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Alpha Tau Announces First Quarter 2026 Financial Results and Provides Corporate Update - Groundbreaking interim results from U.S. REGAIN trial in recurrent glioblastoma demonstrate 100% local disease control, 67% complet

Key Takeaway: Alpha Tau Medical Ltd. reported its first quarter 2026 financial results, highlighting significant progress in its clinical trials, including 100% local disease control in the REGAIN trial for recurrent glioblastoma and 67% complete response rate. The company also announced completion of patient enrollment in its pivotal ReSTART trial for recurrent cutaneous squamous cell carcinoma. Despite a net loss of $22.9 million, Alpha Tau maintains a solid cash balance of $80.2 million to support its ongoing research and development efforts. The growing recognition of the company's clinical data at major conferences further underscores its potential in oncology.

Market Sentiment Analysis

POSITIVE FACTORS

  • 100% local disease control in U.S. REGAIN trial for glioblastoma.
  • 67% complete response rate observed in the same trial.
  • Company has a strong cash balance of $80.2 million for future developments.
  • Recognition at international conferences highlights growing scientific credibility.

CONCERNS & RISKS

  • Net loss of $22.9 million for Q1 2026, increasing from $8.7 million in Q1 2025.
  • Increased development expenses due to ramped-up clinical activities.
  • Dependence on successful enrollment and outcomes of ongoing trials.

