$DRTS Total Catalyst Map

On May 8, 2026, Alpha Tau announced completion of enrollment of 88 patients in the ReSTART trial in recurrent cutaneous squamous cell carcinoma, or cSCC. It is the company’s first U.S. pivotal trial to reach this milestone.

The program concerns patients with limited treatment options. Confirmed objective response and its duration at six months are among the central elements of the assessment: persistence of benefit will therefore be as important as the initial response rate. ReSTART announcement

The next catalyst is the release of topline results, which the company expects in late 2026 or early 2027. This is an indicative window communicated in the August 10 update. Corporate update

A convincing result could increase confidence in the U.S. regulatory path and provide a firmer basis for commercial preparation. Responses with limited durability, safety problems, or difficult-to-interpret data would instead carry considerable weight.

For DRTS, ReSTART matters because it connects a relatively advanced part of clinical development with a possible commercial authorization. Success in earlier small studies remains a starting point; the results from the 88 patients still need to be assessed.

On January 5, 2026, Alpha Tau announced submission of the first module of its PMA application, covering nonclinical studies, for the treatment of recurrent cSCC. First PMA module

The modular format allows parts of the documentation to be submitted and reviewed progressively. The complete application also includes clinical evidence, manufacturing, and other elements required by the FDA. FDA: PMA application methods

The next events to watch are progress on the remaining modules, completion of the dossier, and requests from the regulator. As of October 21, 2026, no date for an FDA decision had been made public.

The company’s August roadmap adds a conditional planning scenario: slide 4 places the data readout and potential submission in late 2026 or early 2027, followed by potential FDA approval in the first half of 2027. This is a company scenario dependent on clinical results, submission, review, and the regulator’s decisions. It is not an FDA deadline or a guaranteed approval date. August investor presentation, slide 4

A routine administrative update would have an intermediate level of significance. An important confirmation concerning the regulatory pathway, a request for additional studies, or a final decision could have a much greater effect, because it would change the timing, costs, and probability of market access.

The results announced on May 11, 2026, with data updated through May 3, concerned three patients with recurrent glioblastoma: two complete responses and one case of stable disease, the latter accompanied by a reduction in tumor size.

Local disease control was therefore 100%, while complete responses occurred in two of the three patients. One associated grade 3 serious adverse event was also reported and subsequently resolved. Initial REGAIN results

In June, the company announced FDA clearance to enroll the remaining seven planned patients and add two U.S. centers. Subsequent guidance indicated completion of recruitment in the second half of 2026 and additional data around year-end. Trial progress, August 10 guidance

On October 19, 2026, the company announced that the FDA had approved an IDE supplement expanding REGAIN from up to 10 to up to 20 patients at the three authorized U.S. academic cancer centers. The updated protocol opens the study to patients with IDH-mutant grade 4 tumors, adds progression-free survival as a secondary endpoint, introduces regular quality-of-life assessments, and provides for an additional interim analysis six months after the fifth patient’s treatment, which took place in July 2026. Based on initial discussions, the company believes the expanded trial could generate data that may support market submission requirements in this disease: a company assessment, not an FDA commitment. October 19 announcement (SEC)

With up to 20 patients now allowed, completion of the original ten-patient enrollment is no longer the milestone to watch. The next scheduled step is the Society for Neuro-Oncology (SNO) 2026 Annual Meeting in Philadelphia: a safety interim analysis, in an abstract authored by the study’s principal investigator at Ohio State University, will be presented on November 13, 2026, from 7:30 to 9:30 p.m. ET, with new trial data building on the interim results of the first three patients. It will be the trial’s first appearance at a scientific meeting. October 19 announcement (SEC)

The decisive question is how reproducible the initial result proves to be: responses in subsequent patients, duration, progression, and neurological safety.

A consistent signal could support further development and increase interest in the technology in deep-seated organs. Early progression or significant toxicity could rapidly temper expectations. The expansion of the protocol carries medium weight on its own; a convincing expansion of the evidence, starting with the SNO data, would have high impact.

