Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 123

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 4
Chunk 123
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 combinations with immunotherapies. We have
engaged with a number of prestigious medical and educational institutions and, as of December 31, 2024, we have fourteen clinical
studies ongoing worldwide.

Squamous Cell Carcinoma of the Skin, Head and
Neck

SCCs are cancers which grow
out of squamous epithelial cells, commonly found on the skin or in the lining of bodily organs or respiratory and upper digestive tracts.
According to the Skin Cancer Foundation, approximately 1.8 million cases of SCC of the skin are diagnosed every year in the United States.
Over 50,000 cases of SCC of the head and neck are diagnosed every year in the United States, with SCC making up approximately 90% of head
and neck cancers. We estimate that approximately 23% of cutaneous SCC cases have at least one high-risk factor, approximately 3% will
result in local recurrence and approximately 2% will lead to nodal metastasis. We selected SCC of the skin, head and neck as an initial
target for the Alpha DaRT because of the relative simplicity of delineation and delivery to superficial solid tumors, as well as the ability
to easily assess the Alpha DaRT’s effects on the tumors and the surrounding tissue on an ongoing basis and to monitor for any potential
serious adverse events.

Rabin Medical Center, Israel, and
IRST, Italy (completed; 2017 - 2019)

We evaluated the feasibility,
safety and efficacy of the Alpha DaRT technology in a first-in-human study of locally advanced and recurrent squamous cell carcinoma cancers
of the skin and head and neck, the results of which were subsequently published in the International Journal for Radiation Oncology, Biology,
Physics and which elected a positive editorial reaction in the same journal. The trial was conducted in an elderly (median age = 80.5
years) and largely pre-treated patient population, with 42% of the treated lesions having already received radiation therapy. Efficacy
was evaluated in 28 tumors of the skin and head and neck, and results showed that Alpha DaRT achieved a >78% complete response rate.
The Alpha DaRT was generally well-tolerated, with limited local toxicity and no systemic toxicity.

Efficacy results

Change in tumor size was assessed
by physical examination when possible, or in most cases, by radiological imaging, including PET-CT or CT scans. Tumor response was assessed
during a 30-to-45 day