Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 183

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 4A
Chunk 183
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Item 4A. Unresolved Staff Comments

None.

Item 5. Operating and Financial Review and
Prospects

You should read the following
discussion together with the consolidated financial statements and related notes included elsewhere in this Annual Report. The statements
in this discussion regarding industry outlook, our expectations regarding our future performance, planned investments in our expansion
into additional geographies, research and development, sales and marketing and general and administrative functions as well as other non-historical
statements in this discussion are forward-looking statements. These forward-looking statements are subject to numerous risks and uncertainties,
including, but not limited to, the risks and uncertainties described in Item 3. D entitled “ Risk Factors” and “ Cautionary
Statement Regarding Forward-Looking Statements” included elsewhere in this Annual Report. Our actual results may differ materially
from those contained in or implied by any forward-looking statements.

Overview

We are a clinical-stage oncology
therapeutics company focused on harnessing the innate relative biological effectiveness and short range of alpha particles for use as
a localized radiation therapy for solid tumors. Our proprietary Alpha DaRT®technology is designed to utilize the specific
therapeutic properties of alpha particles while aiming to overcome, and even harness for potential benefit, the traditional shortcomings
of alpha radiation’s limited range. We believe that our Alpha DaRT technology has the potential to be broadly applicable across
multiple targets and tumor types. We are currently focused on developing the Alpha DaRT for use in a number of potential applications,
particularly in refractory or unresectable localized tumors which are not being adequately addressed by standard of care, tumor types
with a high unmet need (such as pancreatic adenocarcinoma or glioblastoma multiforme), and metastatic tumors in combination with systemic
therapies such as checkpoint inhibitors.

In our initial proof of concept
of the safety and efficacy of the Alpha DaRT technology, we have evaluated, and continue to evaluate, the feasibility, safety and efficacy
of the Alpha DaRT technology for the treatment of superficial lesions, i. e., tumors of the skin, head or neck, in multiple clinical trials
conducted in clinical sites around the world. In a first-in-human study of locally advanced and recurrent squamous cell carcinoma, or
SCC, cancers of the skin and head and neck, efficacy was evaluated in 28 tumors, and results showed that Alpha DaRT achieved 100% objective
response rate and over 78% complete response rate. The Alpha DaRT was