On July 21, 2026, results were announced from the Israeli study in locally advanced or metastatic head and neck cancer: 11 patients enrolled, nine evaluable for response, four complete responses, and five partial responses. Median overall survival of 18.2 months and progression-free survival of 5.4 months were reported.

Two patients had died before response assessment; one before receiving Alpha DaRT. The study was small and had no control group. The comparison with previous pembrolizumab studies is therefore historical and does not isolate the device’s contribution. July 21 results

Possible next steps include a larger protocol, authorization to conduct a trial in the U.S., and the start of recruitment. Scientific presentations also indicate interest in a randomized trial and use before surgery, without an announced timetable. AHNS presentation

Controlled confirmation could strengthen the case for Alpha DaRT as a component of combination treatments. Authorization of a trial alone would carry less weight: it opens the possibility of obtaining a more reliable clinical answer.

Use of Keytruda in a study does not, by itself, constitute a commercial agreement with Merck.

The pancreatic program builds on earlier experience in Israel and Canada. In the Israeli data presented at DDW, for example, the 19 evaluable patients included four partial responses and fifteen cases of stable disease: the 100% local disease control rate therefore consisted mainly of disease stabilization. DDW data

IMPACT addresses a further step: adding Alpha DaRT to first-line chemotherapy in newly diagnosed patients with inoperable, locally advanced or metastatic pancreatic cancer.

On August 31, the company announced completion of enrollment with 48 patients across ten centers, following three expansions of the program. Regimens include mFOLFIRINOX or gemcitabine with nab-paclitaxel. Safety is the primary objective; other data include survival, progression, pain, and, in the locally advanced cohort, the possibility of resection.

The updated window for initial data is early 2027. The results are intended to help inform the design of a future pivotal trial. IMPACT update

The potential impact is high because a feasible and clinically promising combination could expand the technology’s role in pancreatic cancer. Interpretation will require results separated by disease stage, adequate follow-up over time, and clarity about the treatments received.

Expansion of a trial demonstrates interest and execution; efficacy must emerge from the results. Safety problems with chemotherapy or inconsistent benefits could weigh on the assessment of the entire program.

The first European treatment in the ACAPELLA program was announced on April 23, 2026. The trial plans to enroll up to 40 patients with inoperable, locally advanced pancreatic cancer, following a response or stable disease achieved with mFOLFIRINOX. The treatment sequence includes Alpha DaRT followed by capecitabine. ACAPELLA announcement

The program explores a different treatment position from IMPACT: intervening after initial systemic treatment to improve control of residual disease.

Catalysts will include progress in enrollment and data on safety, duration of disease control, and the possibility of surgery. The company has not announced a date for publication of results.

A consistent signal could broaden the platform’s potential uses. Interpretation will need to account for the fact that these patients have already been selected for responding or maintaining stable disease during chemotherapy.

The first treatment in the Italian CTP-PANC-03 study was announced on May 7, 2026. Up to 15 patients are planned, with an interim safety analysis after the first five.

The protocol permits both endoscopic ultrasound-guided and percutaneous access, through the skin. This option could broaden the ways in which the tumor can be reached and the specialists involved. The fact that the protocol allows both routes does not mean that the first patient was treated percutaneously. University of Verona study

The next useful event will be an update demonstrating procedural safety and reproducibility. The company has not announced a window for the result.

The potential value primarily concerns the technology’s practicality: an effective treatment must also be deliverable reliably. A simple recruitment update would have low impact; data that materially broaden access to treatment would be more significant.

On July 15, Alpha Tau announced the first patient treated in the ADMIRE study at Banner MD Anderson Cancer Center. The program plans to enroll up to 28 patients across eight centers and concerns recurrent cSCC in immunocompromised individuals. ADMIRE announcement

In this population, some systemic therapies can face important limitations. A local treatment with a favorable benefit-risk profile could therefore address a specific clinical need.

