Alpha Tau Medical Ltd. (DRTS) SEC Filings & Earnings Calls

MOU is non-binding and subject to regulatory and ethics committee approvals; no guarantee of a definitive agreement or trial initiation.

“Any such trial would be subject to regulatory and ethics committee approvals.” · word for word

Alpha Tau has limited operating history and has incurred significant losses; needs additional funding.

“Alpha Tau’s limited operating history; Alpha Tau’s incurrence of significant losses to date; Alpha Tau’s need for additional funding and ability to raise capital when needed.”

Clinical trial risk remains; glioblastoma is a challenging indication with limited treatment options.

“Glioblastoma is the most common malignant primary brain tumor in the U.S. with extremely limited treatment options.”

Clinical trial risk: data release not expected until early 2027; pivotal study design pending.

“With data release targeted for early 2027, IMPACT is intended to inform the design of a planned pivotal study.” · word for word

No material financial or operational risk disclosed; dual listing is a strategic move with limited immediate impact.

“No risk factors or financial metrics mentioned in the filing.”

Clinical trial risk; no efficacy data yet.

“First patient treated; no results reported.”

Small sample size (3 patients); early stage trial.

“interim results from the first three patients”

Dependence on Tolmar's commercialization efforts and potential termination rights.

“Tolmar has the right to terminate the Tolmar Agreements without cause at any time.” · word for word

Clinical data from pooled analysis, not a pivotal trial; further validation needed.

“Pooled analysis of three Phase I/II studies; IMPACT trial recruitment ongoing.”

Clinical and regulatory risk: REGAIN trial is small (up to 10 patients); ReSTART is pivotal but FDA approval not guaranteed; pancreatic data is early-stage.

“REGAIN study is expected to enroll up to ten U.S. patients... ReSTART is the Company’s first U.S. pivotal study to complete enrollment - a critical milestone on the path toward potential FDA pre-market approval (PMA)” · word for word

Small sample size (n=3) limits statistical significance; one grade 3 SAE observed.

“Only three patients treated; one grade 3 SAE (seizure with temporary paralysis) resolved with steroids.”

Clinical trial risk; interim data may not predict final outcomes.

“interim clinical data from REGAIN trial”

Trial results pending; regulatory approval not guaranteed.

“Pivotal trial data not yet available; FDA PMA process ongoing.”

Clinical trial risk remains; early-stage feasibility study with small sample size

“Study is feasibility and safety; no efficacy data reported yet.”

No efficacy or safety data disclosed; clinical readout risk remains.

“abstract accepted for podium presentation; no results provided in filing.”

Clinical data from small, early-stage trials; regulatory and commercial risk remains.

“pooled analysis of two first-in-human trials; 26 subjects treated.” · word for word

Clinical data not yet published; abstract only accepted; full results pending.

“Abstract to be published May 21, 2026; no efficacy/safety data disclosed.”

Clinical data still early; full results not yet disclosed; regulatory approval uncertain.

“Forward-looking statements highlight risks including regulatory approval, clinical trial enrollment, and need for additional funding.”

No revenue and history of losses

“We have incurred significant losses since inception and have not generated any revenue to date. We expect to incur losses over the next several years and may not be able to achieve or sustain revenues or profitability in the future.” · word for word

Novel technology development risk

“Our approach to the development of our proprietary Alpha DaRT technology represents a novel approach to radiation therapy, which creates significant and potentially unpredictable challenges for us.” · word for word

Regulatory approval uncertainty

“We may not receive, or may be delayed in receiving, the necessary marketing authorizations or certifications for our Alpha DaRT technology or any future products or product candidates, and failure to timely obtain necessary marketing authorizations or certifications for our product candidates would have a material adverse effect on our business.” · word for word

Dependence on sole suppliers for key components

“We rely on several sole suppliers for certain components of our Alpha DaRT technology.” · word for word

Dependence on radioisotope supply

“We may be unable to obtain a sufficient or sufficiently pure supply of radioisotopes to support clinical development or at commercial scale.” · word for word

Clinical trial risks remain; patient recruitment and regulatory approvals are ongoing.

“Multiple meaningful milestones targeted in the coming months, including completion of patient recruitment in the U.S. pivotal ReSTART skin cancer trial.” · word for word

Dependence on successful clinical outcomes and regulatory approvals for commercialization.

“The Company submitted the first module of its pre-market approval (PMA) application to the U.S. Food and Drug Administration (FDA).”

Post-market surveillance study required; reimbursement not yet established; approval limited to one indication initially.

“As part of the approval, Alpha Tau will need to conduct a post-market surveillance (PMS) study enrolling 66 patients” · word for word

Clinical trial risks; regulatory uncertainty

“No assurance of positive regulatory decision; clinical trial outcomes uncertain”

Early-stage study; regulatory approval and commercial success uncertain

“First-in-human study; further trials needed for approval”

Regulatory approval risk remains; PMA process is lengthy and uncertain; ReSTART study results not yet available.

“Forward-looking statements highlight risks including ability to receive regulatory approval, need for additional funding, and clinical trial outcomes.”

Clinical trial risk; early-stage data; small sample size (up to 10 patients); no efficacy data yet.

“Pilot study with up to 10 patients; primary objective is feasibility and safety; no efficacy results reported.”

Early-stage clinical trial; no efficacy data; patient recruitment risk.

“Pilot study with up to 30 patients; recruitment expected to complete by end of Q1 2026.”

Clinical trial risks: small sample size (12 patients), early stage, potential failure to show efficacy or safety.

“The clinical trial is expected to enroll up to 12 U.S. patients... primary objective is to evaluate safety.” · word for word

Pre-revenue clinical-stage company; net loss and cash burn

“Net loss of $30.5 million for nine months; cash $75.9M”