Full Press Release Details

Tau Announces First Quarter 2026 Financial Results and Provides Corporate Update
Groundbreaking interim results from U.S. REGAIN trial in recurrent glioblastoma demonstrate 100% local disease control, 67% complete
response rate, and favorable safety profile -
Completion of patient enrollment in the U.S. pivotal ReSTART trial in recurrent cutaneous squamous cell carcinoma, the Company's
first U.S. pivotal study -
Pooled data from two pancreatic cancer trials presented at Digestive Disease Week (DDW) 2026 demonstrated 100% local disease control
and favorable safety, the first oral presentation of Alpha DaRT pancreatic data at a premier international gastroenterology
Abstracts accepted for presentation at the 2026 ASCO Annual Meeting and at the AHNS 12th International Conference on Head and Neck Cancer,
reflecting growing scientific recognition across multiple solid tumor indications -
FDA approval of an IDE supplement to expand the IMPACT pancreatic cancer trial to patients receiving gemcitabine with Abraxane
(nab-paclitaxel) and recruit additional patients -
First patient successfully treated for pancreatic cancer in Europe at CHU Grenoble Alpes under the multicenter ACAPELLA trial in France,
and first patient successfully treated in Italy at the University of Verona's Pancreas Institute -
Cash, cash equivalents, short-term deposits and restricted deposits balance of $80.2 million provides runway for continued clinical advancement
and commercial preparation -
May 18, 2026 - Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer
of the innovative alpha-radiation cancer therapy Alpha DaRT , reported first quarter 2026 financial results and provided
first quarter of 2026 has been a truly defining period for Alpha Tau, reflecting the convergence of two powerful dynamics that have been
years in the making: the maturation of clinical data from our most advanced programs, and the global initiation of novel trials addressing
some of the most pressing unmet needs in oncology," said Alpha Tau CEO Uzi Sofer. "The groundbreaking interim
results from our U.S. REGAIN trial in recurrent glioblastoma, with 100% local disease control and a 67% complete response rate as of
May 3, represent powerful potential clinical benefit in patients facing a devastating disease with virtually no curative options. Our
pancreatic cancer program has also continued to build compelling data, first with positive new results from our Montreal study presented
at the ASCO Gastrointestinal Cancers Symposium, then with the oral presentation of pooled pancreatic data at Digestive Disease Week 2026,
and most recently with the expansion of our IMPACT pancreatic trial to include patients receiving gemcitabine with Abraxane
the same time, we have continued to make significant strides toward commercialization on both sides of the Pacific, following
our receipt of PMDA marketing approval in Japan for Alpha DaRT in unresectable locally advanced or locally recurrent head and neck cancer,"
continued Mr. Sofer. "In Japan, we are working closely with our selected leading clinical centers to advance the post-market surveillance
study that supports our marketing approval. In the United States, we are advancing steadily along our path to potential FDA approval,
with the recent completion of patient enrollment with 88 patients in our pivotal ReSTART trial, our very first U.S. pivotal study to
reach this milestone."
"Taken together, this quarter is a true
culmination of years of disciplined execution across each of our strategic priorities. With a strong balance sheet with $80.2 million
of liquidity to support our continued momentum, we aim to translate this remarkable progress into meaningful impact for patients."
Corporate Highlights:
Upcoming Milestone Targets:
Results for the Three Months Ended March 31, 2026
and Development expenses for the three months ended March 31, 2026 were $11.0 million, compared to $7.2 million for the same period in
2025, primarily due to increased clinical trial activity, increased employee compensation and benefits, including share-based compensation,
increased raw material purchases, and milestone payments associated with our receipt of PMDA marketing authorization in Japan.
expenses for the three months ended March 31, 2026 were $0.2 million, compared to $0.5 million for the same period in 2025, primarily
due to decreased employee compensation and benefits and marketing conference activities.
and Administrative expenses for the three months ended March 31, 2026 were $2.1 million, compared to $1.7 million for the same period
in 2025, primarily due to increased employee compensation and benefits, including share-based compensation, and higher professional fees.
expenses, net, for the three months ended March 31, 2026 were $9.6 million, compared to financial income, net, of $0.7 million for the
same period in 2025, primarily due to the remeasurement of warrants liability.
the three months ended March 31, 2026, the Company had a net loss of $22.9 million, or $0.26 per share, compared to a net loss of $8.7
million, or $0.12 per share, for the three months ended March 31, 2025.
of March 31, 2026, the Company had cash and cash equivalents, short-term deposits and restricted deposits of $80.2 million, compared
to $76.9 million at December 31, 2025.
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.
Alpha Tau Medical Ltd.
in 2016, Alpha Tau is an Israeli oncology therapeutics 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.
press release includes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of
1995. When used herein, words including "anticipate," "will," "plan," "may," "continue,"
and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to
expectations, milestone targets, beliefs, plans, including with respect to clinical trials and planned treatments, regulatory approvals
and expected responses, studies, patient recruitment, projections, objectives, performance, our ability to commercialize, applications
with regulatory bodies 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; 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 9, 2026 , 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.
CONSOLIDATED BALANCE SHEETS
December 31, March 31, 2026
2025 Unaudited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 12,202 $ 4,636
Short-term deposits 60,924 71,783
Restricted deposits 3,777 3,808
Prepaid expenses and other receivables 1,395 1,121
Total current assets 78,298 81,348
LONG-TERM ASSETS:
Long-term prepaid expenses 479 462
Property and equipment, net 19,661 19,222
Operating lease right-of-use assets 7,214 7,741
Total long-term assets 27,354 27,425
Total assets $ 105,652 $ 108,773
CONSOLIDATED BALANCE SHEETS
in thousands (except share and per share data)
December 31, March 31, 2026
2025 Unaudited
LIABILITIES AND SHAREHOLDERS' EQUITY
CURRENT LIABILITIES:
Trade payables $ 3,868 $ 3,718
Other payables and accrued expenses 5,508 5,529
Current maturities of operating lease liabilities 1,131 1,201
Total current liabilities 10,507 10,448
LONG-TERM LIABILITIES:
Long-term loan 6,352 6,403
Warrants liability 5,354 15,748
Operating lease liabilities 6,243 6,737
Deferred tax liability 97 85
Total long-term liabilities 18,046 28,973
Total liabilities 28,553 39,421
SHAREHOLDERS' EQUITY:
Ordinary shares of no-par value per share - Authorized: 362,116,800 shares as of December 31, 2025 and March 31, 2026; Issued and outstanding: 88,009,737 and 90,176,067 shares as of December 31, 2025 and March 31, 2026 respectively - -
Additional paid-in capital 267,235 282,427
Accumulated deficit (190,136 ) (213,075 )
Total shareholders' equity 77,099 69,352
Total liabilities and shareholders' equity $ 105,652 $ 108,773
CONSOLIDATED STATEMENTS OF OPERATIONS
in thousands (except share and per share data)
Three months ended March 31,
2025 2026
Unaudited
Research and development, net $ 7,170 $ 10,975
Marketing expenses 459 241
General and administrative 1,679 2,097
Total operating loss 9,308 13,313
Financial (income) expenses, net (716 ) 9,637
Loss before taxes on income 8,592 22,950
Tax on income (tax benefit) 99 (11 )
Net loss 8,691 22,939
Net comprehensive loss $ 8,691 $ 22,939
Net loss per share, basic and diluted $ (0.12 ) $ (0.26 )
Weighted-average shares used in computing net loss per share, basic and diluted 70,450,897 89,705,391

Frequently Asked Questions

What were the interim results of the REGAIN trial?

The REGAIN trial showed 100% local disease control and a 67% complete response rate.

What is Alpha DaRT used for?

Alpha DaRT is designed for treating solid tumors through targeted alpha-irradiation.

How much cash did Alpha Tau have by March 31, 2026?

Alpha Tau reported $80.2 million in cash and equivalents as of March 31, 2026.

What is the ReSTART trial focused on?

The ReSTART trial focuses on recurrent cutaneous squamous cell carcinoma.

When was Alpha Tau founded?

Alpha Tau was founded in 2016 as an oncology therapeutics company.

Last updated: May 18, 2026