The next catalysts will be recruitment, initial responses, and their duration. The company has not announced a date for publication of results.

A positive outcome could strengthen Alpha DaRT’s positioning in a distinct segment. The risk is that patient frailty, disease characteristics, or complications make the results less favorable than expected. ADMIRE’s evidence will need to be assessed independently of ReSTART.

FDA authorization to begin the U.S. pilot study in locally recurrent prostate cancer was announced in December 2025. Trial authorization

In the August 10 update, the company indicated that the first U.S. patient would be treated in the second half of 2026. As of October 21, 2026, the company had not announced treatment of the first U.S. patient. Company guidance

The first treatment would demonstrate the program’s operational start. Subsequent results will need to clarify local control, safety, and functional impact.

The commercial potential makes the indication interesting, but the initial population is specific: local recurrence. Assigning value to the entire prostate cancer market would require further evidence and an appropriate regulatory pathway.

The agreement announced in June brought in $20 million in equity capital and $15 million for manufacturing capacity. It also provides for up to $96.5 million in clinical and regulatory milestones, plus $65 million in commercial milestones, for the first indication.

Alpha Tau retains development and manufacturing responsibilities; Tolmar handles U.S. commercialization. The supply price is linked to 60% of onward net sales, subject to adjustments: that percentage does not represent Alpha Tau’s profit margin.

There is also a bladder cancer option, with additional investment and conditional payments. Agreement terms

The next catalysts will be the achievement of milestones that trigger payments, manufacturing execution, and possible exercise of the option.

For the stock, actual amounts, conditions, and the underlying clinical development will matter. The contract’s theoretical maximum does not equal available cash. A major agreement can reduce funding needs and improve commercial access; clinical delays can defer both.

On February 24, 2026, Alpha Tau announced Shonin marketing approval granted by the MHLW following PMDA review for unresectable, locally advanced or locally recurrent head and neck cancer. The indication is specific and does not automatically extend to other cancers. Approval announcement

An additional element emerges from ministry documents: an April 30 notice includes Alpha DaRT System in insurance category A2, effective May 1, 2026. This category concerns devices assessed within certain medical fee schedules. The document does not set a separate per-patient price, nor does it show revenue already earned. MHLW: insurance coverage, page 2

The post-marketing surveillance program plans to include 66 patients. The regulatory documentation describes hospitalization for the first 33 while the sources remain implanted, with the possibility of revisiting that requirement following a safety assessment. Ministry documentation

The catalysts to follow are therefore centers actually operating, patients treated, surveillance progress, economic terms, and revenue.

Credible commercial data could begin to make the platform’s value measurable. Slow adoption, high procedural costs, or safety constraints could reduce expectations. The company has not given a firm date for an acceleration in commercial activity.

The August corporate presentation includes GBM and brain metastases among the development areas. This documents strategic interest, but does not, by itself, demonstrate that a dedicated U.S. study has already been authorized or started. Corporate presentation, page 26

Steps to watch include a specific protocol, a possible IDE request and clearance, site openings, and the first treatment. The company has not announced dates for this sequence.

The potential lies in extending use of the technology to other intracranial diseases. However, metastases originating from different cancers have different biological characteristics: results in glioblastoma cannot automatically be transferred to them.

Formalization of the program would reduce uncertainty about the project. Its clinical value would depend on the data it produces.

Exploratory areas deserve a place in the map, with attention to their different levels of maturity.

Liver metastases. In May 2024, the first patient treated in the feasibility and safety program at McGill University Health Centre was announced, with a target of up to ten patients. The next useful development would be an interpretable clinical series covering safety, treatment distribution, and effects on tumor tissue. The company has not announced a publication date. First patient in the liver program

Lung and other international programs. The pipeline includes lung development in Israel and further possibilities in the United Kingdom and Japan. For developments that remain poorly defined, the observable catalyst is publication of a protocol, a documented start, or a dataset, before assigning them a deadline. Clinical pipeline, Corporate overview

ALL Protocol. The first glioblastoma treatment outside the U.S., announced in June at Hadassah, belongs to this broader pathway. Cases can help explore new applications, but remain distinct from the cohorts in dedicated studies. Description of the ALL program

The potential value comes from turning early observations into reproducible programs. Performance of a procedure, by itself, does not demonstrate antitumor benefit.

