 2 or higher ‘late toxicities’, defined as toxicities occurring six months afterAlpha DaRT treatment or later, observed in this cohort.
Upcoming Near-Term Milestones
- Expecting to release interim safety and feasibility data in Q4 2023 from the first five patients treated in the Company’s study examining the use of
Alpha DaRT to treat patients inMontreal, Canada with advanced inoperable pancreatic cancer. For more information please see here: https://www.clinicaltrials.gov/study/NCT04002479 - Expecting to submit to the PMDA in
Japan in Q4 2023 for pre-market approval forAlpha DaRT in patients with recurrent head & neck cancer. - Planning treatment of the first patient in the Canadian liver metastases safety and feasibility trial in Q4 2023 or Q1 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 H1 2024.
- Targeting completion of patient recruitment in the ReSTART pivotal
U.S. multi-center trial in recurrent cutaneous squamous cell carcinoma in Q2 2024. For more information please see here: https://www.clinicaltrials.gov/study/NCT05323253
Financial results for nine months ended
R&D expenses for the nine months ended September 30, 2023 were $18.9 million, compared to $15.5 million for the same period in 2022, due to increased employee compensation and benefits, including share-based compensation, increased pre-clinical study and clinical trial expenses particularly in our
Marketing expenses for the nine months ended September 30, 2023 were $1.5 million, compared to $0.6 million for the same period in 2022, due to increased employee compensation and benefits, including share-based compensation for marketing personnel including our chief commercial officer hired in 2022, as well as increased marketing activities.
G&A expenses for the nine months ended September 30, 2023 were $5.3 million, compared to $8.1 million for the same period in 2022, due to decreased compensation expenses as well as one-time expenses in 2022 associated with the Company’s merger with
Financial income, net, for the nine months ended
For the nine months ended September 30, 2023, the Company had a net loss of $21.8 million, or
Balance Sheet Highlights
As of September 30, 2023, the Company had cash, restricted cash, deposits and restricted deposits in the amount of $90.1 million, compared to $105.4 million on December 31, 2022. The Company expects that this cash balance will be sufficient to fund operations for at least two years.
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 | ||||||
Audited | Unaudited | ||||||
ASSETS | |||||||
CURRENT ASSETS: | |||||||
Cash and cash equivalents | $ | 5,836 | $ | 82 | |||
Restricted cash | 850 | - | |||||
Short-term deposits | 98,694 | 87,137 | |||||
Restricted deposits | - | 2,886 | |||||
Prepaid expenses and other receivables | 1,097 | 1,334 | |||||
Total current assets | 106,477 | 91,439 | |||||
LONG-TERM ASSETS: | |||||||
Long term prepaid expenses | 391 | 441 | |||||
Property and equipment, net | 7,471 | 7,767 | |||||
Right-of-use asset | 5,810 | 7,092 | |||||
Total long-term assets | 13,672 | 15,300 | |||||
Total assets | $ | 120,149 | $ | 106,739 | |||
The accompanying notes are an integral part of the interim consolidated financial statements.
CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands (except share and per share data)
2022 | 2023 | |||||||
Audited | Unaudited | |||||||
LIABILITIES AND SHAREHOLDERS’ EQUITY | ||||||||
CURRENT LIABILITIES: | ||||||||
Trade payables | $ | 1,423 | $ | 2,273 | ||||
Other payables and accrued expenses | 2,246 | 3,118 | ||||||
Current maturities of operating lease liabilities | 669 | 848 | ||||||
Total current liabilities | 4,338 | 6,239 | ||||||
LONG-TERM LIABILITIES: | ||||||||
Warrants liability | 5,630 | 5,443 | ||||||
Operating lease liabilities | 4,524 | 5,204 | ||||||
Total long-term liabilities | 10,154 | 10,647 | ||||||
Total liabilities | 14,492 | 16,886 | ||||||
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 | 198,247 | ||||||
Accumulated deficit | (86,602 | ) | (108,394 | ) | ||||
Total shareholders' equity | 105,657 | 89,853 | ||||||
Total liabilities and shareholders' equity | $ | 120,149 | $ | 106,379 | ||||
The accompanying notes are an integral part of the interim consolidated financial statements.
CONSOLIDATED STATEMENTS OF OPERATIONS
U.S. dollars in thousands (except share and per share data)
Nine months ended | |||||||
2022 | 2023 | ||||||
Unaudited | |||||||
Research and development, net | $ | 15,510 | $ | 18,934 | |||
Marketing expenses | 577 | 1,472 | |||||
General and administrative | 8,064 | 5,331 | |||||
Total operating loss | 24,151 | 25,737 | |||||
Financial expenses (income), net | 6,198 | (3,953 | ) | ||||
Loss before taxes on income | 30,349 | 21,784 | |||||
Income tax expense | 17 | 8 | |||||
Net loss | 30,366 | 21,792 | |||||
Net comprehensive loss | $ | 30,366 | $ | 21,792 | |||
Net loss per share, basic and diluted | $ | 0.49 | $ | 0.31 | |||
Weighted-average shares used in computing net loss per share, basic and diluted | 61,654,800 | 69,314,585 | |||||
Source:
2023 GlobeNewswire, Inc., source