This Report and the related exhibits,
other than the quote included in Exhibit 99.1, are incorporated by reference into the registrant’s Registration Statements on Form
F-3 (File Nos. 333-271073, 333-264306,
333-274457, 333-288240
and 333-295359) and Form S-8
(File Nos. 333-264169, 333-270406,
333-277733, 333-285745
and 333-294151).
Exhibit
99.1
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% 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
conference -
-
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 -
JERUSALEM,
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
a corporate update.
“The
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®
(nab-paclitaxel).”
“At
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.”
Recent
Corporate Highlights:
| ● | In
May 2026, Alpha Tau announced groundbreaking interim results as of May 3 from the U.S. REGAIN
trial of Alpha DaRT in recurrent glioblastoma (GBM), conducted at The Ohio State University
Comprehensive Cancer Center. In the first three patients treated, 100% local disease control,
a 67% complete response rate (two complete responses and one stable disease with a 30% tumor
reduction), and a favorable safety profile were observed, with only one associated grade
3 serious adverse event that resolved with administration of steroids. The REGAIN study is
expected to enroll up to ten U.S. patients with recurrent GBM not amenable to surgical resection.
For more information, please see here: https://www.clinicaltrials.gov/study/NCT06910306 |
| ● | In
May 2026, Alpha Tau announced the completion of patient enrollment in its U.S. multicenter
pivotal ReSTART trial of Alpha DaRT for the treatment of recurrent cutaneous squamous cell
carcinoma (cSCC), with 88 patients enrolled, making ReSTART the Company’s first U.S.
pivotal study to complete enrollment - a critical milestone on the path toward potential
FDA pre-market approval (PMA). Alpha DaRT has received Breakthrough Device Designation from
the FDA for this indication, and the Company submitted the first module of its modular PMA
application in January 2026. For more information, please see here: https://www.clinicaltrials.gov/study/NCT05323253 |
| ● | In
May 2026, Alpha Tau presented updated pooled results from two first-in-human pancreatic cancer
trials at Digestive Disease Week (DDW) 2026, with 100% local disease control observed in
evaluable patients and a favorable safety profile. The oral presentation, delivered in the
Pancreatic Cancer I: Diagnosis and Treatment session, marked the first time clinical results
of Alpha DaRT in pancreatic cancer have been featured at a major international gastroenterology
conference. |
| ● | In
May 2026, Alpha Tau treated the first patient in Italy with Alpha DaRT for locally advanced
pancreatic cancer, in a feasibility and safety study conducted at the world-renowned Pancreas
Institute of the University of Verona. The protocol is the first Alpha DaRT pancreatic cancer
protocol worldwide to permit both endoscopic ultrasound (EUS)-guided and percutaneous delivery
of Alpha DaRT sources, broadening physician access across multiple interventional specialties. |
| ● | In
May 2026, Alpha Tau announced that an abstract entitled “Management of Locally Advanced
and Metastatic Head and Neck Squamous Cell Carcinoma in Elderly Patients Using Diffusing
Alpha-Emitter Radiation Therapy in Combination with Pembrolizumab” was accepted for
podium presentation at the AHNS 12th International Conference on Head and Neck Cancer, taking
place July 18-22, 2026 in Boston. The presentation reports complete top-line data from a
clinical study conducted at Hadassah Medical Center, marking a key milestone in the Company’s
combination therapy strategy. |
| ● | In
April 2026, Alpha Tau announced that an abstract entitled “Combined Safety and Efficacy
Results from Three Clinical Studies Evaluating Alpha Radiotherapy for Advanced Pancreatic
Cancer,” presenting a pooled analysis of 58 patients across three prospective clinical
studies conducted in Canada and Israel, was accepted for presentation at the 2026 ASCO Annual
Meeting taking place May 29 - June 2, 2026. The abstract is expected to be published on the
ASCO conference website on May 21, 2026. |
| ● | In
April 2026, Alpha Tau announced FDA approval of an Investigational Device Exemption (IDE)
supplement to expand its U.S. multicenter IMPACT pancreatic cancer pilot trial to include
patients receiving gemcitabine with Abraxane® (nab-paclitaxel). The supplement
also adds ten newly diagnosed patients - five with unresectable locally advanced and five
with metastatic pancreatic adenocarcinoma - bringing total planned enrollment to 40 patients.
Patient recruitment is now expected to complete in Q3 2026 to allow for site approvals and
additional enrollment. For more information, please see here: https://www.clinicaltrials.gov/study/NCT06698458. |
| ● | In
April 2026, Alpha Tau successfully treated the first European pancreatic cancer patient with
Alpha DaRT at CHU Grenoble Alpes, under the ACAPELLA multicenter trial in France evaluating
Alpha DaRT in combination with capecitabine for patients with inoperable locally advanced
pancreatic ductal adenocarcinoma who have completed first-line mFOLFIRINOX chemotherapy,
a population for whom no standard consolidation therapy exists. |
Expected
Upcoming Milestone Targets:
| ● | Completion
of patient recruitment in IMPACT pancreatic cancer pilot study in the U.S. in Q3 2026, with
initial data targeted for late 2026 or early 2027. For more information, please see here:
https://www.clinicaltrials.gov/study/NCT06698458 |
| ● | Completion
of patient recruitment in REGAIN recurrent GBM trial in the U.S. in the second half of 2026,
with additional data expected to be released by around the end of 2026. For more information,
please see here: https://clinicaltrials.gov/study/NCT06910306 |
| ● | Top-line
data in the ReSTART pivotal U.S. multi-center trial in recurrent cutaneous squamous cell
carcinoma around the end of 2026. For more information, please see here: https://www.clinicaltrials.gov/study/NCT05323253 |
Financial
Results for the Three Months Ended March 31, 2026
Research
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.
Marketing
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.
General
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.
Financial
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.
For
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.
Balance
Sheet Highlights
As
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.
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 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 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.
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,” “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.
Investor
Relations Contact:
IR@alphatau.com
INTERIM
CONSOLIDATED BALANCE SHEETS
U.S. dollars
in thousands
| | |
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 | |
INTERIM
CONSOLIDATED BALANCE SHEETS
U.S. dollars
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 | |
INTERIM
CONSOLIDATED STATEMENTS OF OPERATIONS
U.S. dollars
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 | |