The Hudson facility in New Hampshire received its radioactive materials license in October 2025. License announcement

In the annual report published in March 2026, the company still described equipping and validation activities, with the objective of starting production during 2026. That forecast does not confirm that all activities have been completed. Annual report

The catalyst is a concrete update on operations, usable capacity, supply reliability, and costs. Manufacturing availability must keep pace with the increase in centers and patients.

Good execution could reduce the risk of bottlenecks. A significant delay or a supply problem could have high impact if it interfered with trials or commercial launches. Expansions linked to Tolmar should be followed according to their specific program.

Tolmar demonstrates that Alpha Tau can structure agreements by indication and territory. The annual report also describes preliminary arrangements with Medison for potential activities in Israel and Canada, which are not definitive agreements and do not mark the start of sales. Annual report: commercialization and agreements

A new partner could contribute capital, trial funding, distribution, or commercial expertise. Its significance for DRTS would primarily depend on upfront payments, costs assumed by the partner, rights granted, and economic terms.

A substantial contract could improve the ability to develop the program and reduce funding needs. An exploratory arrangement would have more limited value.

The company has not announced a timetable for a new major agreement. Potential interest from a company and a signed contract represent different stages.

As of June 30, 2026, Alpha Tau reported $104.8 million in cash and deposits, including a restricted component. The company estimated that its resources were sufficient for at least two years: a management assessment referring to that point in time and the associated plans.

The accounting loss for the half-year does not directly measure cash consumption, partly because of the effect of warrant revaluation. In addition, the at-the-market share sales program with Wainwright, for up to $100 million, represents a financing option; it does not prove that the entire amount has been raised. Half-year financial analysis

At June 30, there were approximately 13.6 million public warrants and 2.14 million private warrants, with an exercise price of $11.50. These are financial-statement figures, not a count updated in real time. Exercise methods, including cashless exercise, affect the relationship between new shares and cash raised. Financial notes

The next financial results will need to clarify clinical spending, manufacturing investment, share count, and the composition of cash receipts. Financing can support development while simultaneously diluting shareholders. Assessing its impact requires the size, price, terms, and use of proceeds.

The CEO’s September 9 letter confirms that Alpha Tau became a dual-listed company, adding Tel Aviv alongside Nasdaq. The Israeli listing is therefore a step that has already occurred. CEO letter

Subsequent developments to watch include greater liquidity, participation by local investors, and possible index inclusion.

As of October 21, 2026, the company had not announced the inclusion of DRTS in the TA-125 with a firm date.

Actual inclusion could generate demand from instruments tracking the index and improve trading activity. The reaction would also depend on how much the event had been anticipated and the actual size of the flows. This channel affects the market for the shares, without itself adding clinical evidence or sales.

The official calendar lists the following events from October 2026 onward:

• October 6, 2026: Barclays Biotech 1×1 Day, New York (one-on-one meetings), now listed among past events.
• October 15, 2026: Investment Generation Conference, Rishon Letzion, now listed among past events.
• December 1–3, 2026: Piper Sandler and Citi events.
• February 17, 2027: Citi 2027 Virtual Oncology Leadership Summit.
• March 8–10, 2027: Barclays 29th Annual Global Healthcare Conference, Miami Beach.

The dates are listed by the company and may be updated. The two October events were announced on October 5; the company’s next release, on October 19, concerned the REGAIN expansion. Official events calendar, October conferences announcement

These occasions can broaden visibility, clarify programs, and attract new participants. A participation announcement alone, however, normally carries limited significance.

If new data or substantive changes emerged during a presentation, the impact would reflect that information. An analyst’s reassessment can also influence trading, but remains an external evaluation rather than a company result.